| Page Range | 50305-50489 | |
| FR Document |
| Page and Subject | |
|---|---|
| 82 FR 50307 - Temporary Certification for Certain Records Related to the Assassination of President John F. Kennedy | |
| 82 FR 50305 - Combatting the National Drug Demand and Opioid Crisis | |
| 82 FR 50417 - EnPowered; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 82 FR 50446 - Sunshine Act Meetings | |
| 82 FR 50372 - Information Collection; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery | |
| 82 FR 50445 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Material Hoists, Personnel Hoists, and Elevators Standard | |
| 82 FR 50481 - Agency Information Collection Activities; Renewal of an Approved Information Collection: Motor Carrier Records Change Form | |
| 82 FR 50443 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-IMS Global Learning Consortium, Inc. | |
| 82 FR 50444 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Cable Television Laboratories, Inc. | |
| 82 FR 50358 - Hours of Service of Drivers: Application for Exemption; National Pork Producers Council (NPPC) | |
| 82 FR 50444 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-3D PDF Consortium, Inc. | |
| 82 FR 50443 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-OpenDaylight Project, Inc. | |
| 82 FR 50444 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-National Fire Protection Association | |
| 82 FR 50418 - Fast-41 Best Practices: Delegated State Permitting Programs | |
| 82 FR 50418 - Adequacy Status of the Kenosha County, Wisconsin Area for Submitted 8-Hour Ozone Attainment Demonstration for Transportation Conformity Purposes | |
| 82 FR 50418 - Notice of Proposed Administrative Settlement Pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act | |
| 82 FR 50348 - Hazardous Waste Management System; Identification and Listing of Hazardous Waste | |
| 82 FR 50425 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 82 FR 50426 - Formations of, Acquisitions by, and Mergers of Savings and Loan Holding Companies | |
| 82 FR 50440 - Notice of Proposed Filing of Plats of Survey, South Dakota | |
| 82 FR 50441 - Notice of Filing of Plats of Survey, Colorado | |
| 82 FR 50477 - Request for Comments on Small Business Administration Draft FY 2018-2022 Strategic Plan | |
| 82 FR 50438 - Notice of HUD-Held Multifamily Loan Sale (MLS 2018-1) | |
| 82 FR 50373 - Notice of Public Meeting of the Ohio Advisory Committee To Discuss the Committee's Next Topic of Civil Rights Study: Educational Funding in Ohio | |
| 82 FR 50480 - Membership in the National Parks Overflights Advisory Group | |
| 82 FR 50460 - Fixed Income Market Structure Advisory Committee | |
| 82 FR 50428 - Request for Information on Effective, Large-Scale, Sustainable Approaches To Help People Quit Using Tobacco by Employing Evidence-Based Treatment Options | |
| 82 FR 50427 - Notice of Availability of the Final Environmental Assessment and Finding of No Significant Impact for HHS/CDC Chamblee Campus 2025 Master Plan, Chamblee, Georgia | |
| 82 FR 50322 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Fishery of the South Atlantic; 2017 Recreational Accountability Measure and Closure for Greater Amberjack | |
| 82 FR 50484 - Notice of OFAC Sanctions Actions | |
| 82 FR 50429 - Final Immediately Dangerous to Life or Health (IDLH) Value Profiles | |
| 82 FR 50312 - Tribal Transportation Program; Delay of Compliance Date | |
| 82 FR 50427 - Public Availability of General Services Administration Fiscal Year 2016 Service Contract Inventory | |
| 82 FR 50309 - Order Establishing a New De Minimis Threshold Phase-In Termination Date | |
| 82 FR 50431 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic | |
| 82 FR 50460 - Submission for OMB Review; Comment Request | |
| 82 FR 50477 - Proposed Collection; Comment Request | |
| 82 FR 50485 - Notice of OFAC Sanctions Actions; Sanctions Actions Pursuant to Executive Order 13581 | |
| 82 FR 50317 - Safety Zone; Monongahela River, Monongahela, PA | |
| 82 FR 50394 - Carbon and Alloy Steel Wire Rod From the United Kingdom: Preliminary Affirmative Determination of Sales at Less Than Fair Value, and Preliminary Affirmative Determination of Critical Circumstances | |
| 82 FR 50389 - Carbon and Alloy Steel Wire Rod From Spain: Preliminary Affirmative Determination of Sales at Less Than Fair Value and Preliminary Determination of Critical Circumstances, in Part | |
| 82 FR 50383 - Carbon and Alloy Steel Wire Rod From the Republic of South Africa: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Preliminary Affirmative Determination of Critical Circumstances, and Preliminary Determination of No Shipments | |
| 82 FR 50375 - Carbon and Alloy Steel Wire Rod From Ukraine: Preliminary Affirmative Determination of Sales at Less Than Fair Value | |
| 82 FR 50377 - Carbon and Alloy Steel Wire Rod From Turkey: Preliminary Affirmative Determination of Sales at Less Than Fair Value, and Preliminary Negative Determination of Critical Circumstances | |
| 82 FR 50386 - Carbon and Alloy Steel Wire Rod From the Republic of Korea: Preliminary Affirmative Determination of Sales at Less Than Fair Value, and Preliminary Negative Determination of Critical Circumstances | |
| 82 FR 50381 - Carbon and Alloy Steel Wire Rod From Italy: Preliminary Affirmative Determination of Sales at Less Than Fair Value | |
| 82 FR 50413 - Revised Non-Foreign Overseas per Diem Rates | |
| 82 FR 50388 - Polyethylene Terephthalate Resin From the Sultanate of Oman: Rescission of Antidumping Duty Administrative Review; 2015-2017 | |
| 82 FR 50396 - Brass Sheet and Strip From France, Germany, Italy, and Japan: Continuation of Antidumping Duty Orders | |
| 82 FR 50435 - Office of the Director, National Institutes of Health; Notice of Meeting | |
| 82 FR 50436 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting | |
| 82 FR 50437 - Center for Scientific Review; Notice of Closed Meetings | |
| 82 FR 50435 - Center for Scientific Review; Notice of Closed Meetings | |
| 82 FR 50324 - Energy Conservation Program: Test Procedure for Distribution Transformers | |
| 82 FR 50416 - Inland Waterways Users Board Meeting Notice | |
| 82 FR 50482 - Hours of Service of Drivers: Application for Exemption; Hub Group Trucking Inc. | |
| 82 FR 50483 - Notice of Submission of Proposed Information Collection to OMB Agency Request for Renewal of a Previously Approved Collection: On-Line Complaint Form for Service-Related Issues in Air Transportation | |
| 82 FR 50324 - Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease | |
| 82 FR 50423 - Open Commission Meeting, Tuesday, October 24, 2017 | |
| 82 FR 50421 - Information Collections Being Reviewed by the Federal Communications Commission | |
| 82 FR 50424 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority | |
| 82 FR 50420 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority | |
| 82 FR 50487 - Advisory Committee on Disability Compensation; Notice of Meeting | |
| 82 FR 50413 - Submission for OMB Review; Comment Request | |
| 82 FR 50321 - Business Data Services in an Internet Protocol Environment; Technology Transitions; Special Access for Price Cap Local Exchange Carriers; AT&T Corporation Petition for Rulemaking | |
| 82 FR 50478 - Reporting and Recordkeeping Requirements Under OMB Review | |
| 82 FR 50486 - Senior Executive Service; Legal Division Performance Review Board | |
| 82 FR 50315 - Safety Zone, Savannah River, Savannah, GA | |
| 82 FR 50346 - eInduction Option, Seamless Acceptance Program, and Full-Service Automation Option, Verification Standards | |
| 82 FR 50477 - Reporting and Recordkeeping Requirements Under OMB Review | |
| 82 FR 50433 - E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability | |
| 82 FR 50479 - Eighteenth Tactical Operations Committee (TOC) Meeting | |
| 82 FR 50479 - Thirteenth RTCA SC-229 406 MHz ELT Joint Plenary With EUROCAE WG-98 | |
| 82 FR 50446 - Agency Information Collection Activities: Proposed Collection; Comment Request; Consumer Assistance Center | |
| 82 FR 50315 - Drawbridge Operation Regulation; China Basin, San Francisco, CA | |
| 82 FR 50458 - Proposed Collection; Comment Request; 30-Day Notice for Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery | |
| 82 FR 50441 - Certain Access Control Systems and Components Thereof Notice of Request for Statement on the Public Interest | |
| 82 FR 50442 - Certain Composite Aerogel Insulation Materials and Methods for Manufacturing the Same; Notice of Request for Statements on the Public Interest | |
| 82 FR 50374 - Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment Assistance | |
| 82 FR 50379 - Biodiesel From Indonesia: Preliminary Affirmative Determination of Sales at Less Than Fair Value | |
| 82 FR 50391 - Biodiesel From Argentina: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Preliminary Affirmative Determination of Critical Circumstances, in Part | |
| 82 FR 50411 - Western Pacific Fishery Management Council; Public Meetings | |
| 82 FR 50459 - Product Change-Priority Mail Express, Priority Mail, and First-Class Package Service Negotiated Service Agreement | |
| 82 FR 50459 - Product Change-Priority Mail Express Negotiated Service Agreement | |
| 82 FR 50459 - Product Change-Priority Mail Negotiated Service Agreement | |
| 82 FR 50459 - Product Change-Priority Mail and First-Class Package Service Negotiated Service Agreement | |
| 82 FR 50412 - New England Fishery Management Council; Public Meeting | |
| 82 FR 50397 - New England Fishery Management Council; Public Meeting | |
| 82 FR 50412 - Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting | |
| 82 FR 50488 - Agency Information Collection Activity: Survey of Healthcare Experiences of Patients (SHEP) | |
| 82 FR 50487 - Agency Information Collection Activity: Veterans' Health Benefits Handbook Questionnaire | |
| 82 FR 50489 - Agency Information Collection Activity: Application for Cash Surrender or Policy Loan | |
| 82 FR 50468 - Self-Regulatory Organizations; NASDAQ BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to the Exchange's Name Change | |
| 82 FR 50472 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing of Amendments No. 2 and No. 3, and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendments No. 2 and No. 3, To List and Trade Shares of the Aptus Fortified Value ETF, a Series of ETF Series Solutions, Under Rule 14.11(c) | |
| 82 FR 50461 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change To List and Trade Shares of the Hartford Schroders Tax-Aware Bond ETF Under NYSE Arca Rule 8.600-E | |
| 82 FR 50475 - Self-Regulatory Organizations; NYSE American LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend NYSE American Equities Rules 7.31E To Establish a Minimum Dollar Threshold Into the Price Protection Mechanisms | |
| 82 FR 50469 - Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rules for Excluding Days From the Exchange's ADV and Market Maker Plus Tier Calculations in the Schedule of Fees | |
| 82 FR 50360 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition to List the Western Glacier Stonefly as an Endangered or Threatened Species; Proposed Threatened Species Status for Meltwater Lednian Stonefly and Western Glacier Stonefly | |
| 82 FR 50438 - Waterway Suitability Assessment for Operation of Liquefied Hazardous Gas Terminal; Port Arthur, TX | |
| 82 FR 50319 - Supplemental Standards of Ethical Conduct | |
| 82 FR 50373 - Notice of Public Meeting of the New York Advisory Committee for Discussion and Approval of the Draft Report of Broken Windows Policing | |
| 82 FR 50444 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Collection: International Terrorism Victim Expense Reimbursement Program Application | |
| 82 FR 50478 - Additional Designation of North Korean Entities Pursuant to E.O. 13382 | |
| 82 FR 50371 - Submission for OMB Review; Comment Request | |
| 82 FR 50366 - Fisheries Off West Coast States; Highly Migratory Fisheries; California Drift Gillnet Fishery; Implementation of a Federal Limited Entry Drift Gillnet Permit | |
| 82 FR 50363 - Merchant Marine Act and Magnuson-Stevens Act Provisions; Fishing Vessel, Fishing Facility and Individual Fishing Quota and Harvesting Rights Lending Program Regulations | |
| 82 FR 50417 - Information Session; Implementation of the Water Infrastructure Finance and Innovation Act of 2014 | |
| 82 FR 50420 - Notice of a Public Meeting of the National Drinking Water Advisory Council | |
| 82 FR 50426 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 82 FR 50426 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 82 FR 50397 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the Biorka Island Dock Replacement Project | |
| 82 FR 50435 - National Advisory Committee on Rural Health and Human Services | |
| 82 FR 50429 - Packaging, Storage, and Disposal Options To Enhance Opioid Safety-Exploring the Path Forward; Public Workshop; Request for Comments | |
| 82 FR 50371 - Notice of Public Information Collection Requirements Submitted to OMB for Review | |
| 82 FR 50313 - Global Terrorism Sanctions Regulations | |
| 82 FR 50447 - Electronic Loan, Deposit, and Investment Data Collection |
Forest Service
Economic Development Administration
International Trade Administration
National Oceanic and Atmospheric Administration
Army Department
Engineers Corps
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
Fish and Wildlife Service
Indian Affairs Bureau
Land Management Bureau
Antitrust Division
Victims of Crime Office
National Endowment for the Arts
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Foreign Assets Control Office
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Commodity Futures Trading Commission.
Order.
The Commodity Futures Trading Commission (“Commission” or “CFTC”) is issuing an order (“Order”), pursuant to the Commission regulation establishing the
Issued by the Commission on October 26, 2017.
Matthew Kulkin, Director, 202-418-5213,
The Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”)
When § 1.3(ggg) was adopted, establishing the $3 billion
Staff issued for public comment the Swap Dealer
In October 2016, the Commission issued an order, pursuant to § 1.3(ggg)(4)(ii)(C)(
As contemplated by the October 2016 Order, significant strides are being made in updating, improving, and reassessing the available swap data regarding the swap marketplace in a more granular manner. Though this data analysis is ongoing, the Commission believes that it will in the near future have more detailed data analysis to inform its consideration of possible modifications to the
This timing creates some uncertainty for currently unregistered swap dealers that may be subject to registration if the $3 billion
Additionally, the Commission notes that a year's delay would provide additional time for the new Commissioners
Accordingly, the Commission believes that it is prudent to extend the phase-in period by one year. This extension will provide additional time for Commission staff to conduct data analysis regarding the
For the reasons discussed above, and pursuant to its authority under § 1.3(ggg)(4)(ii)(C)(
The Paperwork Reduction Act (“PRA”)
Section 15(a) of the Commodity Exchange Act (“CEA”) requires the Commission to consider the costs and benefits of its actions before promulgating a regulation under the CEA or issuing certain orders.
As discussed above, § 1.3(ggg)(4)(i) provides an exception from the swap dealer definition for persons who engage in a
The $3 billion threshold, which, absent this Order, would be effective on December 31, 2018, sets the baseline for the Commission's consideration of the costs and benefits of this Order.
There are several policy objectives underlying swap dealer regulation and the
The Commission also considers policy objectives furthered by a
Extending the phase-in period by one year will delay realization of the policy benefits associated with the $3 billion
Section 15(a) of the CEA requires the Commission to consider the effects of its actions in light of the following five factors. This Order will delay the potential costs and benefits discussed below by one year.
Providing regulatory protections for swap counterparties who may be less experienced or knowledgeable about the swap products offered by swap dealers (particularly end-users who use swaps for hedging or investment purposes) is a fundamental policy goal advanced by the regulation of swap dealers. The Commission recognizes that the $3 billion
Other goals of swap dealer regulation are swap market transparency, orderliness, and efficiency. These benefits are achieved through regulations requiring, for example, swap dealers to keep trading records and report trades, provide counterparty disclosures about swap risks and pricing, and undertake portfolio reconciliation and compression exercises. Accordingly, the Commission notes that a lower
However, the Commission also recognizes that the efficiency and competitiveness of the swap market may be negatively impacted if the
The Commission preliminarily believes that a $3 billion
The Commission notes that a $3 billion
The Commission has not identified any other public purpose considerations for this Order.
Section 15(b) of the CEA requires the Commission to take into consideration the public interest to be protected by the antitrust laws and endeavor to take the least anticompetitive means of achieving the objectives of the CEA, in issuing any order or adopting any Commission rule or regulation. The Commission does not anticipate that the Order discussed herein will result in anti-competitive behavior.
In light of the foregoing,
The Commission retains the authority to condition further, modify, suspend, terminate, or otherwise restrict any of the terms of the Order provided herein, in its discretion.
On this matter, Chairman Giancarlo and Commissioner Quintenz voted in the affirmative. Commissioner Behnam voted in the negative.
Bureau of Indian Affairs, Interior.
Interim final rule.
This interim final rule updates the Tribal Transportation Program regulations published in 2016 to delay the deadline for Tribes to comply with requirements to collect data on proposed roads for the National Tribal Transportation Facility Inventory (NTTFI).
This rule is effective October 31, 2017. Submit comments by November 30, 2017. Compliance with § 170.443 for proposed roads currently in the NTTFI to remain in the inventory is required by November 7, 2019.
You may submit comments by either: (1) Federal rulemaking portal
Mr. LeRoy Gishi, Division of Transportation, Office of Indian Services, Bureau of Indian Affairs, (202) 513-7711,
Regulations governing the Tribal Transportation Program published last year.
Executive Order (E.O.) 12866 provides that the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget (OMB) will review all significant rules. OIRA has determined that this rule is not significant.
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. We have developed this rule in a manner consistent with these requirements.
This rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:
(a) Does not have an annual effect on the economy of $100 million or more because this rule affects only surface transportation for Tribes.
(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions because it does not affect costs or prices.
(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises because the rule addresses Tribal surface transportation within the United States.
This rule does not impose an unfunded mandate on State, local, or Tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531
This rule does not affect a taking of private property or otherwise have taking implications under E.O. 12360. A takings implication assessment is not required.
Under the criteria in section 1 of E.O. 13132, this rule does not have sufficient Federalism implications to warrant the preparation of a summary impact statement, because the rule primarily addresses the relationship between the Federal Government and Tribes. A Federalism summary impact statement is not required.
This rule complies with the requirements of E.O. 12988. Specifically, this rule:
(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and written to minimize litigation; and
(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.
The Department of the Interior strives to strengthen its government-to-government regulations with Indian Tribes through a commitment to consultation with Indian Tribes and recognition of their right to self-governance and Tribal sovereignty. We
This rule contains information collection requirements, and the Office of Management and Budget (OMB) has approved the information collections under the Paperwork Reduction Act (PRA) under OMB Control Number 1076-0161, which expires December 31, 2019. Please note that an agency may not sponsor or request, and an individual need not respond to, a collection of information unless it displays a valid OMB Control Number.
This rulemaking does not constitute a major Federal action significantly affecting the quality of the human environment because it is of an administrative, technical, and procedural nature. It is therefore subject to categorical exclusion, see 43 CFR 46.210(i), and no extraordinary circumstances exist, see 43 CFR 46.215.
This rulemaking is not a significant energy action under the definition in E.O. 13211. A Statement of Energy Effects is not required.
We are required by Executive Orders 12866 (section 1(b)(12)), and 12988 (section 3(b)(1)(B)), and 13563 (section 1(a)), and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
(a) Be logically organized;
(b) Use the active voice to address readers directly;
(c) Use common, everyday words and clear language rather than jargon;
(d) Be divided into short sections and sentences; and
(e) Use lists and tables wherever possible.
If you feel that we have not met these requirements, send us comments by one of the methods listed in the
This rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.
Highways and roads, Indians—lands.
For the reasons stated in the preamble, the Department of the Interior, Bureau of Indian Affairs, amends part 170 in Title 25 of the Code of Federal Regulations as follows:
Pub. L. 112-141, Pub. L. 114-94; 5 U.S.C. 2; 23 U.S.C. 201, 202; 25 U.S.C. 2, 9.
(b) For those proposed roads that currently exist in the NTTFI, the requirements identified above as paragraphs (a)(1) through (a)(8) of this section, must be completed and submitted for approval to BIA and FHWA by November 7, 2019, in order to remain on the inventory.
Office of Foreign Assets Control, Treasury.
Final rule.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is amending the Global Terrorism Sanctions Regulations pursuant to a provision of the Countering America's Adversaries Through Sanctions Act of 2017. This provision requires the imposition of certain terrorism-related sanctions with respect to foreign persons that are officials, agents, or affiliates of Iran's Islamic Revolutionary Guard Corps.
The Department of the Treasury's Office of Foreign Assets Control: Assistant Director for Licensing, tel.: 202-622-2480, Assistant Director for Regulatory Affairs, tel.: 202-622-4855, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; or the Department of the Treasury's Office of the Chief Counsel (Foreign Assets Control), Office of the General Counsel, tel.: 202-622-2410.
This document and additional information concerning OFAC are available from OFAC's Web site (
On June 6, 2003, OFAC issued the Global Terrorism Sanctions Regulations, 31 CFR part 594 (the “Regulations”) (68 FR 34196, June 6, 2003), to implement Executive Order 13224 of September 23, 2001 (66 FR 49079, September 25, 2001) (E.O. 13224). OFAC has amended the Regulations on several occasions. Today, OFAC is amending the Regulations pursuant to section 105 of the Countering America's Adversaries Through Sanctions Act of 2017, Public Law 115-44, Aug. 2, 2017, 131 Stat. 886 (22 U.S.C. 9401
Pursuant to Presidential Memorandum of October 11, 2017: Delegation of Certain Functions and Authorities under the Countering America's Adversaries Through Sanctions Act of 2017, the President delegated to the Secretary of State and the Secretary of the Treasury the functions and authorities vested in the President by section 105(b) of CAATSA
The names of persons whose property and interests in property are blocked pursuant to § 594.201(a) are published in the
Because the Regulations involve a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date, as well as the provisions of Executive Order 13771, are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.
The collections of information related to the Regulations are contained in 31 CFR part 501 (the “Reporting, Procedures and Penalties Regulations”). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.
Administrative practice and procedure, Banks, Banking, Blocking of assets, Credit, Penalties, Reporting and recordkeeping requirements, Terrorism.
For the reasons set forth in the preamble, the Department of the Treasury's Office of Foreign Assets Control amends part 31 CFR part 594 to read as follows:
3 U.S.C. 301; 22 U.S.C. 287c; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890 (28 U.S.C. 2461 note); Pub. L. 110-96, 121 Stat. 1011; Pub. L. 115-44, 131 Stat. 886 (22 U.S.C. 9401
(a) * * *
(5) Foreign persons that are identified on the Specially Designated Nationals and Blocked Persons List (SDN List) maintained by the Office of Foreign Assets Control as officials, agents, or affiliates of Iran's Islamic Revolutionary Guard Corps (IRGC).
The names of persons whose property and interests in property are blocked pursuant to § 594.201(a) are published in the
Any action that the Secretary of the Treasury is authorized to take pursuant to Executive Order 13224 of September 23, 2001, and any further Executive orders relating to the national emergency declared therein, and any action that the Secretary of the Treasury is authorized to take pursuant to Presidential Memorandum of October 11, 2017: Delegation of Certain Functions and Authorities under the Countering America's Adversaries Through Sanctions Act of 2017 or any further Presidential action relating to Title I of the Countering America's Adversaries Through Sanctions Act of 2017 (Pub. L. 115-44), may be taken by the Director of the Office of Foreign Assets Control or by any other person to whom the Secretary of the Treasury has delegated authority so to act.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the 3rd Street Drawbridge across China Basin, mile 0.0 at San Francisco, CA. The deviation is necessary to allow participants to cross the bridge during the Leukemia Lymphoma Society Light the Night Walk. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.
This deviation is effective from 6 p.m. to 9 p.m. on November 16, 2017.
The docket for this deviation, USCG-2017-1012, is available at
If you have questions on this temporary deviation, call or email Carl T. Hausner, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516; email
The City of San Francisco has requested a temporary change to the operation of the 3rd Street Drawbridge over China Basin, mile 0.0, at San Francisco, CA. The drawbridge navigation span provides a vertical clearance of 3 feet above Mean High Water in the closed-to-navigation position. The draw opens on signal if at least one hour notice is given, as required by 33 CFR 117.149. Navigation on the waterway is recreational.
The drawspan will be secured in the closed-to-navigation position from 6 p.m. to 9 p.m. on November 16, 2017, to allow participants to cross the bridge during the Leukemia Lymphoma Society Light the Night Walk. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.
Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators 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 on the Savannah River in Savannah, GA from statute mile 13 to statute mile 15. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by a boat parade. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Savannah or a designated representative.
This rule is effective from 4 p.m. to 11 p.m. on November 25, 2017.
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 MST2 Adam White, Marine Safety Unit Savannah Office of Waterways Management, Coast Guard; telephone 912-652-4353, extension 233, or 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 the public interest. Immediate action is needed to respond to the potential safety hazards associated with a boat parade. The Coast Guard received information on October 5, 2017 regarding the operations beginning on November 25, 2017. The operation would begin before the rulemaking process would be completed. Because of the dangers posed by the parade, the safety zone is necessary to provide for the safety of persons, vessels, and the marine environment in the event area. Therefore, it is impracticable and contrary to the public interest to delay promulgating this rule, as it is necessary to protect the safety of waterway users.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP Savannah has determined that potential hazards associated with the boat parade starting November 25, 2017, will be a safety concern for anyone on the Savannah River in Savannah, GA from statute mile 13 to statute mile 15. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the parade is underway.
This rule establishes a safety zone from 4 p.m. until 11 p.m. on November 25, 2017. The safety zone will cover all navigable waters on the Savannah River from statute mile 13 to statute mile 15. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the parade is underway. No vessel or person will be permitted to enter, transit through, anchor in, or remain within the safety zone without obtaining permission from the COTP or a designated representative.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. The safety zone affects only a small portion of the Savannah River for seven hours during the evening when vessel traffic is normally lower. Moreover, vessels and persons seeking to enter, transit through, anchor in, or remain within the regulated area may seek authority from the COTP or a designated representative. The Coast Guard will provide notification of the regulated area to the local maritime community by Local Notice to Mariners, Broadcast Notice to Mariners via VHF-FM marine channel 16, and Marine Safety Security Bulletin release.
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, call1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting only seven hours that will prohibit entry on the Savannah River in Savannah, GA from statute mile 13 to statute mile 15. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegations No. 0170.1.
(a)
(b)
(c)
(2) Persons or vessels desiring to enter, transit through, anchor in, or remain within the safety zone may contact COTP Savannah by telephone at (912) 652-4353, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted by the COTP Savannah or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the COTP Savannah or a designated representative.
(3) The Coast Guard will provide notice of the regulated areas by Local Notice to Mariners, Broadcast Notice to Mariners, Marine Safety Security Bulletins, and on-scene designated representatives.
(e)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for navigable waters of the Monongahela River from mile marker (MM) 31.5 to (MM) 32.5. The safety zone is necessary to provide for the safety of life on these navigable waters near Monongahela, PA from potential hazards created by a land based fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative.
This rule is effective from 8:30 p.m. through 10:30 p.m. on November 17, 2017.
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 MST1 Jennifer Haggins, Marine Safety Unit Pittsburgh, U.S. Coast Guard; telephone 412-221-0807, 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 it is impracticable.
The Coast Guard received a notice of the event on September 7, 2017. After receiving and fully reviewing the event information, circumstances and exact location, the Coast Guard determined that a safety zone was necessary to protect personnel, vessels, and the marine environment from potential hazards created from a land based fireworks display. It would be impracticable to complete the full NPRM process for this safety zone because we need to establish it by November 17, 2017 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Pittsburgh (COTP) has determined that a safety zone is needed on November 17, 2017. This rule
This rule establishes a safety zone from 8:30 p.m. through 10:30 p.m. on November 17, 2017. The safety zone will cover all navigable waters on the Monongahela River from MM 31.5 to MM 32.5. The duration of the safety zone is intended to protect personnel, vessels, and the marine environment from potential hazards created from a land based fireworks display. No vessel or person will be permitted to enter the safety zone 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 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, and duration of the safety zone. This safety zone impacts a small portion of the waterway and for a limited duration of two hours. Vessel traffic will be informed about the safety zone through local notices to mariners. Moreover, the Coast Guard will issue Broadcast Notices to Mariners via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to transit 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, call1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such 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 two hours that will prohibit entry on the Monongahela River from MM 31.5 to MM 32.5, during the land based fireworks event. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) Persons or vessels requiring entry into or passage through the zone must request permission from the COTP or a designated representative. The designated representative may be contacted at 412-221-0807.
(3) All persons and vessels shall comply with the instructions of the COTP or a designated representative. Designated representatives include United States Coast Guard commissioned, warrant, and petty officers.
(d)
Postal Regulatory Commission.
Final rule.
The Commission revises its existing ethics rules to replace those duplicative rules with rules that reflect the Commission's current regulatory role under the Postal Accountability and Enhancement Act.
David A. Trissell, General Counsel, at 202-789-6820.
On May 24, 2017, the Postal Regulatory Commission (Commission) issued a notice of proposed rulemaking to amend the Commission's ethics rules, 39 CFR subpart A of part 3000.
Executive branch employees are subject to multiple federal ethics laws, regulations issued by OGE, and executive orders. Because existing 39 CFR subpart A of part 3000 contains several rules that are duplicative of rules contained in 5 CFR part 2638 and 5 CFR part 5601, as amended, the Commission will revise existing 39 CFR subpart A of part 3000. The Commission will replace those duplicative rules with rules that reflect the Commission's current regulatory role under the Postal Accountability and Enhancement Act (PAEA), Public Law 109-435, 120 Stat. 3198 (2006). The revised rules will treat employees' and former employees' interactions with the Postal Service substantially the same as if those interactions were with entities that are not part of the federal government.
The ethics rules contained in 39 CFR subpart A of part 3000 were adopted in a 1971 rulemaking, in which the Civil Service Commission promulgated employee conduct regulations on the Commission's behalf. 36 FR 5412 (Mar. 23, 1971). In 1993, the Commission collaborated with OGE to revise the Commission's ethics rules in 39 CFR subpart A of part 3000. 58 FR 42873, 42874 (Aug. 12, 1993). The Commission amended the ethics rules in 2001 to eliminate a redundant provision. 66 FR 32544, 32545 (Jun. 15, 2001).
In 2006, the PAEA changed the agency's name from the Postal Rate Commission to the Postal Regulatory Commission and made several changes to the Commission's regulatory role. In 2007, the Commission amended its ethics rules to correct the statutory authority and the agency's name, both of which were changed by the PAEA. 72 FR 33164, 33165 (Jun. 15, 2007). In 2016, the Commission amended its ethics rules to redesignate the numbering to be consistent with the
Because the ethics rules in existing 39 CFR subpart A of part 3000 are redundant to rules contained in title 5 of the Code of Federal Regulations, the Commission undertook this rulemaking to streamline its regulations. Order No. 3907 at 4-5. Further, the PAEA's changes to the Commission's responsibilities drive the need to modernize the ethics rules to ensure that consistent rules will apply to employees' and former employees' interactions with entities outside the federal government and with the Postal Service.
The Commission received two sets of comments pertaining to the proposed revisions to the supplemental standards of ethical conduct and the Commission's ethics rules.
He observes that the proposed deletions are primarily editorial revisions made to delete duplicative and outdated sections.
Neither commenter suggested changes to the proposed rules. The Public Representative supports the proposed rules.
Specifically, the Commission deletes the four rules in existing 39 CFR subpart A of part 3000, which are redundant to provisions contained in title 5 of the Code of Federal Regulations, as displayed in the following table:
Further, as detailed in Order No. 3907, the Commission issues replacement rules that will improve transparency and the ability of Commission employees to adhere to the highest ethical standards. Specifically, these rules treat employees' and former employees' interactions with the Postal Service substantially the same as if those interactions were with entities that are not part of the federal government. As noted by the Public Representative, this will serve the public interest and reinforce public perception of the Commission's integrity with respect to the oversight of the Postal Service.
The Commission makes two editorial revisions. First, the Commission corrects the format of the cross-references to title 5 of the Code of Federal Regulations in proposed §§ 3000.10 and 3000.15.
Second, the Commission clarifies the text of proposed § 3000.10(a), relating to the obligation of Commission employees seeking employment with the Postal Service to provide written notice of disqualification to the DAEO. The Commission adds a cross-reference to reflect that this obligation supplements the requirement that Commission employees seeking non-federal employment provide written notice of disqualification to the DAEO. Also, the Commission adds a procedural sentence memorializing that the DAEO will inform the employee and the employee's supervisor in writing of each matter from which the employee is disqualified from participating. This clarifying revision will better ensure that the employee is disqualified from all applicable matters. For these reasons and those reasons detailed in Order No. 3907, the Commission adopts the proposed rules without substantial changes.
1. Subpart A of part 3000 of title 39, Code of Federal Regulations, is
2. The Secretary shall arrange for publication of this order in the
Conflict of interests.
By the Commission.
For the reasons discussed in the preamble, the Commission amends chapter III of title 39 of the Code of Federal Regulations as follows:
39 U.S.C. 503; 504, 3603; E.O. 12674; 54 FR 15159; 3 CFR,1989 Comp., p. 215, as modified by E.O. 12731, 56 FR 42547, 3 CFR, 1990 Comp., p. 396, 5 CFR parts 2634 and 2635.
All former employees of the Postal Regulatory Commission (Commission) are subject to the following restrictions on appearance and practice before the Commission on behalf of any participant, including the United States Postal Service (Postal Service):
(a) No former employee of the Commission may practice or act as an attorney, expert witness, or representative in connection with any proceeding or matter before the Commission that the former employee has handled, advised, or participated in the consideration of while in the service of the Commission.
(b) No former employee of the Commission may within 1 year after his or her employment has ceased, practice before or act as an attorney, expert witness, or representative in connection with any proceeding or matter before the Commission that was under the official responsibility of such individual, as defined in 18 U.S.C. 202(b), while in the service of the Commission.
(a) Notwithstanding 5 CFR 2635.603(a), an employee that seeks employment with the Postal Service must provide written notice of disqualification to the Designated Agency Ethics Official (DAEO) consistent with 5 CFR 5601.103(a). The DAEO will inform the employee and the employee's supervisor in writing of each matter from which the employee is disqualified from participating.
(b) An employee may withdraw written notice under paragraph (a) of this section consistent with 5 CFR 5601.103(b).
Regardless of 5 CFR 2635.203(b)(7), a Commission employee may not accept a gift from the Postal Service, unless another exception or exclusion to 5 CFR 2635.203 applies or a waiver is granted by the DAEO.
Federal Communications Commission.
Final rule; announcement of effective date.
In this document, the Commission announces that the Office of Management and Budget (OMB) has approved, for a period of three years, an information collection associated with the Commission's
The amendment to 47 CFR 61.45(b)(1)(iv), published at June 2, 2017, 82 FR 25660, is effective October 31, 2017.
William Kehoe, Pricing Policy Division, Wireline Competition Bureau, at (202) 418-7122, or email:
This document announces that, on October 13, 2017, OMB approved, for a period of three years, the information collection requirement relating to § 61.45(b)(1)(iv) of the Commission's rules, as contained in the Commission's
To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to
As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received final OMB approval on October 13, 2017, for the information collection requirements contained in the modifications to the Commission's rules in 47 CFR part 61. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.
No person shall be subject to any penalty for failing to comply with a
The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.
The total annual reporting burdens and costs for the respondents are as follows:
On April 20, 2017, the Commission adopted the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS implements an accountability measure (AM) for the recreational sector of greater amberjack in the South Atlantic exclusive economic zone (EEZ) through this temporary rule. NMFS estimates that recreational landings have reached the recreational annual catch limit (ACL) for greater amberjack in the South Atlantic. Therefore, NMFS closes the recreational sector for greater amberjack in the South Atlantic EEZ for the remainder of the current fishing year (see
This rule is effective from 12:01 a.m., local time, October 31, 2017, until 12:01 a.m. local time, on March 1, 2018.
Mary Vara, NMFS Southeast Regional Office, telephone: 727-824-5305, email:
The snapper-grouper fishery of the South Atlantic includes greater amberjack and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council (Council) and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.
The recreational ACL for South Atlantic greater amberjack is 1,167,837 lb (529,722 kg), round weight, as specified at 50 CFR 622.193(k)(2)(i). The fishing year for South Atlantic greater amberjack is from March 1 through the end of February (50 CFR 622.7(d)). Under the recreational AM at 50 CFR 622.193(k)(2)(i), when landings of the greater amberjack recreational sector reach, or are projected to reach, its ACL, NMFS is required to close the recreational sector for greater amberjack by filing a notification to that effect with the Office of the Federal Register unless NMFS determines that no closure is necessary based on the best scientific information available.
NMFS has determined that the recreational ACL has been reached in the current fishing year of March 1, 2017, through February 28, 2018, and that a closure is necessary. Therefore, this temporary rule implements an AM to close the greater amberjack recreational sector in the South Atlantic for the remainder of the current fishing year. As a result, the recreational sector for greater amberjack in the South Atlantic EEZ will close effective at 12:01 a.m., local time October 31, 2017.
On October 18, 2017, NMFS closed the commercial sector of greater amberjack in the South Atlantic because the sector had reached the commercial quota (equivalent to the commercial ACL) (82 FR 47640, October 13, 2017). Because the commercial sector for South Atlantic greater amberjack has already closed for the remainder of the current fishing year, all harvest of South Atlantic greater amberjack will end on October 31, 2017. Both the commercial and recreational sectors for South Atlantic greater amberjack will reopen on March 1, 2018, the start of the next fishing year.
During this closure, the bag and possession limits for greater amberjack in or from the South Atlantic EEZ are zero. The prohibition on harvest or possession of greater amberjack applies on board a vessel for which a valid Federal commercial or charter vessel/headboat permit for South Atlantic
The Regional Administrator for the NMFS Southeast Region has determined this temporary rule is necessary for the conservation and management of South Atlantic greater amberjack and is consistent with the Magnuson-Stevens Act and other applicable laws.
This action is taken under 50 CFR 622.193(k)(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 greater amberjack 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 implementing the AM itself has been 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 South Atlantic greater amberjack. 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
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Request for information; re-opening of public comment period.
On September 22, 2017, the U.S. Department of Energy (DOE) published a request for information (RFI) pertaining to the test procedures for distribution transformers. The RFI provided an opportunity for submitting written comments, data, and information by October 23, 2017. This document announces that the period for submitting comments on the RFI is to be re-opened until November 6, 2017.
The comment period for the RFI, published on September 22, 2017 (82 FR 44347), is re-opened until November 6, 2017. DOE will accept written comments, data, and information in response to the RFI received no later than November 6, 2017.
Interested persons are encouraged to submit comments by any of the following methods:
•
•
•
•
No telefacsimilies (faxes) will be accepted. For detailed instructions on submitting comments and additional information on the rulemaking process, see section III of the RFI published on September 22, 2017.
The docket Web page can be found at
Mr. Jeremy Dommu, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Program, EE-5B 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-9870. Email:
Mary Greene, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-1817. Email:
For further information on how to submit a comment, review other public comments and the docket, contact the Appliance and Equipment Standards Program staff at (202) 287-1445 or by email:
DOE published a RFI pertaining to the test procedure for distribution transformers on September 22, 2017. 82 FR 44347. The RFI initiated a data collection process to consider whether to amend DOE's test procedures for distribution transformers. DOE requested written comment, data, and information pertaining to these test procedures by October 23, 2017.
The National Electrical Manufacturers Association (NEMA), an interested party in the matter, requested a two-week extension of the public comment period for the RFI published in the
DOE believes that re-opening the comment period to allow additional time for interested parties to submit comments is appropriate. Therefore, DOE is re-opening the comment period until November 6, 2017 to provide interested parties additional time to prepare and submit comments. Comments received between the original October 23 closing date and the new November 6 closing date are considered timely filed. Therefore, individuals who submitted late comments during the original comment period do not need to re-submit comments.
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA, the Agency, or we) is proposing to revoke its regulation authorizing the use of health claims on
Submit either electronic or written comments on the proposed rule by January 16, 2018.
You may submit comments as follows. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 16, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Crystal Rivers, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1444.
The proposed rule would revoke the regulation authorizing the use of a health claim regarding the relationship between soy protein and risk of coronary heart disease (CHD) (§ 101.82 (21 CFR 101.82)). In this proposed rule, we tentatively conclude, based on our reevaluation of the totality of the publicly available scientific evidence now available, that the evidence does not support our previous determination that there is SSA to support an authorized health claim for the relationship between soy protein and reduced risk of CHD.
In 1999, we authorized a health claim about the relationship between soy protein and a reduced risk of CHD (§ 101.82). In the
The proposed rule would revoke the soy protein and CHD claim in § 101.82 because it does not meet the SSA standard. Our decision about whether to authorize a health claim represents FDA's determination as to whether there is “significant scientific agreement” among qualified experts that the publicly available scientific evidence supports the substance/disease relationship that is the subject of a proposed health claim. In our reevaluation of the scientific evidence in this proposed rule, we use our approach outlined in the “Evidence-Based Review System for the Scientific Evaluation of Health Claims” (hereinafter the 2009 guidance) to evaluate the totality of publicly available scientific evidence to determine if the SSA standard in section 403(r)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. (343(r)(3)) is met (Ref. 1). Our reevaluation of the totality of the publicly available scientific evidence indicates that, although some evidence suggests a relationship between soy protein intake and reduced risk of CHD, the totality of the evidence is inconsistent and not conclusive. Therefore, we have tentatively determined that the strength of the totality of the publicly available data does not meet the SSA standard for a relationship between soy protein intake and CHD risk.
The costs of this proposed rule, if finalized, are relabeling the estimated 200 to 300 products currently making the health claim. We estimate total annualized costs of $35,000 to $81,000, when the relabeling costs are annualized over 20 years at a 7 percent discount rate. The initial one-time costs are $370,000 to $860,000.
The benefit of this rule is better information for the consumers who are considering purchasing products with soy protein. This may generate an unknown amount of increased consumer surplus. Some consumers may react to this new information by switching their consumption to products that they enjoy more, or products that still have an authorized health claim. By basing their consumption decisions on more recent and accurate scientific information, they may get more consumer surplus, in the form of enjoyment and/or potential health benefits, from the bundle of products they consume.
In the
In our 1998 evaluation of the scientific evidence for a relationship between consumption of soy protein and blood total and LDL-cholesterol levels (two validated surrogate endpoints for risk of CHD), we found the data suggestive, but not sufficient, to establish a dose-response for this relationship. However, we found consistent, clinically significant reductions of total- and LDL-cholesterol levels in controlled trials that used at least 25 grams (g) of soy protein per day. Thus, we proposed to base the qualifying level of soy protein on a total daily intake of 25 g, as suggested by the petitioner. For the purposes of health claims, we assumed there are four eating occasions a day (
In the
FDA evaluates new scientific information that becomes available to determine whether it necessitates a change to an SSA health claim. On December 21, 2007, we published a notice in the
Subsequently, we received a citizen petition dated August 8, 2008 (Docket Number FDA-2008-P-0452-001) (hereinafter “the 2008 citizen petition”), requesting that the Commissioner of Food and Drugs revoke § 101.82. On January 4, 2016, we denied the petitioner's request because the limited relevant evidence submitted in the petition and a supplement to the petition did not provide sufficient grounds for us to revoke the soy protein and CHD health claim. However, as noted in the response to the citizen petition, we considered the relevant studies included in the petition as part of our reevaluation.
The Nutrition Labeling and Education Act of 1990 (NLEA) (Pub. L. 101-535) amended the FD&C Act by, among other things, adding section 403(r) to the FD&C Act. This section specifies, in part, that a food is misbranded if it bears a claim that expressly or by implication characterizes the relationship of a nutrient to a disease or health-related condition unless the claim is made in accordance with section 403(r)(3) of the FD&C Act (for conventional foods) or 403(r)(5)(D) of the FD&C Act (for dietary supplements).
The NLEA also directed FDA to issue regulations authorizing health claims (
Additionally, our regulations, at 21 CFR 10.40(a), provide that we may promulgate regulations necessary to enforce the FD&C Act as appropriate and may initiate such action in any of the ways specified in § 10.25 (21 CFR 10.25). Specifically, § 10.25(b) provides that the Commissioner may initiate a proceeding to revoke a regulation. Accordingly, we are acting within our statutory and regulatory authorities to propose to revoke the authorized health claim for soy protein and a reduced risk of CHD. If this proposed rule is finalized, the use of an authorized health claim would be prohibited and a food that bears the health claim on the label or in labeling would misbrand the food (see section 403(r)(1)(B) of the FD&C Act).
In situations where we determine that the totality of the publicly available scientific evidence does not meet the statutory SSA standard, we may consider whether there is credible evidence to support a “qualified” health claim and what qualifying statements and other information should accompany the claim to ensure that it is truthful and not misleading. If, when we finalize this rule, we conclude there is not SSA, but there is some credible evidence for the use of a qualified health claim about the relationship between soy protein and a reduced risk of CHD, we intend to issue a statement of enforcement discretion for the use of a qualified health claim.
Health claims characterize the relationship between a substance and a reduction in risk of contracting a particular disease or developing a health-related condition (
Next, we consider the totality of publicly available data and information to determine whether the scientific evidence could support a relationship between the substance and the disease or health-related condition. We begin this process by organizing the evidence into categories, such as human studies, meta-analyses, review articles, animal studies, and in vitro studies, so we can thoroughly and systematically assess the evidence during the evaluation process. Each category of evidence may offer us helpful information and a better understanding of the topic; however, only well-designed, well-conducted human studies provide both the level of scientific rigor and generalizability to human populations needed to potentially support a health claim relationship. We focus our review on reports of human intervention studies and observational studies. Of the two types of studies, well-conducted intervention studies provide the strongest evidence of an effect and are the most reliable category of studies for determining a cause-and-effect relationship (Ref. 1). In an intervention study, subjects similar to each other are randomly assigned to either receive the intervention or not to receive the
We use animal and
We evaluate the individual reports of human studies to determine whether any scientific conclusions can be drawn from each study. The absence of critical factors, such as a control group or a statistical analysis, means that scientific conclusions cannot be drawn from the study (Ref. 5-6). Studies from which we cannot draw any scientific conclusions do not support the health claim relationship, and we eliminate such studies from further review.
Because health claims involve reducing the risk of a disease in people who do not already have the disease that is the subject of the claim, we consider evidence from studies in individuals diagnosed with the disease that is the subject of the health claim only if it is scientifically appropriate to extrapolate to individuals who do not have the disease. The available scientific evidence should demonstrate that: (1) The mechanism(s) for the mitigation or treatment effects measured in the diseased populations are the same as the mechanism(s) for risk reduction effects in non-diseased populations; and (2) the substance affects these mechanisms in the same way in both diseased and healthy people. If such evidence is not available, then we cannot draw any scientific conclusions from studies that use diseased subjects to evaluate the substance/disease relationship. Next, we rate the remaining human intervention and observational studies for methodological quality. This quality rating is based on several criteria related to study design (
We then evaluate the results of the remaining human studies and then rate the overall strength of the total body of publicly available evidence (Ref. 1). We consider the study type (
In our reevaluation of the scientific evidence for a relationship between soy protein and reduced risk of CHD, we have used the approach outlined in the 2009 guidance to evaluate the totality of the current publicly available scientific evidence regarding this relationship (see section 403(r)(3)(B) of the FD&C Act). In this section, we present our reevaluation of the totality of the publicly available scientific evidence, including the studies we previously reviewed in promulgating the regulation that authorized the 1999 soy protein and CHD health claim (64 FR 57700), as well as studies published after we authorized the health claim in 1999. The 2009 guidance represents FDA's current
For the purposes of the reevaluation, we identified a total of 709 publications, drawn from studies included in the 1999 final rule, comments submitted to the 2007 notice of reevaluation, the 2008 citizen petition, and searches of the more recent literature. These publications consisted of 30 in vitro studies; 85 animal studies; 27 government documents; 163 review articles, meta-analyses, letters, abstracts, and books or book chapters; 11 Web sites; 3 articles written in a foreign language; and 141 publications that did not evaluate the substance/disease relationship. The publications also included 11 observational studies that evaluated the substance/disease relationship and 238 publications describing intervention studies that evaluated the relationship between soy protein intake and CHD risk.
Although useful for background information, review articles, meta-analyses, book chapters, letters, and government reports do not contain sufficient information on the individual studies which they reviewed and, therefore, we could not draw any scientific conclusions from this information. For example, we could not determine factors such as the study population characteristics or the composition of the products used (
We use animal and
For the purposes of this review, we categorized the intervention studies based on whether the subjects: (1) Added soy protein to the diet (supplement) in addition to the subjects' usual diet; (2) were instructed to substitute soy protein for animal protein in their diet; and (3) were provided test diets (feeding studies) with soy protein for animal protein (usually casein) in the control diet. In studies where soy proteins were used as a substitute for animal proteins, changes in the total fat, saturated fat, cholesterol, and dietary fiber content of the diet can occur. A reduced intake of total fat (Ref. 10), saturated fat ((Ref. 10), or cholesterol (Ref. 11) has been shown to lower blood cholesterol, and an increased intake of dietary fiber (Ref. 12) has shown the same (Ref. 10), and we have authorized SSA health claims for reduced risk of CHD based on these substance and disease relationships (§ 101.75, § 101.81). Therefore, to determine the independent effect of soy protein intake on blood cholesterol levels, total fat, saturated fat, cholesterol, and dietary fiber need to be controlled for in the studies. Studies that substituted soy protein for animal protein or feeding studies that did not properly control for these nutrients and/or did not report these nutrients were eliminated from further review. For studies in which soy protein was added to the usual diet, the addition of soy protein should not result in significant changes in the total fat, saturated fat, cholesterol, and dietary fiber in the diet (because soy protein does not have significant amounts of these nutrients) (Ref. 13-15). Therefore, we did not eliminate these types of studies that did not control for and/or did not report these nutrients.
To determine the independent effects of soy protein on blood pressure, studies need to control for the amount of sodium and potassium, because both nutrients influence blood pressure (Ref. 16). Studies that substituted soy protein for animal protein or feeding studies where subjects were provided soy protein in test diets that did not properly control for these nutrients and/or did not report these nutrients were eliminated from further review. For studies that added soy protein to the diet, the addition of soy protein should not result in significant changes in the amount of sodium and potassium in the diet; therefore, we did not eliminate these types of studies that did not control for and/or did not report these nutrients (Ref. 13-15). Furthermore, because the nutrients that affect blood pressure (sodium and potassium) and cholesterol (saturated fat, dietary fiber, and cholesterol) are different, some studies might be appropriate for supporting one surrogate endpoint, but not the other. Thus, for the purposes of this assessment, we discuss some studies twice.
Of the 238 total publications describing intervention studies that evaluated the relationship between soy protein intake and CHD risk, 9 publications did not report data on a FDA-recognized surrogate endpoint of CHD risk (
The remaining 229 publications described 212 intervention studies that evaluated soy protein intake and CHD
As stated previously in this section, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from 154 intervention studies due to significant design flaws. These studies include 17 studies that did not include a control group or provide an appropriate control for the comparison to the relative effects of soy protein (Ref. 26-42). Without an appropriate control group, we could not determine if the changes in LDL cholesterol were due to soy protein intake or uncontrolled extraneous factors (Ref. 1). Therefore, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies
Ten studies did not conduct statistical analyses between the control group and treatment group. The statistical analysis of the substance/disease relationship is a critical factor because it provides the comparison between subjects that consumed soy protein and those that did not consume soy protein (
In eight studies (Ref. 53-60), the duration of the study intervention was too short (less than 3 weeks) to adequately determine if changes in serum cholesterol levels were due to the consumption of soy protein (Ref. 1, 61). Therefore, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies.
Seventy-six studies, described in 84 publications, that substituted soy protein for animal protein or were feeding studies reported large differences in or did not report information on other dietary components that have an effect on blood cholesterol (
One study, Zittermann et al. (2004) was a randomized, crossover study (Ref. 1) in which 14 German women consumed 5 cookies made with soy flour or 5 cookies made with wheat flour while they remained on their usual diet for one menstrual cycle (30.8 ± 0.9 days). The composition of the test cookies and of the amount of soy protein in the cookies was not adequately described. Furthermore, while the study reported that subjects were to consume the cookies while they remained on their usual diet, the study reported significantly higher intake of dietary fiber (P <0.0001) in the soy period (cookies made with soy flour) than in the control period. When an intervention study involves providing a whole food rather than a food component, the experimental and control diets should be similar enough that the relationship between the substance and disease can be evaluated (Ref. 1). Because the composition of the test cookies were not adequately described, it is not clear why there are differences in dietary fiber intake between the two groups. Thus, we could not draw scientific conclusions about the relationship between soy protein and CHD when the amounts of other substances that are known to affect the risk of CHD (
Nine studies, described in 11 publications that evaluated soy protein intake and blood cholesterol, contained added phytosterols in the treatment group (Ref. 131-132, 147-155). We have an existing regulation for a SSA health claim for the relationship between plant sterol/stanol esters and reduced risk of CHD; however, because plant sterol/stanol esters can reduce blood cholesterol, it is not possible to clearly delineate what may be causing a change in serum cholesterol levels (Ref. 1). Therefore, the results of these studies could not be interpreted, and we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies.
For the remaining 58 intervention studies from which we could draw scientific conclusions, we used the criteria established by the National Heart, Lung and Blood Institute (NHLBI) to sort studies that measured blood cholesterol into 3 categories: (1) Studies that had subjects with desirable or borderline blood cholesterol (TC <240 mg/dL or LDL-cholesterol less than 160 mg/dL); (2) studies that had subjects with high blood cholesterol (TC >240 or LDL cholesterol >160 mg/dL); and (3) studies that had some subjects with desirable or borderline cholesterol level and other subjects with high cholesterol levels (Ref. 156). Additionally, studies that measured blood pressure were sorted based on criteria established by NHLBI into three categories: (1) Normal (Systolic Blood Pressure (SBP) <120 mmHg or Diastolic Blood Pressure (DBP) <80 mmHg); (2) pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg); and (3) hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg) (Ref. 157-158). Studies were further sorted by whether the studies added (supplemented) soy protein to the diet, were feeding studies, or were substitution studies. Because some studies measured both blood cholesterol and blood pressure, we discussed these studies twice (see tables 4-8 in Ref. 230).
Carmignani et al. (2014) was a 16-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 40 postmenopausal Brazilian women consumed daily 40 g/day placebo powder of maltrodextrin (n=20) or 40 g/day protein powder containing 24 g/day isolated soy protein (90 mg/day naturally occurring isoflavones) (n=20) in addition to their usual diet (Ref. 159). There was no significant difference in blood TC and LDL cholesterol between the soy protein group and the control group.
Liu et al. (2012) was a 6-month, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 120 postmenopausal Chinese women consumed daily 15 g/day milk protein plus 100 mg/day isoflavone supplement (control) (n=60) or 15 g/day isolated soy protein plus 100 mg/day isoflavone supplement (n=60) in addition to their usual diet (Ref. 160). There was no significant difference in the change in blood TC and LDL cholesterol between the milk protein and isoflavone group (control) and the soy protein and isoflavone group.
Santo et al. (2008) was a 28-day, randomized, double-blind, controlled parallel trial of moderate quality in
Evans et al. (2007) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 22 postmenopausal American women consumed: (1) 25 g/day isolated soy protein plus 20 g/day soy lecithin; (2) 25 g/day isolated soy protein plus placebo lecithin; (3) placebo protein (50:50 calcium/sodium caseinate) and 20 g/day soy lecithin; and (4) double placebo (protein placebo and soy lecithin) in addition to their usual diet, for a duration of 4 weeks each (Ref. 162). There was no significant difference in blood TC and LDL cholesterol between the isolated soy protein plus soy lecithin and placebo protein plus soy lecithin treatment period (control). There was also no significant difference in blood TC and LDL between the isolated soy protein plus placebo lecithin and double placebo period (control).
Maesta et al. (2007) was a 16-week, randomized, single-blind, placebo-controlled, parallel trial of moderate quality in which 46 postmenopausal Brazilian women consumed: (1) 25 g/day isolated soy protein (n=10); (2) 25 g/day isolated soy protein, plus resistance exercise (n=14); (3) 25 g/day maltodextrin (control) (n=11); or (4) 25 g/day maltodextrin plus resistance exercise (n=11) (control) in addition to their usual diet (Ref. 163). There was no significant difference in blood TC and LDL cholesterol between the soy protein and control groups.
Kohno et al. (2006) was a two-part, randomized, double-blind, placebo-controlled, parallel trial of moderate quality (Ref. 164). In the first part of the trial, 126 Japanese men and women, in addition to their usual diet, consumed daily 5 g casein (control) (n=61) or 5 g of soybean β-conglycinin (storage protein component of soy protein isolate) in the form of a candy (n=65) for 12 weeks. There was no significant difference between the two diets for blood TC or LDL cholesterol. In the second part of the trial, 95 Japanese men and women consumed daily 5 g casein (n=50) or 5g soybean β-conglycinin (n=45) for 20 weeks. There was no significant difference between the two diets for blood TC or LDL cholesterol.
McVeigh et al. (2006) was a randomized, single-blind, controlled, crossover trial of moderate quality in which 35 Canadian men consumed 32 g/day soy protein isolate depleted of isoflavones (1.64 mg/day), 32 g/day soy protein isolate (62 mg/day isoflavones), or 32 g/day milk protein isolate for a duration of 57 days each (Ref. 165). There was no significant difference between blood TC and LDL cholesterol between the soy protein and casein groups.
Sagara et al. (2004) was a 5-week, randomized, double-blind, placebo-controlled parallel trial of moderate quality in which 50 Scottish men consumed 20 g/day of isolated soy protein powder in biscuits, cereal bars, and bread rolls (n=25) or biscuits, cereal bars, and bread rolls without added soy protein in addition to their usual diets (n=25) (Ref. 166). There was no significant difference in blood TC between the two groups.
Teixeira et al. (2004) was a randomized, controlled, crossover trial of moderate quality in which 14 men American men with type 2 diabetes with nephropathy consumed an estimated 35 g/day of soy protein isolate and casein (control) in addition to their usual diets for a duration of 8 weeks each (Ref. 167). There was no significant difference in blood TC and LDL cholesterol between the soy protein and casein group.
Murray et al. (2003) was a 6-month, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 30 American postmenopausal women consumed: (1) 38 g/day soy protein isolate containing (25 g soy protein) plus 1.0 mg estradiol (n=8); (2) 38 g textured milk protein plus 1.0 mg estradiol (n=7) (control); (3) 38 g/day soy protein isolate containing (25 g soy protein) plus 0.5 mg estradiol (n=8); or (4) 38 g/day textured milk protein plus 0.5 mg estradiol(control) (n=7) in addition to their usual diet (Ref. 168). The baseline TC levels in the 38 g/day textured milk protein plus 1.0 mg estradiol group were significantly higher than the (25 g soy protein) plus 1.0 mg estradiol group. If the baseline cholesterol values between groups are significantly different, then it is difficult to determine if differences at the end of the study were due to the intervention or to differences observed at the beginning of the study (Ref. 1). Thus, we could not draw scientific conclusions from this arm of the study. For the soy protein group plus 0.5 mg estradiol and the textured milk protein plus 0.5 mg estradiol (control) groups, the baseline cholesterol levels were similar and conclusions could be drawn. However, there was no significant difference in blood TC and LDL cholesterol between the soy protein group plus 0.5 mg estradiol and the textured milk protein plus 0.5 mg estradiol control group.
Jayagopal et al. (2002) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 32 postmenopausal British women with type 2 diabetes consumed 30 g/day of isolated soy protein or 30 g/day of cellulose (control) in addition to their usual diet for a duration of 12 weeks each (Ref. 169). Blood TC and LDL cholesterol was significantly lower (P <0.05) in soy protein period compared to the cellulose period.
Higashi et al. (2001) (trial one) was a randomized, controlled, crossover trial of moderate quality in which 14 Japanese men consumed daily milk or yogurt only (no placebo) and 20 g/day soy protein isolate mixed in milk or yogurt in addition to their usual diet for a duration of 4 weeks each (Ref. 26). There was no significant difference in blood TC and LDL cholesterol between the soy protein period and the control period (milk or yogurt only).
Teede et al. (2001) and Dalais et al., (2003) was a 3-month randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 179 Australian men and postmenopausal women consumed a casein placebo (n=93) or 40 g/day soy protein isolate (n=86) mixed with a beverage twice a day in addition to their usual diet (Ref. 170-171). There was no significant difference in blood TC and LDL cholesterol between the casein control group and soy protein isolate group. In a subgroup analysis of the postmenopausal women (n=55 casein and n=51 soy protein) by Dalais et al. (2003), there was no significant difference in blood TC between the casein control group and soy protein isolate group. However, blood LDL cholesterol was significantly (P <0.05) lower in the soy protein isolate group compared to the casein control group.
Washburn et al. (1999) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 42 perimenopausal American women consumed daily: (1) 20 g/day complex carbohydrate supplement mixed with a beverage (control); (2) 20 g/day isolated soy protein (34 mg/day naturally occurring phytoestrogens) supplement mixed with a beverage as a single dose; and (3) 20 g/day soy protein supplement (34 mg/day naturally occurring phytoestrogens) mixed with beverages split into two
Gooderham et al. (1996) was a 28-day randomized, controlled, parallel trial of moderate quality in which 20 Canadian men consumed daily a supplement containing 60 g/day of soy protein isolate (n=10) or a supplement containing 60 g/day of casein (control) (n=10) in addition to their usual diet (Ref. 173). There was no significant difference in blood TC and LDL cholesterol between the soy protein isolate group and casein group.
Mangano et al. (2013) was a 1-year, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 97 postmenopausal American women consumed: (1) 18 g/day isolated soy protein plus 105 mg/day isoflavone tablets (n=25); (2) 18 g/day isolated soy protein plus placebo tablets (n=24); (3) 18 g/day control protein (casein, whey, and egg protein) plus 105 mg/day isoflavone tablets (n=26); or (4) control protein and placebo tablets (n=22) in a beverage or food. Subjects were counseled to reduce animal protein foods by approximately 3 oz/day, which is an amount equivalent to the protein powder provided in the study (Ref. 174). There was no significant difference in blood TC or LDL cholesterol between any of the soy protein groups and the control groups.
Steinberg et al. (2003) was a randomized, double-blind, controlled, crossover trial of moderate quality in which 28 postmenopausal American women consumed: (1) 25 g/day of isolated soy protein (107 mg/day naturally occurring isoflavones); (2) 25 g/day of isolated soy protein depleted of isoflavones (2 mg/day isoflavones); and (3) 25 g/day total milk protein (control) for a duration of 6 weeks each (Ref. 175). Subjects mixed the protein powders with a beverage and were instructed to incorporate the protein into their diet without increasing protein or energy intake. There was no significant difference in blood TC and LDL cholesterol between soy protein groups and milk protein control group.
Bakhit et al. (1994) was a randomized, controlled, crossover trial of moderate quality in which 21 American men consumed muffins containing: (1) 25 g/day isolated soy protein plus 20 g/day of dietary fiber from cellulose; (2) 25 g/day isolated soy protein plus 20 g/day of soybean cotyledon fiber; (3) 25 g/day casein plus 20 g/day soybean cotyledon fiber (control); and (4) 25 g/day casein plus 20 g/day of dietary fiber from cellulose (control) for a duration of 4 weeks each (Ref. 176). Subjects were counseled to incorporate the muffins into a low-fat, low-cholesterol diet. There were no significant differences between isolated soy protein groups and control groups for blood TC and LDL cholesterol.
van Raaji et al. (1981) was a 4-week, controlled, parallel trial of moderate quality in which 69 Dutch men and women were fed an average Western diet with different types of dietary protein incorporated into specifically developed products. The dietary protein groups were: (1) 54 g/day of isolated soy protein (n=24); (2) 17 g/day soy (approximately a 2:1 mixture of casein:soy) (n=20); or (3) 55 g/day casein (control) (n=25) (Ref. 177). Participants were matched for initial serum cholesterol, energy intake, and sex. There was no significant difference in blood TC between the isolated soy protein groups and casein control group. However, blood LDL was significantly lower (P <0.05) in the isolated soy protein group compared to the casein control group.
Takatsuka et al. (2000) was a 60-day, randomized, controlled, parallel trial of moderate quality in which 52 premenopausal Japanese women consumed approximately 16 g/day of soy protein from soy milk (n=27) in addition to their usual diet or followed their usual diet as a control diet (n=25) (Ref. 178). The control diet was a usual diet and therefore not a true placebo. The change in blood TC was significantly lower (P = 0.022) in the soy milk group compared to the control group. However, there was no significant difference in the change in blood LDL cholesterol between the two groups.
Mitchell and Collins (1999) was a 4-week, randomized, controlled, parallel trial of moderate quality in which 10 British men consumed: (1) One liter of soy milk (n=4); (2) one liter of rice milk (control) (n=3); or (3) one liter of semi skimmed cow's milk (control) (n=3) in addition to their usual diets. There was no significant difference in blood TC between groups (Ref. 179).
Murkies et al., (1995) was a 12-week randomized, double-blind, controlled parallel trial of moderate quality in which 47 postmenopausal Australian women consumed 45 g/day of wheat flour with an estimated 4.6 g/day wheat protein (control) (n=24) or 45 g/day soy flour with an estimated 15 g/day of soy protein (n=23) in addition to their usual diet (Ref. 180). There was no significant difference in blood TC between the two groups.
Matthan et al. (2007) was a randomized, controlled, crossover trial of moderate quality in which 28 American subjects were fed four diets: (1) Animal protein (control), (2) soybean diet (~37.5 g/day soy protein), (3) soy flour (~37.5 g/day soy protein), and (4) and soy milk (~37.5 g/day soy protein) for a duration of 6 weeks each (Ref. 181). Blood LDL cholesterol was significantly lower (P <0.05) in the soymilk diet period compared to the animal protein diet period (control). However, there was no significant difference in blood TC between the soymilk diet period and the animal protein diet period. Furthermore, there was no significant difference in blood TC or LDL cholesterol between the animal protein diet period (control) and the soybean diet period or the soy flour diet period.
Jenkins et al. (1989) was a controlled, crossover trial of moderate quality in which 11 obese Canadian women who consumed a low calorie diet (1,000 kcal) had 2 meals replaced by soy-based liquid formula made from soy flour and soy protein isolate, and a milk-based liquid formula for a duration of 4 weeks each. The soy formula provided approximately 17 g/day soy protein, and the cow's milk formula provided 18 g/day milk protein (control) (Ref. 182). There was no significant difference in blood TC and LDL cholesterol between the soy formula and the cow's milk formula groups.
Bosello et al. (1988) was a 75-day, controlled, parallel trial of moderate quality in which 24 obese Italian subjects were fed a very low calorie diet (375 kcal/day) for 15 days (Ref. 183). The very low calorie diets were then integrated with a commercial textured preparation that provided approximately 27 g/day of casein (control) or approximately 28 g/day soy protein that was consumed daily for 60 days. The 60-day hypocaloric diet provided a total of 800 kcal/day (375 kcal/day from the very low calorie diet and 425 kcal/day from commercial textured preparation). Blood TC and LDL cholesterol was significantly lower (P <0.01) after consuming the soy protein diet compared to the casein diet.
Greany et al. (2004) was a randomized, controlled, crossover trial of moderate quality in which 33 postmenopausal American women consumed: (1) 26 g/day of soy protein isolate; (2) 26 g/day soy protein isolate plus probiotic capsules; (3) 26 g/day milk protein; and (4) 26 g/day milk protein plus probiotic capsules for a duration of 6 weeks each (Ref. 184). Subjects were counseled to substitute the protein powders in two divided doses for other protein containing foods in their diet. For the analysis, the soy protein and milk protein diets (control), with or without probiotics, were combined. Blood TC and LDL cholesterol was significantly lower (P <0.05) after consuming the soy protein isolate compared to the milk protein control period.
Wong et al. (1998) was a randomized, controlled, crossover trial of high quality in which 13 American subjects with normal or borderline high cholesterol and 13 American subjects with high cholesterol consumed a National Cholesterol Education Program (NCEP) Step 1 soy protein diet that provided approximately 50 g/day isolated soy protein or an NCEP Step 1 animal protein diet that provided approximately 50 g/day animal protein (control) for a duration of 5 weeks each (Ref. 185). Blood LDL cholesterol was significantly lower (P <0.05) after the soy protein period compared to the animal protein period for both the normal and borderline high subjects and high cholesterol subjects. However, there was no significant difference in blood TC between the soy protein diet and the control diet for both the normal and borderline high subjects and high cholesterol subjects.
Goldberg et al. (1982) was a randomized, controlled, crossover trial of moderate quality in which 12 American subjects with high cholesterol and 4 American subjects with normal or borderline high cholesterol consumed daily: (1) An animal protein diet (control); and (2) an isolated soy protein diet for a duration of 6 weeks each. The soy protein diet contained an estimated 99 g/day of isolated soy protein (Ref. 186). Blood TC and LDL cholesterol in the 12 subjects with high cholesterol was significantly lower (P <0.025) after the soy protein diet compared to the animal protein diet. However, there was no significant difference in blood TC and LDL between the two diets in the four subjects with normal or borderline high cholesterol.
Hoie et al. (2007) was an 8-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 88 German subjects consumed: (1) 25 g/day of isolated soy protein in its native, non-denatured form (n=28); (2) 25 g/day of isolated soy protein (n=32); or (3) 25 g/day of milk protein (derived from caseinate and skimmed milk powder) (n=28) (control) in addition to their usual diets (Ref. 187). Blood TC and LDL cholesterol was significantly lower (P <0.001 and P = 0.002, respectively) after consuming the non-denatured isolated soy protein compared to milk protein group. Blood TC cholesterol was also significantly lower (P = 0.008) after consuming isolated soy protein compared to milk protein group. However, there was no significant difference for blood LDL cholesterol after consuming isolated soy protein compared to milk protein group.
Hoie et al. (2006) was a 4-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 80 German subjects consumed daily: (1) Ultra-heat-treated chocolate-flavored milk containing 24.4 g/day isolated soy protein and 30.4 g/day milk protein (n=20); (2) 43.3 g/day milk protein (control) (n=20); (3) ultra-heat-treated chocolate flavored milk containing 12.2 g/day isolated soy protein and 15.2 g/day milk protein (n=20); or (4) 21.7 g/day milk protein (control) (n=20) (Ref. 188). There was no significant difference in blood TC or LDL cholesterol between the group that consumed the ultra-heat-treated chocolate-flavored milk containing 24.4 g/day isolated soy protein and 30.4 g/day milk protein group and the control milk protein group. There was also no significant difference in blood TC and LDL cholesterol between the group that consumed ultra-heat-treated chocolate-flavored milk containing 12.2 g/day soy protein and 15.2 g/day milk protein per day (n=20) or the control milk protein group.
Hoie et al. (2005a) was an 8-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 77 German subjects consumed 25 g/day soy protein (n=39) or 25 g/day milk protein (derived from caseinate and skimmed milk powder) (control) (n=38) in addition to their usual diets (Ref. 189). Blood LDL cholesterol was significantly lower (P <0.05) in the soy protein group when compared to the casein group. There was no difference in blood TC between the soy protein group and casein group.
Hoie et al. (2005b) was an 8-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 117 German subjects consumed: (1) 25 g/day soy protein (n=39); (2) 15 g/day soy protein plus 10 g/day milk protein (derived from caseinate and skimmed milk powder) (n=39); or (3) 25 g/day milk protein (derived from caseinate and skimmed milk powder) (control) (n=39) in addition to their usual diets (Ref. 190). Blood LDL cholesterol was significantly lower (P = 0.002) after consumption of 25 g/day soy protein compared to the 25 g/day casein group. TC was also significantly lower (P = 0.002) after consumption of 25 g/day soy protein compared to the 25 g/day casein group. In the 15 g/day soy protein plus 10 g/day casein group blood LDL cholesterol was significantly lower (P = 0.011) compared to 25 g/day casein control group. TC was also significantly lower (P = 0.001) after consumption of 15 g/day soy protein plus 10 g/day casein compared to 25 g/day casein control group.
Teede et al. (2005) was a 3-month, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 40 postmenopausal Australian women consumed 40 g/day isolated soy protein (n=19) or a casein placebo in addition to their usual diet (n=21) (Ref. 191). There was no significant difference in blood TC or LDL cholesterol between the soy protein and casein group.
Harrison et al. (2004) was a 5-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 112 British men and women consumed foods (bread, cracker biscuits, and snack bars) that provided 25 g/day isolated soy protein (n=59) or the same foods without soy protein as a control (n=53) in addition to their usual diet (Ref. 192). There was no significant difference in blood TC and LDL cholesterol between the soy protein and control groups.
Blum et al. (2003) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 24 postmenopausal Israeli women consumed 25 g/day milk protein (control) and 25 g/day isolated soy protein in addition to their usual diets for a duration of 6 weeks each (Ref. 193). Blood TC and LDL cholesterol was significantly lower (P <0.05) after consuming soy protein isolate compared to milk protein period.
Cuevas et al. (2003) was a randomized, double-blind, controlled, crossover trial of moderate quality in which 18 postmenopausal Chilean women consumed diets providing 40 g/
Gardner et al. (2001) was a 12-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 94 postmenopausal American women consumed: (1) 42 g/day total milk protein (control) (n=30); (2) 42 g/day isolated soy protein with isoflavones depleted (3 mg/day) (n=33); or (3) 42 g/day isolated soy protein (80 mg/day naturally occurring isoflavones) (n=31) in addition to their usual diet (Ref. 195). There was no significant difference in blood TC or LDL cholesterol between the isolated soy protein groups and the total milk protein control group.
Hori et al. (2001) was a 3-month, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 21 Taiwanese men consumed: (1) Casein hydrolysate (n=7); (2) 3 g/day of a crude type of soy protein hydrolysate (n=7); or (3) 6 g/day of a crude type of soy protein hydrolysate (n=7) in addition to their usual diet. Blood TC was significantly lower (P <0.05) after consuming 3 g/day of a crude type of soy protein hydrolysate group for 3 months compared to the casein hydrolysate control (Ref. 196). Blood TC was also significantly lower after consuming 6 g/day crude type of soy protein hydrolysate group after 2 and 3 months compared to the casein hydrolysate control. Blood LDL cholesterol was significantly lower (P <0.05) after consuming 3 g/day of a crude type of soy protein hydrolysate group after 2 and 3 months compared to the casein hydrolysate control. Blood LDL cholesterol was also significantly lower (P <0.05) after consuming 6 g/day a crude type of soy protein hydrolysate group after 1, 2, and 3 months compared to the casein hydrolysate group.
Chen et al. (2006) was a 12-week, randomized, double-blind, placebo-controlled, parallel trial of high quality in which 26 Taiwanese subjects on dialysis consumed daily their usual dialysis diet that incorporated 30 g/day milk protein (control) (n=13) or an isolated soy protein diet containing 30 g/day soy protein (n=13) (Ref. 197). Blood TC was significantly lower (P <0.05) in the isolated soy protein diet compared to the milk protein control. There was no significant difference in blood LDL cholesterol between the milk protein control and isolated soy protein diet.
Ma et al. (2005) was a 5-week, randomized, double-blind, controlled, parallel trial of moderate quality in which 159 American subjects consumed daily 28 g/day milk protein supplement (n=78) (control) or a 32 g/day isolated soy protein supplement (n=81) in a beverage. Subjects were counseled to modify their protein and carbohydrate intake to account for the protein supplement intake. There was no significant difference in blood TC and LDL cholesterol between the two diets (Ref. 198).
West et al. (2005) and Hilpert et al. (2005) both discuss a randomized, double-blind, controlled, crossover trial of high quality in which 32 American subjects were fed an NCEP Step 1 diet that incorporated 25 g/day milk protein or 25 g/day soy protein isolate for a duration of 6 weeks each (Ref. 199-200). On each diet, 15 g of the protein supplement was consumed in a muffin while the remaining protein supplement was provided to the subjects to integrate into the meals provided. There was no significant difference in blood TC and LDL cholesterol between the milk protein and soy protein isolate diets.
Jenkins et al. (2002 a and b) was a randomized, single-blind, controlled, crossover trial of moderate quality in which 41 Canadian men and women were fed an NCEP Step 2 diet in which the main protein containing foods were replaced with test foods made with: (1) Approximately 60 g/day dairy and egg protein; (2) 50 g/day of soy protein isolate (10 mg/day naturally occurring isoflavones); and (3) 50 g/day soy protein isolate (73 mg/day naturally occurring isoflavones) for a duration of 1 month each (Ref. 201-202). The percent change in blood TC and LDL cholesterol was significantly lower (P <0.01) after consuming the soy protein diets compared to the dairy and egg protein diet (control).
Lichtenstein et al. (2002) was a randomized, double-blind, controlled, crossover, feeding trial of moderate quality in which 42 American men and women consumed diets of: (1) Isolated soy protein depleted of isoflavones (25 g soy protein/1,000 kcal); (2) isolated soy protein enriched with isoflavones (25 g soy protein plus 50 mg isoflavones/1,000 kcal); (3) animal protein with no added isoflavones (25 g animal protein/1,000 kcal); and (4) animal protein with added isoflavones (25 g animal protein and 50 mg isoflavones/1,000 kcal) for a duration of 6 weeks each (Ref. 203). The mean soy intake for women was 55 g/day and 71 g/day for men. The treatment effects for blood TC and LDL cholesterol were significantly lower (P = 0.017 and P = 0.042, respectively) after consuming the soy protein diets compared to the animal protein diets. For 20 subjects with LCL-C >160 mg/dL, the treatment effects for blood TC and LDL-C were significantly lower (P <0.001 and P = 0.003) after consuming the soy protein diets compared to the animal protein diets. These data were also reported in Wang et al., (2004) and Desroches et al., (2004) (Ref. 204-205).
Van Horn et al. (2001) was a 6-week, randomized, controlled, parallel trial of high quality in which 126 postmenopausal American women consumed an NCEP Step 1 diet in which they isocalorically substituted: (1) Oats and 29 g/day milk protein (n=31) (control); (2) wheat and 29 g/day isolated soy protein (n=31); (3) oats and 29 g/day isolated soy protein (n=31); or (4) wheat and 29 g/day milk protein (n=32) (control) for other carbohydrates and dairy type foods (Ref. 206). There was no significant difference in blood TC or LDL cholesterol between the two control and the two soy protein diets.
Gardner et al. (2007) was a 4-week, randomized, single-blind, controlled, crossover trial of high quality in which 28 American men and women consumed daily: (1) 1 percent cow's milk (control); (2) whole bean soy milk; and (3) soy protein isolate milk, in addition to an American Heart Association diet (Ref. 207). The whole bean soy milk and the soy protein isolate milk provided 25 g/day of soy protein, and the 1 percent cow's milk provided 25 g/day of milk protein. Blood LDL cholesterol was a significantly lower (P = 0.02) after consuming whole bean soy milk when compared to 1 percent cow's milk. Blood LDL cholesterol was also significantly lower (P = 0.02) after consuming the soy protein diet compared to the 1 percent cow's milk diet.
Jenkins et al. (2000) was a randomized, controlled, crossover trial of moderate quality in which 25 Canadian men and women consumed daily an NCEP Step 2 diet that incorporated: (1) A commercial breakfast cereal containing 8 g/day wheat protein (control); and (2) a breakfast cereal made with 70 percent soy flour that provided 36 g/day soy protein for a duration of 3 weeks each (Ref. 208). There was no significant
Twenty-eight studies, described in 30 publications, either substituted soy protein in the diet or were feeding studies. These studies did not control for or provide information on sodium and potassium intake in the diet (Ref. 44, 55, 66, 74, 77, 84, 91, 96-97, 99, 114, 116, 123, 125-126, 131-132, 139-140, 144, 149-151, 153-154, 181, 201-202, 208-209). Because sodium and potassium intake also influence blood pressure, the independent effects of soy protein intake and blood pressure could not be determined. Therefore, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies.
Four studies did not include an appropriate control protein for a comparison of the relative effects of soy protein (Ref. 40, 42, 210-211). Without an appropriate control group, it cannot be determined if the changes in SBP or DBP were due to soy protein intake or uncontrolled, extraneous factors. Therefore, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies.
Chiechi et al. (2002) was a 6-month, randomized, parallel trial in which 67 subjects with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) consumed their usual diet (n=43) or their usual diet plus a soy food serving each day (
Anderson et al. (2007) was a 16-week, randomized, single-blind, controlled, parallel trial of moderate quality in which 35 obese American women with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) were fed daily 3 meal replacement shakes containing approximately 22 g/day of casein (control) (n=18) or 21 g/day isolated soy protein (n=17) each (Ref. 89). There was no significant difference in SBP or DBP between the casein and soy protein diet.
Azadbakht et al. (2007) was a randomized, controlled, crossover trial of moderate quality in which 42 postmenopausal Iranian women with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) consumed daily: (1) A Dietary Approaches to Stop Hypertension (DASH) control diet; (2) a 30 g/day soy protein diet; and (3) a 30 g/day soy nut diet for a duration of 8 weeks each (Ref. 65). The soy protein and soy nut diets were the same as the DASH diet with soy protein and soy nuts being substituted for red meat for the control diet. There was no significant difference in SBP or DBP between the DASH control diet and the soy protein and soy nut diets.
Evans et al. (2007) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 22 pre-hypertensive (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg), postmenopausal American women consumed: (1) 25 g/day isolated soy protein plus 20 g/day soy lecithin; (2) 25 g/day isolated soy protein plus placebo lecithin; (3) placebo protein (50:50 calcium/sodium caseinate) and 20 g/day soy lecithin; and (4) double placebo (protein placebo and soy lecithin) in addition to their usual diet for a duration of 4 weeks each (Ref. 162). There was no significant difference in SBP or DBP between the soy protein plus placebo lecithin group and the double placebo group (control) or between the soy protein plus soy lecithin group and the placebo protein plus soy lecithin period (control).
Harrison et al. (2004) was a 5-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 112 British men and women with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) consumed foods (bread, cracker biscuits, and snack bars) that provided 25 g/day isolated soy protein (n=59) or the same foods without soy protein as a control (n=53) in addition to their usual diet (Ref. 192). There was no significant difference in SBP and DBP between the soy protein and control groups.
Cuevas et al. (2003) was a randomized, double-blind, controlled, crossover trial of moderate quality in which 18 pre-hypertensive (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) postmenopausal Chilean women consumed diets providing 40 g/day caseinate (control) or 40 g/day isolated soy protein in addition to an NCEP Step 1 diet for a duration of 4 weeks each (Ref. 194). There was no significant difference in SBP or DBP between the soy protein diet and caseinate control diet.
Teede et al. (2001) was a 3-month randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 179 pre-hypertensive (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) Australian men and postmenopausal women consumed a casein placebo (n=93) or 40 g/day soy protein isolate mixed with a beverage twice a day (n=86) in addition to their usual diet (Ref. 170). SBP was significantly lower (P <0.05) in the soy protein isolate group compared to casein control group. However, there was no significant difference in DBP between the casein control group and soy protein isolate group.
Washburn et al. (1999) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 42 pre-hypertensive (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg), perimenopausal American women consumed: (1) A complex carbohydrate supplement (20 g/day) mixed with a beverage (control); (2) 20 g/day isolated soy protein supplement mixed with a beverage as a single dose; and (3) 20 g/day soy protein supplement mixed with beverages split into two equal doses in addition to their usual diet for a duration of 6 weeks each (Ref. 172). There was no difference in SBP or DBP between the soy protein supplement mixed with a beverage as a single dose period and the complex carbohydrate control period. However, SBP and DBP were significantly lower (P <0.05) after consuming the 20 g/day soy protein supplement mixed with beverages split into two equal doses compared to the complex carbohydrate supplement.
He et al. (2005) was a 12-week, randomized, double-blind, parallel trial of moderate quality in which 276 Chinese men and women with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) or hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg) consumed cookies containing 40 g/day complex carbohydrates from wheat (n=139) (control) or cookies with 40 g/day isolated soy protein (n=137) (Ref. 212). Subjects were instructed to reduce other food intake to keep total energy intake constant. Most subjects consumed the cookies in place of their usual breakfast or usual lunch. SBP and DBP were significantly (P <0.001) lower for those who consumed the soy protein cookies compared to the wheat cookies (control).
Sagara et al. (2004) was a 5-week randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 50 Scottish men with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) or hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg) consumed 20 g/day of isolated soy protein powder in biscuits, cereal bars, and bread rolls (n=25) or biscuits, cereal bars, and bread rolls without added soy protein in addition to their usual diets (n=25) (Ref. 166). There was no significant difference in SBP or DBP between the soy protein and control group.
Webb et al. (2008) was a 5-day, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 25 hypertensive (SBP ≥140 mmHg or DBP ≥90 mmHg) British men and women with CHD consumed 25.7 g/day soy protein isolate (n=13) or 25.7 g/day milk protein isolate (n=12) in addition to their usual diets (Ref. 60). There was no significant difference in SBP or DBP between the soy protein isolate group and the control milk protein isolate group.
Jayagopal et al. (2002) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 32 hypertensive (SBP ≥140 mmHg or DBP ≥90 mmHg) postmenopausal British women with type 2 diabetes consumed 30 g/day of isolated soy protein or 30 g/day of cellulose (control) in addition to their usual diet for a duration of 12 weeks each (Ref. 169). There was no significant difference in SBP and DBP between the control diet and the soy protein diet.
Rivas et al. (2002) was a 3-month randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 40 hypertensive (SBP ≥140 mmHg or DBP ≥90 mmHg) Spanish men and women consumed daily 1 liter of soy milk (18 g/day soy protein) or 1 liter of cow's milk (15.5 g/day protein) in addition to their usual diet (Ref. 213). SBP and DBP was significantly lower (P <0.0001) in the soy milk group compared to the cow's milk group.
FDA identified 11 observational studies that evaluated soy protein and CHD risk (Ref. 214-224). All of these observational studies calculated soy protein intake from estimated dietary intake. In observational studies that calculated nutrient intake from conventional foods, measures of soy protein intake were based on recorded dietary intake methods such as food frequency questionnaires, diet recalls, or diet records, in which the type and amount of foods consumed were estimated. A common weakness of observational studies is the limited ability to ascertain the actual food or nutrient intake for the population studied as a result of poor memory, over- or underestimation of portion sizes, and recall bias (Ref. 225). Furthermore, the nutrient content of foods can vary due to a number of factors, including soil composition, food processing and cooking procedures, and storage conditions (
In addition, soy foods contain not only soy protein, but also other nutrients that may be associated with the metabolism of soy protein or the pathogenesis of CHD. Therefore, because soy protein containing foods consist of many nutrients and substances, it is difficult to study the nutrient or food components in isolation (Ref. 3). For studies based on recorded dietary intake of such foods, it is not possible to accurately determine whether any observed effects of soy protein on coronary heart disease risk were due to: (1) Soy protein alone; (2) interactions between soy protein and other nutrients; (3) other nutrients acting alone or together; or (4) decreased consumption of other nutrients or substances contained in foods displaced from the diet by the increased intake of soy protein containing foods. In some instances, epidemiological studies based on the recorded dietary intake of conventional foods may indicate a benefit for a particular nutrient with respect to a disease; however, it is subsequently demonstrated in an intervention study that the nutrient-containing dietary supplement does not confer a benefit or actually increases risk of the disease (Ref. 226). For example, previous epidemiological studies reported an association between fruits and vegetables high in beta-carotene and a reduced risk of lung cancer (Ref. 227). However, subsequent intervention studies, the Alpha-Tocopherol and Beta Carotene Prevention Study (ATBC) and the Carotene and Retinol Efficiency Trial (CARET), demonstrated that beta-carotene supplements increase the risk of lung cancer in smokers and asbestos-exposed workers, respectively (Ref. 228-229). These studies illustrate that the effect of a nutrient provided as a dietary supplement exhibits different health effects compared to when it is consumed as part of a usual diet among many other food components. Furthermore, these studies demonstrate the potential public health risk of relying on results from epidemiological studies in which the effect of a nutrient is based on recorded dietary intake of conventional foods as the sole source for concluding that a relationship exists between a specific nutrient and disease risk (
For the reasons provided in this section, scientific conclusions cannot be drawn from observational studies on foods for soy protein as a food ingredient or component of food.
In evaluating the scientific evidence using our evidence-based review system (Ref. 1), we considered the strength of evidence for a relationship between soy protein intake and reduced risk of CHD. When evaluating the strength of the evidence, we consider study types, methodological quality, quantity of evidence for and against the claim (taking into account the numbers of various types of studies and study sample sizes), relevance to the U.S. population or target subgroup, replication of study results supporting the claim, and overall consistency of the evidence (beneficial effect, no effect) (Ref. 1). For the outcome of an intervention study to demonstrate an effect, the validated surrogate or clinical endpoint evaluated in the intervention group should be statistically significantly different from the same validated surrogate or clinical endpoint evaluated in the control group (P <0.05). After assessing the totality of the scientific evidence, we then determine whether there is SSA to support an
Our decision about whether to authorize a health claim represents our determination as to whether there is significant scientific agreement among qualified experts that the publicly available scientific evidence supports the substance/disease relationship that is the subject of a proposed health claim. The SSA standard is intended to be a strong standard that provides a high level of confidence in the validity of the substance/disease relationship. SSA occurs well after the stage of emerging science, where data and information permit an inference, but does not require consensus based on unanimous and incontrovertible scientific opinion. We explained in our 2009 guidance (Ref. 1) that we may evaluate new information that becomes available to determine whether it necessitates a change to an existing SSA claim to maximize the public health benefit of our health claims review. The 2009 guidance represents our current thinking on the meaning of the SSA standard in section 403(r)(3) of the FD&C Act and § 101.14(c) and the process for evaluating the scientific evidence for a health claim pursuant to these authorities.
As noted in section V, we reevaluated, consistent with the 2009 guidance (Ref. 1), the studies included in the 1999 final rule as well as new studies that were published since the original review. As discussed in section V.C and D, the totality of the scientific evidence includes 58 well-designed, well-executed intervention studies. Of these 58 studies, 46 are intervention studies of high or moderate quality that measured blood TC or LDL cholesterol, and 12 are intervention studies of high or moderate quality that measured SBP or DBP. The results of these studies were inconsistent and not conclusive.
Of the 46 studies intervention studies of high or moderate quality that measured blood TC or LDL cholesterol, 25 studies were conducted on subjects with desirable or borderline cholesterol levels, defined as a blood TC less than 240 mg/dL or LDL cholesterol less than 160 mg/dL; 18 were conducted on subjects with high TC levels, defined as TC levels less than 240 mg/dL or LDL cholesterol greater than or equal to 160 mg/dL; and 3 studies included subjects with desirable or borderline TC levels and subjects with high TC levels. Of the 46 intervention studies that looked at the relationship between blood TC and/or LCL cholesterol and soy protein intake, only 19 intervention studies showed a benefit in significantly reducing the risk of CHD, while the other 27 intervention studies did not. Study findings also were inconsistent regardless of whether soy protein was added to diet as a supplement or whether the studies were substitution or feeding studies. The study findings also were inconsistent regardless of the study size (10 subjects to 179 subjects) or the dose of soy protein (3 g to 92 g/day). Of the 12 high or moderate quality intervention studies that measured SBP or DBP from which a conclusion could be drawn, only 4 showed a benefit in lowering SBP or DBP with soy protein consumption, while the other 8 studies did not show a benefit. Again, the study findings were inconsistent regardless of baseline SBP or DBP, study size (18 subjects to 276 subjects), or dose (18 g to 60 g/day). Consistency of findings among similar and different study designs is important for evaluating causation and the strength of scientific evidence (Ref. 1). The totality of the evidence does not provide a basis on which experts would find SSA because of the high degree of inconsistency of findings across similar and different studies with high or moderate methodological quality. This degree of inconsistency would not be seen when SSA exists because, when there is SSA, we would find most of the studies to consistently find a beneficial relationship between a substance and a disease risk.
Although there is some evidence that suggests a relationship between soy protein intake and reduced risk of CHD, the strength of the totality of the current, publicly available scientific evidence, discussed in sections V and VI and the references cited therein, which includes many studies that post-date the publication of our 1999 rule, is inconsistent and not conclusive. See also tables 4-8 in Ref. 230. The additional evidence now available to us includes a number of new studies that do not support the relationship, and a number of studies that are inconclusive that also do not support a relationship. This combined body of evidence represents the totality of the scientific evidence that is currently available. We have now evaluated this entire body of evidence, which consists of the studies in the 1999 rule as well as new evidence published since that time, using the evidence based process described in our 2009 guidance. The totality of the evidence, which includes the new, non-supportive studies, does not support the statutory standard for authorizing a health claim. We have determined that the totality of the scientific evidence does not provide significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported. Therefore, we have tentatively concluded that, currently, there is not significant scientific agreement among experts, under section 403(r)(3)(B)(i) of the FD&C Act, that a health claim about a relationship between soy protein intake and CHD risk is supported by the evidence. We request comment and any supporting data and information concerning this tentative conclusion. However, while the totality of the publicly available scientific evidence does not support a finding of SSA, if, when we finalize this rule, we conclude there is not SSA, but there is some credible evidence for the use of a qualified health claim about the relationship between soy protein and a reduced risk of CHD, we intend to issue a statement of enforcement discretion for the use of a qualified health claim.
In the 1999 soy protein final rule authorizing the use of a health claim regarding soy protein and the risk of CHD (64 FR 57700) (now codified at § 101.82) (the 1999 authorized soy protein health claim), the petitioner determined that use of soy as a dietary protein is generally recognized as safe. Under the health claim petition process, we evaluate whether the proponent of the claim demonstrates, to FDA's satisfaction, that the food ingredient is “safe and lawful” under the applicable food safety provisions of the FD&C Act. In the 1999 soy protein final rule, we concluded that there was not sufficient evidence to challenge the petitioner's assertion that soy protein ingredients are GRAS. The petitioner met the showing required by § 101.14(b)(3)(ii) that the substance be “safe and lawful.” We have reviewed the scientific evidence relative to the safety of soy protein as a food ingredient and the evidence does not change our previous conclusion that the use of soy protein at the levels necessary to justify a claim has been demonstrated, to our satisfaction, to be safe and lawful under the applicable food safety provisions of the FD&C Act.
As discussed above, FDA may reevaluate the science related to an authorized health claim and may take action to revoke the claim (see section 403(r)(7)(B) of the FD&C Act (21 U.S.C. 343(r)(7)(B)). Based on our review of the totality of the publicly available scientific evidence, we have tentatively concluded that the SSA standard is not met for a relationship between soy protein and reduced risk of CHD. Therefore, we are proposing to revoke
We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, Executive Order 13771, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 13771 requires that the costs associated with new regulations shall “be offset by the elimination of existing costs associated with at least two prior regulations.” It has been determined that this proposed rule is an action that does not impose more than de minimis costs as described below and thus is not a regulatory or deregulatory action for purposes of Executive Order 13771. This proposed rule is a significant regulatory action under Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because up to 40 small businesses could be required to relabel one or more products, we find that the proposed rule may 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 proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $148 million, using the most current (2016) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in any year expenditure that meets or exceeds this amount.
The costs of this rule are relabeling the estimated 200 to 300 products currently making the health claim. We estimate total annualized costs of $35,000 to $81,000, when the relabeling costs are annualized over 20 years at a 7-percent discount rate. The initial, one-time costs are $370,000 to $860,000.
The benefit of this rule is better information for the consumers who are considering purchasing products with soy protein. This may generate an unknown amount of increased consumer surplus. Some consumers may react to this new information by switching their consumption to products that they enjoy more, or products that still have an authorized health claim. We request public comment on how many consumers are likely to react to the changes in health claims caused by this proposed rule, and what the nature of their reaction will be. By basing their consumption decisions on more recent and accurate scientific information, they will get more consumer surplus, in the form of enjoyment and/or potential health benefits, from the bundle of products they consume.
The Economic Analysis of Impacts of the proposed rule performed in accordance with Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act is available at
We intend that the effective date for a final rule resulting from this rulemaking be 30 days after the final rule's date of publication in the
With respect to a compliance date, we intend that any adjustments to a product's labeling occur in a manner consistent with our uniform compliance date (see 81 FR 85156, November 25, 2016). Thus, if we issue a final rule before December 31, 2018, then the compliance date would be January 1, 2020.
We have determined under 21 CFR 25.32(p) that this action, revoking a health claim, is categorically excluded from an environmental assessment or an environmental impact statement.
FDA tentatively concludes that this proposed rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires Agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State law conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts “any requirement respecting any claims of the type described in [21 U.S.C. 343(r)(1)] made in the label or labeling of food that is not identical to the requirement of [21 U.S.C. 343(r)] * * *.” 21 U.S.C. 343-1(a)(5). However, the statutory provision does not preempt any State requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food (Pub. L. 101-535, section 6, 104 Stat. 2353 (1990)). If this proposed rule is made final, the final rule would revoke the health claim related to soy protein and coronary heart disease in the label or labeling of food under 21 U.S.C. 343(r).
The following references are on display in the Dockets Management Staff (see
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 101 be amended as follows:
15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271.
Postal Service
Proposed rule.
The Postal Service is proposing to amend
Submit comments on or before November 30, 2017.
Mail or deliver written comments to the manager, Product Classification, U.S. Postal Service, 475 L'Enfant Plaza SW., Room 4446, Washington, DC 20260-5015. If sending comments by email, include the name and address of the commenter and send to
Heather Dyer at (207) 482-7217, or Garry Rodriguez at (202) 268-7281.
The Postal Service is proposing to amend DMM sections 705.20,
Administrative practice and procedure, Postal Service.
Although we are exempt from the notice and comment requirements of the Administrative Procedure Act (5 U.S.C. 553(b), (c)) regarding proposed rulemaking by 39 U.S.C. 410(a), we invite public comments on the following proposed revisions to
5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-1737; 39 U.S.C. 101, 401, 403, 404, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3622, 3626, 3632, 3633, and 5001.
* * * For additional information on the eInduction Option see Publication 6850,
The six eInduction option verification descriptions, error thresholds, and postage assessments, are provided in 20.5.1 through 20.5.6.
An Undocumented Container error occurs when a scanned IMcb is not found in an eDoc, or is included in an eDoc and associated to a postage statement in estimated (EST) status. Containers will be flagged as Undocumented 10 days after the scan unload date/time if no eDoc has been uploaded or if the postage statement is still in EST status. The threshold is 0%. All errors will be subject to an
All containers must be linked to a finalized postage statement in eInduction to verify payment. The error threshold is 0%. Payment verification errors are logged when a scanned and accepted eInduction container is associated with a postage statement that is not in FIN or FPP status at the time of scanning. Containers above the error threshold will be subject to an assessment amount equal to the containers eDoc postage amount as indicated on the non-finalized postage statements. For payment errors logged on physical siblings of logical containers, the full postage of the logical container is charged to the first physical sibling container scanned. Any additional scans among other physical siblings will log errors, but will not result in an additional charge. Assessments will be logged against the eDoc submitter CRID.
eInduction requires IMcbs to remain unique for 45 days. The error threshold is 0.17%. Duplicate errors are logged when an IMcb is scanned and accepted during more than one FAST appointment in the previous 45 days. Though a duplicate error will not be logged if the duplicate scan takes place within 5 hours of the original scan. Errors above the threshold are subject to an assessment amount equal to the average postage paid for each container mailed by the eDoc submitter CRID over the invoice period.
Containers claiming a destination entry discount must be delivered to the correct entry locations per the active version of the Mail Direction File. The error threshold is 1.05%. Misshipped errors are logged when the container is scanned at an incorrect entry location, per the Mail Direction File. Errors over the threshold are subject to an assessment amount equal to the difference between the eDoc postage claimed, and the correct postage amount for the container. For misshipped errors logged against physical siblings of logical containers, postage is recalculated on the logical container, and divided by the number of physical siblings. This amount is then applied to each physical sibling in error to the eDoc submitter CRID.
Pieces claiming a Zone Discount must be entered at the valid facility. The error threshold is 0.01%. Zone Discount errors are logged when the Zone Discount claimed in the eDoc is a lower entry zone than the zone calculated between the location where the container was entered, and the eDoc destination. Errors above the threshold are subject to an assessment amount equal to the difference between the eDoc postage claimed, and the correct postage amount for the container. For containers claiming a non-numeric Zone Discount in the eDoc, correct postage amount is calculated using the piece rate for the Entry Discount that is valid at the actual entry point for the mail class, shape, weight, mail prep, and presort identified in the eDoc. For Zone Discount errors logged against physical siblings of logical containers, postage is recalculated on the logical container, and divided by the number of physical siblings. This amount is then applied to each physical sibling in error to the eDoc submitter CRID.
eInduction pieces are required to be entered at a valid facility when claiming a destination entry discount. The error threshold is 0.5%. EPD errors are logged when one or more pieces on a container claim an entry discount level that is not available at the location where the container was entered. Errors above threshold are subject to an assessment amount equal to the difference between the eDoc postage claimed and the correct postage amount for the container. For EPD errors logged against physical siblings of logical containers, postage is recalculated on the logical container, and divided by the number of physical siblings. This amount is then applied to each physical sibling in error to the eDoc submitter CRID.
* * * For additional information, on the Seamless Acceptance Program see Publication 6850,
The five seamless acceptance program verification descriptions, error thresholds, and postage assessments, are provided in 22.4.1 through 22.4.5.
An Undocumented error is logged when the IMb gathered during sampling or MPE scan cannot be linked to any eDoc submitted within the last 45 days. The error threshold is 0.3%. Pieces above the error threshold will be subject to an assessment amount equal to the average piece rate by mail class and CRID for the assessment month.
A valid delivery point must be provided in the piece IMb. The error threshold is 2%. Delivery Point errors are logged when the delivery point provided in the eDoc is either not valid, or contains a generic +4 information with an address record type that is not General Delivery. Errors above the threshold are subject to an assessment amount equal to difference between the eDoc piece postage and correct postage amount.
A Nesting/Sortation error is logged when the piece scanned is nested in a different tray or bundle than the tray or bundle that was identified in the eDoc. The error threshold is 1%. Errors above this threshold are subject to an assessment amount equal to the difference between the eDoc piece postage and the correct postage amount.
The Postage Adjustment Factor (PAF) is a method to apply an error rate determined from handheld scanner samplings to the entire population of mailings within a calendar month. PAF is calculated on a monthly basis and measures the difference between the correct postage and the postage paid, expressed as a ratio of the correct postage due to the sum of eDoc postage for the sampled pieces. General PAF is used for errors in postage and weight verifications. The General PAF threshold is 1.05. A mailer will only be subject to an assessment when the eDoc submitter has exceeded the PAF threshold in the current billing month and three or more times in the previous 11 billing months. The General PAF is applied to the total monthly eDoc postage for the eDoc submitter and assessments are issued to the eDoc submitter.
The Mail Characteristic, Postage Adjustment Factor (PAF), is used for errors in the processing category, mail class, nonprofit eligibility and content. The threshold is 1.05. A mailer will only be subject to an assessment when the eDoc submitter has exceeded the Mail Characteristic PAF threshold in the current billing month and three or more times in the previous 11 billing months. The Mail Characteristic PAF is applied at the eDoc Submitter CRID level and is calculated using the adjusted and eDoc postage attributed to the Mail Owner.
* * * For additional information on the full-service automation option see Publication 6850,
The six full-service verification descriptions, error thresholds, and postage assessments, are provided in 23.6.1 through 23.6.6.
The MID is a code used for identification of mail's responsible party. A valid MID is one that is registered within the Postal Service systems and provided in the eDoc. The error threshold is 2%. Errors over the threshold will be subject to an assessment amount equal to the removal of the full-service discount claimed for each piece in error above the threshold.
The STID is a three-digit code included in the IMb for a mailpiece to provide mail class and service level. The error threshold is 2%. Errors over the threshold will be subject to an assessment amount equal to the removal of the full-service discount claimed for each piece in error above the threshold.
The By/For relationship recognizes the Mail Owner and Mail Service Provider in the eDoc. The error threshold is 5%. An error occurs when a valid Mail Preparer is not identified, a valid Mail Owner is not identified, Mail Preparer is incorrectly recorded as the Mail Owner, or the Mail Owner is incorrectly identified as the Mail Preparer. Errors above the threshold are subject to an assessment amount equal to the removal of the full-service discount claimed for each piece in error above the threshold.
Barcode uniqueness is met when a barcode is unique across all mailers and mailings for 45 days. The error threshold is 2%. Errors occur when the IMcb, IMtb or IMb is not unique across all mailings from all mailers over the previous 45 days of the postage statement mailing date that was provided in the eDoc. Errors above the threshold are subject to an assessment equal to the removal of the full-service discount claimed for each piece in error above the threshold.
The entry facility location must be identified in the eDoc by a Locale Key or ZIP Code. The error threshold is 2%. Errors above the threshold are subject to an assessment amount of the full-service discount claimed for each piece in error above the threshold.
Mailings that will be copalletized must be identified in the original eDoc submission and properly documented within 14 days of the mailing date to link trays or sacks to the container. The error threshold is 5%. Errors above the threshold are subject to an assessment amount equal to the full-service discount claimed.
If the proposal is adopted, we will publish an appropriate amendment to 39 CFR part 111 to reflect these changes.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to grant a petition submitted by Blanchard Refining Company LLC—(Blanchard) to exclude (or delist) the residual solids generated from the reclamation of oil bearing hazardous secondary materials (OBSMs) on-site at Blanchard's Galveston Bay Refinery (GBR), located in Texas City, Texas from the lists of hazardous wastes. EPA used the Delisting Risk Assessment Software (DRAS) Version 3.0.35 in the evaluation of the impact of the petitioned waste on human health and the environment.
We will accept comments until November 30, 2017. We will stamp comments received after the close of the comment period as late. These late comments may or may not be considered in formulating a final decision. Your requests for a hearing must reach EPA by November 15, 2017. The request must contain the information prescribed in 40 CFR 260.20(d) (hereinafter all CFR cites refer to 40 CFR unless otherwise stated).
Submit your comments, identified by Docket ID No. EPA-R06-RCRA-2017-0556, at
For technical information regarding the Blanchard Refinery petition, contact Michelle Peace at 214-665-7430 or by email at
Your requests for a hearing must reach EPA by November 15, 2017. The request must contain the information described in 40 CFR 260.20(d).
Blanchard submitted a petition under 40 CFR 260.20 and 260.22(a). Section 260.20 allows any person to petition the Administrator to modify or revoke any provision of parts 260 through 266, 268 and 273. Section 260.22(a) specifically provides generators the opportunity to petition the Administrator to exclude a waste on a “generator specific” basis from the hazardous waste lists. EPA bases its proposed decision to grant the petition on an evaluation of waste-specific information provided by the petitioner. This decision, if finalized, would conditionally exclude the petitioned waste from the requirements of hazardous waste regulations under the Resource Conservation and Recovery Act (RCRA).
If finalized, EPA would conclude that Blanchard's petitioned waste is non-hazardous with respect to the original listing criteria. EPA would also conclude that Blanchard's reclamation process minimizes short-term and long-term threats from the petitioned waste to human health and the environment.
The information in this section is organized as follows:
EPA is proposing to approve the delisting petition submitted by Blanchard to have the residual solids excluded, or delisted from the definition of a hazardous waste. The residual solids are listed as F037. Blanchard's residual solids are listed as a hazardous waste, based on the potential presence of Appendix VII inorganic constituents of concern, lead and chromium, and Appendix VII organic constituents of concern benzene, benzo(a)pyrene and chrysene.
Blanchard's petition requests an exclusion from the F037 waste listing pursuant to 40 CFR 260.20 and 260.22. Blanchard does not believe that the petitioned waste meets the criteria for which EPA listed it. Blanchard also believes no additional constituents or factors could cause the waste to be hazardous. EPA's review of this petition included consideration of the original listing criteria and the additional factors required by the Hazardous and Solid Waste Amendments of 1984 (HSWA). See section 3001(f) of RCRA, 42 U.S.C. 6921(f), and 40 CFR 260.22 (d)(1)-(4) (hereinafter all sectional references are to 40 CFR unless otherwise indicated). In making the initial delisting determination, EPA evaluated the petitioned waste against the listing criteria and factors cited in §§ 261.11(a)(2) and (a)(3). Based on this review, EPA agrees with the petitioner that the waste is non-hazardous with respect to the original listing criteria. If EPA had found, based on this review, that the waste remained hazardous based on the factors for which the waste was originally listed, EPA would have proposed to deny the petition. EPA evaluated the waste with respect to other factors or criteria to assess whether there is a reasonable basis to believe that such additional factors could cause the waste to be hazardous. EPA considered whether the waste is acutely toxic, the concentration of the constituents in the waste, their tendency to migrate and to bioaccumulate, their persistence in the environment once released from the waste, plausible and specific types of management of the petitioned waste, the quantities of waste generated, and waste variability. EPA believes that the petitioned waste does not meet the listing criteria and thus should not be a listed waste. EPA's proposed decision to delist waste from Blanchard is based on the information submitted in support of this rule, including descriptions of the wastes and analytical data resulting from Blanchard's delisting demonstration conducted on the petitioned waste.
If the residual solids are delisted, contingent upon approval of the delisting petition, storage containers with Blanchard's delisted residual solids will be transported to an authorized, solid waste landfill (
RCRA section 3001(f) specifically requires EPA to provide a notice and an opportunity for comment before granting or denying a final exclusion. Thus, EPA will not grant the exclusion until it addresses all timely public comments (including those at public hearings, if any) on this proposal.
RCRA section 3010(b)(1) at 42 USCA 6930(b)(1), allows rules to become effective in less than six months when the regulated facility does not need the six-month period to come into compliance. That is the case here, because this rule, if finalized, would reduce the existing requirements for persons generating hazardous wastes.
EPA believes that this exclusion should be effective immediately upon final publication because a six-month deadline is not necessary to achieve the purpose of section 3010(b), and a later effective date would impose unnecessary hardship and expense on this petitioner. These reasons also provide good cause for making this rule effective immediately, upon final
Because EPA is issuing this exclusion under the Federal RCRA delisting program, only states subject to Federal RCRA delisting provisions would be affected. This would exclude states which have received authorization from EPA to make their own delisting decisions.
EPA allows states to impose their own non-RCRA regulatory requirements that are more stringent than EPA's, under section 3009 of RCRA, 42 U.S.C. 6929. These more stringent requirements may include a provision that prohibits a Federally issued exclusion from taking effect in the state. Because a dual system (that is, both Federal (RCRA) and state (non-RCRA) programs) may regulate a petitioner's waste, EPA urges petitioners to contact the state regulatory authority to establish the status of their wastes under the state law.
EPA has also authorized some states (for example, Louisiana, Oklahoma, Georgia, Illinois) to administer a RCRA delisting program in place of the Federal program, that is, to make state delisting decisions. Therefore, this exclusion does not apply in those authorized states unless that state makes the rule part of its authorized program. If Blanchard transports the delisted waste to or manages the delisted waste in any state with delisting authorization, Blanchard must obtain delisting authorization from that state before it can manage the delisted waste as non-hazardous in the state.
EPA published an amended list of hazardous wastes from non-specific and specific sources on January 16, 1981, as part of its final and interim final regulations implementing section 3001 of RCRA. EPA has amended this list several times and published it in 40 CFR 261.31 and 261.32.
EPA lists these wastes as hazardous because: (1) The wastes typically and frequently exhibit one or more of the characteristics of hazardous wastes identified in Subpart C of part 261 (that is, ignitability, corrosivity, reactivity, and toxicity), (2) the wastes meet the criteria for listing contained in § 261.11(a)(2) or (a)(3), or (b) the wastes are mixed with or derived from the treatment, storage or disposal of such characteristic and listed wastes and which therefore become hazardous under § 261.3(a)(2)(iv) or (c)(2)(i), known as the “mixture” or “derived-from” rules, respectively.
Individual waste streams may vary, however, depending on raw materials, industrial processes, and other factors. Thus, while a waste described in these regulations or resulting from the operation of the mixture or derived-from rules generally is hazardous, a specific waste from an individual facility may not be hazardous.
For this reason, 40 CFR 260.20 and 260.22 provide an exclusion procedure, called delisting, which allows persons to prove that EPA should not regulate a specific waste from a particular generating facility as a hazardous waste.
A delisting petition is a request from a facility to EPA or an authorized state to exclude wastes from the list of hazardous wastes. The facility petitions EPA because it does not consider the wastes hazardous under RCRA regulations.
In a delisting petition, the petitioner must show that wastes generated at a particular facility do not meet any of the criteria for which the waste was listed. The criteria for which EPA lists a waste are in part 261 and further explained in the background documents for the listed waste.
In addition, under 40 CFR 260.22, a petitioner must prove that the waste does not exhibit any of the hazardous waste characteristics (that is, ignitability, reactivity, corrosivity, and toxicity) and present sufficient information for EPA to decide whether factors other than those for which the waste was listed warrant retaining it as a hazardous waste. (See part 261 and the background documents for the listed waste.)
Generators remain obligated under RCRA to confirm whether their waste remains non-hazardous based on the hazardous waste characteristics, even if EPA has “delisted” the waste.
Besides considering the criteria in 40 CFR 260.22(a) and § 3001(f) of RCRA, 42 U.S.C. 6921(f), and in the background documents for the listed wastes, EPA must consider any factors (including additional constituents) other than those for which EPA listed the waste, if a reasonable basis exists that these additional factors could cause the waste to be hazardous.
EPA must also consider as hazardous waste mixtures containing listed hazardous wastes and wastes derived from treating, storing, or disposing of listed hazardous waste. See § 261.3(a)(2)(iii and iv) and (c)(2)(i), called the “mixture” and “derived-from” rules, respectively. These wastes are also eligible for exclusion and remain hazardous wastes until excluded. See 66 FR 27266 (May 16, 2001).
In June 2017, Blanchard petitioned EPA to exclude from the lists of hazardous wastes contained in §§ 261.31 and 261.32, residual solids (F037) generated during reclamation activities conducted at its GBR facility located in Texas City, Texas. The waste falls under the classification of listed waste pursuant to §§ 261.31 and 261.32. Specifically, in its petition, Blanchard requested that EPA grant a conditional exclusion for the annual generation volume of 20,000 cubic yards of F037 residual solids.
Blanchard owns and operates the GBR facility, located in Texas City, Galveston County, Texas. Blanchard is a wholly-owned subsidiary of Marathon Petroleum Company LP. Blanchard's demonstration evaluated representative samples of its residual solids resulting from the indirect thermal desorption reclamation of OBSMs managed on-site at Blanchard's GBR facility. OBSMs managed on-site at Blanchard's GBR facility result from separate management practices within GBR's petroleum refining operations. Blanchard's approved Sampling and Analysis Plan (SAP) identified three (3) management practices, which result in the generation of three (3) corresponding categories of OBSMs with unique physical properties. The three (3) identified categories of Blanchard's OBSMs include, Category 1, Oil/Water/Solid Separation Sludges (K048 through K052, F037 and F038); Category 2, Crude Oil and Clarified Slurry Oil Sediments (K169 and K170); and Category 3, Stabilized Spent Hydrotreating and Hydrorefining Catalysts (K171 and K172).
Blanchard's demonstration utilized a commercial indirectly-fired thermal desorption unit (“ITDU”) located at US Ecology Texas' (“USET”) permitted commercial facility in Robstown, Texas. Blanchard considered it prudent to
USET's commercial ITDU was designed and constructed by TD*X Associates LP (“TD*X”), located in Beaumont, Texas. TD*X currently operates the commercial ITDU on-site at USET's Robstown facility, under contract with USET. USET has extensive experience in the management and processing of Blanchard's OBSMs, and is currently contracted with Blanchard to provide such services at USET's Robstown facility.
Blanchard has entered into a services agreement with US Ecology Thermal Services LLC (“USETS”) to provide and operate an ITDU, on-site at its GBR facility. USETS is the refinery services affiliate of USET. Blanchard's proposed ITDU will be designed, constructed and operated by TD*X, as part of USETS's services agreement with Blanchard. The processing capabilities, efficiencies and capacity of Blanchard's proposed ITDU are comparable to USET's commercial ITDU that was utilized under Blanchard's demonstration.
To support its petition, Blanchard conducted individual sampling events on residual solids resulting from the reclamation of Blanchard's three (3) identified categories of OBSMs. Each separate sampling event consisted of four (4) composite samples taken during a 24-hour period of representative operation. Each composite sample was comprised of individual grab samples (
EPA believes that the descriptions of the Blanchard analytical characterization provide a reasonable basis to grant Blanchard's petition for an exclusion of the residual solids. EPA believes the data submitted in support of the petition show the residual solids is non-hazardous. Analytical data for the residual solids samples were used in the DRAS to develop delisting levels. The residual solids from Category 3 can only be delisted if stabilization of the residual solids occur. Data from the stabilized Category 3 residual solids demonstrate the concentrations from the stabilized residuals meet the delisting requirements. The data summaries for COCs are presented in Table I. EPA has reviewed the sampling procedures used by Blanchard and has determined that it satisfies EPA criteria for collecting representative samples of the variations in constituent concentrations in the residual solids. In addition, the data submitted in support of the petition show that COCs in Blanchard's waste are presently below health-based levels used in the delisting decision-making. EPA believes that Blanchard has successfully demonstrated that the residual solids are non-hazardous.
For this delisting determination, EPA used such information gathered to identify plausible exposure routes (
EPA believes that the EPACMTP fate and transport model represents a reasonable worst-case scenario for possible groundwater contamination resulting from disposal of the petitioned waste in a surface impoundment, and that a reasonable worst-case scenario is appropriate when evaluating whether a waste should be relieved of the protective management constraints of RCRA Subtitle C. The use of some reasonable worst-case scenarios resulted in conservative values for the compliance-point concentrations and ensures that the waste, once removed from hazardous waste regulation, will not pose a significant threat to human health or the environment.
The DRAS also uses the maximum estimated waste volumes and the maximum reported total concentrations to predict possible risks associated with releases of waste constituents through surface pathways (
In most cases, because a delisted waste is no longer subject to hazardous waste control, EPA is generally unable to predict, and does not presently control, how a petitioner will manage a waste after delisting. Therefore, EPA currently believes that it is inappropriate to consider extensive site-specific factors when applying the fate and transport model. EPA does control the type of unit where the waste is disposed. The waste must be disposed in the type of unit the fate and transport model evaluates.
The DRAS results which calculate the maximum allowable concentration of chemical constituents in the waste are presented in Table I. Based on the comparison of the DRAS and TCLP Analyses results found in Table I, the petitioned waste should be delisted because no COCs tested are likely to be present or formed as reaction products or by-products in Blanchard's waste.
EPA concluded, after reviewing Blanchard's processes, that no other hazardous COCs, other than those for which tested, are likely to be present or formed as reaction products or by-products in the waste. In addition, on the basis of explanations and analytical data provided by Blanchard, pursuant to § 260.22, EPA concludes that the petitioned waste does not exhibit any of the characteristics of ignitability, corrosivity, reactivity or toxicity. See §§ 261.21, 261.22 and 261.23, respectively.
During the evaluation of Blanchard's petition, EPA also considered the potential impact of the petitioned waste via non-groundwater routes (
The descriptions of Blanchard's hazardous waste process and analytical characterization provide a reasonable basis for EPA to grant the exclusion. The data submitted in support of the petition show that constituents in the waste are below the leachable concentrations (see Table I). EPA believes that Blanchard's residual solids will not impose any threat to human health and the environment.
Thus, EPA believes Blanchard should be granted an exclusion for the residual solids. EPA believes the data submitted in support of the petition show Blanchard's residual solids is non-hazardous. The data submitted in support of the petition show that constituents in Blanchard's waste is presently below the compliance point concentrations used in the delisting decision and would not pose a substantial hazard to the environment. EPA believes that Blanchard has successfully demonstrated that the residual solids sludge is non-hazardous.
EPA therefore, proposes to grant an exclusion to Blanchard for the residual solids described in its petition. EPA's decision to exclude this waste is based on descriptions of the treatment activities associated with the petitioned waste and characterization of the residual solids.
If EPA finalizes the proposed rule, EPA will no longer regulate the petitioned waste under Parts 262 through 268 and the permitting standards of Part 270.
The petitioner, Blanchard, must comply with the requirements in 40 CFR part 261, Appendix IX, Table 1. The text below gives the rationale and details of those requirements.
This paragraph provides the levels of constituents for which Blanchard must test the residual solids, below which these wastes would be considered non-hazardous. EPA selected the set of inorganic and organic constituents specified in Paragraph (1) of 40 CFR part 261, Appendix IX, Table 1, (the exclusion language) based on information in the petition. EPA compiled the inorganic and organic constituents list from the composition of the waste, descriptions of Blanchard's treatment process, previous test data provided for the waste, and the respective health-based levels used in delisting decision-making. These delisting levels correspond to the allowable levels measured in the TCLP concentrations.
The purpose of this paragraph is to ensure that Blanchard manages and disposes of any residual solids that contains hazardous levels of inorganic and organic constituents according to Subtitle C of RCRA. Managing the residual solids as a hazardous waste until the verification testing is performed will protect against improper handling of hazardous material. If EPA determines that the data collected under this paragraph do not support the data provided for in the petition, the exclusion will not cover the petitioned waste. The exclusion is effective upon publication in the
Blanchard must complete a rigorous verification testing program on the residual solids to assure that the solids do not exceed the maximum levels specified in Paragraph (1) of the exclusion language. This verification program will occur as residual solids are discharged from Blanchard's reclamation process, prior to containment and disposal. The volume of residual solids generated may not exceed 20,000 cubic yards of sludge material annually. Any volume of residual solids generated in excess of 20,000 cubic yards during any twelve-month period must be disposed as hazardous wastes. If EPA determines that the data collected under this paragraph do not support the data provided for the petition, the exclusion will not cover the generated residual solids. If the data from the verification testing program demonstrate that the residual solids meet the delisting levels, Blanchard may commence disposing of the residual solids as non-hazardous solid waste. Blanchard will notify EPA in writing, if and when it begins and ends disposal of the delisted residual solids.
If Blanchard significantly changes the reclamation process described in its petition or starts any processes that generate(s) the waste that may or could affect the composition or type of waste generated as established under Paragraph (1) (by illustration, but not limitation, changes in equipment or operating conditions of the treatment process), they must notify EPA in writing. Blanchard may no longer handle the residual solids generated from the new process as non-hazardous until they have completed verification testing described in Paragraph (3)(A) and (B).
Blanchard describes an application where it may periodically elect to modify operating conditions under its reclamation process to accommodate the addition of chemical stabilization reagents. The facility also provided data on stabilized materials as part of its petition. In the event Blanchard initiates the inclusion of stabilization during operation of its reclamation process, they may no longer handle the residual solids generated from the modified process as non-hazardous until the residual solids meet the delisting levels set in Paragraph (1) under initial verification testing requirements set in Paragraph (3)(A) and verify that no additional constituents are leaching from the stabilized residual solids. Following completion of modified operation of its reclamation process, Blanchard can resume normal operating conditions and testing requirements under Paragraph (3), which were in place prior to initiating the addition of stabilization.
To provide appropriate documentation that Blanchard's residual solids meet the delisting levels, Blanchard must compile, summarize, and keep delisting records on-site for a minimum of five years. It should keep all analytical data obtained through Paragraph (3) of the exclusion language including quality control information for five years. Paragraph (4) of the exclusion language requires that Blanchard furnish these data upon request for inspection by any employee or representative of EPA or the State of Texas.
If the proposed exclusion is made final, it will apply only to the volume of 20,000 cubic yards of residual solids generated annually at Blanchard's GBR facility after successful verification testing. EPA would require Blanchard to
When this exclusion becomes final, Blanchard's management of the residual solids covered by this petition would be relieved from Subtitle C jurisdiction, and the residual solids from Blanchard will be disposed of in an authorized, solid waste landfill (
The purpose of Paragraph (6) of the exclusion language is to require Blanchard to disclose new or different information related to a condition at Blanchard's facility or disposal of the waste, if it is pertinent to the delisting. Blanchard must also use this procedure, if the annual testing fails to meet the levels found in Paragraph (1). This provision will allow EPA to reevaluate the exclusion, if a source provides new or additional information to EPA. EPA will evaluate the information on which EPA based the decision to see if it is still correct, or if circumstances have changed so that the information is no longer correct or would cause EPA to deny the petition, if presented. This provision expressly requires Blanchard to report differing site conditions or assumptions used in the petition, in addition to failure to meet the annual testing conditions within 10 days of discovery. If EPA discovers such information itself or from a third party, it can act on it as appropriate. The language being proposed is similar to those provisions found in RCRA regulations governing no-migration petitions at § 268.6.
EPA believes that it has the authority under RCRA and the Administrative Procedures Act (APA), 5 U.S.C. 551 (1978)
EPA believes a clear statement of its authority in delisting is merited, in light of EPA's experience. See Reynolds Metals Company at 62 FR 37694 and 62 FR 63458 where the delisted waste leached at greater concentrations in the environment than the concentrations predicted when conducting the TCLP, thus leading EPA to repeal the delisting. If an immediate threat to human health and the environment presents itself, EPA will continue to address these situations on a case-by-case basis. Where necessary, EPA will make a good cause finding to justify emergency rulemaking.
In order to adequately track wastes that have been delisted, EPA is requiring that Blanchard provide a one-time notification to any state regulatory agency through which or to which the delisted waste is being carried. Blanchard must provide this notification sixty (60) days before commencing this activity.
If Blanchard violates the terms and conditions established in the exclusion, EPA will start procedures to withdraw the exclusion. Where there is an immediate threat to human health and the environment, EPA will evaluate the need for enforcement activities on a case-by-case basis. EPA expects Blanchard to conduct the appropriate waste analysis and comply with the criteria explained above in Paragraph (1) of the exclusion.
EPA is requesting public comments on this proposed decision. Submit your comments, identified by Docket ID No. EPA-R06-RCRA-2017-0556, at
You should submit requests for a hearing to Kishor Fruitwala, Section Chief (6MM-RP), Multimedia Division, Environmental Protection Agency (EPA), 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202.
You may review the RCRA regulatory docket for this proposed rule at the Environmental Protection Agency Region 6, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202. It is available for viewing in EPA Freedom of Information Act Review Room from 9:00 a.m. to 4:00 p.m., Monday through Friday, excluding Federal holidays. Call (214) 665-6444 for appointments. The public may copy material from any regulatory docket at no cost for the first 100 pages, and at fifteen cents per page for additional copies. Docket materials are available either electronically in
Under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), this rule is not of general applicability and therefore, is not a regulatory action subject to review by the Office of Management and Budget (OMB). This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Similarly, because this rule will affect only a particular facility, this proposed rule does not have tribal implications,
The Congressional Review Act, 5 U.S.C. 801
EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. The Agency's risk assessment did not identify risks from management of this material in an authorized, solid waste landfill (
Environmental protection, Hazardous Waste, Recycling, Reporting and record-keeping requirements.
For the reasons set forth in the preamble, 40 CFR part 261 is proposed to be amended as follows:
42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y) and 6938.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of application for exemption; request for comments.
FMCSA announces that the National Pork Producers Council (NPPC) has requested an exemption from the requirement that a motor carrier require each of its drivers to use an electronic logging device (ELD) no later than December 18, 2017, to record the driver's hours-of-service (HOS). NPPC states it requests the exemption for all livestock haulers as defined in the application (
Comments must be received on or before November 30, 2017.
You may submit comments identified by Federal Docket Management System (FDMS) Number FMCSA-2017-0297 by any of the following methods:
•
•
•
•
• Each submission must include the Agency name and the docket number for this notice. Note that DOT posts all comments received without change to
For information concerning this notice, contact Mr. Tom Yager, Chief, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; Telephone: 614-942-6477. Email:
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice (FMCSA-2017-0297), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comments online, go to
FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain parts of the Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the
The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the
NPPC filed this application for exemption on behalf of itself and the following organizations: American Beekeeping Federation; American Farm Bureau Federation; Livestock Marketing Association; National Aquaculture Association; National Cattleman's Beef Association; North American Meat Institute; and the U.S. Cattlemen's Association.
NPPC requests an exemption for all livestock haulers, which they define as “livestock, poultry, aquaculture, and insect producers, processors and transporters,” from the requirement in 49 CFR part 395 that no later than December 18, 2017, a motor carrier require each of its drivers to use an electronic logging device (ELD) to record the driver's hours-of-service (HOS).
NPPC states that it is seeking this limited exemption from ELDs for livestock haulers because:
(1) Livestock haulers are not, and will not be prepared to meet the December 18, 2017 compliance date;
(2) The current ELD retail marketplace does not clearly support the needs of livestock haulers and questions remain as to whether current ELD devices can accommodate HOS exemptions currently utilized by the livestock industry;
(3) There is a significant lack of education and awareness by livestock haulers and the livestock producers they service regarding the ELD mandate, current exemptions, and the use and operation of ELDs, requiring time for adequate outreach and training to take place; and
(4) Concern over the ELD mandate has exposed incompatibilities between the HOS rules and the livestock industry, and is causing disruption for livestock haulers, increasing already severe driver shortages, and endangering the health and welfare of the millions of animals transported by livestock carriers daily.
NPPC notes that their industry is encountering two problem areas regarding the use of ELDs. First, because the ELD initiative fails to directly address the unique requirements of the livestock industry, those drivers who are aware of the program have had difficulty researching the ELD marketplace and identifying cost-effective solutions that are compatible with livestock hauling. NPPC claims that the vendors in the commercial ELD marketplace lack an understanding of the unique needs of the livestock industry and essential design features for their products. Second, nationwide, the average age of American truck drivers is 49. For livestock haulers, the age is likely significantly higher. As a result, these drivers are less familiar with the use of new technology and require more time to train on ELD use. Forcing these drivers to comply with the ELD mandate without appropriate training unfairly discriminates against older drivers who are otherwise more experienced and qualified to haul livestock.
NPPC claims that granting this exemption for the extremely limited segment of the overall transportation economy engaged in the shipment of livestock, will achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent an exemption.
In their application, NPPC explains that livestock haulers are responsible for the daily transportation of millions of animals. They state that the welfare and safety of the animals in transit, together with the safety of other drivers on the road, are the industry's top priorities. NPPC advises that most livestock haulers have participated in additional specialized training, including the pork industry's Transport Quality Assurance (TQA) program and the beef industry's Master Castle Transporter (MCT) program, which provide instruction on proper animal handling and transportation methods. These voluntary education programs were developed by and are offered through the U.S. Department of Agriculture.
The pork industry's TQA program is designed to address the driver safety and animal welfare needs of the approximately 600,000 pigs transported every day on U.S. roads. While the program is voluntary, most major packers require that any driver arriving on their property be TQA-certified. The beef industry's MCT training program was designed by cattle experts and volunteers to educate haulers about low-stress safe handling and transportation methods for cattle. According to the MCT training program, proper handling and transport of cattle reduces sickness, prevents bruising, and improves the quality of the meat. These drivers also transport live fish, which requires a driver to focus on road safety, equipment maintenance, fish health, and water quality. Moving live fish by truck also requires specialized equipment, species-specific loading, and on-time delivery.
NPPC states that the emphasis these programs place on animal welfare benefits driver safety, as it encourages livestock haulers to slow down, be more aware of their surroundings and road conditions, and avoid rough-road situations that could result in animal injury. In addition to general highway safety and accident prevention measures, these programs also focus on the primary underlying goal of the HOS rule—addressing fatigue. For example, the pork industry's TQA program educates haulers about driver fatigue prevention by stressing adequate rest, appropriate climate conditions in the cab, a healthy diet, and how to recognize the signs of fatigue.
NPPC states that granting a limited exemption from the ELD mandate for livestock haulers will enable FMCSA and the livestock industry to undertake the training and education necessary for livestock haulers to understand ELDs. It will also provide an opportunity for FMCSA to develop livestock-specific solutions to the underlying HOS concerns of the industry.
A copy of NPPC's application for exemption is available for review in the docket for this notice.
Fish and Wildlife Service, Interior.
Proposed rule; reopening of the comment period.
We, the U.S. Fish and Wildlife Service (Service), announce the reopening of the comment period on our October 4, 2016, proposed rule to list the western glacier stonefly (
The comment period on the October 4, 2016, proposed rule (81 FR 68379) is reopened. Comments should be received on or before November 30, 2017. Comments submitted electronically using the Federal eRulemaking Portal (see
You may submit comments by one of the following methods:
(1)
(2)
We request that you send comments only by the methods described above. We will post all comments on
Jodi Bush, Field Supervisor, U.S. Fish and Wildlife Service, Montana Ecological Services Field Office, 585 Shepard Way, Helena, MT 59601; telephone 406-449-5225; facsimile 406-449-5339;
We will accept written comments and information during this reopened comment period regarding the new information indicating additional streams and springs occupied by the western glacier stonefly (Giersch
In addition, we continue to seek comments on the following topics as requested in our October 4, 2016, proposed rule (81 FR 68379):
(1) The meltwater lednian stonefly and the western glacier stonefly biology, range, and population trends, including:
(a) Biological or ecological requirements of the species, including habitat requirements for feeding, breeding, and sheltering;
(b) Genetics and taxonomy;
(c) Historical and current range, including distribution patterns;
(d) Historical and current population levels, and current and projected trends; and
(e) Past and ongoing conservation measures for the species, their habitat, or both.
(2) Factors that may affect the continued existence of the species, which may include habitat modification or destruction, overutilization, disease, predation, the inadequacy of existing regulatory mechanisms, or other natural or manmade factors.
(3) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to these species and existing regulations that may be addressing those threats.
(4) Additional information concerning the historical and current status, range, distribution, and population size of these species, including the locations of any additional populations.
If you submitted comments or information on the proposed rule (81 FR 68379) during the initial comment period from October 4, 2016, to December 5, 2016, please do not resubmit them. Any such comments are incorporated as part of the public record of this rulemaking proceeding, and we will fully consider them in the preparation of our final determination. Our final determination will take into consideration all written comments and any additional information we receive during all comment periods. The final decision may differ from the proposed rule, based on our review of all information received during this rulemaking proceeding.
Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include. Please note that submissions merely stating support for or opposition to the action under consideration without providing supporting information, although noted, will not be considered in making a determination, as section 4(b)(1)(A) of the Act directs that determinations as to whether any species is an endangered or a threatened species must be made “solely on the basis of the best scientific and commercial data available.”
You may submit your comments and materials concerning the proposed rule by one of the methods listed in
If you submit information via
Comments and materials we receive, as well as supporting documentation we used in preparing the proposed rule, will be available for public inspection on
In accordance with our joint policy on peer review published in the
On October 4, 2016, we published a 12-month finding for the western glacier stonefly and a proposed rule to list the western glacier stonefly and meltwater lednian stonefly as threatened species under the Act (81 FR 68379). We combined the 12-month finding and proposed rule in one document for efficiency. Please refer to that proposed rule for information about western glacier stonefly and meltwater lednian stonefly taxonomy, descriptions of the two species, distribution and abundance, habitat, and biology, as well as a detailed description of previous Federal actions concerning the western glacier stonefly and meltwater lednian stonefly prior to October 4, 2016. As discussed in our proposed rule, we became aware of information in August 2016 indicating additional streams and springs occupied by western glacier stonefly in southwestern Montana and northwestern Wyoming. Furthermore, in March 2017, we became aware of additional information on western glacier stonefly, indicating a larger range than previously known. This new information from August 2016 and March 2017 is described below.
We received updated information on the distribution of western glacier stonefly from the United States Geological Survey (USGS) on August 22, 2016. This information was included in a final report to the Service examining the status, distribution, and ecology of the meltwater lednian stonefly and the western glacier stonefly (Giersch
In addition, a study funded by the Wyoming Natural Diversity Database estimated the degree to which western glacier stonefly were genetically different amongst the three mountain ranges (Glacier National Park, Absaroka-Beartooth Wilderness, and Grand Teton National Park) (Hotaling
A complete list of references cited in this document is available on the Internet at
The primary authors of this document are the staff members of the Montana Ecological Services Field Office.
The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS' Fisheries Finance Program (FFP) provides long-term financing to the commercial fishing and aquaculture industries for fishing vessels, fisheries facilities, aquaculture facilities, and certain designated individual fishing quota (IFQ). Section 302 of the Coast Guard Authorization Act of 2015 (Pub. L. 114-120) included new authority to finance the purchase of harvesting rights in a fishery that is federally managed under a limited access system. The FFP proposes to add a new section to the existing FFP regulations to implement this statutory change. The net effect of this proposed change to the regulations will be to provide additional authority for the program to lend, while leaving the original IFQ authority to Fishery Management Councils to use as needed.
Comments must be submitted in writing on or before November 30, 2017,
You may submit comments, identified by NOAA-NMFS-2017-0064, by any one of the following methods:
•
•
Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this proposed rule may be submitted to
Paul Marx, at 301-427-8771 or via email at
Under the authority of Chapter 537 of Title 46 of the United States Code, 46 U.S.C. 53701,
46 U.S.C. 53706 authorizes the FFP to finance or refinance the purchase of individual fishing quotas in accordance with section 303(d)(4) of the Magnuson-Stevens Fishery Conservation and Management Act (MSA), now codified at 16 U.S.C. 1853a(g). Under this provision of the MSA, an FMC may submit, and NMFS may approve and implement, a loan program to aid in (1) the acquisition of IFQ by fishermen who fish from “small vessels,” and (2) the first time purchase of IFQ by “entry level fishermen.” Therefore, under this authority, the FFP cannot initiate or implement a lending program to finance or refinance the purchase of IFQ until the appropriate FMC submits a request to NMFS and provides guidance for the requisite criteria.
NMFS currently administers two loan programs pursuant to the existing IFQ authority: The Northwest Halibut/Sablefish and Bering Sea and Aleutian Islands Crab IFQ loan programs. NMFS anticipates no effects to either of these existing loan programs as a result of this proposed action.
The new authority provided by Public Law 114-120 broadens the FFP's existing authority, and authorizes the Program to finance the purchase of harvesting rights in a fishery that is federally managed under a limited access system. NMFS will interpret “limited access system” in accordance with section 3(27) of the MSA for purposes of this authority. The MSA defines “limited access system” as “a system that limits participation in a fishery to those satisfying certain eligibility criteria or requirements contained in a fishery management plan or associated regulation.” 16 U.S.C. 1802(27). Such definition includes, but is not limited to, IFQ fisheries.
The new authority provided by Public Law 114-120 does not require FMCs to initiate a request to establish a loan program in a fishery that is federally managed under a limited access system in order for the FFP to provide financing in such a fishery. However, under the MSA, FMCs are primarily responsible for developing fishery management plans (FMPs) for fisheries within their authority that require conservation and management. It is possible that the availability of fisheries loans may have unanticipated effects on the
Section 302 of the Coast Guard Authorization Act of 2015 imposes no limitations on the extent of financing to be provided by the FFP for the purchase of harvesting rights. However, it does reserve $59 million of direct loan authority for historical uses, defined at 46 U.S.C. 53701(8). Thus, NMFS anticipates that the balance of annual direct loan authority—currently $41 million—may be available to finance or refinance the purchase of harvesting rights in federally managed fisheries under a limited access system. This action will allow NMFS to fully use the program's loan authority either for historical purposes or any authorized new purposes should it be determined that demand or lack of demand in either area would result in unused loan authority.
Lending for harvesting rights would follow existing FFP lending procedures and guidelines. Borrowers must be U.S. citizens or entities eligible to document a vessel for coastwise trade under 46 U.S.C. 50501, meet all general FFP requirements, and meet all requirements to hold the harvesting rights under the applicable FMP at the time of loan closing. The FFP may require additional lending conditions and security terms such as loan guarantees or security interests in other collateral to bring credit risk to acceptable levels. Affiliated businesses, the borrower's principals or majority shareholders, persons or entities with a financial interest in the borrower, or any individuals holding community property rights may also be required to provide a guaranty.
In addition, all loan applicants are subject to background and credit investigations, which may include, but are not limited to, reviews for unresolved fishing violations, criminal background checks, delinquent debt investigations, and credit reports. Like other FFP loan programs, lending for harvesting rights is subject to a statutory loan limit of up to 80 percent of the actual cost of the transaction, set as the purchase price or, in the case of refinancing, the current market value. The FFP retains sole discretion to determine the transaction's actual cost or current market value.
Harvesting rights loan amounts can carry up to a 25-year term and can be used to either purchase new rights or refinance the debt associated with the prior purchase(s) of harvesting rights. In addition to maintaining a 20 percent minimum equity stake, borrowers refinancing existing debt will only receive the lesser of the outstanding amount of debt to be refinanced or 80 percent of the current market value of the harvesting right.
If a borrower seeking refinancing fails to have the requisite 20 percent equity stake (measured as the difference between the current market value of the primary collateral and the amount of the loan), that borrower will need to pay down debt to meet the required level. In addition, under FFP standards, borrowers are only eligible for refinancing if their initial purchase would have been eligible for financing. The program will refinance harvesting rights acquired prior to this regulation if the buyer's original purchase would have been eligible for FFP financing under the terms of this action.
Prospective borrowers may apply for a loan through any of the NOAA Fisheries Service regional FFP offices (St. Petersburg, FL; Gloucester, MA; Seattle, WA). They must pay the appropriate application fee, set by 46 U.S.C. 53713(b) as one-half of one percent of the loan amount requested, which is made up of two parts. Half is the “filing fee,” and is nonrefundable when the FFP officially accepts the application. The other half, known as the “commitment fee,” becomes nonrefundable when the FFP executes and mails an Approval-in-Principle (AIP) letter to the applicant. The FFP may refund the commitment fee if the FFP declines the application or the application is withdrawn prior to the issuance of an AIP letter.
This proposed action would add the following section, as explained here.
This new section provides regulatory provisions specific to the harvesting rights loans. At the time a borrower submits an application, he or she must satisfy the criteria listed in this new section in order to be eligible to receive financing under the program. The borrower must comply with any limitations on the quantity of harvesting rights that may be owned by one holder, as specified in the applicable FMP and implementing regulations. The FFP will not finance harvesting rights in excess of ownership limitations.
This proposed rule is published under the authority of, and is consistent with, Chapter 537 of Title 46 of the United States Code and the Magnuson-Stevens Act, as amended. The NMFS Assistant Administrator has determined that this proposed rule is consistent with Chapter 537 of Title 46 of the U.S. Code, the Magnuson-Stevens Act, as amended, and other applicable law, subject to further consideration after public comment.
In addition to public comment about the proposed rule's substance, NMFS also seeks public comment on any ambiguity or unnecessary complexity from the language used in this proposed rule.
NMFS has preliminarily determined that this rule qualifies to be categorically excluded from further NEPA review. This action is consistent with categories of activities identified in CE G7 of the Companion Manual for NOAA Administrative Order 216-6A, and we have not identified any extraordinary circumstances that would preclude this categorical exclusion. NMFS is accepting comments and information during the public comment period for the proposed rule relevant to our preliminary categorical exclusion determination.
This proposed rule has been determined to be not significant for purposes of Executive Order 12866.
This proposed rule does not duplicate, overlap, or conflict with any other relevant Federal rules.
Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.
This proposed rule contains collections-of-information subject to the PRA, which have been approved by OMB under control number 0648-0012. The application requirements contained in these rules have been approved under OMB control number 0648-0012. Public reporting burden for placing an application for FFP financing is estimated to average eight hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see
The Chief Counsel for Regulation of the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities.
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601,
Participation in the FFP is entirely voluntary. This action imposes no mandatory requirements on any business. Once final, this proposed rule will implement programs authorized by law. Specifically, these rules enact regulatory additions to create a new lending purpose authorized by Section 302 of the Coast Guard Authorization Act of 2015 (Pub. L. 114-120) and will be implemented in accordance with 50 CFR part 253, subpart B. This action will create new § 253.31.
As defined by NMFS for RFA purposes, this rule may affect small fishing entities that have annual revenues of $11.0 million or less, including, but not limited to, vessel owners, vessel operators, individual fishermen, small corporations, and others engaged in commercial fishing activities regulated by NOAA. Borrowers under this authority may also include large businesses. Notably, because the FFP is a voluntary program that provides loans to qualified borrowers, non-borrowers—large or small—would not be regulated by this rule.
Although the FFP requires certain supporting documentation during the life of a loan, the requirements do not impose unusual burdens when compared to the burdens imposed by other lenders. Moreover, because the basic need for financing would continue to exist without the FFP, the individuals seeking financing would still need to comply with similar, if not identical, requirements imposed by another lender. Records required to participate in the FFP are usually within the normal records already maintained by fishermen. It should take fewer than eight hours per application to meet these requirements.
The information required from borrowers, such as income tax returns, insurance policies, permits, licenses, etc., is already available to them. Depending on circumstances, the FFP may require other supporting documents, including financial statements, property descriptions, and other documents that can be acquired at reasonable cost if they are not already available.
FFP lending is a source of long-term, fixed rate capital financing and imposes no regulatory requirements on anyone other than those applying for loans. FFP borrowers make a voluntary decision to use the available lending.
These loan programs will only have positive impacts on borrowers. Because participation is voluntary and requires effort and the outlay of an application fee, borrowers for harvesting rights financing are assumed to have made a determination that using FFP financing provides a benefit, such that the FFP's long-term, fixed rate financing provides only a positive economic impact. Importantly, the FFP does not regulate or manage the affairs of its borrowers, and the regulations impose no additional compliance, operating or other fees or costs on small entities other than a financing relationship would require.
As a result of this certification, an initial regulatory flexibility analysis is not required and none has been prepared.
Aquaculture, Community development groups, Direct lending, Financial assistance, Fisheries, Fishing, Individual fishing quota, harvesting rights (privileges).
For the reasons set forth in the preamble, NMFS proposes to amend 50 CFR part 253, subpart B, as follows:
46 U.S.C. 53701 and 16 U.S.C. 4101
(a)
(1)
(2)
(3) [Reserved]
(b)
(1) The borrower must meet all regulatory and statutory requirements to hold the harvesting rights at the time any such loan or refinancing loan would close.
(2) NMFS will accept and consider the input of a Regional Fishery Management Council at any time regarding the availability of loans in a fishery under the Council's authority.
(i) The Council may submit an explanation to NMFS, in writing, as to why the availability of financing for harvesting rights in a fishery would harm the achievement of the goals and objectives of the Fishery Management Plan applicable to the fishery. If NMFS accepts the Council's reasoning, harvesting rights loans will not be provided, or will cease to be provided, in that fishery.
(ii) If NMFS determines that harvesting rights loans will not be provided in a fishery, NMFS will publish a notice in the
(iii) In such a scenario, pending applications will be returned and loan fees returned as exceptional circumstances justify the action.
(3) The harvesting rights to be financed must be issued in a manner in which they can be individually identified such that a valid and specific security interest can be recorded. This determination shall be solely made by the Program.
(c)
(i) The harvesting rights being refinanced would have been eligible for Program financing at the time the borrower purchased them, if Program financing had been available,
(ii) The borrower meets all other applicable lending requirements, and
(iii) The refinancing is in an amount up to 80 percent of the harvesting rights' current market value, as determined at the sole discretion of the Program, and subject to the limitation that the Program will not disburse any amount that exceeds the outstanding principal balance, plus accrued interest (if any), of the existing harvesting rights' debt being refinanced or its fair market value, whichever is less.
(2) In the event that the current market value of harvesting rights and principal loan balance do not meet the 80 percent requirement in paragraph (1)(iii) of this section, borrowers seeking refinancing may be required to provide additional down payment.
(d)
(e)
(f)
(g)
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS is proposing regulations under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (MSA) to implement a March 2017 recommendation by the Pacific Fishery Management Council (Council) to amend the Fishery Management Plan for U.S. West Coast Fisheries for Highly Migratory Species (HMS FMP). The proposed rule would bring the State of California's limited entry (LE) drift gillnet (DGN) permit program under MSA authority. All current California DGN permit holders would be eligible to apply for, and receive, a Federal DGN permit, and no additional DGN permits would be created. The proposed rule is administrative in nature and is not anticipated to result in increased activity, effort, or capacity in the fishery.
Comments on the proposed rule and supporting documents must be submitted in writing on or before December 15, 2017.
You may submit comments on this document, identified by NOAA-NMFS-2017-0052, by any of the following methods:
•
•
Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this proposed rule may be submitted to the West Coast Regional Office and by email to
Copies of the draft Regulatory Impact Review and other supporting documents are available via the Federal eRulemaking Portal:
Lyle Enriquez, NMFS, West Coast Region, 562-980-4025, or
The HMS FMP was prepared by the Council and is implemented under the authority of
Since 2014, the Council has considered transitioning California's LE DGN permit program from state to MSA authority. On March 12, 2017, the Council adopted a final preferred alternative that would amend the HMS FMP and transition the State of California LE DGN permit program from state management to Federal management under MSA authority and entitle all fishermen authorized to fish with large-mesh DGN gear under state law to be eligible to receive a Federal LE DGN permit. As of August 31, 2017, 70 California LE DGN permits were issued for the 2016-2017 fishing season, and 67 have been renewed for the 2017-2018 fishing season. The average number of active DGN vessels per year from 2010 through 2016 is 20 vessels. The action would neither increase capacity within the DGN fishery, nor would it incentivize or stimulate fishing effort or activity of current latent permits. After the initial issuance of Federal DGN permits, no additional permits would be issued, and permits that are not renewed in future years would permanently expire. NMFS would not reissue the expired permits.
In order to participate in the DGN fishery, current participants must possess a State of California LE DGN permit, a California commercial fishing license, a California general gill/trammel net permit, and a California swordfish permit. Additionally, the vessel that the participant fishes from must have a Federal Pacific Highly Migratory Species (HMS) permit with a DGN gear endorsement. After the LE DGN permit transitions from the State of California to Federal management, each participant will need to hold all the same permits and licenses, except that the Federal LE DGN permit will take the place of the State of California LE DGN permit. Although these permits and licenses would be required to fish, possession of a current and up-to-date State of California LE DGN permit is the only permit required to initially obtain a Federal LE DGN permit.
This proposed rule would adopt many of the current State of California management measures associated with the fishery. For example, NMFS would adopt current California requirements regarding the assignment of a permit (
Upon the date of publication of the final rule, all 70 state-eligible permit holders would be eligible to receive a Federal DGN permit if they have renewed their state DGN permit by March 31, 2018. Permit holders who fail to renew their state DGN permit by March 31, 2018, will not be eligible for a Federal DGN permit. As of August 31, 2017, 67 permit holders have renewed their state LE DGN permit. If a state LE DGN permit is transferred after publication of the proposed rule, the transferee, but not the transferor, would be eligible to receive a Federal LE DGN permit upon publication of the final rule.
Federal LE DGN permits would be issued annually for the fishing year starting April 1 and ending March 31 of the following year. Permits would expire on March 31 of each year and, after initial issuance (expected in 2018), the permit renewal deadline would be April 30 of each fishing year. A completed DGN permit renewal form must be received by NMFS no later than close-of-business April 30. Any renewal form received after that date would result in the permanent expiration of the Federal DGN permit. A permit owner who fails to submit a renewal form by the deadline may submit a renewal form to NMFS with a written statement that the failure to renew the permit by the deadline was proximately caused by the permit owner's illness or injury. When a permit owner has died, the owner's estate or other personal representative may submit a statement explaining that the permit owner's death has prevented a timely renewal. The permit holder, or in the case of a deceased permit owner, the estate or other personal representative, will need to provide written proof of illness, injury or death. NMFS will not consider any such renewal request made after July 31. A permit holder would need to hold a Federal LE DGN permit for a vesting period of at least three years before it would be eligible to be transferred. This vesting period would extend across both state and Federal permit programs (
This proposed rule also includes technical edits to existing regulatory text. These edits add the word “general” before instances of “HMS permit” to distinguish the existing HMS permit from the new LE DGN permit; update a web address from which permit applications may be obtained; update the reference to the NMFS “Southwest Region” to refer to the West Coast Region, into which it was incorporated; and update the description of the NMFS regional “Sustainable Fisheries Division” to describe it as part of the West Coast Region.
Pursuant to section 304 (b)(1)(A) of the MSA, the NMFS West Coast Regional Administrator has determined that this proposed rule is consistent with the HMS FMP, other provisions of the MSA, and other applicable law, subject to further consideration after public comment.
This proposed rule has been determined to be not significant for purposes of Executive Order 12866. This proposed rule is not an Executive Order 13771 regulatory action because this proposed rule is not significant under Executive Order 12866.
This proposed rule contains a collection-of-information requirement subject to the Paperwork Reduction Act (PRA) and which has been approved by OMB under control number 0648-0204. Public reporting burden for the additional collection of information is estimated to average thirty minutes per form, including time for reviewing instructions, gathering the information needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number. All currently approved NOAA collections of information may be viewed at:
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The proposed rule is administrative in nature and adopts current State of California permit requirements as they relate to the DGN fishery. This action is not expected to increase capacity, incentivize or stimulate fishing effort or activity of current latent permits, or change current fishing practices.
For Regulatory Flexibility Act (RFA) purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primarily industry is commercial fishing (50 CFR 200.2). A business primarily involved in commercial fishing (NAICS 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and its combined annual receipts are not in excess of $11 million for all of its affiliated operations worldwide. NMFS has determined that all current participants in the DGN fishery are small entities under the NMFS standard. The average ex-vessel revenue for the U.S. West Coast DGN fishery from 2011 to 2015 is $745,600, with an average of 20 vessels participating per year. Therefore, the average ex-vessel revenue per active participant is $37,280. The increase in administrative costs, if any, resulting from this action would be less than 1% of ex-vessel revenues per active participant. In addition, because each affected entity is a small business, there would be no disproportionate economic impacts between large and small entities.
Currently, participants must possess a Federal Pacific Highly Migratory Species (HMS) permit ($30), as well as a State of California commercial fishing license ($136.99), a California general gill/trammel net permit ($469.25), and a California LE DGN permit ($469.25) that includes a swordfish permit for fishing with hook-and-line or harpoon. If a fisherman does not participate in the DGN fishery, but participates in the harpoon or hook-and-line fishery, they must purchase a swordfish permit for $469.25. If this action is implemented, fishermen would receive a Federal LE DGN permit. The fee for a Federal LE DGN permit would be determined by only the administrative cost of issuing the permit, and it is expected that the Federal LE DGN permit would cost less than $100, which is far less than the California LE DGN permit cost of $469.25. There are three likely scenarios associated with implementing a Federal LE DGN permit, discussed below; in each scenario, the economic effects are not significant, as they would lead to either a reduction in costs or an insignificant increase in costs.
In the first scenario, fishermen would acquire a Federal LE DGN permit. If the State of California does not amend its regulations and continues to require that fishermen purchase a State of California LE DGN permit (with the swordfish permit included), the cost increase would be only the additional cost of the Federal LE DGN permit. In the second scenario, if fishermen purchase a Federal LE DGN permit and state regulations are amended to no longer require the State of California LE DGN permit, but either a swordfish permit is still required or fishermen continue participating in the harpoon or hook-and-line fishery, there would be a cost increase equal to the cost of the Federal LE DGN permit, while the savings from not purchasing the state LE DGN permit would be offset by the cost of purchasing the swordfish permit. In the third scenario, if fishermen purchase a Federal LE DGN permit, a state LE DGN permit is no longer required, and either a swordfish permit is not required or fishermen do not participate in the harpoon or hook-and-line fishery, the fishermen would realize a cost savings, and the amount of cost savings would equal the difference between the cost of the state LE DGN permit ($469.25) and the cost of the Federal LE DGN permit (expected to be less than $100).
As noted above, all entities subject to this action are considered small entities for RFA purposes. Based on the analysis provided above, the proposed action, if adopted, would not have a significant adverse economic impact on these small business entities. As a result, an initial regulatory flexibility analysis is not required and none has been prepared.
Fisheries, Fishing, Reporting, and recordkeeping requirements.
For the reasons set out in the preamble, 50 CFR part 660 is proposed to be amended as follows:
16 U.S.C. 1801
(a) * * *
(1) A commercial fishing vessel of the United States must be registered for use under a general HMS permit that authorizes the use of specific gear, and a recreational charter vessel must be registered for use under a HMS permit if that vessel is used:
(i) To fish for HMS in the U.S. EEZ off the States of California, Oregon, and Washington; or
(ii) To land or transship HMS shoreward of the outer boundary of the U.S. EEZ off the States of California, Oregon, and Washington.
(4) Only a person eligible to own a documented vessel under the terms of 46 U.S.C. 12102(a) may be issued or may hold (by ownership or otherwise) a general HMS permit.
(b) * * *
(1) Following publication of the final rule implementing the FMP, NMFS will issue general HMS permits to the owners of those vessels on a list of vessels obtained from owners previously applying for a permit under the authority of the High Seas Fishing Compliance Act, the Tuna Conventions Act of 1950, the Marine Mammal Protection Act, and the Fishery Management Plan for Pelagic Fisheries of the Western Pacific Region, or whose vessels are listed on the vessel register of the Inter-American Tropical Tuna Commission.
(3) An owner of a vessel subject to these requirements who has not received a permit under this section from NMFS and who wants to engage in the fisheries must apply to the SFD for the required permit in accordance with the following:
(i) A West Coast Region Federal Fisheries application form may be obtained from the SFD or downloaded from the West Coast Region home page (
(ii) A minimum of 15 days should be allowed for processing a permit application. If an incomplete or improperly completed application is filed, the applicant will be sent a notice of deficiency. If the applicant fails to correct the deficiency within 30 days following the date of notification, the application will be considered abandoned.
(iii) A permit will be issued by the SFD. If an application is denied, the SFD will indicate the reasons for denial.
(iv)
(B) Upon receipt of an appeal authorized by this section, the Regional Administrator will notify the permit applicant, or permit holder as appropriate, and will request such additional information and in such form as will allow action upon the appeal.
(C) Upon receipt of sufficient information, the Regional Administrator will decide the appeal in accordance with the permit provisions set forth in this section at the time of the application, based upon information relative to the application on file at NMFS and the Council and any additional information submitted to or obtained by the Regional Administrator, the summary record kept of any hearing and the hearing officer's recommended decision, if any, and such other considerations as the Regional Administrator deems appropriate. The Regional Administrator will notify all interested persons of the decision, and the reasons for the decision, in writing, normally within 30 days of the receipt of sufficient information, unless additional time is needed for a hearing.
(D) If a hearing is requested, or if the Regional Administrator determines that one is appropriate, the Regional Administrator may grant an informal hearing before a hearing officer designated for that purpose after first giving notice of the time, place, and subject matter of the hearing to the applicant. The appellant, and, at the discretion of the hearing officer, other interested persons, may appear personally or be represented by counsel at the hearing and submit information and present arguments as determined appropriate by the hearing officer. Within 30 days of the last day of the hearing, the hearing officer shall recommend in writing a decision to the Regional Administrator.
(E) The Regional Administrator may adopt the hearing officer's recommended decision, in whole or in part, or may reject or modify it. In any event, the Regional Administrator will notify interested persons of the decision, and the reason(s) therefore, in writing, within 30 days of receipt of the hearing officer's recommended decision. The Regional Administrator's decision will constitute the final administrative action by NMFS on the matter.
(F) Any time limit prescribed in this section may be extended for a period not to exceed 30 days by the Regional Administrator for good cause, either upon his or her own motion or upon written request from the appellant stating the reason(s) therefore.
(4) General HMS permits issued under this subpart will remain valid until the first date of renewal, and permits may be subsequently renewed for 2-year terms. The first date of renewal will be the last day of the vessel owner's birth month in the second calendar year after the permit is issued (
(e)
(f)
(1)
(2)
(3)
(4)
(5)
(ii) Adverse decisions shall be in writing and shall state the reasons for the adverse decision.
(iii) The SFD may decline to act on an application for issuing, renewing, transferring, or assigning a limited entry permit and will notify the applicant, if the permit sanction provisions of the Magnuson-Stevens Act at 16 U.S.C. 1858(a) and implementing regulations at 15 CFR part 904, subpart D, apply.
(6)
(7)
(8)
(i) The permit holder suffers from a serious illness or permanent disability that prevents the permit holder from earning a livelihood from commercial fishing.
(ii) If a deceased permit holder's estate or heirs submit a transfer request within six months of the permit holder's death.
(iii) Upon dissolution of marriage if the permit is held as community property.
(9)
(ii) The permit owner is responsible for renewing a limited entry permit.
(iii) The deadline for receipt or postmark of a Federal DGN permit renewal application is April 30 of the permit year (
(iv) A DGN permit that is allowed to expire will not be renewed unless the permit owner requests reissuance by July 31 (three months after the renewal application deadline) and NMFS determines that failure to renew was proximately caused by illness, injury, or death of the permit owner. If the permit expires, it will be forfeited and NMFS will not reissue the permit to anyone.
(10)
(ii) A permit holder may designate another individual to fish under their permit for up to 15 days per fishing year (April 1 to March 31 of the following year); the substitute must comply with all other Federal permitting requirements. A permit holder shall notify NMFS of a substitution at least 24 hours prior to the commencement of the trip.
(iii) If the person who owns a Federal DGN permit is prevented from being on-board a fishing vessel because the person died, is ill, or is injured, NMFS may allow an exemption to the owner on-board requirement for more than 15 days. The person requesting the exemption must send a letter to NMFS requesting an exemption from the owner on-board requirements, with appropriate evidence as described at paragraph (f)(10)(iv) or (v) of this section. All exemptions for death, injury, or illness will be evaluated by NMFS and a decision will be made in writing to the permit owner (or, in the case of the death of the permit owner, to the estate or heirs of the permit owner) within 60 calendar days of receipt of the original exemption request.
(iv) Evidence of death of the permit owner shall be provided to NMFS in the form of a copy of a death certificate. In the interim before the estate is settled, if the deceased permit owner was subject to the owner on-board requirements, the estate of the deceased permit owner may send a letter to NMFS with a copy of the death certificate, requesting an exemption from the owner-on-board requirements. An exemption due to death of the permit owner will be effective only until such time that the estate of the deceased permit owner has registered the deceased permit owner's permit to a beneficiary, transferred the permit to another owner, or three years after the date of death as proven by a death certificate, whichever is earliest. An exemption from the owner-on-board requirement will be conveyed in a letter from NMFS to the estate of the permit owner and is required to be on the vessel during DGN fishing operations.
(v) Evidence of illness or injury that prevents the permit owner from participating in the fishery shall be provided to NMFS in the form of a letter from a certified medical practitioner. This letter must detail the relevant medical conditions of the permit owner and how those conditions prevent the permit owner from being on-board a fishing vessel during DGN fishing. An exemption due to injury or illness will be effective only for the fishing year of the request for exemption. In order to extend a medical exemption for a succeeding year, the permit owner must submit a new request and provide documentation from a certified medical practitioner detailing why the permit owner is still unable to be on-board a fishing vessel. An exemption from the owner-on-board requirement will be conveyed in a letter from NMFS to the permit owner and is required to be on the vessel during DGN fishing operations.
U.S. Agency for International Development (USAID) has submitted the following information collection to OMB for review and clearance under the Paperwork Reduction Act of 1995.
Comments regarding this information collection are best assured of having their full effect if received by November 30, 2017.
Comments should be addressed to: Desk Officer for USAID, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), 725 17th Street NW., Washington, DC 20503 or email address: OIRA
Copies of submission may be obtained by calling (202) 712-5007.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by November 30, 2017 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Forest Service, USDA.
Notice; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension with no revision of a currently approved information collection,
Comments must be received in writing on or before January 2, 2018 to be assured of consideration. Comments received after that date will be considered to the extent practicable.
Comments concerning this notice should be addressed to the Assistant Director—Directives and Regulations, Office of Regulatory and Management Services, Mail Stop 1150, USDA Forest Service, 1400 Independence Avenue SW., Washington, DC 20250. Comments also may be submitted via facsimile to (703) 605-1575, or by email to
Comments submitted in response to this notice may be made available to the public through relevant Web sites and upon request. For this reason, please do not include in your comments information of a confidential nature, such as sensitive personal information or proprietary information. If you send an email comment, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. Please note that responses to this public comment request containing any routine notice about the confidentiality of the communication will be treated as public comments that may be made available to the public notwithstanding the inclusion of the routine notice.
The public may inspect the draft supporting statement and/or comments received at Forest Service, USDA, 201 14th Street SW., Washington, DC 20250, 1st floor CE, during normal business hours. Visitors are encouraged to call ahead to (202) 205-1082 to facilitate entry to the building. The public may request an electronic copy of the draft supporting statement and/or any comments received be sent via return email. Requests should be emailed to
Nicholas DiProfio, Directives and Regulations Staff, Office of Regulatory and Management Services, by phone (202) 205-1082 or by email at
This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. The solicitation of feedback will target areas such as: Timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public.
If this information is not collected, vital feedback from customers and stakeholders on the Agency's services will be unavailable. The Agency will only submit a collection for approval under this generic clearance if it meets the following conditions:
• The collections are voluntary;
• The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government;
• The collections are noncontroversial and do not raise issues of concern to other Federal agencies;
• Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future;
• Personally identifiable information (PII) is collected only to the extent necessary and is not retained;
• Information gathered is intended to be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency (if released, the agency must indicate the qualitative nature of the information);
• Information gathered will not be used for the purpose of substantially informing influential policy decisions; and
• Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study. Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population.
This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential nonresponse bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.
As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs,
Comment is invited on: (1) Whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the agency, including whether the information will have practical or scientific utility; (2) the accuracy of the agency's estimate of the burden of the 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 the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission request for Office of Management and Budget approval.
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the New York Advisory Committee (Committee) will hold a meeting on Thursday, November 9, 2017, at 12:00 p.m. (Eastern) for the purpose of a discussion and vote for approval on the draft report of Broken Windows Policing.
The meeting will be held on Thursday, November 9, 2017, at 12:00 p.m. EST.
David Barreras, DFO, at
Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 877-852-6576, conference ID: 9818903. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to David Barreras at
Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Ohio Advisory Committee (Committee) will hold a meeting on Tuesday, November 21, 2017, at 12:00 p.m. EST for the purpose of discussing preparations for a study of Civil Rights and Educational Funding in Ohio.
The meeting will be held on Tuesday, November 21, 2017, at 12:00 p.m. EST.
Melissa Wojnaroski, DFO, at
Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 877-604-9665, conference ID: 8623758. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The
Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at
Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via
Economic Development Administration, U.S. Department of Commerce.
Notice and opportunity for public comment.
The Economic Development Administration (EDA) has received petitions for certification of eligibility to apply for Trade Adjustment Assistance from the firms listed below. Accordingly, EDA has initiated investigations to determine whether increased imports into the United States of articles like or directly competitive with those produced by each of these firms contributed importantly to the total or partial separation of the firm's workers, or threat thereof, and to a decrease in sales or production of each petitioning firm.
Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance for Firms Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice. These petitions are received pursuant to section 251 of the Trade Act 1974, as amended.
Please follow the requirements set forth in EDA's regulations at 13 CFR 315.9 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that carbon and alloy steel wire rod (wire rod) from Ukraine is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2016, through December 31, 2016.
Applicable October 31, 2017.
Julia Hancock, Annathea Cook, or Courtney Canales, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-1394, (202) 482-0250, or (202) 482-4997, respectively.
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 26, 2017.
The products covered by this investigation are wire rod from Ukraine. For a complete description of the scope of this investigation,
In accordance with the preamble to the Department's regulations,
The Department is conducting this investigation in accordance with section 731 of the Act. Pursuant to section 776(a) and (b) of the Act, the Department has preliminarily relied upon facts otherwise available, with adverse inferences for ArcelorMittal Steel Kryvyi Rih (AMKR) and Public Joint Stock Company Yenakiieve Iron And Steel Works (Yenakiieve). The Department has preliminarily determined that Duferco S.A. (Duferco) was not the first in the supply chain to have knowledge that subject merchandise was destined for the U.S. and as such, has been deselected as a respondent in this proceeding. For further discussion,
Sections 733(d)(1)(A)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination the Department shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and
The Department has preliminarily determined the estimated weighted-average dumping margin for each of the individually examined respondents under section 776 of the Act. Consequently, pursuant to section 735(c)(5)(B) of the Act, the Department's normal practice under these circumstances has been to calculate the “all-others” rate as a simple average of the alleged dumping margins from the petition.
The Department preliminarily determines that the following estimated weighted-average dumping margins exist:
In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Normally, the Department discloses to interested parties the calculations performed in connection with a preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of the notice of preliminary determination in the
Because the mandatory respondents in this investigation did not provide information requested by the Department, and the Department preliminarily determines that each has been uncooperative, we will not conduct verification.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 50 days after the date of publication of the preliminary determination, unless the Secretary alters the time limit. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination.
In accordance with section 773(f) of the Act, the Department will notify the International Trade Comission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The products covered by this investigation are certain hot-rolled products of carbon steel and alloy steel, in coils, of approximately round cross section, less than 19.00 mm in actual solid cross-sectional diameter. Specifically excluded are steel products possessing the above-noted physical characteristics and meeting the Harmonized Tariff Schedule of the United States (HTSUS) definitions for (a) stainless steel; (b) tool steel; (c) high-nickel steel; (d) ball bearing steel; or (e) concrete reinforcing bars and rods. Also excluded are free cutting steel (also known as free machining steel) products (
The products under investigation are currently classifiable under subheadings 7213.91.3011, 7213.91.3015, 7213.91.3020, 7213.91.3093; 7213.91.4500, 7213.91.6000, 7213.99.0030, 7227.20.0030, 7227.20.0080, 7227.90.6010, 7227.90.6020, 7227.90.6030, and 7227.90.6035 of the HTSUS. Products entered under subheadings 7213.99.0090 and 7227.90.6090 of the HTSUS also may be included in this scope if they meet the physical description of subject merchandise above. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this proceeding is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that certain carbon and alloy steel wire rod (wire rod) from the Republic of Turkey (Turkey) is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2016, through December 31, 2016.
Applicable October 31, 2017.
Ryan Mullen or Ian Hamilton, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5260 or (202) 482-4798, respectively.
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 26, 2017.
The products covered by this investigation are wire rod from Turkey. For a complete description of the scope of this investigation,
In accordance with the preamble to the Department's regulations,
The Department is conducting this investigation in accordance with section 731 of the Act. The Department has calculated export prices in accordance with section 772(a) of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying the preliminary conclusions,
On July 6, 2017, the petitioners filed a critical circumstances allegation with respect to imports of wire rod from Turkey.
Sections 733(d)(1)(A)(ii) of the Act provides that in the preliminary determination the Department shall determine an estimated all-others rate for all exporters and producers not individually investigated in accordance with section 735(c)(5) of the Act. Section 735(c)(5)(A) of the Act states that generally this rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for
In this investigation, the Department calculated estimated weighted-average dumping margins for Habas and Icdas that are not zero,
The Department preliminarily determines that the following weighted-average dumping margins exist:
In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
The Department normally adjusts cash deposits for estimated antidumping duties by the amount of export subsidies countervailed in a companion countervailing duty (CVD) proceeding, when CVD provisional measures are in effect. Accordingly, where the Department preliminarily made an affirmative determination for countervailable export subsidies, the Department offset the estimated weighted-average dumping margin by the appropriate CVD rate. The adjusted cash deposit rate may be found in the Preliminary Determination section above. Should provisional measures in the companion CVD investigation expire prior to the expiration of provisional measures in this LTFV investigation, the Department will direct CBP to begin collecting estimated antidumping duty cash deposits unadjusted for countervailed export subsidies at the time that the provisional CVD measures expire. These suspension of liquidation instructions will remain in effect until further notice.
The Department intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
As provided in section 782(i) of the Act, the Department intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the final verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination.
In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary affirmative determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The products covered by this investigation are certain hot-rolled products of carbon steel and alloy steel, in coils, of approximately round cross section, less than 19.00 mm in actual solid cross-sectional diameter. Specifically excluded are steel products possessing the above-noted physical characteristics and meeting the Harmonized Tariff Schedule of the United States (HTSUS) definitions for (a) stainless steel; (b) tool steel; (c) high-nickel steel; (d) ball bearing steel; or (e) concrete reinforcing bars and rods. Also excluded are free cutting steel (also known as free machining steel) products (
The products under investigation are currently classifiable under subheadings 7213.91.3011, 213.91.3015, 7213.91.3020, 7213.91.3093; 7213.91.4500, 7213.91.6000, 7213.99.0030, 7227.20.0030, 7227.20.0080, 7227.90.6010, 7227.90.6020, 7227.90.6030, and 7227.90.6035 of the HTSUS. Products entered under subheadings 7213.99.0090 and 7227.90.6090 of the HTSUS also may be included in this scope if they meet the physical description of subject merchandise above. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this proceeding is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that biodiesel from Indonesia is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2016, through December 31, 2016.
Effective October 31, 2017.
Myrna Lobo or Alexander Cipolla, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-2371 or (202) 482-4956, respectively.
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 19, 2017.
The product covered by this investigation is biodiesel from Indonesia. For a complete description of the scope of this investigation,
In accordance with the preamble to the Department's regulations,
The Department is conducting this investigation in accordance with section
On July 25, 2017, the National Biodiesel Board Fair Trade Coalition (petitioner) filed a particular market situation (PMS) allegation with respect to the respondents' home market sales prices and reported costs of production.
The respondents and the GOI argue that the prices set by the GOI are based on market prices, and the total compensation each respondent receives for sales of biodiesel in Indonesia reflects the full market value of its biodiesel. The respondents also contend that their sales that are not controlled by the government constitute a viable home market. Each respondent argues that the lower prices paid for CPO are not enough for a PMS finding, and that they should be examined in the context of the concurrent countervailing duty (CVD) investigation.
Based on the facts on the record, the Department preliminarily finds that the GOI's regulation of the domestic biodiesel market amounts to a particular market situation in Indonesia that renders the home market prices of Wilmar Trading PTE Ltd. (Wilmar), the only respondent for which we are preliminarily calculating a weighted-average dumping margin, outside the ordinary course of trade. Therefore, the Department is preliminarily relying on constructed value (CV) as the basis for NV in this investigation for Wilmar. The Department also preliminarily finds that a PMS exists in Indonesia with regard to the cost of CPO as a component of the cost of manufacturing (COM) for biodiesel. Therefore, the Department has adjusted Wilmar's COM to account for the distorted cost of CPO. For a full description of the methodology underlying the PMS determination,
Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination the Department shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding rates that are zero,
In this investigation, the Department preliminarily assigned a rate based entirely on facts available to Musim Mas. Therefore, the only rate that is not zero,
The Department preliminarily determines that the following estimated weighted-average dumping margins exist:
In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
The Department normally adjusts cash deposits for estimated antidumping duties by the amount of export subsidies countervailed in a companion CVD proceeding in accordance with section 772(c)(1)(C), when CVD provisional measures are in effect. Accordingly, where the Department preliminarily made an affirmative determination for countervailable export subsidies, the Department has offset the estimated weighted-average dumping margin by the appropriate CVD rate. In the preliminary determination in the companion CVD investigation, the Department found no countervailable export subsidies.
These suspension of liquidation instructions will remain in effect until further notice.
The Department intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
As provided in section 782(i)(1) of the Act, the Department intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation, unless the Secretary alters the time limit. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination, unless extended.
In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The product covered by this investigation is biodiesel, which is a fuel comprised of mono-alkyl esters of long chain fatty acids derived from vegetable oils or animal fats, including biologically based waste oils or greases, and other biologically-based oil or fat sources. The investigation covers biodiesel in pure form (B100) as well as fuel mixtures containing at least 99 percent biodiesel by volume (B99). For fuel mixtures containing less than 99 percent biodiesel by volume, only the biodiesel component of the mixture is covered by the scope of the investigation.
Biodiesel is generally produced to American Society for Testing and Materials International (ASTM) D6751 specifications, but it can also be made to other specifications. Biodiesel commonly has one of the following Chemical Abstracts Service (CAS) numbers, generally depending upon the feedstock used: 67784-80-9 (soybean oil methyl esters); 91051-34-2 (palm oil methyl esters); 91051-32-0 (palm kernel oil methyl esters); 73891-99-3 (rapeseed oil methyl esters); 61788-61-2 (tallow methyl esters); 68990-52-3 (vegetable oil methyl esters); 129828-16-6 (canola oil methyl esters); 67762-26-9 (unsaturated alkylcarboxylic acid methyl ester); or 68937-84-8 (fatty acids, C12-C18, methyl ester).
The B100 product subject to the investigation is currently classifiable under subheading 3826.00.1000 of the Harmonized Tariff Schedule of the United States (HTSUS), while the B99 product is currently classifiable under HTSUS subheading 3826.00.3000. Although the HTSUS subheadings, ASTM specifications, and CAS numbers are provided for convenience and customs purposes, the written description of the scope is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that carbon and alloy steel wire rod (wire rod) from Italy is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2016, through December 31, 2016.
Applicable October 31, 2017.
Victoria Cho or Mark Flessner, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5075 or (202) 482-6312, respectively.
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended
The products covered by this investigation are wire rod from the Italy. For a complete description of the scope of this investigation,
In accordance with the preamble to the Department's regulations,
In accordance with section 771(33)(F) of the Act, 19 CFR 351.401(f), and the Department's practice,
The Department is conducting this investigation in accordance with section 731 of the Act. The Department has calculated export prices in accordance with section 772(a) of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act. Furthermore, pursuant to section 776(a) and (b) of the Act, the Department has preliminarily relied upon facts otherwise available with adverse inferences to assign a margin for Ferriera Valsider S.p.A. (Ferriera Valsider). For a full description of the methodology underlying the preliminary determination,
Sections 733(d)(1)(A)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination the Department shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and
In this investigation, the Department preliminarily calculated a rate that is not zero,
The Department preliminarily determines that the following estimated weighted-average dumping margins exist:
In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
The Department intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
As provided in section 782(i)(1) of the Act, the Department intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination.
In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The products covered by this investigation are certain hot-rolled products of carbon steel and alloy steel, in coils, of approximately round cross section, less than 19.00 mm in actual solid cross-sectional diameter. Specifically excluded are steel products possessing the above-noted physical characteristics and meeting the Harmonized Tariff Schedule of the United States (HTSUS) definitions for (a) stainless steel; (b) tool steel; (c) high-nickel steel; (d) ball bearing steel; or (e) concrete reinforcing bars and rods. Also excluded are free cutting steel (also known as free machining steel) products (
The products under investigation are currently classifiable under subheadings 7213.91.3011, 7213.91.3015, 7213.91.3020, 7213.91.3093, 7213.91.4500, 7213.91.6000, 7213.99.0030, 7227.20.0030, 7227.20.0080, 7227.90.6010, 7227.90.6020, 7227.90.6030, and 7227.90.6035 of the HTSUS. Products entered under subheadings 7213.99.0090 and 7227.90.6090 of the HTSUS may also be included in this scope if they meet the physical description of subject merchandise above. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of these proceedings is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that carbon and alloy steel wire rod (wire rod) from the Republic of South Africa (South Africa) is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2016, through December 31, 2016.
Applicable October 31, 2017.
Moses Song or John McGowan, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 26, 2017.
The products covered by this investigation are wire rod from South Africa. For a complete description of the scope of this investigation,
In accordance with the preamble to the Department's regulations,
The Department is conducting this investigation in accordance with section 731 of the Act. Based on the record evidence and the Department's practice, we preliminarily find that mandatory respondent ArcelorMittal South Africa Limited (AMSA), mandatory respondent Scaw South Africa (Pty) Ltd. (also known as Scaw Metals Group) (Scaw), and Consolidated Wire Industries (CWI) are affiliated and should be collapsed into one entity (
On April 26, 2017, Davsteel Division of Cape Gate (Pty) Ltd. (Cape Gate), one of the three South African producers/exporters named in the petition,
In accordance with section 733(e) of the Act and 19 CFR 351.206, the Department preliminarily finds that critical circumstances exist for the collapsed entity AMSA/Scaw/CWI and all other producers and exporters. For a description of the methodology and results of the Department's critical circumstances analysis,
Pursuant to section 735(c)(5)(B) of the Act, if the estimated weighted-average dumping margins established for all exporters and producers individually examined are zero,
The Department preliminarily determines that the following estimated weighted-average dumping margins exist:
In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Section 733(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the later of (a) the date which is 90 days before the date on which the suspension of liquidation was first ordered, or (b) the date on which notice of initiation of the investigation was published. The Department preliminarily finds that critical circumstances exist for imports of subject merchandise produced or exported by AMSA/Scaw/CWI and all other exporters/producers. In accordance with section 733(e)(2)(A) of the Act, the suspension of liquidation shall apply to unliquidated entries of shipments of subject merchandise from the producer or exporter identified in this paragraph that were entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the publication of this notice. These suspension of liquidation instructions will remain in effect until further notice.
Normally, the Department discloses to interested parties the calculations performed in connection with a preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of the notice of preliminary determination in the
Because the examined respondent (
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 50 days after the date of publication of the preliminary determination, unless the Secretary alters the time limit. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW.,
Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination.
In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The products covered by this investigation are certain hot-rolled products of carbon steel and alloy steel, in coils, of approximately round cross section, less than 19.00 mm in actual solid cross-sectional diameter. Specifically excluded are steel products possessing the above-noted physical characteristics and meeting the Harmonized Tariff Schedule of the United States (HTSUS) definitions for (a) stainless steel; (b) tool steel; (c) high-nickel steel; (d) ball bearing steel; or (e) concrete reinforcing bars and rods. Also excluded are free cutting steel (also known as free machining steel) products (
The products under investigation are currently classifiable under subheadings 7213.91.3011, 7213.91.3015, 7213.91.3020, 7213.91.3093, 7213.91.4500, 7213.91.6000, 7213.99.0030, 7227.20.0030, 7227.20.0080, 7227.90.6010, 7227.90.6020, 7227.90.6030, and 7227.90.6035 of the HTSUS. Products entered under subheadings 7213.99.0090 and 7227.90.6090 of the HTSUS may also be included in this scope if they meet the physical description of subject merchandise above. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of these proceedings is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that Carbon and Alloy Steel Wire Rod (wire rod) from the Republic of Korea (Korea) is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2016, through December 31, 2016.
Applicable October 31, 2017.
Lingjun Wang or Toni Page, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-2316 or (202) 482-1398.
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 26, 2017.
The products covered by this investigation are wire rod from Korea. For a complete description of the scope of this investigation,
In accordance with the preamble to the Department's regulations,
The Department is conducting this investigation in accordance with section 731 of the Act. The Department has calculated export prices in accordance with section 772(a) of the Act. Constructed export prices have been calculated in accordance with section 772(b) of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying the preliminary determination,
In accordance with section 733(e) of the Act and 19 CFR 351.206, the Department preliminarily finds that critical circumstances do not exist for POSCO or All-Other producers and exporters. For a full description of the methodology and results of the Department's critical circumstances analysis,
Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination the Department shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero or
The Department calculated an individual estimated weighted-average dumping margin for POSCO, the only individually exporter/producer to receive an individually calculated rate. Because the only individually calculated dumping margin is not zero,
The Department preliminarily determines that the following estimated weighted-average dumping margins exist:
In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
The Department intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
As provided in section 782(i)(1) of the Act, the Department intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75
In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The products covered by this investigation are certain hot-rolled products of carbon steel and alloy steel, in coils, of approximately round cross section, less than 19.00 mm in actual solid cross-sectional diameter. Specifically excluded are steel products possessing the above-noted physical characteristics and meeting the Harmonized Tariff Schedule of the United States (HTSUS) definitions for (a) stainless steel; (b) tool steel; (c) high-nickel steel; (d) ball bearing steel; or (e) concrete reinforcing bars and rods. Also excluded are free cutting steel (also known as free machining steel) products (
The products under investigation are currently classifiable under subheadings 7213.91.3011, 7213.91.3015, 7213.91.3020, 7213.91.3093; 7213.91.4500, 7213.91.6000, 7213.99.0030, 7227.20.0030, 7227.20.0080, 7227.90.6010, 7227.90.6020, 7227.90.6030, and 7227.90.6035 of the HTSUS. Products entered under subheadings 7213.99.0090 and 7227.90.6090 of the HTSUS also may be included in this scope if they meet the physical description of subject merchandise above. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this proceeding is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) is rescinding the administrative review of the antidumping duty (AD) order on polyethylene terephthalate resin (PET resin) from the Sultanate of Oman (Oman) for the period of review (POR),
Applicable October 31, 2017.
Jonathan Hill, AD/CVD Operations, Office IV, Enforcement & Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3518.
On July 6, 2017, based on a timely request for review by OCTAL SAOC FZC (OCTAL), the Department published in the
Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if the parties that requested the review withdraw their requests within 90 days of the publication of the notice of initiation of the requested review. OCTAL withdrew its review request by the 90-day deadline, and no other party requested an administrative review of the AD order. Therefore, we are rescinding the administrative review of the AD order on PET resin from Oman covering the period October 15, 2015, through April 30, 2017 in its entirety.
The Department will instruct U.S. Customs and Border Protection (CBP) to assess AD duties on all appropriate entries. Because the Department is rescinding this administrative review in its entirety, the entries to which this administrative review pertains shall be assessed AD duties that are equal to the cash deposits of estimated AD duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions to CBP within 15 days after the publication of this notice in the
This notice serves as the only reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with
This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, 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.
This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that carbon and alloy steel wire rod (wire rod) from Spain is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2016, through December 31, 2016.
Applicable October 31, 2017.
Davina Friedmann or Chelsey Simonovich, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0698 or (202) 482-1979, respectively.
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 20, 2017.
The products covered by this investigation are wire rod from Spain. For a complete description of the scope of this investigation, see Appendix I.
In accordance with the preamble to the Department's regulations,
In accordance with section 771(33)(F) of the Act, 19 CFR 351.401(f), and the Department's practice,
The Department is conducting this investigation in accordance with section 731 of the Act. The Department has calculated export prices in accordance with section 772(a) of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act. Furthermore, pursuant to section 776(a) and (b) of the Act, the Department has preliminarily relied upon adverse facts available for ArcelorMittal Espana S.A. (AME). For a full description of the
In accordance with section 733(e) of the Act and 19 CFR 351.206, the Department preliminarily finds that critical circumstances do not exist for CELSA and all-other companies, but do exist for AME. For a full description of the methodology and results of the Department's critical circumstances analysis, see the Preliminary Decision Memorandum.
Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination the Department shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and de minimis margins, and any margins determined entirely under section 776 of the Act. In this investigation, the Department preliminarily assigned a rate based entirely on facts available to AME. Therefore, the only rate that is not zero,
The Department preliminarily determines that the following estimated weighted-average dumping margins exist:
In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
The Department intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
As provided in section 782(i)(1) of the Act, the Department intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination.
In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The products covered by this investigation are certain hot-rolled products of carbon steel and alloy steel, in coils, of approximately round cross section, less than 19.00 mm in actual solid cross-sectional diameter. Specifically excluded are steel products possessing the above-noted physical characteristics and meeting the Harmonized Tariff Schedule of the United States (HTSUS) definitions for (a) stainless steel; (b) tool
The products under investigation are currently classifiable under subheadings 7213.91.3011, 7213.91.3015, 7213.91.3020, 7213.91.3093, 7213.91.4500, 7213.91.6000, 7213.99.0030, 7227.20.0030, 7227.20.0080, 7227.90.6010, 7227.90.6020, 7227.90.6030, and 7227.90.6035 of the HTSUS. Products entered under subheadings 7213.99.0090 and 7227.90.6090 of the HTSUS also may be included in this scope if they meet the physical description of subject merchandise above. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this proceeding is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that biodiesel from Argentina is being, or is likely to be, sold in the United States at less than fair value. The period of investigation is January 1, 2016, through December 31, 2016.
Effective October 31, 2017.
David Lindgren, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3870.
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 19, 2017.
The product covered by this investigation is biodiesel from Argentina. For a complete description of the scope of this investigation,
In accordance with the preamble to the Department's regulations,
The Department is conducting this investigation in accordance with section 731 of the Act. The Department has calculated export prices in accordance with section 772(a) of the Act. Constructed export prices have been calculated in accordance with section 772(b) of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying the preliminary determination,
In accordance with section 733(e) of the Act and 19 CFR 351.206, the Department preliminarily finds that critical circumstances exist for LDC Argentina S.A. (LDC) and “all other” producers or exporters not individually examined. We preliminarily find that critical circumstances do not exist for Vicentin S.A.I.C. (Vicentin) and certain affiliated companies (collectively, the Vicentin Group).
On August 2, 2017, the National Biodiesel Board Fair Trade Coalition (petitioner) filed a particular market situation (PMS) allegation with respect to the respondents' home market sales prices and reported costs of production.
The respondent Vicentin argues that the Department has a preference for using home market prices and that the standard for finding a PMS and rejecting home market prices is that the government control must be so extensive that pricing is not longer profitable.
Based on the facts on the record, the Department preliminarily finds that the GOA's regulation of the domestic biodiesel market amounts to a PMS in Argentina that renders the home market prices of the Vicentin Group and LDC outside the ordinary course of trade. Therefore, the Department is preliminarily relying on constructed value as the basis for NV in this investigation for both respondents. The Department also preliminarily finds that a PMS exists in Argentina with regard to the price of soybeans as a component of the cost of manufacturing (COM) for biodiesel. Therefore, the Department has adjusted the Vicentin Group's and LDC's COM to account for the distorted cost of soybeans. For a full description of the methodology underlying the PMS determination,
Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that, in the preliminary determination, the Department shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding rates that are zero,
In this investigation, the Department calculated estimated weighted-average dumping margins for LDC and the Vicentin Group that are not zero,
The Department preliminarily determines that the following estimated weighted-average dumping margins exist:
In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
The Department normally adjusts cash deposits for estimated antidumping duties by the amount of export subsidies countervailed in a companion CVD proceeding in accordance with section 772(c)(1)(C), when CVD provisional measures are in effect. Accordingly, where the Department preliminarily made an affirmative determination for countervailable export subsidies, the Department has offset the estimated weighted-average dumping margin by the appropriate CVD rate. In the preliminary determination in the companion CVD investigation, the Department found that Vicentin had a countervailable export subsidy while LDC did not.
Section 733(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the later of (a) the date which is 90 days before the date on which the suspension of liquidation was first ordered, or (b) the date on which notice of initiation of the investigation was published. The Department preliminarily finds that critical circumstances exist for imports of subject merchandise produced or exported by LDC and “all other” exporters and producers not individually examined. In accordance with section 733(e)(2)(A) of the Act, the suspension of liquidation shall apply to unliquidated entries of shipments of subject merchandise from the producer(s) or exporter(s) identified in this paragraph that were entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the publication of this notice.
These suspension of liquidation instructions will remain in effect until further notice.
The Department intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
As provided in section 782(i)(1) of the Act, the Department intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation, unless the Secretary alters the time limit. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination.
In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The product covered by this investigation is biodiesel, which is a fuel comprised of mono-alkyl esters of long chain fatty acids derived from vegetable oils or animal fats, including biologically-based waste oils or greases, and other biologically-based oil or fat sources. The investigation cover biodiesel in pure form (B100) as well as fuel mixtures containing at least 99 percent biodiesel by volume (B99). For fuel mixtures containing less than 99 percent biodiesel by volume, only the biodiesel component of the mixture is covered by the scope of the investigation.
Biodiesel is generally produced to American Society for Testing and Materials International (ASTM) D6751 specifications, but it can also be made to other specifications. Biodiesel commonly has one of the following Chemical Abstracts Service (CAS) numbers, generally depending upon the feedstock used: 67784-80-9 (soybean oil methyl esters); 91051-34-2 (palm oil methyl esters); 91051-32-0 (palm kernel oil methyl esters); 73891-99-3 (rapeseed oil methyl esters); 61788-61-2 (tallow methyl esters); 68990-52-3 (vegetable oil methyl esters); 129828-16-6 (canola oil methyl esters);
The B100 product subject to the investigation is currently classifiable under subheading 3826.00.1000 of the Harmonized Tariff Schedule of the United States (HTSUS), while the B99 product is currently classifiable under HTSUS subheading 3826.00.3000. Although the HTSUS subheadings, ASTM specifications, and CAS numbers are provided for convenience and customs purposes, the written description of the scope is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that carbon and alloy steel wire rod (wire rod) from the United Kingdom is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2016, through December 31, 2016.
Applicable October 31, 2017.
Alice Maldonado, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4682.
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 26, 2017.
The products covered by this investigation are wire rod from the United Kingdom. For a complete description of the scope of this investigation,
In accordance with the preamble to the Department's regulations,
The Department is conducting this investigation in accordance with section 731 of the Act. The Department selected two respondents in this investigation, British Steel Limited (British Steel) and Longs Steel UK Limited (Longs Steel). British Steel submitted information on the record of this investigation demonstrating that it purchased Longs Steel during the POI. British Steel also submitted information supporting its claim that it operates essentially as a new company. After analyzing this information, the Department preliminarily finds that British Steel is not the successor-in-interest to Longs Steel. For further discussion,
With respect to British Steel, the Department has calculated export prices in accordance with section 772(a) of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act.
In accordance with section 733(e) of the Act and 19 CFR 351.206, the Department preliminarily finds that critical circumstances exist for British Steel, Longs Steel, and all other producers/exporters. For a full description of the methodology and results of the Department's critical circumstances analysis,
Sections 733(d)(1)(A)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination the Department shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and
In this investigation, the Department preliminarily assigned a rate based entirely on facts available to Longs Steel. Therefore, the only rate that is not zero,
The Department preliminarily determines that the following estimated weighted-average dumping margins exist:
In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Section 733(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the later of (a) the date which is 90 days before the date on which the suspension of liquidation was first ordered, or (b) the date on which notice of initiation of the investigation was published. The Department preliminarily finds that critical circumstances exist for imports of subject merchandise produced or exported by British Steel, Longs Steel, and all other exporters. In accordance with section 733(e)(2)(A) of the Act, the suspension of liquidation shall apply to unliquidated entries of shipments of subject merchandise from the producer(s) or exporter(s) that were entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the publication of this notice. These suspension of liquidation instructions will remain in effect until further notice.
The Department intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
As provided in section 782(i)(1) of the Act, the Department intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination.
In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The products covered by this investigation are certain hot-rolled products of carbon. Specifically excluded are steel products possessing the above-noted physical characteristics and meeting the Harmonized Tariff Schedule of the United States (HTSUS) definitions for (a) stainless steel; (b) tool steel; (c) high-nickel steel; (d) ball bearing steel; or (e) concrete reinforcing bars and rods. Also excluded are free cutting steel (also known as free machining steel) products (
The products under investigation are currently classifiable under subheadings 7213.91.3011, 7213.91.3015, 7213.91.3020, 7213.91.3093, 7213.91.4500, 7213.91.6000, 7213.99.0030, 7227.20.0030, 7227.20.0080, 7227.90.6010, 7227.90.6020, 7227.90.6030, and 7227.90.6035 of the HTSUS. Products entered under subheadings 7213.99.0090 and 7227.90.6090 of the HTSUS may also be included in this scope if they meet the physical description of subject merchandise above. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of these proceedings is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of the determination by the Department of Commerce (the Department) and the International Trade Commission (ITC) that revocation of the antidumping duty (AD) orders on brass sheet and strip from France, Germany, Italy, and Japan would likely lead to a continuation or recurrence of dumping and material injury to an industry in the United States, the Deparment is publishing a notice of continuation of the AD orders.
Applicable October 31, 2017.
Aimee Phelan, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0697.
On March 6, 1987, the Department published in the
On March 3, 2017, the Department published the notice of initiation of the fourth sunset reviews of these AD orders on brass sheet and strip
The Department conducted these sunset reviews on an expedited basis, pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2), because it received a complete and adequate response from the domestic interested pastries, but no substantive responses from respondent interested parties. As a result of these expedited sunset reviews, the Department determined that revocation of the AD orders on brass sheet and strip from France, Germany, Italy, and Japan would likely lead to continuation or recurrence of dumping and, therefore, notified the ITC of the magnitude of the margins likely to prevail should the orders be revoked.
On October 19, 2017, pursuant to sections 751(c) and 752(a) of the Act, the ITC published a notice of its determination that revocation of the AD orders on brass sheet and strip from France, Germany, Italy, and Japan would likely lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time.
The product covered by the orders is brass sheet and strip, other than leaded and tinned brass sheet and strip, from France, Germany, Italy, and Japan. The chemical composition of the covered product is currently defined in the Copper Development Association (“C.D.A.”) 200 Series or the Unified
Although the HTSUS item numbers are provided for convenience and customs purposes, the written description of the scope of the orders remains dispositive.
As a result of the determinations by the Department and the ITC that revocation of the AD orders would likely lead to continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act and 19 CFR 351.218(a), the Department hereby orders the continuation of the AD orders on brass sheet and strip from France, Germany, Italy, and Japan.
U.S. Customs and Border Protection will continue to collect AD cash deposits at the rates in effect at the time of entry for all imports of subject merchandise. The effective date of continuation of these orders will be the date of publication in the
These five-year sunset reviews and this notice are in accordance with section 751(c) of the Act and published pursuant to section 777(i)(1) of the Act, and 19 CFR 351.218(f)(4).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Herring Advisory Panel to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Monday, November 20, 2017 at 10 a.m.
The meeting will be held at the Holiday Inn, 700 Myles Standish Blvd., Taunton, MA 02780; telephone: (508) 823-0430.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Advisory Panel will review analyses prepared for Herring Amendment 8 Draft Environmental Impact Statement (DEIS) specific to the range of alternatives developed to address potential localized depletion and user conflicts in the herring fishery. The panel may identify preferred alternatives for the Committee to consider the following day. The panel is not scheduled to discuss the other measures under consideration in Amendment 8, Acceptable Biological Catch (ABC) control rule alternatives. The Council reviewed the ABC control rule alternatives at the September 2017 meeting and declined to select a preferred alternative, but approved that portion of Amendment 8 to proceed for submission and public comment. They will discuss recommendations for the Committee to consider for Herring Research Set-Aside research priorities for fishing years 2019-21 and discuss any challenges the program has had in recent years. They will discuss other business, as necessary.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. This meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of an incidental harassment authorization.
In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an incidental harassment authorization (IHA) to the Federal Aviation Administration (FAA) to incidentally harass, by Level A and Level B harassment, marine mammals during construction activities associated with the Biorka dock replacement project in Symonds Bay, AK.
This Authorization is applicable from May 1, 2018, through April 30, 2019.
Shane Guan, Office of Protected
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
An Incidental Take Authorization (ITA) shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.
NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.
The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.
Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
To comply with the National Environmental Policy Act (NEPA) of 1969 (NEPA; 42 U.S.C. 4321
On March 31, 2017, NMFS received a request from the FAA for an IHA to take marine mammals incidental to pile driving and removal and down the hole (DTH) drilling in association with the Biorka Island Dock Replacement Project (Project) in Symonds Bay, Alaska. The FAA's request is for take of five species by Level A and Level B harassment. Neither the FAA nor NMFS expect mortality to result from this activity and, therefore, an IHA is appropriate.
In-water work associated with the in-water construction is expected to be completed within 70 days starting May 1, 2018. We expect the in-water construction work to occur between May 1, 2018 through September 30, 2018; however, this IHA is valid for one year, from May 1, 2018, through April 30, 2019.
The FAA is constructing a replacement dock on Biorka Island in Symonds Bay near Sitka, Alaska. The purpose of the Project is to improve and maintain the sole point of access to Biorka Island and the navigational and weather facilities located on the island. The existing dock has deteriorated and reached the end of its useful life. Regular and repetitive heavy surging seas, along with constant use have destroyed the face of the existing floating marine dock, and have broken cleats making it difficult to tie a vessel to the existing dock. In its present condition, small vessels cannot use the dock to provide supplies to facilities on the island. The existing barge landing area is reinforced seasonally by adding fill to the landing at the shoreline, which is periodically washed away by storms and wave action. The Project would reconstruct the deteriorated existing dock and construct an improved barge landing area. A detailed description of the planned dock replacement project is provided in the
Table 1 provides a summary of the six methods of construction (“scenarios”) used in the modeling of the zone of influence (ZOI)s for the Biorka Project. The ZOIs effectively represent the mitigation zone that would be established around each pile to prevent Level A harassment to marine mammals, while providing estimates of the areas within which Level B harassment might occur.
A notice of NMFS's proposal to issue an IHA to the FAA was published in the
There are five marine mammal species that may transit through the waters nearby the Project area, and are likely to potentially be taken by the specified activity. These include the Steller sea lion (
Sections 3 and 4 of the FAA's application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. Additional information regarding population trends and threats may be found in NMFS's Stock Assessment Reports (SAR;
Table 2 lists all species with expected occurrence in Symonds Bay and Sitka Sound and summarizes information related to the population or stock, including potential biological removal (PBR), where known. For taxonomy, we follow Committee on Taxonomy (2016). PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS's SARs). While no mortality is anticipated
A detailed description of the of the species likely to be affected by the Project, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the
The effects of underwater noise from construction activities for the Project have the potential to result in behavioral harassment of marine mammals in the vicinity of the action area. The
This section provides an estimate of the number of incidental takes authorized through this IHA, which informed NMFS' consideration of both the “small numbers” and the negligible impact determination.
Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
Authorized takes would be by Level A and Level B harassment, in the form of disruption of behavioral patterns for individual marine mammals resulting from exposure to vibratory and impact pile driving and removal and DTH drilling, and potential PTS for animals that may transit through the Level A zones (described below) undetected (Table 6). Based on the nature of the activity and the anticipated effectiveness of the mitigation measures (
As described previously, no mortality or serious injury is anticipated or authorized for this activity. Below we describe how the take is estimated.
Described in the most basic way, we estimate take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) and the number of days of activities. Below, we describe these components in more detail and present the take estimate.
The estimation of marine mammal takes typically uses the following calculation since site-specific density is unavailable:
Using the best available science, NMFS has developed acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).
Level B Harassment for non-explosive sources—Though significantly driven by received level, the onset of behavioral disturbance from anthropogenic noise exposure is also informed to varying degrees by other factors related to the source (
The FAA's Project activities include the use of continuous (vibratory pile driving and DTH drilling) and impulsive (impact pile driving) sources, and therefore the 120 and 160 dB re 1 μPa (rms) are applicable.
Level A harassment for non-explosive sources—NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (NMFS 2016) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). The FAA's Project activity includes the use of impulsive (impact pile driving) and non-impulsive (vibratory pile driving and DTH drilling) sources.
These thresholds were developed by compiling and synthesizing the best available science and soliciting input multiple times from both the public and peer reviewers to inform the final product, and are provided in the table below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2016 Technical Guidance, which may be accessed at:
Here, we describe operational and environmental parameters of the activity that will feed into identifying the area ensonified above the acoustic thresholds.
Pile driving and removal and DTH drilling generates underwater noise that can potentially result in disturbance to marine mammals in the Project area. Transmission loss (TL) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:
JASCO Applied Sciences (JASCO) conducted acoustic modeling of pile installation and removal activities planned for the Project, which is included as Appendix A of the FAA's application. To assess potential underwater noise exposure of marine mammals during construction activities, Quijano and Austin (2017) determined source levels for six different construction scenarios (see Table 1). The source levels are frequency-dependent and suitable for modeling underwater acoustic propagation using JASCO's Marine Operations Noise Model (MONM). The modeling predicted the extent of ensonification and the acoustic footprint from construction activities, taking into account the effects of pile driving equipment, bathymetry, sound speed profile, and seabed geoacoustic parameters. Auditory weighting was applied to the modeled sound fields to estimate received levels relative to hearing sensitivities of five marine mammal hearing groups following NMFS 2016 guidance.
The results are based on currently adopted sound level thresholds for auditory injury (Level A) expressed as peak pressure level (PK) and 24-hr SEL, and behavioral disturbance (Level B) expressed as sound pressure level (SPL). Using these guidelines, Quijano and Austin (2017) calculated the maximum extent (distance and ensonified areas) of the Level A and Level B exposure zones for each marine mammal functional hearing group. This was calculated for both impact and vibratory pile driving of 18- and 30-inch (in) piles for each of the following six Project scenarios.
The model required, as input, source sound levels in
1. Piles driven into the sediment by impact, vibratory, or downhole drilling were characterized as sound-radiating sources. Source levels in
2. Underwater sound propagation was applied to predict how sound propagates from the pile into the water column as a function of range, depth, and azimuthal direction. Propagation depends on several conditions including the frequency content of the sound, the bathymetry, the sound speed in the water column, and sediment geoacoustics; and
3. The propagated sound field was used to compute received levels over a grid of simulated receivers, from which distances to criteria thresholds and maps of ensonified areas were generated.
Modeled results are presented as tables of distances at which SPLs or SELs fell below thresholds defined by criteria. For marine mammal injury, the Level A thresholds considered here follow the NMFS guidelines (NMFS 2016). A detailed description of the modeling process is provided in Appendix A of the FAA's IHA application. A list of modeling parameters, including pile driving duration for computation of SEL, are provided in Table 1.
In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations.
At-sea densities for marine mammal species have not been determined for marine mammals in Sitka Sound; therefore, all estimates here are determined by using observational data from biologists, peer-reviewed literature, and information obtained from personal communication with researchers and state and Federal biologists, and from local charter boat operators.
Harbor seals are expected to be in the Project area in low numbers (see
Steller sea lion abundance in the Project area is dependent on prey availability. Prey species are uncommon during the Project window; therefore, sea lion abundance is expected to be low. The FAA estimates that five sea lions may be in the Project area every day (70 days) of construction, therefore, we estimate that 350 sea lions may be taken by Level B harassment. We estimate that these takes would be split equally between the east distinct population segment (DPS) and west DPS (175 each). The Level A zone is less than 10 m for all but Scenario 6, which is 80 m; however, to be conservative, the FAA is requesting a small group of Steller sea lions may be taken by Level A harassment. This would equate to six total animals if split equally by DPS (3 each).
Humpback whales are found in Sitka Bay seasonally. During mid-summer, tour boats generally see four to five whales per day, in the middle of Sitka Sound. Therefore, a count of 5 humpback whales per day (70 days) was used to estimate takes per day on every day of construction for a total of 350 takes by Level B harassment. All takes would be from the Central North Pacific stock under the MMPA. For ESA purposes, 93.9 percent would be from the Hawaii DPS (328 animals) and 6.1 percent would be from the Mexico stock (22 animals) based on Wade
Generally, transient killer whales follow the movements of Steller sea lions and harbor seals on which they prey. Given the low numbers of Steller sea lions in Sitka Sound during summer, it is consistent that transient killer whales would also be rare or infrequent in the Project area (
Harbor porpoise are expected to occur in the Project area in low numbers during the construction window. Sightings during this time period are infrequent; this species is not observed every day. The mean group size of harbor porpoise in Southeast Alaska was estimated to be between 2 to 3 individuals (Dahlheim
Here we describe how the information provided above is brought together to produce a quantitative take estimate.
All estimates are conservative and include the following assumptions:
• All pilings installed at each site would have an underwater noise disturbance equal to the piling that causes the greatest noise disturbance (
• Exposures were based on an estimated total of 70 work days. Each activity ranges in number of days needed to be completed (Table 1).
• All marine mammal individuals potentially available are assumed to be present within the relevant area, and thus incidentally taken;
• An individual can only be taken once during a 24-hour period; and,
• Exposures to sound levels at or above the relevant thresholds equate to take, as defined by the MMPA.
Estimates of potential instances of take may be overestimates of the number of individuals taken. In the context of stationary activities such as pile driving and in areas where resident animals may be present, this number represents the number of total take that may accrue to a smaller number of individuals, with some number of animals being exposed more than once per individual. While pile driving and removal can occur any day throughout the in-water work window, and the analysis is conducted on a per day basis, only a fraction of that time (typically a matter of hours on any given day) is actually spent pile driving/removal. The potential effectiveness of mitigation measures in reducing the number of takes is typically not quantified in the take estimation process. For these reasons, these take estimates may be conservative.
In order to issue an IHA under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds,
In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, we carefully balance two primary factors:
(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat—which considers the nature of the potential adverse impact being mitigated (likelihood, scope, range), as well as the likelihood that the measure will be effective if implemented; and the likelihood of effective implementation, and;
(2) The practicability of the measures for applicant implementation, which may consider such things as cost, impact on operations, and, in the case of a military readiness activity, personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.
The ZOIs were used to develop mitigation measures for pile driving and removal activities at the Project area. The ZOIs effectively represent the mitigation zone that would be established around each pile to prevent Level A harassment to marine mammals, while providing estimates of the areas within which Level B harassment might occur. In addition to the specific measures described later in this section, the FAA would conduct briefings between construction supervisors and crews, marine mammal monitoring team, and staff prior to the start of all pile driving activity, and when new personnel join the work, in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.
The following measures would apply to the FAA's mitigation through shutdown and disturbance zones:
Given the size of the disturbance zone for vibratory pile driving and DTH drilling, it is impossible to guarantee that all animals would be observed or to make comprehensive observations of fine-scale behavioral reactions to sound, and only a portion of the zone (
The following additional measures apply to visual monitoring:
(1) Monitoring will be conducted by qualified observers, who will be placed at the best vantage point(s) practicable to monitor for marine mammals and implement shutdown/delay procedures when applicable by calling for the shutdown to the hammer operator. A minimum of two observers will be required for all pile driving/removal
(a) Independent observers (
(b) At least one observer must have prior experience working as an observer;
(c) Other observers (that do not have prior experience) may substitute education (undergraduate degree in biological science or related field) or training for experience;
(d) Where a team of three or more observers are required, one observer should be designated as lead observer or monitoring coordinator. The lead observer must have prior experience working as an observer; and
(e) NMFS will require submission and approval of observer resumes.
(2) Qualified MMOs are trained biologists, and need the following additional minimum qualifications:
(a) Visual acuity in both eyes (correction is permissible) sufficient for discernment of moving targets at the water's surface with ability to estimate target size and distance; use of binoculars may be necessary to correctly identify the target;
(b) Ability to conduct field observations and collect data according to assigned protocols;
(c) Experience or training in the field identification of marine mammals, including the identification of behaviors;
(d) Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;
(e) Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates and times when in-water construction activities were suspended to avoid potential incidental injury from construction sound of marine mammals observed within a defined shutdown zone; and marine mammal behavior; and
(f) Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.
(3) Prior to the start of pile driving activity, the shutdown zone will be monitored for 30 minutes to ensure that it is clear of marine mammals. Pile driving will only commence once observers have declared the shutdown zone clear of marine mammals; animals will be allowed to remain in the shutdown zone (
(4) If a marine mammal approaches or enters the shutdown zone during the course of pile driving operations, activity will be halted and delayed until either (A) the animal has voluntarily left and been visually confirmed beyond the shutdown zone, (B) 15 minutes have passed without re-detection of small cetaceans and pinnipeds, or (C) 30 minutes have passed without re-detection of large cetaceans, whichever happens sooner. Monitoring will be conducted throughout the time required to drive a pile.
(5) If a species for which authorization has not been granted, or a species for which authorization has been granted but the authorized takes are met, approaches or is observed within the Level B harassment zone, activities will shut down immediately using delay and shut-down procedures. Activities will not restart until the animals have been confirmed to have left the area.
The use of a soft start procedure is believed to provide additional protection to marine mammals by warning or providing a chance to leave the area prior to the hammer operating at full capacity, and typically involves a requirement to initiate sound from the hammer at reduced energy followed by a waiting period. This procedure is repeated two additional times. It is difficult to specify the reduction in energy for any given hammer because of variation across drivers and, for impact hammers, the actual number of strikes at reduced energy will vary because operating the hammer at less than full power results in “bouncing” of the hammer as it strikes the pile, resulting in multiple “strikes.” For impact driving, we require an initial set of three strikes from the impact hammer at reduced energy, followed by a 30-second waiting period, then 2 subsequent 3 strike sets. Soft start will be required at the beginning of each day's impact pile driving work and at any time following a cessation of impact pile driving of 30 minutes or longer.
The FAA will use cushions during impact pile driving.
The FAA will only conduct construction activities during daytime hours. Construction will also be restricted to the months of May through September to avoid overlap with times when marine mammals have higher densities in the Project area.
We have carefully evaluated the FAA's mitigation measures and considered their effectiveness in past implementation to determine whether they are likely to effect the least practicable impact on the affected marine mammal species and stocks and their habitat.
Any mitigation measure(s) we prescribe should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:
(1) Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal);
(2) A reduction in the number (total number or number at biologically important time or location) of individual marine mammals exposed to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing takes by behavioral harassment only);
(3) A reduction in the number (total number or number at biologically important time or location) of times any individual marine mammal would be exposed to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing takes by behavioral harassment only);
(4) A reduction in the intensity of exposure to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing the severity of behavioral harassment only);
(5) Avoidance or minimization of adverse effects to marine mammal habitat, paying particular attention to the prey base, blockage or limitation of passage to or from biologically important areas, permanent destruction of habitat, or temporary disturbance of habitat during a biologically important time; and
(6) For monitoring directly related to mitigation, an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.
Based on our evaluation of the FAA's measures, as well as any other potential measures considered by NMFS, NMFS has determined that the mitigation measures provide the means of effecting
In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the action area. Effective reporting is critical to both compliance and ensuring that the most value is obtained from the required monitoring.
Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:
• Occurrence of marine mammal species in action area (
• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (
• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;
• How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) population, species, or stock;
• Effects on marine mammal habitat (
• Mitigation and monitoring effectiveness.
The FAA will collect sighting data and behavioral responses to construction for marine mammal species observed in the region of activity during the period of activity. All MMOs will be trained in marine mammal identification and behaviors and are required to have no other construction-related tasks while conducting monitoring. A minimum of two MMOs will be required for all pile driving/removal activities. The FAA will monitor the shutdown zone and disturbance zone before, during, and after pile driving, with observers located at the best practicable vantage points. Based on our requirements, the FAA would implement the following procedures for pile driving and removal:
• MMOs would be located at the best vantage point(s) in order to properly see the entire shutdown zone and as much of the disturbance zone as possible;
• During all observation periods, observers will use binoculars and the naked eye to search continuously for marine mammals;
• If the shutdown zones are obscured by fog or poor lighting conditions, pile driving at that location will not be initiated until that zone is visible. Should such conditions arise while driving, removal, or drilling is underway, the activity would be halted; and
• The shutdown and disturbance zones around the pile will be monitored for the presence of marine mammals before, during, and after any pile driving or removal activity.
We require that observers use approved data forms. Among other pieces of information, the FAA will record detailed information about any implementation of shutdowns, including the distance of animals to the pile and description of specific actions that ensued and resulting behavior of the animal, if any. In addition, the FAA will attempt to distinguish between the number of individual animals taken and the number of incidences of take. We require that, at a minimum, the following information be collected on the sighting forms:
• Date and time that monitored activity begins or ends;
• Construction activities occurring during each observation period;
• Weather parameters (
• Water conditions (
• Species, numbers, and, if possible, sex and age class of marine mammals;
• Description of any observable marine mammal behavior patterns, including bearing and direction of travel, and if possible, the correlation to SPLs;
• Distance from pile driving or removal activities to marine mammals and distance from the marine mammals to the observation point;
• Description of implementation of mitigation measures (
• Locations of all marine mammal observations; and
• Other human activity in the area.
The SSV will establish source levels for impact pile driving, vibratory pile driving, and DTH drilling. The FAA will provide all monitoring data to NMFS. The reports would include the following information:
1. Size and type of piles;
2. A detailed description of the noise attenuation device, including design specifications;
3. The impact hammer energy rating used to drive the piles, and the make and model of the hammer and the output energy;
4. The physical characteristics of the bottom substrate into which the piles were driven;
5. The depth of water into which the pile was driven;
6. The depth into the substrate into which the pile was driven;
7. A description of the sound monitoring equipment;
8. The distance between hydrophones and pile;
9. The depth of the hydrophones and depth of water at hydrophone locations;
10. The distance from the pile to the water's edge;
11. The total number of strikes to drive each pile and for all piles driven during a 24-hour period;
12. The results of the hydroacoustic monitoring;
13. Source levels for peak and RMS SPLs and single strike SEL at 10 m from the pile, and RMS pulse duration that contains 90 percent of pulse energy.
14. The distance at which peak, cumulative SEL, and RMS values exceed the respective threshold values;
15. For vibratory pile driving, SEL based on 30 second averaging of sound intensity;
16. The spectragraphs for each pile type; and
17. A description of any observable marine mammal behavior in the immediate area and, if possible, correlation to underwater sound levels occurring at that time.
A minimum of two piles of the 18-in and two piles of the 30-in piles for each construction type (
One bottom-mounted hydrophone will be placed at the nearest distance, approximately 10 meters, from each pile being monitored. An additional hydrophone will be placed at mid-water depth at a distance of 100 to 200 m from the pile to provide two sound-level readings during ambient and pile driving conditions. A third hydrophone may be deployed at a greater distance (
A draft report will be submitted to NMFS within 90 days of the completion of marine mammal monitoring, or 60 days prior to the requested date of issuance of any future IHA for projects at the same location, whichever comes first. The report will include marine mammal observations pre-activity, during-activity, and post-activity during pile driving and removal days, and will also provide descriptions of any behavioral responses to construction activities by marine mammals and a complete description of all mitigation shutdowns and the results of those actions and an extrapolated total take estimate based on the number of marine mammals observed during the course of construction. A final report must be submitted within 30 days following resolution of comments on the draft report.
NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
Pile driving and removal activities associated with the dock replacement Project, as outlined previously, have the potential to disturb or displace marine mammals. Specifically, the specified activities may result in take, in the form of Level A and Level B harassment (PTS and behavioral disturbance), from underwater sounds generated from pile driving and removal. Potential takes could occur if individuals of these species are present in the ensonified zone when pile driving and removal occurs. Most of the Level A takes are precautionary as marine mammals are not expected to enter and stay in the Level A ensonified area for the duration needed to incur PTS. However, if all authorized takes be Level A harassment were to occur, they would be of small numbers compared to the stock sizes and would not adversely affect the stock through effects on annual rates of recruitment or survival. Additionally, the FAA's mitigation measures, including a shutdown of construction activities if animals enter the Level A zone, further reduces the chance for PTS in marine mammals. Therefore, the effects to marine mammals are expected to be negligible.
No temporary threshold shift (TTS), serious injury, or mortality is anticipated given the nature of the activities and measures designed to minimize the possibility of injury to marine mammals. The potential for these outcomes is minimized through the construction method and the implementation of the planned mitigation measures. Specifically, vibratory and impact hammers and drilling will be the primary methods of installation. Impact pile driving produces short, sharp pulses with higher peak levels and much sharper rise time to reach those peaks. If impact driving is necessary, implementation of soft start and shutdown zones significantly reduces any possibility of injury. Given sufficient “notice” through use of soft start (for impact driving), marine mammals are expected to move away from a sound source that is annoying prior to it becoming potentially injurious, however, as noted previously a small number of potential takes by PTS are authorized and have been analyzed. The FAA will use a minimum of two MMOs stationed strategically to increase detectability of marine mammals, enabling a high rate of success in implementation of shutdowns to avoid injury.
The FAA's Project activities are localized and of relatively short duration (a maximum of 70 days for pile driving and removal). The entire Project area is limited to Symonds Bay and into Sitka Sound for some scenarios. These localized and short-term noise exposures may cause short-term behavioral modifications in harbor seals, Steller sea lions, harbor porpoises, killer whales, and humpback whales. Moreover, the mitigation and monitoring measures are expected to reduce the likelihood of injury. Additionally, no important feeding and/or reproductive areas for marine mammals of any of these species/stocks are known to be within the ensonified area during the construction window.
Effects on individuals that are taken by Level B harassment, on the basis of reports in the literature as well as monitoring from other similar activities, will likely be limited to reactions such as increased swimming speeds, increased surfacing time, or decreased foraging (if such activity were occurring) (
The Project also is not expected to have significant adverse effects on affected marine mammals' habitat. The Project activities would not modify existing marine mammal habitat for a significant amount of time. The activities may cause some fish to leave the area of disturbance, thus temporarily impacting marine mammals' foraging opportunities in a limited portion of the foraging range. However, because of the short duration of the activities and the relatively small area of the habitat that may be affected, and the decreased potential of prey species to be in the Project area during the construction work window, the impacts to marine mammal habitat are not expected to cause significant or long-term negative consequences.
In summary and as described above, the following factors primarily support our determination that the impacts resulting from this activity are not expected to adversely affect the species or stocks through effects on annual rates of recruitment or survival:
• No mortality or serious injury is anticipated or authorized;
• Level B harassment may consist of, at worst, temporary modifications in behavior (
• The lack of important feeding, pupping, or other areas in the action area during the construction window;
• Mitigation is expected to minimize the likelihood and severity of the level of harassment; and
• The small percentage of the species/stock that may be affected by Project activities (<15 percent for all species/stocks).
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the monitoring and mitigation measures, NMFS finds that the total marine mammal take from the FAA's construction activities will have a negligible impact on the affected marine mammal species or stocks.
As noted above, only small numbers of incidental take may be authorized under Section 101(a)(5)(D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.
Table 7 details the number of instances that animals could be exposed to received noise levels that could cause Level A and Level B harassment for the planned work at the Project site relative to the total stock abundance. The numbers of animals authorized to be taken for each species or stock is considered small relative to the relevant species or stock size even if each estimated instance of take occurred to a new individual. The total percent of the population (if each instance was a separate individual) for which take is requested is less than 15 percent for each stock (Table 7). For pinnipeds, especially harbor seals occurring in the vicinity of the Project area, there will almost certainly be some overlap in individuals present day-to-day, and the number of individuals taken is expected to be notably lower.
Based on the analysis contained herein of the Project activities (including the mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.
In order to issue an IHA, NMFS must find that the specified activity will not have an “unmitigable adverse impact” on the subsistence uses of the affected marine mammal species or stocks by Alaskan Natives. NMFS has defined “unmitigable adverse impact” in 50 CFR 216.103 as: an impact resulting from the specified activity: (1) That is likely to reduce the availability of the species to a level insufficient for a harvest to meet subsistence needs by: (i) Causing the marine mammals to abandon or avoid
Harbor seals and Steller sea lions are subsistence harvested in Alaska. During 2012, the estimated subsistence take of harbor seals in southeast Alaska was 595 seals with 49 of these taken near Sitka (Wolfe
The peak hunting season in southeast Alaska occurs during the month of November and again over the March to April time frame (Wolfe
The Project is in an area where subsistence hunting for harbor seals or sea lions could occur (Wolfe
To satisfy requirements under Section 106 of the National Historic Preservation Act, R&M Consultants, Inc. reached out to the Sitka Tribe of Alaska, Central Council of the Tlingit and Haida, and Sealaska regarding cultural resources in 2016. No issues or concerns with the Project were raised during this effort.
Based on the description of the specified activity, the measures described to minimize adverse effects on the availability of marine mammals for subsistence purposes, and the mitigation and monitoring measures, NMFS has determined that there will not be an unmitigable adverse impact on subsistence uses from the FAA's activities.
Section 7(a)(2) of the Endangered Species Act of 1973 (ESA: 16 U.S.C. 1531
NMFS is authorizing take of two DPSs (
NMFS has issued an IHA to the FAA for the potential harassment of small numbers of five marine mammal species incidental to the Biorka Island dock replacement project in Sitka, AK, provided the previously mentioned mitigation, monitoring and reporting requirements are incorporated.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The Western Pacific Fishery Management Council (Council) will hold its 172nd meeting by teleconference and webinar to discuss and make recommendations on fishery management issues in the Western Pacific Region.
The Council will meet on November 15, 2017, between 2 p.m. and 5 p.m. (Hawaii Standard Time (HST)); 1 and 4 p.m. (American Samoa Standard Time (ASST)); and November 16, 2017, between 10 a.m. and 1 p.m. (Marianas Standard Time (MST)). All times listed are local island times. For specific time and agenda, see
The meeting will be held by teleconference and webinar. The teleconference numbers are: U.S. toll-free: 1 (888) 482-3560, International Access: +1 (647) 723-3959, and Access Code: 5228220. The webinar can be accessed at:
The following venues will also be host sites for the teleconference: Council Conference Room, 1164 Bishop Street, Suite 1400, Honolulu, Hawaii; Land Grant Conference Room, American Samoa Community College, Agriculture, Community and Natural Resources, Mapusaga Road, Malaeimi Village, American Samoa; Guam Hilton Resort and SPA, 202 Hilton Road, Tumon Bay, Guam; Department of Land and Natural Resources Conference Room, Santa Remedio Drive, Lower Base, Saipan, MP.
Kitty M. Simonds, Executive Director; telephone: (808) 522-8220.
Public comment opportunity will be provided in the agenda. The order in which agenda items are addressed may change. The meeting will run as late as necessary to complete scheduled business. Written comments must be received by November 10, 2017. Background documents will be available from, and written comments should be sent to, Kitty M. Simonds, Executive Director; Western Pacific Fishery Management Council, 1164 Bishop Street, Suite 1400, Honolulu, HI 96813; phone: (808) 522-8220 or fax: (808) 522-8226.
Non-Emergency issues not contained in this agenda may come before the Council for discussion and formal Council action during its 172nd meeting. However, Council action on regulatory issues will be restricted to those issues specifically listed in this document and any regulatory issue arising after publication of this document that requires emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take action to address the emergency.
Agenda items noted as “Final Action Items” refer to actions that result in Council transmittal of a proposed fishery management plan, proposed plan amendment, or proposed regulations to the U.S. Secretary of Commerce, under Sections 304 or 305 of the Magnuson-Stevens Fishery Conservation and Management Act.
The host sites are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, (808) 522-8220 (voice) or (808) 522-8226 (fax), at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The Mid-Atlantic Fishery Management Council's (MAFMC's) Summer Flounder, Scup, and Black Sea Bass Advisory Panel will hold a public meeting via webinar, jointly with the Atlantic States Marine Fisheries Commission's (ASMFC's) Summer Flounder, Scup, and Black Sea Bass Advisory Panel.
The meeting will be held on Monday, November 20, 2017, from 2 p.m. to 5 p.m. See
The meeting will take place over webinar with a telephone-only connection option. Details on how to connect to the webinar by computer and by telephone will be available at:
Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526-5255.
The Mid-Atlantic Fishery Management Council's Summer Flounder, Scup, and Black Sea Bass Advisory Panel, together with the Atlantic States Marine Fisheries Commission's Advisory Panel, will meet on Monday, November 20, 2017. The purpose of this meeting is to review and provide feedback on proposed recreational management measures (
A detailed agenda and background documents will be made available on the Council's Web site (
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Herring
This meeting will be held on Tuesday, November 21, 2017 at 8:30 a.m.
The meeting will be held at the Holiday Inn, 700 Myles Standish Blvd., Taunton, MA 02780; telephone: (508) 823-0430.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The committee will review analyses prepared for Herring Amendment 8 Draft Environmental Impact Statement (DEIS) specific to the range of alternatives developed to address potential localized depletion and user conflicts in the herring fishery. The committee may identify preferred alternatives for the Council to consider. The committee is not scheduled to discuss the other measures under consideration in Amendment 8, Acceptable Biological Catch (ABC) control rule alternatives. The Council reviewed the ABC control rule alternatives at the September 2017 meeting and declined to select a preferred alternative, but approved that portion of Amendment 8 to proceed for submission and public comment. They will discuss recommendations for the Council to consider for Herring Research Set-Aside research priorities for fishing years 2019-21 and discuss any challenges the program has had in recent years. They will discuss other business, as necessary.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has
This meeting is physically accessible to people with disabilities. This meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
Department of the Army, DoD.
30-day information collection notice.
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by November 30, 2017.
Comments and recommendations on the proposed information collection should be emailed to Mr. Vlad Dorjets, DoD Desk Officer, at
Fred Licari, 571-372-0493, or
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 03F09, Alexandria, VA 22350-3100.
Defense Travel Management Office, DoD.
Notice of Revised Non-Foreign Overseas Per Diem Rates.
The Defense Travel Management Office is publishing Civilian Personnel Per Diem Bulletin Number 307. This bulletin lists revisions in the per diem rates prescribed for U.S. Government employees for official travel in Alaska, Hawaii, Puerto Rico, the Northern Mariana Islands and Possessions of the United States when applicable. AEA changes announced in Bulletin Number 194 remain in effect. Bulletin Number 307 is being published in the
The revised per diem rates go into effect November 1, 2017.
Ms. Sonia Malik, 571-372-1276.
This document gives notice of revisions in per diem rates prescribed by the Defense Travel Management Office for non-foreign areas outside the contiguous United States. Per Diem Bulletins published periodically in the
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice; correction.
Due to circumstances beyond the control of the Designated Federal Officer and the Department of Defense, the Inland Waterways Users Board was unable to provide public notification changing the meeting location of its meeting of November 3, 2017, which was previously announced in the
The notice of an open meeting scheduled for November 3, 2017 published in the
Mr. Mark R. Pointon, the Designated Federal Officer (DFO) for the committee, in writing at the Institute for Water Resources, U.S. Army Corps of Engineers, ATTN: CEIWR-GM, 7701 Telegraph Road, Casey Building, Alexandria, VA 22315-3868; by telephone at 703-428-6438; and by email at
This is a supplemental notice in the above-referenced proceeding of EnPowered`s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 14, 2017.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) is announcing plans to hold information sessions on: November 8, 2017 in Denver, Colorado; November 16, 2017 in Nashville, Tennessee; and November 29, 2017 in Lenexa, Kansas. In addition, EPA will host a series of webinars covering the same topics on December 6, 13, and 20, 2017. The purpose of both the sessions and webinars is to provide prospective borrowers with a better understanding of the Water Infrastructure Finance and Innovation Act (WIFIA) program requirements and application process.
Under WIFIA, EPA can provide long-term, low-cost supplemental loans and loan guarantees for regionally and nationally significant water infrastructure projects. During each information session, EPA will provide an overview of the program's statutory and eligibility requirements, application and selection process, and creditworthiness assessment. It will also explain the financial benefits of WIFIA credit assistance and provide tips for completing the application materials. The intended audience is prospective borrowers including municipal entities, corporations, partnerships, and State Revolving Fund programs, as well as the private and non-governmental organizations that support prospective borrowers.
The session in Denver, Colorado will be held on November 8, 2017 from 9:00 a.m.-3:00 p.m. (MT). The session in Nashville, Tennessee will be held on November 16, 2017 from 9:00 a.m.-3:00 p.m. (CT). The session in Lenexa, Kansas will be held on November 29, 2017 from 9:00 a.m.-3:00 p.m. (CT).
The session in Denver will be held at: US EPA Region 8 Headquarters, 1595 Wynkoop Street, Denver, Colorado 80202. The session in Nashville will be held at: William R. Snodgrass—Tennessee Tower, 312 Rosa L. Parks Avenue, Conference Center North, 3rd Floor, Room D, Nashville, Tennessee 37243. The session in Lenexa will be held at: EPA Region 7 Headquarters, 11201 Renner Boulevard, Lenexa, Kansas 66219.
For further information about this notice, including registration information, contact Karen Fligger, EPA Headquarters, Office of Water, Office of Wastewater Management at tel.: 202-564-2992; or email:
Water Infrastructure Finance and Innovation Act, 33 U.S.C. 3901 et. seq.
Environmental Protection Agency (EPA).
Notice; request for public comment.
In accordance with section 122(h)(1) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended (“CERCLA”), notice is hereby given of a proposed administrative settlement concerning the Bandera Road Ground Water Plume Superfund Site, located in City of Leon Valley, Bexar County, Texas.
The settlement requires Savings Square Partners, Ltd., settling party, to pay a total of $1,820,000 as payment of past response costs to the Hazardous Substances Superfund. The settlement includes a covenant not to sue pursuant to sections 106 and 107(a) of CERCLA, 42 U.S.C. 9606 and 9607(a).
For thirty (30) days following the date of publication of this notice, the Agency will receive written comments relating to this notice and will receive written comments relating to the settlement. The Agency will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency's response to any comments received will be available for public inspection at 1445 Ross Avenue, Dallas, Texas 75202-2733.
Comments must be submitted on or before November 30, 2017.
The proposed settlement and additional background information relating to the settlement are available for public inspection at 1445 Ross Avenue, Dallas, Texas 75202-2733. A copy of the proposed settlement may be obtained from Lawrence Andrews, 1445 Ross Avenue, Dallas, Texas 75202-2733 or by calling (214) 665-7397. Comments should reference the Bandera Road Ground Water Plume Superfund Site, City of Leon, Bexar County, Texas, and EPA Docket Number 06-06-17 and should be addressed to Lawrence Andrews at the address listed above.
Jacob Piehl, 1445 Ross Avenue, Dallas, Texas 75202-2733 or call (214) 665-2138.
Environmental Protection Agency (EPA).
Notice of adequacy.
In this notice, the Environmental Protection Agency (EPA) is notifying the public that we find that the motor vehicle emissions budgets (MVEBs) for volatile organic compounds (VOCs) and oxides of nitrogen (NO
This finding is effective November 15, 2017.
Michael Leslie, Environmental Engineer, Control Strategies Section (AR-18J), Air Programs Branch, Air and Radiation Division, United States Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 353-6680,
Throughout this document, whenever “we”, “us” or “our” is used, we mean EPA.
Today's notice is an announcement of a finding that we have already made. On September 6, 2017, EPA sent a letter to the Wisconsin Department of Natural Resources stating that the 2017 and 2018 MVEBs contained in the Attainment Demonstration for Kenosha County in Wisconsin are adequate for transportation conformity purposes. Receipt of these MVEBs was announced on EPA's transportation conformity Web site, and no comments were submitted. The finding is available at EPA's conformity Web site:
The 2017 and 2018 MVEBs, in tons per day (tpd), for VOCs and NO
Transportation conformity is required by section 176(c) of the Clean Air Act. EPA's conformity rule requires that transportation plans, programs, and projects conform to state air quality implementation plans and establishes the criteria and procedures for determining whether or not they do conform. Conformity to a State Implementation Plan (SIP) means that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the national ambient air quality standards.
The criteria by which we determine whether a SIP's MVEBs are adequate for transportation conformity purposes are outlined in 40 CFR 93.118(e)(4). Please note that an adequacy review is separate from EPA's completeness review, and it also should not be used to prejudge EPA's ultimate approval of the SIP. Even if we find a budget adequate, the SIP could later be disapproved.
42 U.S.C. 7401-7671 q.
Environmental Protection Agency (EPA).
Notice; request for public comment.
On January 18, 2017, the Federal Permitting Improvement Steering Council, published
Comments must be received on or before November 20, 2017.
Submit comments and additional materials, identified by docket EPA-HQ-OA-2017-0600 to the Federal eRulemaking Portal:
Laura Gentile, Office of Policy, Mail Code 1104-A, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: 202-564-3158; email address:
FAST-41 seeks to enhance coordination and transparency of Federal environmental reviews and authorizations required prior to construction of covered infrastructure projects. This statute applies specifically to authorizations and environmental reviews which are led by and/or issued by a Federal agency. However, states may choose to participate in the environmental review and authorization process under FAST-41. This statute only applies to “covered projects” which 42 U.S.C. 4370m(6)(A) defines as:
The term “covered project” means any activity in the United States that requires authorization or environmental review by a Federal agency involving construction of infrastructure for renewable or conventional energy production, electricity transmission, surface transportation, aviation, ports and waterways, water resource projects, broadband, pipelines, manufacturing, or any other sector as determined by a majority vote of the Council that—
(i)(I) is subject to NEPA;
(II) is likely to require a total investment of more than $200,000,000; and
(III) does not qualify for abbreviated authorization or environmental review processes under any applicable law; or
(ii) is subject to NEPA and the size and complexity of which, in the opinion of the Council, make the project likely to benefit from enhanced oversight and coordination, including a project likely to require—
(I) authorization from or environmental review involving more than 2 Federal agencies; or
(II) the preparation of an environmental impact statement under NEPA.
FAST-41 required the establishment of the Federal Permitting Improvement Steering Council (FPISC) which is a council that includes a chair and then representatives of certain Federal agencies, the Chairman of the Council on Environmental Quality, and the Director of the Office of Management and Budget. Council agencies include agencies that may be involved in authorization or environmental review of a covered project. The EPA is one such agency and is represented on the FPISC. Pursuant to FAST-41, the FPISC is charged with issuing recommendations on best practices to support the goals of FAST-41.
States may voluntarily choose to participate in the FAST-41 process and make subject to the process all State agencies that have jurisdiction, are required to undertake a review or analysis, or are required to make a determination on issuing a permit, license or other approval for a covered project.
On January 18, 2017, the FPISC published a document titled,
“(i) enhancing early stakeholder engagement, including fully considering and, as appropriate, incorporating recommendations provided in public comments on any proposed covered project;
(ii) ensuring timely decisions regarding environmental reviews and authorizations, including through the development of performance metrics;
(iii) improving coordination between Federal and non-Federal governmental entities, including through the development of common data standards and terminology across agencies;
(iv) increasing transparency;
(v) reducing information collection requirements and other administrative burdens on agencies, project sponsors, and other interested parties;
(vi) developing and making available to applicants appropriate geographic information systems and other tools;
(vii) creating and distributing training materials useful to Federal, State, tribal, and local permitting officials; and
(viii) addressing other aspects of infrastructure permitting, as determined by the Council.”
Under a number of federal environmental laws, the EPA delegates, approves, or authorizes state governments to issue permits or other authorizations under these laws. The EPA has already taken a number of steps related to best practices for delegated and authorized state permitting programs. These include establishing minimum program requirements for authorized and delegated programs consistent with the underlying statutory obligations.
In addition, the EPA regularly communicates with delegated and authorized programs regarding program implementation and oversight. One example of this is that in 2016, the EPA initiated an agency-wide effort, with the consultation and collaboration of stakeholder associations throughout, to articulate a common set of principles and best practices for promoting the efficiency and effectiveness of delegated, authorized, and approved state permitting programs. On August
Consistent with the EPA's obligation under 42 U.S.C. 4370m-5(a)(1), the EPA is now seeking public comment to determine whether and the extent to which any of the best practices identified by the FPISC are generally applicable on a delegation- or authorization-wide basis to permitting under FAST-41. This document satisfies EPA's obligation under FAST-41 to solicit public participation on the FPISC best practices.
Public Law 114-94, div. D, title XLI, sec. 41006(a)(1), Dec. 4, 2015, 129 Stat. 1758.
Dated: October 25, 2017.
Environmental Protection Agency (EPA).
Notice of a public meeting.
The U.S. Environmental Protection Agency (EPA) is announcing a public meeting of the National Drinking Water Advisory Council (NDWAC), as authorized under the Safe Drinking Water Act. During this meeting, the NDWAC will focus discussions on developing recommendations for the EPA Administrator on Health Advisory Communications.
The meeting on December 7, 2017, will be held from 9:30 a.m. to 4:00 p.m., eastern time; and December 8, 2017, from 8:30 a.m. to noon, eastern time.
The public meeting will be held at the U.S. Environmental Protection Agency, William Jefferson Clinton (WJC) East Building, Rooms 1117A & B, 1201 Constitution Avenue NW., Washington, DC 20460.
For more information about this meeting or to request written materials, contact Tracey Ward of the Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency; by phone at 202-564-3796 or by email at
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before January 2, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
As part of its continuing effort to reduce paperwork burdens, and as required by the PRA of 1995 (44 U.S.C. 3501-3520), the FCC invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The Federal Communications Commission (“Commission”) plans to implement and release to the public an “Application for an International Broadcast Station License” (FCC Form 421-IB). The FCC Form 421-IB will be used by applicants to request licenses to operate international broadcast stations. The FCC Form 421-IB has not been implemented yet due to a lack of budget resources and technical staff. After the form has been implemented and the Commission has obtained final approval from the OMB, applicants will file the FCC Form 421-IB with the Commission in lieu of the “Application for an International, Experimental Television, Experimental Facsimile, or a Developmental Broadcast Station,” (FCC Form 310). (Note: The Commission received approval from the OMB for the FCC Form 310 under OMB Control No 3060-1035). In the interim, applicants will continue to file the FCC Form 310 with the Commission.
The Commission stated previously that the FCC Form 421-IB will be available to applicants in the International Bureau Filing System (“MyIBFS”) after its development. The Commission plans to develop a new Consolidated Licensing System (CLS) that will replace MyIBFS. Therefore, the FCC Form 421-IB will be made available to the public in CLS instead of MyIBFS.
The information collected is used by the Commission to assign frequencies for use by international broadcast stations, to grant authority to operate such stations and to determine if interference or adverse propagation conditions exist that may impact the operation of such stations. If the Commission did not collect this information, it would not be in a position to effectively coordinate spectrum for international broadcasters or to act for entities in times of frequency interference or adverse propagation conditions. The orderly nature of the provision of international broadcast service would be in jeopardy without the Commission's involvement.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before January 2, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email:
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
As part of its continuing effort to reduce paperwork burdens, and as required by the PRA, 44 U.S.C. 3501-3520, the FCC invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The data collected on FCC Form 601 includes the FCC Registration Number (FRN), which serves as a “common link” for all filings an entity has with the FCC. The Debt Collection Improvement Act of 1996 requires entities filing with the Commission to use an FRN.
On August 3, 2017, the Commission released the
The Commission now seeks approval for revisions to its currently approved collection of information under OMB Control Number 3060-0798 to permit (1) the collection of renewal-related information for Wireless Radio Service (WRS) licenses, and (2) the filing of requests to extend a permanent discontinuance period for good cause. Regarding renewal of WRS licenses, § 1.949(d) of the Commission's rules requires an applicant for renewal of certain WRS licenses to meet the Renewal Standard,
We do not anticipate that these revisions will have any impact on the burden to complete FCC Form 601. The renewal process remains virtually unchanged for site-based licensees, which will continue to have streamlined processes for renewal under the safe harbors adopted in the
The Commission therefore seeks approval for a revision to its currently approved information collection on FCC Form 601 to revise FCC Form 601 accordingly.
The data collected on FCC 603 include the FCC Registration Number (FRN), which serves as a “common link” for all filings an entity has with the FCC. The Debt Collection Improvement Act of 1996 required that those filing with the Commission to use an FRN, effective December 3, 2001.
Records may include information about individuals or households,
On August 3, 2017, the Commission released the
Specifically, § 1.950(c) requires parties seeking approval for geographic partitioning, spectrum disaggregation, or a combination of both must apply for a partial assignment of authorization by filing FCC Form 603 pursuant to § 1.948 of the Commission's rules. Each request for geographic partitioning must include an attachment defining the perimeter of the partitioned area by geographic coordinates to the nearest second of latitude and longitude, based upon the 1983 North American Datum (NAD83). Alternatively, applicants may specify an FCC-recognized service area (
In addition, § 1.950(d) requires applicants for geographic partitioning, spectrum disaggregation, or a combination of both, to include, if applicable, a certification with their partial assignment of authorization application stating which party will meet any incumbent relocation requirements, except as otherwise stated in service-specific rules. Further, § 1.950(g) provides parties to geographic partitioning, spectrum disaggregation, or a combination of both, with two options to satisfy service-specific performance requirements (
The Commission seeks approval for revisions to its currently approved collection of information under OMB Control Number 3060-0800 to permit the collection of the additional information in connection with partial assignments of authorizations for geographic partitioning, spectrum disaggregation, or a combination of both, pursuant to the rules and information collection requirements adopted by the Commission in the
The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Tuesday, October 24, 2017 which is scheduled to commence at 10:30 a.m. in Room TW-C305, at 445 12th Street SW., Washington, DC.
The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. In your request, include a description of the accommodation you will need and a way we can contact you if we need more information. Last minute requests will be accepted, but may be impossible to fill. Send an email to:
Additional information concerning this meeting may be obtained from the Office of Media Relations, (202) 418-0500; TTY 1-888-835-5322. Audio/Video coverage of the meeting will be broadcast live with open captioning over the Internet from the FCC Live Web page at
For a fee this meeting can be viewed live over George Mason University's Capitol Connection. The Capitol Connection also will carry the meeting live via the Internet. To purchase these services, call (703) 993-3100 or go to
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before January 2, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
As part of its continuing effort to reduce paperwork burdens, and as required by the PRA of 1995 (44 U.S.C. 3501-3520), the FCC invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The Federal Communications Commission (“Commission”) received approval from the OMB to develop a new application titled, “Application for Authority to Construct or Make Changes in an International Broadcast Station (FCC Form 420-IB)” to request authority from the Commission to construct or make changes in an international broadcast station. This application has not been implemented and released to the public yet due to a lack of budget resources and technical staff. After the FCC Form 420-IB has been implemented and the Commission has obtained final approval from the OMB, it will be completed by international broadcasters in lieu of the “Application for Authority to Construct or Make Changes in an International, Experimental Television, Experimental Facsimile, or a Developmental Broadcast Station,” (FCC Form 309). In the interim, applicants will continue to file the FCC Form 309 with the Commission. (Note: The OMB approved the FCC Form 309 under OMB Control No. 3060-1035.
The information collected pursuant to the rules set forth in 47 CFR part 73, subpart F, is used by the Commission to assign frequencies for use by international broadcast stations, to grant authority to operate such stations and to determine if interference or adverse propagation conditions exist that may impact the operation of such stations. If the Commission did not collect this information, it would not be in a position to effectively coordinate spectrum for international broadcasters or to act for entities in times of frequency interference or adverse propagation conditions. The orderly nature of the provision of international broadcast service would be in jeopardy without the Commission's involvement.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 28, 2017.
1.
In connection with this proposal, Southeastern Bancorp, Inc., Dickson, Tennessee has applied to retain ownership of its savings association subsidiary, First Federal Bank, Dickson, Tennessee, pursuant to section 225.28(b)(4)(ii) of Regulation Y.
1.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than November 16, 2017.
1.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 27, 2017.
1.
1.
1.
The companies listed in this notice have applied to the Board for approval, pursuant to the Home Owners' Loan Act (12 U.S.C. 1461
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the HOLA (12 U.S.C. 1467a(e)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 10(c)(4)(B) of the HOLA (12 U.S.C. 1467a(c)(4)(B)). Unless otherwise noted, nonbanking activities
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 28, 2017.
1.
Office of Governmentwide Policy; General Services Administration, (GSA).
Notice of public availability of GSA Fiscal Year 2016 Service Contract Inventories.
In accordance with The Fiscal Year (FY) 2010 Consolidated Appropriations Act, GSA is publishing this notice to advise the public of the availability of the FY 2016 Service Contract Inventories.
October 31, 2017.
Questions regarding the Service Contract Inventory should be directed to Mr. James Tsujimoto in the Office of Acquisition Policy at 202-206-3585 or
In accordance with section 743 of Division C of the FY 2010 Consolidated Appropriations Act (Pub. L. 111-117), GSA is publishing this notice to advise the public of the availability of the FY 2016 Service Contract Inventories. These inventories are available at
Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).
Notice of Availability of the Final Environmental Assessment and Finding of No Significant Impact.
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS) announces the availability of the Final Environmental Assessment (EA) and a Finding of No Significant Impact (FONSI) for the CDC Chamblee Campus 2025 Master Plan.
Angela Wagner, Portfolio Manager, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-K96, Atlanta, Georgia 30329, Telephone: (770) 488-8170.
On March 22, 2017 CDC announced the availability for public comment of a Draft Environmental Assessment (Draft EA) for the implementation of the CDC Chamblee Campus 2025 Master Plan (Master Plan) (82 FR 14733). CDC's Chamblee Campus is located at 4770 Buford Highway, Chamblee, Georgia. The Draft EA was available for a 60-day public comment period that ended on May 22, 2017. Six comments were received to the docket; none of the comments raised specific issues or concerns with the methodology, analysis, conclusion or accuracy of the EA.
The Draft EA was prepared in accordance with the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
The Chamblee Campus 2025 Master Plan provides a framework for future growth on the Chamblee Campus in order to ensure that the campus can support CDC's mission and to guide strategic decisions about the allocation of Federal resources. The Master Plan identifies a number of potential improvements that may be completed through the 2025 timeframe, and establishes design and planning guidelines.
The proposed improvements include: (1) New building construction, including an approximately 386,000 gross square feet (gsf) office building, an approximately 415,000 gsf laboratory building and an adjacent approximately 10,000 gsf laboratory material handling facility; and a new, approximately 20,000 gsf, central utility plant (CUP); (2) building demolition; (3) expansion and reconfiguration of parking on campus; (4) installation of a comprehensive solar photovoltaic system; (5) improvements to the campus entrances; and (6) additional infrastructure improvements.
CDC assessed the potential impacts of the proposed improvements on the
Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).
Request for information.
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is requesting information from the public to inform future activities regarding how to efficiently and cost effectively help people quit using tobacco using evidence-based treatment options.
Written comments must be received on or by January 2, 2018.
Submit comments by any one of the following methods:
•
•
All relevant comments will be posted without change to
Pamela Lemos, Office on Smoking and Health, Centers for Disease Control and Prevention, 4770 Buford Highway, Atlanta, GA 30341; Telephone (770) 488-5709; Email:
Cigarette smoking is the leading cause of premature death and disease in the United States, causing about 480,000 deaths each year and costing the country over $300 billion annually in health care spending and lost productivity.
Most cigarette smokers say that they want to quit, more than half try to quit each year, and almost three in five American adults who ever smoked have quit.
Many resources are available to help smokers connect with evidence-based treatments. Telephone quitlines exist in all states and other innovative and emerging resources are available such as web based platforms, texting, chat, and mobile apps. Many smokers, however, are unaware of these resources or have misconceptions about them.
CDC is seeking information from the public to inform future activities that could efficiently and cost effectively connect tobacco users with evidence-based treatment options to help them quit. We plan to use the information gathered to inform activities including, but not limited to, state tobacco control programming, national governmental and nongovernmental organization work, and other entities that work to make broadly available and sustainable connections between people who want to quit using tobacco and evidence-based cessation assistance.
The goal of this effort is to ensure that all tobacco users who want help quitting are aware of and have ready access to evidence-based treatment options through channels that they are comfortable using, including but not limited to telephone quitlines. We will carefully review and consider all comments received to this request for information.
CDC is specifically interested in receiving information on the following topics:
(1) How can CDC leverage emerging technologies to deliver evidence-based cessation interventions through new and innovative platforms that have broad reach, especially among younger adults, those with low income, and adults with chronic and/or behavioral health conditions?
(2) What are some innovative approaches to reduce the cost—in time, staffing, and funding—of providing effective cessation services to people who want to quit using tobacco?
(3) How might standardization of quitline services achieve greater efficiency while also preserving state quitlines' “brands,” flexibility, and capacity for innovation?
(4) What communication channels and communication strategies should CDC consider employing to ensure that both tobacco users, including those belonging to high-risk and disadvantaged populations, and health care providers are aware of and have access to evidence-based cessation resources?
(5) What role should CDC, state and local health departments, not for profit institutions, traditional healthcare providers, and/or professional healthcare partner organizations, play in ensuring that high-risk populations (such as smokers living below the poverty level or those with behavioral health conditions) have access to tailored cessation services of appropriate intensity to help them successfully quit?
(6) How can CDC support state and local health departments, traditional healthcare providers, not for profit health institutions, and professional healthcare partner organizations to ensure that evidence-based tobacco cessation interventions are integrated into primary and behavioral health care settings on a consistent and sustainable basis?
(7) How can the public health sector most effectively maximize the impact of public and private insurance coverage of cessation treatments as part of efforts to ensure that all tobacco users have barrier-free access to these treatments?
National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of availability.
NIOSH announces the availability of the following four Immediately Dangerous to Life or Health (IDLH) Value Profile documents: Acetonitrile [CAS No. 75-05-8], Chloroacetonitrile [CAS No. 107-14-2], Methacrylonitrile [CAS No. 126-98-7], and Nitrogen dioxide [CAS No. 10102-44-0].
The final IDLH Value Profile documents were published on September 29, 2017.
These documents may be obtained at the following link:
R. Todd Niemeier, MS, CIH, NIOSH, Education and Information Division (EID), Robert A. Taft Laboratories, 1090 Tusculum Ave., MS-C32, Cincinnati, OH 45226, phone 513/533-8166 (not a toll-free number), email:
On May 5, 2017, NIOSH published a request for public review in the
Food and Drug Administration, HHS.
Notice of public workshop; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled “Packaging, Storage, and Disposal Options To Enhance Opioid Safety—Exploring the Path Forward.” The purpose of this 2-day public workshop is to host a scientific discussion with experts and seek input from interested stakeholders regarding the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioid drug products (opioids); guiding principles and considerations for the design of packaging, storage, and disposal options for opioids; integrating packaging, storage, and disposal options into existing health care and pharmacy systems, including both open and closed health care systems (
The public workshop will be held on December 11 and 12, 2017, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by February 12, 2018. See the
The public workshop will be held at the Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. The hotel's phone number is 301-589-0800.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 12, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Irene Z. Chan, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4420, Silver Spring, MD 20993-0002, 301-796-3962,
FDA is deeply concerned about the widespread epidemic of opioid abuse, dependence, and overdose in the United States. FDA believes packaging, storage, and disposal options have the potential to enhance the safety of legally prescribed opioids. The development of such options is an important component of a multi-pronged approach to addressing the current opioid epidemic.
FDA is exploring a scientific framework that supports and encourages the development of packaging, storage, and disposal options that can reduce or deter misuse, abuse, or inappropriate access to opioids, while allowing for the safe use of opioids by patients who need them. FDA will need to define the specific problems that packaging, storage, and disposal options could most effectively address; the guiding scientific principles to consider for the design and evaluation of these options; and the types of data most useful for evaluating them.
The Duke-Margolis Center for Health Policy previously convened an expert workshop on June 1, 2017, to begin examining the potential role of packaging, storage, and disposal options in enhancing opioid safety and deterring misuse, abuse, and inappropriate access. This workshop provided a forum for discussing (1) the role of packaging, storage, and disposal options in addressing factors that enable opioid abuse and misuse or inappropriate access; (2) the current range of existing packaging, storage, and disposal options; (3) approaches to evaluating the impact of packaging, storage, and disposal options on misuse and abuse or inappropriate access of opioids; and (4) considerations for integrating the use of packaging, storage, and disposal options into existing health care and pharmacy systems. Following the June 1, 2017, Duke-Margolis Center for Health Policy expert workshop, an issues paper was developed.
In this 2-day public workshop, FDA plans to explore the appropriate path forward by hosting a scientific discussion with experts and seeking input from interested stakeholders.
Participants will include individuals from a broad set of Federal, State, and private and public stakeholders who are working on the challenges of improving pain management while addressing the opioid abuse epidemic. Public participation and comment is encouraged.
Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by December 1, 2017, midnight Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. We will let registrants know if registration closes before the day of the public workshop.
If you need special accommodations due to a disability, please contact Michelle Eby at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by January 2, 2018.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 2, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
This information collection supports the above captioned Agency guidance. The guidance includes recommendations for planning, notification, and documentation for firms that report postmarketing adverse events. The guidance recommends that each firm's pandemic influenza continuity of operations plan (COOP) include instructions for reporting adverse events, including a plan for the submission of stored reports that were not submitted within regulatory timeframes. The guidance explains that firms that are unable to fulfill normal adverse event reporting requirements during an influenza pandemic should: (1) Maintain documentation of the conditions that prevent them from meeting normal reporting requirements; (2) notify the appropriate FDA organizational unit responsible for adverse event reporting compliance when the conditions exist and when the reporting process is restored; and (3) maintain records to identify what reports have been stored.
Based on the number of manufacturers that would be covered by the guidance, we estimate that approximately 5,000 firms will add the following to their COOP: (1) Instructions for reporting adverse events and (2) a plan for submitting stored reports that were not submitted within regulatory timeframes. We estimate that each firm will take approximately 50 hours to prepare the adverse event reporting plan for its COOP.
We estimate that approximately 500 firms will be unable to fulfill normal adverse event reporting requirements because of conditions caused by an influenza pandemic and that these firms will notify the appropriate FDA organizational unit responsible for adverse event reporting compliance when the conditions exist. Although we do not anticipate such pandemic influenza conditions to occur every year, for purposes of the PRA, we estimate that each of these firms will notify FDA approximately once each year and that each notification will take approximately 8 hours to prepare and submit.
Concerning the recommendation in the guidance that firms unable to fulfill normal adverse event reporting requirements maintain documentation of the conditions that prevent them from meeting these requirements and also maintain records to identify what adverse event reports have been stored and when the reporting process is restored, we estimate that approximately 500 firms will each need approximately 8 hours to maintain the documentation and that approximately 500 firms will each need approximately 8 hours to maintain the records.
We therefore estimate the burden of the collection of information as follows:
Based on our experience with the information collection we have retained our current burden estimate of 258,000 hours annually.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled “E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.” The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance clarifies, updates, and extends the earlier “E9 Statistical Principles for Clinical Trials” in two main areas. Concerning estimands, it provides a framework for discussion of how the aims of a trial relate to the proposed statistical analysis. Concerning sensitivity analysis, it discusses how to use additional analyses to address concerns about the validity of assumptions underlying the main analysis. The draft guidance is intended to better align the choice of statistical methods with questions of regulatory importance and to improve the reliability of decisions about and representations of the effects of medical products.
Submit either electronic or written comments on the draft guidance by April 30, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or 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 guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the
In recent years, regulatory authorities and industry associations from around the world have participated in many important initiatives to promote international harmonization of regulatory requirements under the ICH. FDA has participated in several ICH meetings designed to enhance harmonization, and FDA is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and reduce differences in technical requirements for drug development among regulatory agencies.
ICH was established 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; FDA; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; 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. The Assembly is responsible for the endorsement of draft guidelines and adoption of final guidelines. FDA publishes ICH guidelines as FDA guidance.
In July 2017, the ICH Assembly endorsed the draft guideline entitled “E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials” and agreed that the guidance should be made available for public comment. The draft guidance is the product of the Efficacy Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Efficacy Expert Working Group.
The draft guidance provides guidance on aligning the choice of statistical methods with the goals of a clinical trial; on communicating the rationale for such choices to FDA; and on using sensitivity analysis to characterize the robustness of the conclusions to plausible deviations from the assumptions of the main analysis.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
Persons with access to the internet may obtain the document at
Health Resources and Service Administration (HRSA), Department of Health and Human Services (HHS).
Notice of charter renewal.
HHS is hereby giving notice that the charter for the National Advisory Committee on Rural Health and Human Services (NACRHHS) has been renewed. The effective date of the renewed charter is October 31, 2017.
Paul Moore, Designate Federal Official, NACRHHS, HRSA, 5600 Fishers Lane, Room 17W41C, Rockville, Maryland 20857, telephone (301) 443-0835, fax (301) 443-2803 or by email at
NACRHHS provides advice to the Secretary concerning the provision and financing of health care and human services in rural areas. The current Committee was established under Section 222 of the Public Health Service Act, as amended, 42 U.S.C. 217a. In accordance with Public Law 92-463, it was chartered on October 30, 1987, has been renewed at appropriate intervals, and will operate until October 31, 2019. The Committee will continue to operate in accordance with the provisions of the Federal Advisory Committee Act (FACA).
A copy of the NACRHHS charter is available on the NACRHHS Web site at
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Office of AIDS Research Advisory Council.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(9)(B), Title 5 U.S.C., as amended, for the review of recommendations for the HHS Treatment and Prevention Guidelines for medical care of people living with HIV in the United States. Recommendations made from the working group to the OARAC will include drug names, treatment regimens, and prevention modalities to be used for the clinical care of PLWHA. The Council may revise the draft guidelines and change the content or scope of treatment and prevention for HIV/AIDS as recommended in the final guidelines. Premature disclosure of draft guidelines in an open meeting could negatively impact health and safety due to the premature disclosure of information to medical providers and the public. Draft guidelines could be misunderstood and confuse medical providers and the public as to what is the current HHS guidelines for the treatment and prevention of HIV/AIDS, could lead to premature changes in treatment regimens and prevention modalities that affect the health and safety of PLWHA and the public.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material,
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Coast Guard, DHS.
Request for comments; extension of comment period.
We are extending the comment period on the subject request for comments that we published August 14, 2017. We are extending the deadline by 30 days because interested parties indicated the need for additional time to respond due to the effects from Hurricane Harvey. The comment period is now open through November 30, 2017.
Comments and related material must be received on or before November 30, 2017.
You may submit comments identified by docket number USCG-2017-0194 using the Federal eRulemaking Portal at
If you have questions on this notice, call or email Commander Loan T. O'Brien, U.S. Coast Guard; telephone 409-723-6564, email,
The Coast Guard is extending the comment period on the request for comments entitled “Waterway Suitability Assessment for Operation of Liquefied Hazardous Gas Terminal; Port Arthur, TX” that we published in the
We encourage you to submit comments and related material in response to this notice through the Federal eRulemaking Portal at
If your material cannot be submitted using
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice of sale of two multifamily mortgage loans.
This notice announces HUD's intention to sell two unsubsidized multifamily mortgage loans, without Federal Housing Administration (FHA) insurance, in a competitive, sealed bid sale on or about November 8, 2017 (MLS 2018-1 or Loan Sale). This notice also describes generally the bidding process for the sale and certain persons who are ineligible to bid.
A Bidder's Information Package (BIP) was made available on October 11, 2017 on the HUD Web site at
To become a qualified bidder and receive the BIP, prospective bidders must complete, execute, and submit a Confidentiality Agreement and a Qualification Statement acceptable to HUD. Both documents will be available on the HUD Web site at
John Lucey, Director, Asset Sales Office, Room 3136, U.S. Department of Housing and Urban Development, 451 Seventh Street SW., Washington, DC 20410-8000; telephone 202-402-3927. Hearing- or speech-impaired individuals
HUD announces its intention to sell, in MLS 2018-1, two (2) unsubsidized first lien mortgage loans (Mortgage Loans) secured by two multifamily properties located in Waynesville, Missouri, and Amarillo, Texas. The Mortgage Loans are non-performing mortgage loans. The listing of the Mortgage Loans is included in the BIP. The Mortgage Loans will be sold without FHA insurance and with HUD servicing released. HUD will offer qualified bidders an opportunity to bid competitively on the Mortgage Loans. Qualified bidders may submit bids on one or more of the Mortgage Loans.
The Qualification Statement describes the entities/individuals that may be qualified to bid on the Mortgage Loans if they meet certain requirements as detailed in the Qualification Statement. Some entities/individuals must meet additional requirements in order to be qualified to bid, including but not limited to:
Any mortgagee/servicer who originated one or more of the Mortgage Loans; a mortgagor or an operator, with respect to any HUD insured or subsidized mortgage loan (excluding the Mortgage Loans being offered in the Loan Sale) who is currently in default, violation, or noncompliance with one or more of HUD's requirements or business agreements; and a limited partner, nonmanaging member, investor and/or shareholder who owns a 1% or less interest in one or more of the Mortgage Loans, or in the project securing one or more of the Mortgage Loans; and any of the aforementioned entities'/individuals' principals, affiliates, family members, and assigns.
Interested entities/individuals who fall into one of these categories should review the Qualification Statement to determine whether they may be eligible to qualify to submit a bid on the Mortgage Loans. Other entities/individuals not described herein may also be restricted from bidding on the Mortgage Loans, as fully detailed in the Qualification Statement.
The BIP describes in detail the procedure for bidding in MLS 2018-1. The BIP also includes a standardized non-negotiable loan sale agreement (Loan Sale Agreement).
As part of its bid, each bidder must submit a minimum deposit of the greater of One Hundred Thousand Dollars ($100,000) or ten percent (10%) of the aggregate bid prices for all of such Bidder's bids. In the event the Bidder's aggregate bid is less than One Hundred Thousand Dollars ($100,000), the minimum deposit shall be not less than fifty percent (50%) of the Bidder's aggregate bid. HUD will evaluate the bids submitted and determine the successful bid(s) in its sole and absolute discretion. If a bidder is successful, the bidder's deposit will be non-refundable and will be applied toward the purchase price, with any amount beyond the purchase price being returned to the bidder. Deposits will be returned to unsuccessful bidders after notification to sucessful bidders on or before November 13, 2017. Closings are expected to take place between November 17, 2017 and November 20, 2017.
These are the essential terms of sale. The Loan Sale Agreement, which is included in the BIP, contains additional terms and details. To ensure a competitive bidding process, the terms of the bidding process and the Loan Sale Agreement are not subject to negotiation.
The BIP describes the due diligence process for reviewing loan files in MLS 2018-1. Qualified bidders will be able to access loan information remotely via a high-speed Internet connection. Further information on performing due diligence review of the Mortgage Loans is provided in the BIP.
HUD reserves the right to add Mortgage Loans to or delete Mortgage Loans from MLS 2018-1 at any time prior to the Award Date. HUD also reserves the right to reject any and all bids, in whole or in part, without prejudice to HUD's right to include the Mortgage Loans in a later sale. The Mortgage Loans will not be withdrawn after the award date except as is specifically provided for in the Loan Sale Agreement.
This is a sale of unsubsidized multifamily mortgage loans, pursuant to Section 204(a) of the Departments of Veterans Affairs and Housing and Urban Development, and Independent Agencies Appropriations Act of 1997, (12 U.S.C. 1715z-11a(a)).
HUD selected a competitive sale as the method to sell the Mortgage Loans. This method of sale optimizes HUD's return on the sale of these Mortgage Loans, affords the greatest opportunity for all qualified bidders to bid on the Mortgage Loans, and provides the most efficient vehicle for HUD to dispose of the Mortgage Loans.
In order to bid in the sale, a prospective bidder must complete, execute and submit both a Confidentiality Agreement and a Qualification Statement acceptable to HUD. The following individuals and entities are among those INELIGIBLE to bid on the Mortgage Loans being sold in MLS 2018-1:
1. A mortgagor, including its principals, affiliates, family members, and assigns, with respect to one or more of the Mortgage Loans being offered in the Loan Sale, or an Active Shareholder (as such term is defined in the Qualification Statement);
2. Any individual or entity, and any Related Party (as such term is defined in the Qualification Statement) of such individual or entity, that is a mortgagor or operator with respect to any of HUD's multifamily and/or healthcare programs (excluding the Mortgage Loans being offered in the Loan Sale) and that has failed to file financial statements or is otherwise in default under such mortgage loan or is in violation or noncompliance of any regulatory or business agreements with HUD and fails to cure such default or violation by no later than October 25, 2017;
3. Any individual or entity that is debarred, suspended, or excluded from doing business with HUD pursuant to Title 2 of the Code of Federal Regulations, Part 2424;
4. Any contractor, subcontractorand/or consultant or advisor (including any agent, employee, partner, director, principal or affiliate of any of the foregoing) who performed services for, or on behalf of, HUD in connection with MLS 2018-1;
5. Any employee of HUD, a member of such employee's family, or an entity owned or controlled by any such employee or member of such an employee's family;
6. Any individual or entity that uses the services, directly or indirectly, of any person or entity ineligible under provisions (3) through (5) above to assist in preparing its bid on any Mortgage Loan;
7. An FHA-approved mortgagee, including any principals, affiliates, or assigns thereof, that has received FHA insurance benefits for one or more of the Mortgage Loans being offered in the Loan Sale;
8. An FHA-approved mortgageeand/or loan servicer, including any principals, affiliates, or assigns thereof, that originated one or more of the Mortgage Loans being offered in the Loan Sale if the Mortgage Loan defaulted within two years of
9. Any affiliate, principal or employee of any person or entity that, within the two-year period prior to November 1, 2017, serviced any Mortgage Loan or performed other services for or on behalf of HUD;
10. Any contractor or subcontractor to HUD that otherwise had access to information concerning any Mortgage Loan on behalf of HUD or provided services to any person or entity which, within the two-year period prior to November 1, 2017, had access to information with respect to the Mortgage Loan on behalf of HUD;and/or
11. Any employee, officer, director or any other person that provides or will provide services to the prospective bidder with respect to the Mortgage Loans during any warranty period established for the Loan Sale, that serviced the Mortgage Loans or performed other services for or on behalf of HUD or within the two-year period prior to November 1, 2017, provided services to any person or entity which serviced, performed services or otherwise had access to information with respect to any Mortgage Loan for or on behalf of HUD.
Other entities/individuals not described herein may also be restricted from bidding on the Mortgage Loans, as fully detailed in the Qualification Statement.
The Qualification Statement provides further details pertaining to eligibility requirements. Prospective bidders should carefully review the Qualification Statement to determine whether they are eligible to submit bids on the Mortgage Loans in MLS 2018-1.
HUD reserves the right, in its sole and absolute discretion, to disclose information regarding MLS 2018-1, including, but not limited to, the identity of any successful bidder and its bid price or bid percentage for the Mortgage Loans, upon the closing of the sale of the Mortgage Loans. Even if HUD elects not to publicly disclose any information relating to MLS 2018-1, HUD will have the right to disclose any information that HUD is obligated to disclose pursuant to the Freedom of Information Act and all regulations promulgated thereunder.
This notice applies to MLS 2018-1 and does not establish HUD's policy for the sale of other mortgage loans.
Bureau of Land Management, Interior.
Notice of proposed official filing.
The plats of surveys for the lands described in this notice are scheduled to be officially filed 30 calendar days after the date of this publication in the BLM Montana State Office, Billings, Montana. The surveys, which were executed at the request of the National Park Service, Midwest Regional Office, Omaha, Nebraska, and Superintendent, Crow Creek Indian Reservation, Ft. Thompson, South Dakota, are necessary for the management of these lands.
A person or party who wishes to protest this decision must file a notice of protest in time for it to be received in the BLM Montana State Office no later than 30 days after the date of this publication.
A copy of the plats may be obtained from the Public Room at the BLM Montana State Office, 5001 Southgate Drive, Billings, Montana 59101, upon required payment. The plats may be viewed at this location at no cost.
Josh Alexander, BLM Chief Cadastral Surveyor for Montana; telephone: (406) 896-5123; email:
The lands surveyed are:
A person or party who wishes to protest an official filing of a plat of survey identified above must file a written notice of protest with the BLM Chief Cadastral Surveyor for Montana at the address listed in the
If a notice of protest of the plat(s) of survey is received prior to the scheduled date of official filing or during the 10 calendar day grace period provided in 43 CFR 4.401(a) and the delay in filing is waived, the official filing of the plat(s) of survey identified in the notice of protest will be stayed pending consideration of the protest. A plat of survey will not be officially filed until the next business day after all timely protests have been dismissed or otherwise resolved.
If a notice of protest is received after the scheduled date of official filing and the 10 calendar day grace period provided in 43 CFR 4.401(a), the notice of protest will be untimely, may not be considered, and may be dismissed.
Before including your address, phone number, email address, or other personal identifying information in a notice of protest or statement of reasons, you should be aware that the documents you submit—including your personal identifying information—may be made publicly available in their entirety at any time. While you can ask us to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
43 U.S.C. Chapter 3.
Bureau of Land Management, Interior.
Notice of official filing.
The plats of survey of the following described lands are scheduled to be officially filed in the Bureau of Land Management (BLM), Colorado State Office, Lakewood, Colorado, 30 calendar days from the date of this publication. The surveys, which were executed at the request of the U.S. Forest Service and the BLM, are necessary for the management of these lands.
Unless there are protests of this action, the plats described in this notice will be filed on November 30, 2017.
You may submit written protests to the BLM Colorado State Office, Cadastral Survey, 2850 Youngfield Street, Lakewood, CO 80215-7093.
Randy Bloom, Chief Cadastral Surveyor for Colorado, (303) 239-3856;
The plat and field notes of the dependent resurvey and subdivision of section 23 in Township 36 North, Range 15 West, New Mexico Principal Meridian, Colorado, were accepted on August 11, 2017.
The supplemental plat of section 9 in Township 4 South, Range 86 West, Sixth Principal Meridian, Colorado, was accepted on September 19, 2017.
The plat incorporating the field notes of the subdivision of section and metes-and-bounds survey in Township 45 North, Range 2 East, New Mexico Principal Meridian, Colorado, was accepted on October 6, 2017.
The plat, in 3 sheets, incorporating the field notes of the dependent resurvey and survey in Township 6 North, Range 71 West, Sixth Principal Meridian, Colorado, was accepted on October 16, 2017.
The plat incorporating the field notes of the dependent resurvey and survey in Township 6 North, Range 72 West, Sixth Principal Meridian, Colorado, was accepted on October 16, 2017.
A person or party who wishes to protest any of the above surveys must file a written notice of protest within 30 calendar days from the date of this publication at the address listed in the
43 U.S.C. Chap. 3.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the presiding administrative law judge has issued a Final Initial Determination and Recommended Determination on Remedy and Bonding in the above-captioned investigation. The Commission is soliciting comments on public interest issues raised by the recommended relief, specifically a limited exclusion order directed to respondents Techtronic Industries Company Ltd., Techtronic Industries North America Inc., One World Technologies, Inc., OWT Industries, Inc., Techtronic Trading Ltd., Techtronic Industries Factory Outlets, Inc., and ET Technology (Wuxi). Co., Ltd. and cease and desist orders against respondents Techtronic Industries Company Ltd., Techtronic Industries North America Inc., One World Technologies, Inc., and OWT Industries, Inc. This notice is soliciting public interest comments from the public only. Parties are to file public interest submissions pursuant to Commission rules.
Panyin A. Hughes, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-3042. The public version of the complaint can be accessed on the Commission's electronic docket (EDIS) at
Section 337 of the Tariff Act of 1930 provides that if the Commission finds a violation it shall exclude the articles concerned from the United States:
The Commission is interested in further development of the record on the public interest in these investigations. Accordingly, parties are to file public interest submissions pursuant to pursuant to 19 CFR 210.50(a)(4). In addition, members of the public are hereby invited to file submissions of no more than five (5) pages, inclusive of attachments, concerning the public interest in light of the administrative law judge's Recommended Determination on Remedy and Bonding issued in this investigation on October 23, 2017. Comments should address whether issuance of a limited exclusion order
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the recommended orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the recommended orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the recommended exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the limited exclusion order and cease and desist orders would impact consumers in the United States.
Written submissions from the public must be filed no later than by close of business on November 29, 2017.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the investigation number (“Inv. No. 337-TA-1016”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the presiding administrative law judge (“ALJ”) has issued a Final Initial Determination and Recommended Determination on Remedy and Bonding in the above-captioned investigation. The Commission is soliciting comments on public interest issues raised by the recommended relief should the Commission find a violation. The ALJ recommended only a limited exclusion order with a certification provision prohibiting the entry of certain composite aerogel insulation materials manufactured abroad by or on behalf of Respondent Nano Tech Co., Ltd. of Zhejiang, China, and Respondent Guangdong Alison Hi-Tech Co., Ltd. of Guangzhou, China, that infringe certain claims of U.S. Patent No. 7,078,359, and/or that are manufactured using certain claimed methods of U.S. Patent Nos. 6,989,123 and 7,780,890. This notice is soliciting public interest comments from the public only. Parties are to file public interest submissions pursuant to Commission rules.
Cathy Chen, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2392. 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
Section 337 of the Tariff Act of 1930 provides that if the Commission finds a violation it shall exclude the articles concerned from the United States:
The Commission is interested in further development of the record on the public interest in its investigations. Accordingly, parties are to file public interest submissions pursuant to 19 CFR 210.50(a)(4). In addition, members of the public are hereby invited to file submissions of no more than five (5) pages, inclusive of attachments, concerning the public interest in light of the administrative law judge's Recommended Determination on Remedy and Bonding issued in this investigation on September 29, 2017. Comments should address whether issuance of a limited exclusion order in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the recommended orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the recommended orders;
(iii) indicate the extent to which like or directly competitive articles are produced in the United States or are otherwise available in the United States, with respect to the articles potentially subject to the recommended orders;
(iv) indicate whether complainant, complainant's licensees, and/or third
(v) explain how the recommended orders would impact consumers in the United States.
Written submissions must be filed no later than by close of business on November 24, 2017.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to Commission Rule 210.4(f), 19 CFR 210.4(f). Submissions should refer to the investigation number (“Inv. No. 1003”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in part 210 of the Commission's Rules of Practice and Procedure, 19 CFR 210.
By order of the Commission.
Notice is hereby given that, on October 6, 2017, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, PARCC, Inc., Washington, DC; WEDU COMMUNICATIONS, Seoul, REPUBLIC OF KOREA; Pacific Metrics, Monterey, CA; and Fidelis Inc., Redwood City, CA, have withdrawn as parties to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and IMS Global intends to file additional written notifications disclosing all changes in membership.
On April 7, 2000, IMS Global filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on July 10, 2017. A notice was published in the
Notice is hereby given that, on October 6, 2017, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and OpenDaylight intends to file additional written notifications disclosing all changes in membership.
On May 23, 2013, OpenDaylight filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on July 26, 2017. A notice was published in the
Notice is hereby given that, on October 5, 2017, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and CableLabs intends to file additional written notifications disclosing all changes in membership.
On August 8, 1988, CableLabs filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on June 28, 2017. A notice was published in the
Notice is hereby given that, on September 28, 2017, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
On September 20, 2004, NFPA filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
Notice is hereby given that, on September 29, 2017, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and 3D PDF intends to file additional written notifications disclosing all changes in membership.
On March 27, 2012, 3D PDF filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on July 13, 2017. A notice was published in the
Office for Victims of Crime, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Office of Justice Programs, Office for Victims of Crime, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies.
The Department of Justice encourages public comment and will accept input until January 2, 2018.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Victoria Jolicoeur, Office for Victims of Crime, 810 Seventh Street NW., Washington, DC 20531; by facsimile at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, “Material Hoists, Personnel Hoists, and Elevators Standard,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before November 30, 2017.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the
Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-6881 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at
This ICR seeks to extend PRA authority for the Material Hoists, Personnel Hoists, and Elevators Standard information collection requirements codified in regulations 29 CFR 1926.552. Specifically, the Standard requires the following: Posting rated load capacities, recommended operating speeds, and special hazard warnings or instructions on cars and platforms; establishing and posting operating rules, including a signal system and allowable line speed for various loads, for material hoists at the operator's station of a hoist; and providing cars with a capacity and data plate secured in a conspicuous place on the car or crosshead. The Standard also specifies certification and recordkeeping requirements related to required testing and inspection of hoists. Occupational Safety and Health Act of 1970 sections 2(b)(9) and 8(c) authorize this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on October 31, 2017. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
The OMB is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
44 U.S.C. 3507(a)(1)(D).
9:00 a.m. to 3:15 p.m., Tuesday, November 14, 2017.
The offices of the Morris K. Udall and Stewart L. Udall Foundation, 130 South Scott Avenue, Tucson, AZ 85701.
This meeting of the Board of Trustees will be open to the public.
(1) Call to Order & Chair's Remarks; (2) Executive Director's Remarks; (3) Consent Agenda Approval (Minutes of the April 26, 2017, Board of Trustees Meeting; Board Reports submitted for Education Programs, Finance and Management, Udall Center for Studies in Public Policy-Native Nations Institute-Udall Archives & their Workplan, and U.S. Institute for Environmental Conflict Resolution; resolutions regarding Allocation of Funds to the Udall Center for Studies in Public Policy and Transfer of Funds to the Native Nations Institute for Leadership, Management, and Policy; and Board takes notice of any new and updated personnel policies and internal control methodologies); (4) Udall Center for Studies in Public Policy and Native Nations Institute for Leadership, Management, and Policy; (5) Organizational Development (OD) Work—Status; (6) Finance and Internal Controls; (7) Awards Policy; and (8) Parks in Focus®.
Philip J. Lemanski, Executive Director, 130 South Scott Avenue, Tucson, AZ 85701, (520) 901-8500.
National Credit Union Administration (NCUA).
Notice and request for comments.
The NCUA, as part of its continuing efforts to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on this proposed collection, as required by the Paperwork Reduction Act of 1995. The NCUA is soliciting comments on the information collections associated with the Consumer Assistance Center.
Written comments should be received on or before January 2, 2018 to be assured of consideration.
Interested persons are invited to submit written comments on the information collections to Dawn Wolfgang, National Credit Union Administration, 1775 Duke Street, Suite 5080, Alexandria, Virginia 22314; Fax No. 703-519-8579; or Email at
Requests for additional information should be directed to the address above.
By Gerard Poliquin, Secretary of the Board, the National Credit Union Administration, on October 25, 2017.
National Credit Union Administration (NCUA).
Request for Information (RFI)
The National Credit Union Administration is conducting a comprehensive review of the loan, deposit, and investment information collected electronically during examinations of federally insured credit unions from the core data processing and offline systems used by credit unions.
Comments must be received on or before January 2, 2018.
Comments may be submitted using
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•
NCUA will post all comments received by the deadline on the agency Web site (
Kelly Lay, Business Innovation Director or Amber Gravius, Special Assistant for Business Innovation, Office of the Executive Director, at 1775 Duke Street, Alexandria, VA 22314 or telephone (703) 518-6313 (Ms. Lay) or (703) 548-2411 (Ms. Gravius). Media inquiries should be directed to the NCUA Office of Public and Congressional Affairs at (703) 518-6671 or
The National Credit Union Administration (NCUA) is conducting a comprehensive review of the loan, deposit, and investment information collected electronically during examinations of federally insured credit unions (FICUs). The overarching goal is to modernize, formalize, and standardize data formats collected during examinations from the core data processing and offline systems
a. Achieve a more consistent examination process;
b. Promote agency efficiencies and reduce burden on credit unions;
c. Reduce onsite time by streamlining agency efforts to sort, organize, and format data;
d. Improve data reliability and quality to enable more offsite work;
e. Enhance the objectivity of examination conclusions with a more thorough and advanced portfolio analysis; and
f. Support the Exam Flexibility Initiative's
This RFI is a major step in NCUA's internal modernization efforts. After considerable research and analysis, the agency is now at a point where it can outline the scope of its planned improvements. In turn, NCUA seeks the views of the public on this initiative and is eager to gain input from interested stakeholders on a number of aspects related to the future data collection by NCUA. Specifically, this RFI explains NCUA's objectives and seeks insights from stakeholders in identifying the interrelated considerations and challenges that could arise if NCUA adopts a new standardized data format for loan, deposit, and investment data.
Separate and apart from the normal examination data download process, FICUs with assets greater than $10B must comply with 12 CFR 702, subpart E which implements capital planning and stress testing.
In addition to this RFI, the agency may seek clearance from the Office of Management and Budget to conduct stakeholder calls and form workgroups to gather additional information about barriers and benefits to this modernization initiative. NCUA invites interested parties to respond generally to this modernization initiative and specifically to the questions included in this RFI.
Examiners obtain electronic data at the beginning of every examination, during some supervision contacts, and on an ad hoc basis from credit unions. This raw data, sometimes from multiple sources and in multiple data files, provides examiners with essential information in evaluating credit and deposit risks in FICUs and is integral to risk supervision which is central to safeguarding the integrity of the NCUSIF. Before 1995, this data was in written format. In 1995, NCUA initiated the first electronic data collection
In November 2000, NCUA encouraged adherence to the share and loan data record layout specifications to facilitate the import functions into NCUA's examination software, Automated Integrated Regulatory Examination System (AIRES).
NCUA last changed the loan and share download in April 2003.
In 2009, NCUA informed federal credit unions (FCUs) of the membership data collection and information extracted from the electronic loan and share download gathered during examinations.
The credit union industry is dynamic, with FICUs growing larger and more complex each year. NCUA must ensure its data collection vehicles evolve with industry practices and examination/supervision procedures so:
a. All material FICU risk exposures are captured;
b. data offering little insight into these exposures are no longer solicited; and
c. the reporting burden on supervised institutions—particularly small or non-complex credit unions—is minimized.
Increasing industry complexity, a desire for more effective offsite supervision, and evolving technologies necessitated a review of the current process in favor of opportunities to improve efficiencies and reduce the examination burden on credit unions. Table 1 illustrates the evolution of the FICU industry since NCUA last changed the electronic data collection in April 2003. Although the number of institutions has declined, FICUs continue to grow in assets, loans, shares, membership, and complexity.
Today, examiners
As part of the broader enterprise modernization effort, NCUA desires to improve loan and deposit portfolio analytics used during FICU examinations to provide for more consistent analysis of risk within and across institutions to mitigate losses to the NCUSIF. Data standardization is paramount to effectively use more robust analytic tools and will also benefit credit unions outside of the examination context, as credit unions have been known to use the download when two credit unions are merging to transfer records. It has also been used with some third party vendors for analytics, reporting, and data processing conversions.
NCUA acknowledges there are challenges with a standard data format. Credit unions use dozens of data processing systems and third party vendors for originating, recording, and monitoring loans, deposits, and investments. Additionally, there are many variations and platforms, including credit union developed information technology systems, with varying data content and formats. Responses to the questions in this RFI will inform NCUA of the extent to which FICUs can provide data electronically in a standard format and identify data fields available for electronic collection. Additionally, NCUA welcomes suggested implementation strategies that reduce burden without compromising the agency's ability to safeguard the NCUSIF.
NCUA exercises great care in protecting sensitive and personally identifiable information. As a federal agency, NCUA must comply with mandatory security standards for federal information and information systems
NCUA uses administrative, technical, and physical controls, including but not limited to: Periodic review and authorization of information systems; proactive threat assessment and continuous monitoring; and annual general and role-based security training for employees and contractors. We also leverage independent tests and evaluations from other government agencies and third-party assessors.
The Office of the Inspector General (OIG) conducts independent audits, investigations and other activities to verify NCUA's compliance with applicable standards, laws and regulations related to privacy and information security and keeps the NCUA Board and U.S. Congress fully and currently informed of their work. The OIG conducts a FISMA and Federal Managers' Financial Integrity Act (FMFIA) audit annually to ensure NCUA has effectively implemented all appropriate security and privacy controls.
Responses containing references to studies, research, or data not widely available to the public should include copies of referenced materials. A description of the commenter's organization and its interest in the electronic data will help NCUA use the input provided.
1. To the extent an FICU offers the loan and deposit services and has the investment instruments identified in the section b, are there any example data fields listed in this RFI that cannot be reasonably provided electronically? What other data fields could be provided that NCUA should consider collecting electronically?
2. For electronic data, what file formats (
3. If a FICU cannot provide data electronically, to what extent is the limitation due to the IT systems (
4. What is the number of vendors, systems, or service providers the FICU uses for loans (all types), deposits, and investments you currently can or would extract data for examination purposes? Specifically, how many are used for each category (
5. To what extent does the FICU rely on a third party vendor to create and produce raw data downloads? Does the vendor provide the credit union with the flexibility to self-customize reporting for data attributes?
6. What are the technological challenges NCUA should consider with a standardized data format (
7. What additional initial and annual costs would you estimate a FICU could incur to generate and provide data electronically in a standard format (
8. Does the credit union or vendor have the ability to retain and create the current loan and share download data format (with no changes) as well as new download data formats?
9. Should NCUA eliminate the “critical” and “optional” data
10. With the exception of the example data formats based on data type discussed in this RFI, what alternatives would you propose for NCUA to collect data in a standardized format that minimizes the credit union burden?
11. What implementation strategies and timeline should NCUA consider with this modernization? For example, what is the anticipated timeframe for a FICU or vendor to provide the sample data fields and the associated format? How should NCUA ensure FICUs use the standard data format?
12. What specific information security controls or assurances are expected from NCUA to reasonably safeguard the electronic loan, share, and investment data?
Commenters are also encouraged to discuss any other relevant issues they believe NCUA should consider with respect to the electronic collection of loan, deposit, and investment data.
NCUA is requesting input and feedback on sample data fields and the associated format.
National Endowment for the Arts.
Notice.
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, The National Endowment for the Arts (NEA) has submitted a Generic Information Collection Request (Generic ICR): “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” to OMB for approval under the Paperwork Reduction Act (PRA). Copies of this ICR, with applicable supporting documentation, may be obtained by visiting
Comments should be sent to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the National Endowment for the Arts, Office of Management and Budget, Room 10235, Washington, DC 20503, 202/395-7316, within 30 days from the date of this publication in the
The proposed information collection activity provides a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.
The solicitation of feedback will target areas such as: Timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on the Agency's services will be unavailable.
The Agency will only submit a collection for approval under this generic clearance if it meets the following conditions:
• The collections are voluntary;
• The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government;
• The collections are non-controversial and do not raise issues of concern to other Federal agencies;
• Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future;
• Personally identifiable information (PII) is collected only to the extent necessary and is not retained;
• Information gathered is used only internally for general service improvement and program management purposes and is not intended for release outside of the agency;
• Information gathered is not used for the purpose of substantially informing influential policy decisions; and
• Information gathered yields qualitative information; the collections are not designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study.
Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.
As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.
All written comments will be available for public inspection at
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number.
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on October 25, 2017, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on October 25, 2017, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on October 25, 2017, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on October 25, 2017, it filed with the Postal Regulatory Commission a
Securities and Exchange Commission.
Notice of Federal Advisory Committee Establishment.
The Securities and Exchange Commission is publishing this notice to announce that the Chairman of the Commission, with the concurrence of the other Commissioners, intends to establish the Securities and Exchange Commission Fixed Income Market Structure Advisory Committee.
Written comments may be submitted by the following methods:
• Use the Commission's Internet submission form (
• Send an email message to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
David Dimitrious, Senior Special Counsel, at (202) 551-5131, or Benjamin Bernstein, Attorney-Adviser, at (202) 551-5354, Division of Trading and Markets, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-3628.
In accordance with the requirements of the Federal Advisory Committee Act, 5 U.S.C.—App, the Commission is publishing this notice that the Chairman of the Commission, with the concurrence of the other Commissioners, intends to establish the Securities and Exchange Commission Fixed Income Market Structure Advisory Committee (the “Committee”). The Chairman of the Commission affirms that the establishment of the Committee is necessary and in the public interest.
The Committee's objective is to provide the Commission with diverse perspectives on the structure and operations of the U.S. fixed income markets, as well as advice and recommendations on matters related to fixed income market structure.
No more than 21 voting members will be appointed to the Committee. Such members shall represent a cross-section of those directly affected by, interested in, and/or qualified to provide advice to the Commission on matters related to fixed income market structure. The Committee's membership will be balanced fairly in terms of points of view represented. Non-voting members may also be named.
The charter will provide that the duties of the Committee are to be solely advisory. The Commission alone will make any determinations of actions to be taken and policies to be expressed with respect to matters within the Commission's jurisdiction. The Committee will meet at such intervals as are necessary to carry out its functions. The charter contemplates that the full Committee will meet four times annually. Meetings of subgroups or subcommittees of the full Committee may occur more frequently.
The Committee will operate for two years from the date the charter is filed with the appropriate entities or such earlier date as determined by the Commission unless, before the expiration of that time period, it is renewed in accordance with the Federal Advisory Committee Act. The Committee may be established 15 days after publication of this notice in the
By the Commission.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Under the Investment Company Act of 1940 (15 U.S.C. 80a-1
The purpose of Form N-54A is to notify the Commission that the investment company making the notification elects to be subject to Sections 55 through 65 of the Investment Company Act, enabling the Commission to administer those provisions of the Investment Company Act to such companies.
The Commission estimates that on average approximately 12 business development companies file these notifications each year. Each of those business development companies need only make a single filing of Form N-54A. The Commission further estimates that this information collection imposes a burden of 0.5 hours, resulting in a total annual PRA burden of 6 hours. Based on the estimated wage rate, the total cost to the business development company industry of the hour burden for complying with Form N-54A would be approximately $2,070.
The collection of information under Form N-54A is mandatory. The information provided by the form is not kept confidential. 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,
Pursuant to Section 19(b)(1)
The Exchange proposes to list and trade shares of the Hartford Schroders Tax-Aware Bond ETF under NYSE Arca Rule 8.600-E (“Managed Fund Shares”). The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to list and trade shares (“Shares”) of the Hartford Schroders Tax-Aware Bond ETF (“Fund”) under NYSE Arca Rule 8.600-E, which governs the listing and trading of Managed Fund Shares.
Hartford Funds Management Company, LLC (“HFMC” or “Manager”) will be the investment manager to the Fund. ALPS Distributors, Inc. (“ALPS” or the “Distributor”) will be the principal underwriter to the Fund. HFMC is an indirect subsidiary of The Hartford Financial Services Group, Inc. Schroder Investment Management North America Inc. (“Sub-Adviser”) will be the sub-adviser to the Fund and performs the daily investment of the assets for the Fund.
Commentary .06 to Rule 8.600-E provides that, if the investment adviser to the investment company issuing Managed Fund Shares is affiliated with a broker-dealer, such investment adviser shall erect a “fire wall” between the investment adviser and the broker-dealer with respect to access to information concerning the composition and/or changes to such investment company portfolio.
According to the Registration Statement, the Fund will seek total return on an after-tax basis. The Fund will seek to achieve its investment objective by investing in a diversified portfolio of fixed income debt instruments of varying maturities. Under normal market conditions,
The fixed income debt instruments in which the Fund may invest as part of its principal investment strategy are securities issued or guaranteed by the U.S. government and its agencies, government-sponsored enterprise securities, corporate bonds, agency mortgage-backed securities (including “to be announced” or “TBA” transactions), agency asset-backed securities (“ABS”), “Municipal Securities” (as described below), sovereign debt and debt securities issued by supranational organizations. They may pay fixed, variable, or floating interest rates. The Fund may invest in U.S. dollar denominated foreign securities. The Fund may also invest in cash and cash equivalents.
According to the Registration Statement, in seeking to achieve the Fund's investment objective, the Sub-Adviser will employ a tax-aware investing strategy that attempts to realize total return for shareholders, primarily in the form of current income and price appreciation, by balancing investment considerations and tax considerations.
According to the Registration Statement, the Fund may invest in the following Municipal Securities: General obligation bonds; revenue (or limited obligation) bonds; private activity (or industrial development) bonds; bonds that are collateralized with agency and/or treasury securities, municipal notes; municipal lease obligations; and municipal inverse floaters.
The Fund may hold restricted securities, which are securities that cannot be offered for public resale unless registered under the applicable securities laws or that have a contractual restriction that prohibits or limits their resale. Restricted securities include private placement securities that have not been registered under the applicable securities laws, such as Rule 144A securities, and securities of U.S. and non-U.S. issuers that are issued pursuant to Regulation S.
While the Fund, under normal market conditions, will invest principally in the securities and financial instruments described above, the Fund may invest its remaining assets in the securities and financial instruments described below.
The Fund may invest in non-agency ABS, which are securities backed by a pool of some underlying asset, including but not limited to home equity loans, installment sale contracts, credit card receivables or other assets.
The Fund may invest in collateralized debt obligations (“CDOs”), which include collateralized bond obligations (“CBOs”), collateralized loan obligations (“CLOs”) and other similarly structured securities.
The Fund may invest in non-agency mortgage-related securities.
The Fund may invest in the securities of other registered investment companies, including exchange-traded funds (“ETFs”).
The Fund may engage actively in transactions in derivatives (futures, options, swaps and forward rate agreements), as described below. The Fund will normally use derivatives to supplement the effective management of its duration profile, to gain exposure to particular securities or markets, in connection with hedging transactions, or for purposes of efficient portfolio management, including managing cash flows or as part of the Fund's risk management process.
The Fund may invest in U.S and foreign exchange-traded and over-the counter (“OTC”) put and call options. The Fund may engage in options transactions on any security, index or instrument in which it may invest.
The Fund may invest in U.S and foreign exchange-traded and OTC currency options.
The Fund may invest in U.S. and foreign exchange-traded futures contracts and options on futures contracts with respect to equity and debt securities, foreign currencies, aggregates of equity and debt securities (aggregates are composites of equity or debt securities that are not tied to a commonly known index), interest rates, indices, commodities and other financial instruments.
The Fund may enter into commodity swaps, total return swaps, currency swaps, credit default swaps, asset swaps, inflation swaps, event-linked swaps, interest rate swaps, swaps on specific securities or indices, swaps on rates (such as mortgage prepayment rates), municipal credit default swaps, municipal market data derivatives rate locks, caps, collars, and floors. The Fund may also enter into options on swap agreements (“swaptions”). The Fund may also invest in the Dow Jones CDX (“CDX”), which is a family of indices that track credit derivative indices in various countries around the world. Swaps and swaptions can be both exchange traded and OTC.
The Fund may enter into forward rate agreements.
The Fund may invest in inflation-protected debt securities.
The Fund may invest in OTC and exchange-traded convertible and nonconvertible preferred stock.
The Fund may invest in when-issued and delayed delivery securities and forward commitments.
On each day the NYSE Arca is open (a “Business Day”), before commencement of trading in Shares on the Exchange, HFMC will disclose the Fund's iNAV Basket.
According to the Registration Statement, the Trust will issue and sell Shares of the Fund only in Creation Units at the NAV next determined after receipt of an order in proper form on any Business Day. The number of Shares of the Fund that will constitute a Creation Unit is 50,000. The size of a Creation Unit is subject to change.
The consideration for purchase of Creation Units will generally consist of “Deposit Securities” and the “Cash Component”, which will generally correspond pro rata, to the extent practicable, to the Fund's securities, or, as permitted or required by the Fund, of cash. Together, the Deposit Securities and Cash Component constitute the “Fund Deposit,” which represents the minimum initial and subsequent investment amount for a Creation Unit of the Fund. Creation Units of Shares of the Fund may be issued partially for cash.
The Transfer Agent, through the National Securities Clearing Corporation (“NSCC”), will make available on each Business Day, prior to the Core Trading Session (subject to amendments) on the Exchange (currently 9:30 a.m., Eastern time), the identity and the required number of each Deposit Security and the amount of the Cash Component to be included in the current Fund Deposit (based on information at the end of the previous Business Day).
To be eligible to place orders with the Distributor and to create a Creation Unit of the Fund, an entity must be: (i) A “Participating Party,”
Except as described below, and in all cases subject to the terms of the applicable Participant Agreement, all orders to create Creation Units of the Fund must be received by the Transfer Agent no later than 1:00 p.m., Eastern time) in each case on the date such order is placed for creation of Creation Units to be effected based on the NAV of shares of the Fund as next determined after receipt of an order in proper form. Orders requesting substitution of a “cash-in-lieu” amount or a cash creation, must be received by the Transfer Agent no later than 1:00 p.m., Eastern time. The date on which an order to create Creation Units (or an order to redeem Creation Units, as discussed below) is placed is referred to as the “Transmittal Date”.
Fund Deposits created through the Clearing Process, if available, must be delivered through a Participating Party that has executed a Participant Agreement.
The Participant Agreement authorizes the Transfer Agent to transmit to NSCC on behalf of the Participating Party such trade instructions as are necessary to effect the Participating Party's creation order. Pursuant to such trade instructions from the Transfer Agent to NSCC, the Participating Party agrees to transfer the requisite Deposit Securities (or contracts to purchase such Deposit Securities that are expected to be delivered in a “regular way” manner by the second Business Day) and the Cash Component to the Trust, together with such additional information as may be required by the Transfer Agent and the Distributor as set forth in the Participant Agreement. An order to create Creation Units of the Fund through the Clearing Process is deemed received by the Transfer Agent on the Transmittal Date if (i) such order is received by the Transfer Agent not later than the Order Cutoff Time on such Transmittal Date and (ii) all other procedures set forth in the Participant Agreement are properly followed.
Fund Deposits created outside the Clearing Process must be delivered through a DTC Participant that has executed a Participant Agreement.
Shares may be redeemed only in Creation Units at their NAV next determined after receipt of a redemption request in proper form on a Business Day and only through a Participating Party or DTC Participant who has executed a Participant Agreement.
With respect to the Fund, the Transfer Agent, through the NSCC, makes available immediately prior to the opening of business on the Exchange (currently 9:30 a.m., Eastern time) on each Business Day, the identity of the Fund's securities and/or an amount of cash that will be applicable (subject to possible amendment or correction) to redemption requests received in proper form (as described below) on that day. All orders are subject to acceptance by the Distributor. The Fund's securities received on redemption will generally correspond pro rata, to the extent practicable, to the Fund's securities. The Fund's securities received on redemption (“Fund Securities”) may not be identical to Deposit Securities that
Unless cash only redemptions are available or specified for the Fund, the redemption proceeds for a Creation Unit will generally consist of Fund Securities—as announced on the Business Day of the request for a redemption order received in proper form—plus cash in an amount equal to the difference between the NAV of the Shares being redeemed, as next determined after a receipt of a request in proper form, and the value of the Fund Securities, less the redemption transaction fee and variable fees described below. Notwithstanding the foregoing, the Trust will substitute a “cash-in-lieu” amount to replace any Fund Security that is a non-deliverable instrument.
Orders to redeem Creation Units of the Fund through the Clearing Process, if available, must be delivered through a Participating Party that has executed the Participant Agreement. An order to redeem Creation Units of the Fund through the Clearing Process will be deemed received by the Transfer Agent on the Transmittal Date if such order is received by the Transfer Agent not later than 1:00 p.m. Eastern time on such Transmittal Date and other applicable procedures are properly followed.
Orders to redeem Creation Units of the Fund outside the Clearing Process must be delivered through a DTC Participant that has executed the Participant Agreement. An order to redeem Creation Units of the Fund outside the Clearing Process will be deemed received by the Transfer Agent on the Transmittal Date if such order is received by the Transfer Agent not later than 1:00 p.m. Eastern time on such Transmittal Date and other applicable procedures are properly followed.
The Fund will disclose on the Fund's Web site (
The Web site for the Fund will contain the following information, on a per-Share basis, for the Fund: (1) The prior Business Day's NAV; (2) the reported midpoint of the bid-ask spread at the time of NAV calculation (the “Bid-Ask Price”); (3) a calculation of the premium or discount of the Bid-Ask Price against such NAV; and (4) data in chart format displaying the frequency distribution of discounts and premiums of the Bid-Ask Price against the NAV, within appropriate ranges, for each of the four previous calendar quarters (or for the life of the Fund if, shorter).
The Fund's portfolio holdings will be disclosed on the Fund's Web site daily after the close of trading on the Exchange and prior to the opening of trading on the Exchange the following day. On a daily basis, the Fund will disclose the information required under NYSE Arca Rule 8.600-E(c)(2) to the extent applicable. The Fund's prospectus and Statement of Additional Information (“SAI”) will be available on the Fund's Web site. The Web site information will be publicly available at no charge.
Investors can also obtain the Fund's SAI, shareholder reports, Form N-CSR and Form N-SAR, filed twice a year. The Fund's SAI and shareholder reports will be available free upon request from the Trust, and those documents and the Form N-CSR and Form N-SAR may be viewed on-screen or downloaded from the Commission's Web site at
Quotation and last sale information for the Shares and ETFs will be available via the Consolidated Tape Association (“CTA”) high-speed line, and from the national securities exchanges on which they are listed.
Quotation information from brokers and dealers or pricing services will be available for Municipal Securities. Price information for money market funds will be available from the applicable investment company's Web site and from market data vendors. Pricing information regarding each asset class in which the Fund will invest will generally be available through nationally recognized data service providers through subscription agreements. In addition, the iNAV (which is the Portfolio Indicative Value, as defined in NYSE Arca Rule 8.600-E(c)(3)), will be widely disseminated at least every 15 seconds during the Core Trading Session by one or more major market data vendors or other information providers.
The Fund's investments will be consistent with its investment goal and will not be used to provide multiple returns of a benchmark or to produce leveraged returns.
With respect to the Fund's investments in Municipal Securities, under normal market conditions, except for periods of high cash inflows or outflows, the Fund will satisfy the following criteria:
i. The Fund will have a minimum of 20 non-affiliated issuers;
ii. No single Municipal Securities issuer will account for more than 10% of the weight of the Fund's portfolio;
iii. No individual bond will account for more than 5% of the weight of the Fund's portfolio;
iv. The Fund will limit its investments in Municipal Securities of any one state to 25% of the Fund's total assets, provided that up to and including 40% of the Fund's total assets may be invested in Municipal Securities of issuers in each of California, New York and Texas;
v. The Fund's investments in Municipal Securities will be diversified among issuers in at least 10 states and U.S. territories;
vi. The Fund will be diversified among a minimum of five different sectors of the Municipal Securities market.
Pre-refunded bonds will be excluded from the above limits given that they have a high level of credit quality and liquidity.
The Exchange is submitting this proposed rule change because the portfolio for the Fund will not meet all of the “generic” listing requirements of Commentary .01 to NYSE Arca Rule 8.600-E applicable to the listing of Managed Fund Shares. The Fund's portfolio will meet all such requirements except for those set forth in Commentary .01(b)(1).
The Exchange believes that it is appropriate and in the public interest to approve listing and trading of Shares of the Fund on the Exchange notwithstanding that the Fund would not meet the requirements of Commentary .01(b)(1) to Rule 8.600-E in that the Fund's investments in fixed income securities, including Municipal Securities, will be well-diversified.
The Exchange believes that permitting Fund Shares to be listed and traded on the Exchange, notwithstanding that, as a result principally of the Fund's investments in Municipal Securities, less than 75% of the weight of the Fund's portfolio may consist of components with $100 million minimum or more original principal amount outstanding, would provide the Fund with greater ability to select from a broad range of fixed income securities, including Municipal Securities, as described above, that would support the Fund's investment goal.
The Exchange believes that, notwithstanding that the Fund's portfolio may not satisfy Commentary .01(b)(1) to Rule 8.600-E, the Fund will not be susceptible to manipulation. As noted above, with respect to the Fund's investments in Municipal Securities, such securities will be diversified among a minimum of 20 non-affiliated issuers; no single Municipal Securities issuer will account for more than 10% of the weight of the Fund's portfolio; no individual bond will account for more than 5% of the weight of the Fund's portfolio; the Fund will limit its investments in Municipal Securities of any one state to 25% of the Fund's total assets, provided that up to and including 40% of the Fund's total assets may be invested in Municipal Securities of issuers in each of California, New York and Texas; and the Fund's investments in Municipal Securities will be diversified among issuers in at least 10 states and U.S. territories and will be diversified among a minimum of five different sectors of the Municipal Securities market.
The Exchange notes that, other than Commentary .01(b)(1) to Rule 8.600-E, the Fund's portfolio will meet all other requirements of Rule 8.600-E.
With respect to trading halts, the Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in the Shares of the Fund.
The Exchange deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. Shares will trade on the NYSE Arca Marketplace from 4 a.m. to 8 p.m., Eastern Time in accordance with NYSE Arca Rule 7.34-E (Early, Core, and Late Trading Sessions). The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions. As provided in NYSE Arca Rule 7.6-E, the minimum price variation (“MPV”) for quoting and entry of orders in equity securities traded on the NYSE Arca Marketplace is $0.01, with the exception of securities that are priced less than $1.00 for which the MPV for order entry is $0.0001.
With the exception of the requirements of Commentary .01(b)(1) to Rule 8.600-E as described above in “Application of Generic Listing Requirements”, the Shares of the Fund will conform to the initial and continued listing criteria under NYSE Arca Rule 8.600-E. Consistent with NYSE Arca Rule 8.600-E(d)(2)(B)(ii), the Manager will implement and maintain, or be subject to, procedures designed to prevent the use and dissemination of material non-public information regarding the actual components of the Fund's portfolio. The Exchange represents that, for initial and continued listing, the Fund will be in compliance with Rule 10A-3
The Exchange represents that trading in the Shares will be subject to the existing trading surveillances,
The surveillances referred to above generally focus on detecting securities trading outside their normal patterns, which could be indicative of manipulative or other violative activity. When such situations are detected, surveillance analysis follows and investigations are opened, where appropriate, to review the behavior of all relevant parties for all relevant trading violations.
The Exchange or FINRA, on behalf of the Exchange, or both, will communicate as needed regarding trading in the Shares, ETFs, certain exchange-traded options and certain exchange-traded futures with other markets and other entities that are members of the ISG, and the Exchange or FINRA, on behalf of the Exchange, or both, may obtain trading information regarding trading in the Shares, ETFs, certain exchange-traded options and certain exchange-traded futures from such markets and other entities. In addition, the Exchange may obtain information regarding trading in the Shares, ETFs, certain exchange-traded options and certain exchange-traded futures from markets and other entities that are members of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement. In addition, FINRA, on behalf of the Exchange, is able to access, as needed, trade information for certain fixed income securities held by the Fund reported to FINRA's Trade Reporting and Compliance Engine (“TRACE”). FINRA also can access data obtained from the Municipal Securities Rulemaking Board (“MSRB”) relating to municipal bond trading activity for surveillance purposes in connection with trading in the Shares.
In addition, the Exchange also has a general policy prohibiting the distribution of material, non-public information by its employees.
All statements and representations made in this filing regarding (a) the description of the portfolio, (b) limitations on portfolio holdings or reference assets, or (c) the applicability of Exchange listing rules specified in this rule filing shall constitute continued listing requirements for listing the Shares of the Fund on the Exchange.
The issuer has represented to the Exchange that it will advise the Exchange of any failure by the Fund to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will monitor for compliance with the continued listing requirements. If the Fund is not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under NYSE Arca Rule 5.5-E(m).
Prior to the commencement of trading, the Exchange will inform its Equity Trading Permit Holders in an Information Bulletin (“Bulletin”) of the special characteristics and risks associated with trading the Shares. Specifically, the Bulletin will discuss the following: (1) The procedures for purchases and redemptions of Shares in Creation Unit aggregations (and that Shares are not individually redeemable); (2) NYSE Arca Rule 9.2-E(a), which imposes a duty of due diligence on its Equity Trading Permit Holders to learn the essential facts relating to every customer prior to trading the Shares; (3) the risks involved in trading the Shares during the Early and Late Trading Sessions when an updated iNAV will not be calculated or publicly disseminated; (4) how information regarding the iNAV and the Disclosed Portfolio is disseminated; (5) the requirement that Equity Trading Permit Holders deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (6) trading information.
In addition, the Bulletin will reference that the Fund is subject to various fees and expenses described in the Registration Statement. The Bulletin will discuss any exemptive, no-action, and interpretive relief granted by the Commission from any rules under the Act. The Bulletin will also disclose that the NAV for the Shares will be calculated after 4:00 p.m., Eastern Time each trading day.
The basis under the Act for this proposed rule change is the requirement under Section 6(b)(5)
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices in that the Shares will be listed and traded on the Exchange pursuant to the initial and continued listing criteria in NYSE Arca Rule 8.600-E. The Exchange has in place surveillance procedures that are adequate to properly monitor trading in the Shares in all trading sessions and to deter and detect violations of Exchange rules and applicable federal securities laws. The Exchange or FINRA, on behalf of the Exchange, or both, will communicate as needed regarding trading in the Shares, ETFs, certain exchange-traded options and certain exchange-traded futures with other markets and other entities that are members of the ISG, and the Exchange or FINRA, on behalf of the Exchange, or both, may obtain trading information regarding trading in the Shares, ETFs, certain exchange-traded options and certain exchange-traded futures from such markets and other entities. In addition, the Exchange may obtain information regarding trading in the Shares, ETFs, certain exchange-traded options and certain exchange-traded futures from markets and other entities that are members of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement. In addition, FINRA, on behalf of the Exchange, is able to access, as needed, trade information for certain fixed income securities held by the Fund reported to TRACE. FINRA also can access data obtained from the MSRB relating to municipal bond trading activity for surveillance purposes in connection with trading in the Shares. Neither the Manager nor Sub-Adviser is registered as a broker-dealer but each is affiliated with a broker-dealer. The Manager and Sub-Adviser each has implemented a “fire wall” with respect to such broker-dealer affiliate regarding access to information concerning the composition of and/or changes to the Fund's portfolio.
The Exchange believes that it is appropriate and in the public interest to approve listing and trading of Shares of the Fund on the Exchange notwithstanding that the Fund would not meet the requirements of Commentary .01(b)(1) to Rule 8.600-E in that the Fund's investments in Municipal Securities will be well-diversified.
The Exchange believes that permitting Fund Shares to be listed and traded on the Exchange notwithstanding that, as a result principally of the Fund's investments in Municipal Securities, less than 75% of the weight of the Fund's portfolio may consist of components with $100 million minimum or more original principal amount outstanding would provide the Fund with greater ability to select from a broad range of Municipal Securities, as described above, that would support the Fund's investment goal.
The Exchange believes that, notwithstanding that the Fund's portfolio may not satisfy Commentary .01(b)(1) to Rule 8.600-E, the Fund's portfolio will not be susceptible to manipulation. As noted above, with respect to the Fund's investments in Municipal Securities, such securities will be diversified among a minimum of 20 non-affiliated issuers; no single Municipal Securities issuer will account for more than 10% of the weight of the Fund's portfolio; no individual bond will account for more than 5% of the weight of the Fund's portfolio; the Fund will limit its investments in Municipal Securities of any one state to 25% of the Fund's total assets, provided that up to and including 40% of the Fund's total assets may be invested in Municipal Securities of issuers in each of California, New York and Texas; and the Fund's investments in Municipal Securities will be diversified among issuers in at least 10 states and will be diversified among a minimum of five different sectors of the Municipal Securities market. The Exchange notes that, other than Commentary .01(b)(1) to Rule 8.600-E, the Fund's portfolio will meet all other requirements of Rule 8.600-E.
The proposed rule change is designed to promote just and equitable principles of trade and to protect investors and the public interest in that the Exchange will obtain a representation from the issuer of the Shares that the NAV per Share will be calculated daily and that the NAV and the Disclosed Portfolio will be made available to all market participants at the same time. In addition, a large amount of information is publicly available regarding the Fund and the Shares, thereby promoting market transparency. Quotation and last sale information for the Shares and ETFs will be available via the CTA high-speed line, and from the national securities exchanges on which they are listed. Prior to the commencement of trading, the Exchange will inform its Equity Trading Permit Holders in an Information Bulletin of the special characteristics and risks associated with trading the Shares. Trading in Shares of the Fund will be halted if the circuit breaker parameters in NYSE Arca Rule 7.12-E have been reached or because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable. Trading in the Shares will be subject to NYSE Arca Rule 8.600-E(d)(2)(D), which sets forth circumstances under which Shares of the Funds [sic] may be halted. In addition, as noted above, investors will have ready access to information regarding the Fund's holdings, the iNAV, the Disclosed Portfolio, and quotation and last sale information for the Shares.
The proposed rule change is designed to perfect the mechanism of a free and open market and, in general, to protect investors and the public interest in that it will facilitate the listing and trading of an additional type of actively-managed exchange-traded product that principally will hold fixed income securities and that will enhance competition among market participants, to the benefit of investors and the marketplace. As noted above, the Exchange has in place surveillance procedures relating to trading in the Shares and may obtain information via ISG from other exchanges that are members of ISG or with which the Exchange has entered into a comprehensive surveillance sharing agreement. In addition, as noted above, investors will have ready access to information regarding the Fund's holdings, iNAV, Disclosed Portfolio, and quotation and last sale information for the Shares.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Act. The Exchange notes that the proposed rule change will facilitate the listing and trading of an additional type of actively-managed exchange-traded product that principally will hold fixed income securities and that will enhance competition among market participants, to the benefit of investors and the marketplace.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend its rules as well as certain corporate documents of the Exchange to reflect legal name changes.
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 purpose of this filing is to reflect in the Exchange's governing documents (and the governing documents of its parent company)
• References to “NASDAQ” will be changed to “Nasdaq”.
• References to “NASDAQ BX, Inc.” or “NASDAQ BX” will be changed to “Nasdaq BX, Inc.” or “Nasdaq BX”.
• References to “The NASDAQ Stock Market LLC” or “NASDAQ Stock Market LLC” will be changed to “The Nasdaq Stock Market LLC”.
• References to “NASDAQ PHLX LLC” or “NASDAQ PHLX” will be changed to “Nasdaq PHLX LLC” or “Nasdaq PHLX”.
• References to “The NASDAQ OMX Group, Inc.” or “NASDAQ OMX Group, Inc.” will be changed to “Nasdaq, Inc.”
• In addition to the preceding changes, all references to “OMX” will be removed from the Rulebook.
• References to “NASDAQ Execution Services, LLC” will be changed to as “Nasdaq Execution Services, LLC”.
• In all instances where the word “the” should have been capitalized, (
No other changes are being proposed in this filing. The Exchange represents that these changes are concerned solely with the administration of the Exchange and do not affect the meaning, administration, or enforcement of any rules of the Exchange or the rights, obligations, or privileges of Exchange members or their associated persons in any way. Accordingly, this filing is being submitted under Rule 19b-4(f)(3). In lieu of providing a copy of the marked changes, the Exchange represents that it will make the necessary non-substantive revisions to the Certificate of Incorporation, Second Amended Limited Liability Company Agreement, By-Laws and Rulebook and post updated versions of each on the Exchange's Web site pursuant to Rule 19b-4(m)(2).
The Exchange notes that the following references are not being amended in the Exchange's governing documents and the Exchange's Rulebook:
• Any name with a trademark (TM) or service mark (SM) attached to the name.
• Any references in the Certificate of Incorporation which references a prior name of the Exchange and reflects a historical date wherein that name was in effect.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The name change will align with the parent company, Nasdaq, Inc.
No written comments were either solicited or received.
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 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.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Exchange's provisions for excluding a day from its volume calculations for purposes of determining volume based pricing, and to adopt language that allows the Exchange to remove a day from Market Maker Plus tiers whenever a day is removed from the Exchange's volume calculations.
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 purpose of the proposed rule change is to amend the Exchange's provisions for excluding a day from its volume calculations for purposes of determining volume based pricing, and to adopt language that allows the Exchange to remove a day from Market Maker Plus tiers whenever a day is removed from the Exchange's volume calculations.
To avoid penalizing members when aberrant low volume days result from systems or other issues at the Exchange,
Currently, the Exchange's rules for removing a day from its ADV calculations apply to specific ADV calculations. In particular, the Exchange can remove a day from tier calculations for the following programs: (1) Priority Customer complex order rebates,
Furthermore, the current rules for removing a day may be applied separately for the regular and complex order books, allowing the Exchange to remove a day based on separate impact to the regular or complex market. In connection with the changes discussed above, the Exchange also proposes to eliminate the ability to separately exclude a day for the regular and complex order books by adding the general interpretation to the Preface section so that it applies universally. Although the Exchange had previously filed rule changes that consider the regular and complex order books separately, the Exchange no longer believes that it is necessary to do so, and will therefore not exclude days where, for example, only the complex order book experiences a systems issue. With this rule change the Exchange would generally exclude days for either the simple or complex order books where any systems issue occurs. The Exchange' tiers seek to incentive market participants to transact a greater amount of liquidity on the ISE markets. The Exchange does not desire to disincentive a member simply because the day is shortened due to a holiday or because the market has experienced an unexpected closure. The proposal seeks to provide market participants with the ability to plan for and in the case of unexpected events, not be harmed by shortened or closed days. By not considering the simple and complex order books separately, the Exchange believes that market participants will be incentivized to send both simple and complex order flow without concern on days whether a market event has occurred. This rule change will simplify the operation of this rule. The Exchange notes that NASDAQ PHLX, LLC (“Phlx”), which also trades complex orders, excludes a day for the entire market rather than only for a specific segment of order flow.
Finally, the Exchange operates a Market Maker Plus program that provides tiered rebates to Market Makers
The proposed rule text would allow the Exchange to provide relief to Market Makers as to the Market Maker Plus tier calculation similar to that provided for ADV tiers, except that the Exchange does not proposes to use this authority to remove days from the Market Maker Plus tier calculation where the Exchange closes early for holiday observance. While Market Makers can plan for known events, such as a holiday, they are unable to plan for market events which may close the market for part of a trading day. The Exchange believes that permitting the exception for the unanticipated event therefore provides flexibility to Market Makers in anticipating where to send order flow. The Exchange desires to incentivize Market Makers to send order flow to ISE to meet their tier requirements.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange believes that the proposed change to the ADV calculation is reasonable and equitable as it provides a new framework for removing days from the Exchange's volume calculations that the Exchange believes is beneficial to members. The proposed rule change would apply the rules for excluding a day to all ADV calculations rather than specified incentive programs, thereby further protecting members if the Exchange experiences a systems or other issue that results in a day being excluded from the Exchange's ADV calculations. Without this change, members would only have the day excluded for the specific ADV based pricing programs described in this filing, and would not get the benefit for other un-enumerated programs. While the Exchange had previously filed to separately consider the regular and complex books, the Exchange no longer believes that this authority is necessary. By not considering the simple and complex order books separately, the Exchange believes that market participants will be incentivized to send both simple and complex order flow without concern on days whether a market event has occurred. The Exchange believes that this change will make this rule easier to administer without having a significant impact on members. Moreover, the Exchange believes that the proposed changes preserve the Exchange's intent behind adopting volume-based pricing. Finally, the Exchange further believes that the proposed change is not unfairly discriminatory because it applies equally to all members and ADV calculations.
The Exchange also believes that the proposed language for Market Maker Plus tier calculations is reasonable and equitable since it would allow the Exchange to remove a day from its Market Maker Plus tier calculations in similar circumstances as the Exchange currently removes days from its ADV calculations, and only when beneficial to the member. The Exchange believes that this proposed change is appropriate as it avoids penalizing Market Makers on days where the Exchange is experiencing a systems or other issue. Without this change, Market Makers that are wary of participation on the Exchange following an issue at the Exchange could fall into a lower Market Maker Plus tier, resulting in an effective cost increase for those members. The proposed language for removing a day from the Market Maker Plus tier calculation mirrors the language currently in place for the ADV calculation, except that the Exchange proposes that it will not remove days where the Exchange closes early for holiday observance. While Market Makers can plan for known events, such as a holiday, they are unable to plan for market events which may close the market for part of a trading day. The Exchange believes that permitting the exception for the unanticipated event therefore provides flexibility to Market Makers in anticipating where to send order flow. The Exchange desires to incentivize Market Makers to send order flow to ISE to meet their tier requirements. The Exchange believes that this is appropriate to incentivize Market Makers to continue making quality markets where the Exchange is not experiencing an issue and merely closes early for holiday observance. Finally, the Exchange believes that the proposed language for the Market Maker Plus tier calculation is not unfairly discriminatory as all Market Makers have the ability to qualify for Market Maker Plus by making quality markets on the Exchange and can therefore benefit from the proposed changes. As explained above, all members also benefit from a similar provision that applies to the Exchange's ADV calculations.
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. The proposed rule change would apply the rules for excluding a day to all ADV calculations rather than specified incentive programs, thereby further protecting members if the Exchange experiences a systems or other issue that results in a day being excluded from the Exchange's ADV calculations. This rule changes does not impose an undue burden on competition because without this change, members would only have the day excluded for the specific ADV based pricing programs described in this filing, and would not get the benefit for other un-enumerated programs. The Exchange will uniformly apply the proposed language related to ADV based pricing programs. The proposal to not consider the simple and complex order books separately does not impose an undue burden on competition because the Exchange would uniformly calculate the ADV based pricing programs in a uniform manner for all market participants. The Exchange believes that this change will make this rule easier to administer without having a significant impact on members. Moreover, the Exchange believes that the proposed changes preserve the Exchange's intent behind adopting volume-based pricing.
The proposed rule change is designed adopt a new provision covering the Market Make Plus tier calculation. The proposed language for removing a day from the Market Maker Plus tier calculation mirrors the language currently in place for the ADV calculation, except that the Exchange proposes that it will not remove days where the Exchange closes early for holiday observance. While Market Makers can plan for known events, such as a holiday, they are unable to plan for market events which may close the market for part of a trading day. The Exchange believes that permitting the exception for the unanticipated event therefore provides flexibility to Market Makers in anticipating where to send order flow. The Exchange desires to incentivize Market Makers to send order flow to ISE to meet their tier requirements. The Exchange believes that the proposed modifications to its ADV and Market Maker Plus tier calculations are pro-competitive and will result in lower total costs to end users, a positive outcome of competitive markets.
The Exchange operates in a highly competitive market in which market participants can readily direct their order flow to competing venues. In such an environment, the Exchange must continually review, and consider adjusting, its fees and rebates to remain competitive with other exchanges. For the reasons described above, the Exchange believes that the proposed fee changes reflect this competitive environment.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On July 10, 2017, Bats BZX Exchange, Inc. (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to list and trade the Shares under Rule 14.11(c)(3), which governs the listing and trading of Index Fund Shares on the Exchange. The Shares will be offered by the Trust, which was established as a Delaware statutory trust on February 9, 2012. The Trust is registered with the Commission as an open-end investment company and has filed a registration statement on behalf of the Fund on Form N-1A (“Registration Statement”) with the Commission.
The Fund will seek to track the performance, before fees and expenses, of the Aptus Fortified Value Index. According to the Exchange, the Index does not meet all of the generic listing requirements of Rule 14.11(c)(3)(A)(i). Specifically, Rule 14.11(c)(3)(A)(i) sets forth the requirements for components of an index or portfolio of U.S. Component Stocks, but the Index may include put options, which are not included in the definition of U.S. Component Stocks.
According to the Exchange, the Index is a rules-based, equal-weighted index that is designed to gain exposure to 50 of the most undervalued U.S.-listed common stocks and real estate investment trusts (“REITs”), while hedging against significant U.S. equity market declines when the market is overvalued. More specifically, the Index is composed of an equity component of 50 common stocks and REITs
When the tail hedge is not in effect, the Index will be composed 100% of the equity component. At the time the tail hedge is implemented, the Index will be composed 99.5% of the equity component and 0.50% the tail hedge (based on the theoretical dollar value of the Index at the time that the options are added to the Index). Any tail hedge implementation will occur on the last business day of the applicable month.
According to the Exchange, the Fund may hold: (1) Securities that are possible constituents of the Index; (2) cash and cash equivalents;
After careful review, the Commission finds that the proposed rule change, as modified by Amendments No. 2 and No. 3, is consistent with the Act and the rules and regulations thereunder applicable to a national securities exchange.
The Commission notes that, except for the options position that may be included in the Index (the aggregate market value of which is capped at 0.50% of the theoretical dollar value of the Index at the time that the options are added to the Index),
The Exchange states that its surveillance procedures are adequate to properly monitor the trading of the Shares on the Exchange during all trading sessions and to deter and detect violations of Exchange rules and the applicable Federal securities laws. The Exchange also states that it may obtain information regarding trading in the Shares and the underlying equities and options contracts held by the Fund and included in the Index via the ISG from other exchanges who are members or affiliates of the ISG or with which the Exchange has entered into a comprehensive surveillance sharing agreement.
The Fund will meet and be subject to the requirements of Rule 14.11(c), and other applicable requirements for Index Fund Shares based on a U.S. equity index or portfolio, including, but not limited to, requirements relating to the dissemination of key information such as the Net Asset Value, the Intraday Indicative Value, rules governing the trading of equity securities, trading hours, trading halts, surveillance, and the information circular, as set forth in Exchange rules applicable to Index Fund Shares and the orders approving such rules. In addition, for initial and/or continued listing, the Fund must be in compliance with Rule 10A-3 under the Act.
The Exchange represents that all statements and representations regarding the index composition, the description of the portfolio or reference assets, limitations on portfolio holdings or reference assets, dissemination and availability of index, reference assets, and intraday indicative values, and the applicability of Exchange listing rules specified in the filing constitute continued listing requirements for the Fund. The issuer has represented to the Exchange that it will advise the Exchange of any failure by the Fund or the Shares to comply with the continued listing requirements. Pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will surveil for compliance with the continued listing requirements. If the Fund or the Shares are not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under Rule 14.12. This approval order is based on all of the Exchange's statements and representations, including those set forth above and in Amendments No. 2 and No. 3.
For the foregoing reasons, the Commission finds that the proposed rule change, as modified by Amendments No. 2 and No. 3, is consistent with Section 6(b)(5) of the Act
Interested persons are invited to submit written data, views, and arguments concerning whether Amendments No. 2 and No. 3 are 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.
The Commission finds good cause to approve the proposed rule change, as modified by Amendments No. 2 and No. 3, prior to the thirtieth day after the date of publication of notice of the filing of Amendments No. 2 and No. 3 in the
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend NYSE American Equities Rules 7.31E (Orders and Modifiers) to establish a minimum dollar threshold into the price protection mechanisms provided for in the rule. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend NYSE American Equities Rules 7.31E (Orders and Modifiers) (“Rule 7.31E”) to establish a minimum dollar threshold into the price protection mechanisms provided for in the rule.
Rule 7.31E(a)(1)(B) describes the price protection mechanism for Market Orders,
Additionally, Rule 7.31E(a)(2)(B) (“Limit Order Price Protection”) provides the price protection mechanism for Limit Orders and that a Limit Order to buy (sell) will be rejected if it is priced at or above (below) a specified percentage away from the National Best Offer (National Best Bid) (“NBO” and “NBB”, respectively).
•
•
The Exchange believes that adding a minimum dollar threshold to the Trading Collar and Limit Order Price Protection calculations would enhance the respective price protection mechanisms for securities with a consolidated last sale price below $1.50 because using the current 10 percent multiplier for such securities would result in too narrow of a price protection mechanism. This proposed rule change is consistent with how other exchanges specify static price collar thresholds for lower-price securities. For example, NYSE Arca, Inc. (“NYSE Arca”) Rule 7.35-E(e)(7)
In addition, the Exchange proposes to replace the word “truncated” with the words “rounded down”
The Exchange anticipates implementing the proposed changes in the fourth quarter of 2017 and will announce the timing of such changes by Trader Update.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Exchange Act,
The Exchange believes the proposed changes would remove impediments to and perfect the mechanism of a free and open market and a national market system, and in general, to protect investors and the public interest, because they would enhance the Exchange's price protection mechanisms, which protect from aberrant prices and reduce the likelihood of halts, thus improving continuous trading and price discovery. Further, the proposal to enhance the price protection mechanisms by adding a minimum dollar threshold would assist with the maintenance of fair and orderly markets because such mechanisms protect investors from potentially receiving executions away from the prevailing market prices at any given time. The proposed changes to introduce the $0.15 minimum dollar threshold is not novel and is similar in nature to that of other national securities exchanges which incorporate dollar thresholds into the calculation of the respective price protection mechanisms.
For similar reasons, the Exchange also believes that the proposed rule change is consistent with Section 6(b)(5) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change is not intended to address competitive issues but rather provide for a more effective price protection mechanism, specifically for lower-priced securities.
No written comments were solicited or received with respect to the proposed rule change.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 15c2-1 prohibits the commingling under the same lien of securities of margin customers (a) with other customers without their written consent, and (b) with the broker-dealer. The rule also prohibits the re-hypothecation of customers' margin securities for a sum in excess of the customer's aggregate indebtedness. Pursuant to Rule 15c2-1, respondents must collect information necessary to prevent the re-hypothecation of customer securities in contravention of the rule, issue and retain copies of notices of hypothecation of customer securities in accordance with the rule, and collect written consents from customers in accordance with the rule. The information is necessary to ensure compliance with the rule, and to advise customers of the rule's protections.
There are approximately 79 respondents (
Written comments are invited on: (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 estimates of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information 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:
Small Business Administration (SBA).
Notice and request for comment.
The Small Business Administration (SBA) is requesting comments on its draft Strategic Plan for fiscal years 2018-2022. The draft plan is available on SBA's Web site at
Comments must be received on or before Thursday, November 30, 2017 to be assured for consideration.
You may submit comments by the following methods (Please send comments by one method only):
Luan Loerch-Wilson, Lead Performance Analyst, Small Business Administration at
The draft Small Business Administration
The SBA proposes four strategic goals for the next five years: (1) Support small business revenue and job growth; (2) Build healthy entrepreneurial ecosystems and create business-friendly environments; (3) Restore small businesses and communities after disasters; and, (4) Strengthen the SBA's ability to serve small businesses.
The draft SBA
Small Business Administration.
30-Day notice.
The Small Business Administration (SBA) is publishing this notice to comply with requirements of the Paperwork Reduction Act (PRA), which requires agencies to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the
Submit comments on or before November 30, 2017.
Comments should refer to the information collection by name and/or OMB Control Number and should be sent to:
Curtis Rich, Agency Clearance Officer, (202) 205-7030
A copy of the Form OMB 83-1, supporting statement, and other documents submitted to OMB for review may be obtained from the Agency Clearance Officer.
To obtain the information needed to carry out its oversight responsibilities under the Small Business Investment Act, the Small Business Administration (SBA) requires Small Business Investment Companies (SBICs) to submit financial statements and supplementary information on SBA Form 468. SBA uses this information to monitor SBIC financial condition and regulatory compliance, for credit analysis when considering SBIC leverage applications, and to evaluate financial risk and economic impact for individual SBICs and the program as a whole.
Small Business Administration.
30-Day notice.
The Small Business Administration (SBA) is publishing this notice to comply with requirements of the Paperwork Reduction Act (PRA), which requires agencies to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the
Submit comments on or before November 30, 2017.
Comments should refer to the information collection by name and/or OMB Control Number and should be sent to:
Curtis Rich, Agency Clearance Officer, (202) 205-7030
A copy of the Form OMB 83-1, supporting statement, and other documents submitted to OMB for review may be obtained from the Agency Clearance Officer.
A small business determined to be non-responsible for award of a specific prime Government contract by a Government contracting office has the right to appeal that decision through the Small Business Administration (SBA). The information contained on this form, as well as, other information developed by SBA, is used in determining whether the decision by the Contracting Officer should be overturned.
(1)
Department of State.
Additional identifying information concerning the designated entities Namchongang Trading Corporation and Korea Tangun Trading Corporation, pursuant to E.O. 13382.
Pursuant to the authority in section 1(a)(ii) of Executive Order 13382, “Blocking Property of Weapons of Mass Destruction Proliferators and Their Supporters”, the Secretary of State, in consultation with the Secretary of the Treasury and the Attorney General, has determined that the Korea Kuryonggang Trading Corporation is an alias of Korea Tangun Trading Corporation, and that the Korea Taeryonggang Trading Corporation is an alias of Namchongang Trading Corporation, both of which have previously been designated pursuant to Executive Order 13382.
The designation of and additional identifying information for the entities identified in this notice pursuant to Executive Order 13382 is effective upon publication of this notice.
Philip Foley, Director, Office of Counterproliferation Initiatives, Bureau of International Security and Nonproliferation, Department of State, Washington, DC 20520, tel.: 202-647-5193.
Section 1 of the Order blocks, with certain exceptions, all property and interests in property that are in the United States, or that hereafter come within the United States or that are or hereafter come within the possession or control of United States persons, of: (1) The persons listed in the Annex to the Order; (2) any foreign person determined by the Secretary of State, in consultation with the Secretary of the Treasury, the Attorney General, and other relevant agencies, to have engaged, or attempted to engage, in activities or transactions that have materially contributed to, or pose a risk of materially contributing to, the proliferation of weapons of mass destruction or their means of delivery (including missiles capable of delivering such weapons), including any efforts to manufacture, acquire, possess, develop, transport, transfer or use such items, by any person or foreign country of proliferation concern; (3) any person determined by the Secretary of the Treasury, in consultation with the Secretary of State, the Attorney General, and other relevant agencies, to have provided, or attempted to provide, financial, material, technological or other support for, or goods or services in support of, any activity or transaction described in clause (2) above or any person whose property and interests in property are blocked pursuant to the Order; and (4) any person determined by the Secretary of the Treasury, in consultation with the Secretary of State, the Attorney General, and other relevant agencies, to be owned or controlled by, or acting or purporting to act for or on behalf of, directly or indirectly, any person whose property and interests in property are blocked pursuant to the Order.
Information on the additional designees is as follows:
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Eighteenth TOC Meeting.
The FAA is issuing this notice to advise the public of a meeting of the Eighteenth TOC Meeting.
The meeting will be held December 5, 2017, 09:00 a.m.-4:00 p.m., Eastern Daylight Time.
The meeting will be held at: National Business Aviation Association, 1200 G Street NW., Suite 1100, Washington, DC 20005.
Trin Mitra, TOC Secretariat, 202-330-0665,
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given of the Eighteenth TOC Meeting. The TOC is a component of RTCA, which is a Federal Advisory Committee. The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the Chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Thirteenth RTCA SC-229 406 MHz ELT Joint Plenary with EUROCAE WG-98.
The FAA is issuing this notice to advise the public of a meeting of Thirteenth RTCA SC-229 406 MHz ELT Joint Plenary with EUROCAE WG-98.
The meeting will be held December 12-15, 2017 9:00 a.m.-5:00 p.m.
The meeting will be held at: RTCA Headquarters, 1150 18th Street NW., Suite 910, Washington, DC 20036.
Rebecca Morrison at
Pursuant to section 10(a) (2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of the Thirteenth RTCA SC-229 406 MHz ELT Joint Plenary with EUROCAE WG-98. The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Aviation Administration, (FAA), DOT.
Solicitation of applications.
The Federal Aviation Administration (FAA) and the National Park Service (NPS) invite interested persons to apply to fill one current vacancy and one upcoming vacancy on the National Parks Overflights Advisory Group (NPOAG). This notice invites interested persons to apply to fill the openings, one of which represents air tour operator interests and one of which represents Native American concerns.
Persons interested in these membership openings will need to apply by December 8, 2017.
Keith Lusk, Special Programs Staff, Federal Aviation Administration, Western-Pacific Region Headquarters, 15000 Aviation Boulevard, Lawndale, CA 90261, telephone: (310) 725-3808, email:
The National Parks Air Tour Management Act of 2000 (the Act) was enacted on April 5, 2000, as Public Law 106-181, and subsequently amended in the FAA Modernization and Reform Act of 2012. The Act required the establishment of the advisory group within 1 year after its enactment. The NPOAG was established in March 2001. The advisory group is comprised of a balanced group of representatives of general aviation, commercial air tour operations, environmental concerns, and Native American tribes. The Administrator of the FAA and the Director of NPS (or their designees) serve as ex officio members of the group. Representatives of the Administrator and Director serve alternating 1-year terms as chairman of the advisory group.
In accordance with the Act, the advisory group provides “advice, information, and recommendations to the Administrator and the Director-
(1) On the implementation of this title [the Act] and the amendments made by this title;
(2) On commonly accepted quiet aircraft technology for use in commercial air tour operations over a national park or tribal lands, which will receive preferential treatment in a given air tour management plan;
(3) On other measures that might be taken to accommodate the interests of visitors to national parks; and
(4) At the request of the Administrator and the Director, safety, environmental, and other issues related to commercial air tour operations over a national park or tribal lands.”
The current NPOAG is made up of one member representing general aviation, three members representing the commercial air tour industry, four members representing environmental concerns, and two members representing Native American interests. Current members of the NPOAG are as follows:
Melissa Rudinger representing general aviation; Alan Stephen and Matt Zuccaro represent commercial air tour operators with one current opening; Rob Smith, Dick Hingson, Les Blomberg, and John Eastman represent environmental interests; and Leigh Kuwanwisiwma and Martin Begaye represent Native American tribes. Mr. Kuwanwisiwma's 3-year term expires on April 2, 2018.
In order to retain balance within the NPOAG, the FAA and NPS are seeking candidates interested in filling one open seat representing air tour operator interests and one upcoming vacancy representing Native American concerns. The FAA and NPS invite persons interested in these openings on the NPOAG to contact Mr. Keith Lusk (contact information is written above in
On August 13, 2014, the Office of Management and Budget issued revised guidance regarding the prohibition against appointing or not reappointing federally registered lobbyists to serve on advisory committees (79
Therefore, before appointing an applicant to serve on the NPOAG, the FAA and NPS will require the prospective candidate to certify that
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FMCSA announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for its review and approval and invites public comment. The purpose of this ICR titled “Motor Carrier Records Change Form,” is to more efficiently collect information the Office of Registration and Safety Information (MC-RS) requires to process name and address changes and reinstatements of operating authority.
We must receive your comments on or before January 2, 2018.
You may submit comments identified by Federal Docket Management System (FDMS) Docket Number FMCSA-2017-0267 using any of the following methods:
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Jeff Secrist, Division Chief, East-South Division, FMCSA Office of Registration and Safety Information, FMCSA, West Building 6th Floor, 1200 New Jersey Avenue SE., Washington, DC 20590. Telephone: (202) 385-2367; email
The form prompts users to report the following data points (whichever are relevant to their records change request):
1. What are the legal/doing business as (dba) names of the entity/representative?
2. What is the contact information of entity/representatives (phone number, address, fax number, email address)?
3. What are the requested changes to name or address of entity?
4. What is the docket MC/MX/FX number of the entity?
5. What is the US DOT number of the entity?
6. Is there any change in ownership, management or control of the entity?
7. What kind of changes is the entity making to the company?
8. Which authority does the entity/representative wish to reinstate, motor carrier or broker?
9. Does the entity/representative authorize the fee for the name change or reinstatement?
10. Does the entity/representative authorize the reinstatement of operating authority or name/address change?
11. What is the credit card information (name, number, expiration date, address, date) for the card used to pay the fee?
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of application for exemption; request for comments.
FMCSA announces that the Hub Group Trucking Inc. (HGT) has requested an exemption from the electronic logging device (ELD) requirements to permit an alternative grandfather period for any commercial motor vehicles added to HGT's fleet after the December 18, 2017, compliance date. HGT reports that all of its 2,700 trucks are equipped with automatic on-board recording devices (AOBRDs) and it expects to add at least 160 trucks to its fleet in 2018. If the exemption is granted it would allow HGT to equip the additional trucks with AOBRDs instead of the required ELDs until the company's full transition to ELDs can be accomplished. HGT is confident that its AOBRD-compliant approach between December 18, 2017, and its full transition to ELDs by the end of 2018, would achieve a level of safety that is at least equivalent to the level of safety that would be obtained by strict compliance with a mixed AOBRD-ELD fleet.
Comments must be received on or before November 30, 2017.
You may submit comments identified by Federal Docket Management System (FDMS) Number FMCSA-2017-0277 by any of the following methods:
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• Each submission must include the Agency name and the docket number for this notice. Note that DOT posts all comments received without change to
For information concerning this notice, contact Mr. Tom Yager, Chief, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; Telephone: 614-942-6477. Email:
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice (FMCSA-2017-0277), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comments online, go to
FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain parts of the Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the
The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than,
HGT reports that it is an interstate motor carrier based in Oak Brook, Illinois with 23 terminal locations throughout the United States. HGT operates 2,700 trucks and utilizes approximately 2,700 drivers. The vast majority of HGT's trucks service the intermodal sector of freight transportation. All of HGT's trucks are currently equipped with AOBRDs and the entire fleet has been AOBRD compliant since late 2010.
The current ELD rule under section 49 CFR 395.15 includes a grandfather provision for a compliant AOBRD that a motor carrier installs and requires its drivers to use before the compliance date of December 18, 2017. A motor carrier may continue to use grandfathered AOBRDs no later than December 16, 2019.
HGT is requesting a limited exemption from the ELD rule to allow any truck added to its fleet after December 17, 2017, to be equipped with an AOBRD in lieu of an ELD until full transition to ELDs for all of its fleets can be accomplished. HGT reports that the company plans to add at least 160 new trucks and drivers to its fleet in 2018 to accommodate growth in its business. If the exemption is granted, it would cover these new trucks and drivers.
HGT contends that the company will face several challenges running two different electronic logging systems at the same time if the exemption is not granted. Challenges such as the complexity of managing the data in the back office, and more importantly, complexities in training and managing drivers and staff likely to use both systems.
According to HGT, with two systems, a company its size will create some roadside inspection enforcement-related challenges for the driver, enforcement officials involved, and for HGT's safety compliance staff. HGT further contends that it faces the expense of updating a legacy database to fully populate the new ELD header. HGT's InfoTrak database currently does not contain at least three data elements that must be included in the new ELD “print/display daily header.” Data elements include the driver's name, the driver's license State, and the truck number. HGT reports that it recently spent substantial resources to migrate to a new system that will contain all of the data fields and information needed to auto-populate the required ELD header. Without the exemption, HGT will be forced to spend a great deal of time and money to reprogram its legacy system to ensure compliance for the time between December 18, 2017, and the time in 2018 when HGT implements its new system and fully transitions to ELDs network-wide.
According to HGT, its AOBRD-compliant approach between December 18, 2017, and its full transition to ELDs by the end of 2018, will achieve a level of safety that is at least equivalent to the level of safety that would be obtained by strict compliance with a mixed AORBD-ELD fleet. The requested exemption is for two years.
A copy of HGT's application for exemption is available for review in the docket for this notice.
Office of the Secretary, Department of Transportation.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Department of Transportation's intention to renew an OMB control number for an on-line complaint form by which a consumer can electronically submit a service-related complaint against an airline and other travel-related companies.
Comments on this notice must be received by January 2, 2018.
To ensure that you do not duplicate your docket submissions, please submit them by only one of the following means:
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Daeleen Chesley, Office of the Secretary, Office of the Assistant General Counsel for Aviation Enforcement and Proceedings (C-70), Department of Transportation, 1200 New Jersey Ave. SE., Washington, DC 20590, 202 366-6792 (voice) or at
Among other things, the licensing office is responsible for receiving and investigating service-related consumer complaints filed against airlines and other travel-related companies. Once received, the complaints are reviewed by the office to determine the extent to which these entities are in compliance with federal aviation consumer protection and civil rights laws and what, if any, action should be taken.
The key reason for this request is to enable consumers to continue to file their complaints (or comments) to the Department using an on-line form, whether via their personal computer or on a mobile/electronic device. If the information collection form is not available, the Department may receive fewer complaints from consumers. The lack of consumer-driven information
Filing a complaint using a web-based form is voluntary and minimizes the burden on respondents. Based on CY16 information, 17,162 of the 17,909 cases received by ACPD were filed using the web-based form (95.8%). At times, consumers may also choose to file a complaint with the Department using regular mail or by phone message. The type of information requested on the form includes complainant's name, address, phone number (including area code), email address, and name of the airline or company about which she/he is complaining, as well as the flight date and flight itinerary (where applicable) of a complainant's trip. A consumer may also use the form to give a description of a specific air-travel related problem or to ask for air-travel related information from the ACPD. The Department has limited its informational request to that necessary to meet its program and administrative monitoring and enforcement activities.
The information collection is available for inspection in regulations.gov, as noted in the
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record on the docket.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended; and 49 CFR 1:48.
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's Web site (
On October 26, 2017, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authorities listed below. Dealings in property subject to U.S. jurisdiction in which a person identified as Government of North Korea has an interest are prohibited effective as of the date of that status, which may be earlier than the date of OFAC's determination.
1. JONG, Yong Su, Korea, North; DOB 15 Dec 1950; nationality Korea, North; Gender Male; Passport 563310172; Minister of Labor (individual) [DPRK2].
Designated pursuant to section 1(a)(ii) of Executive Order 13687 of January 2, 2015, “Imposing Additional Sanctions With Respect to North Korea” (E.O. 13687), for being an official of the Government of North Korea.
2. JO, Kyong-Chol (a.k.a. CHO, Kyo'ng-ch'o'l), Korea, North; DOB 1944 to 1945; POB Korea, North; nationality Korea, North; DPRK Director of Military Security Command (individual) [DPRK2].
Designated pursuant to section 1(a)(ii) of E.O. 13687 for being an official of the Government of North Korea.
3. KIM, Kang Jin (a.k.a. KIM, Kang-chin), Korea, North; DOB 22 Apr 1961; POB Pyongyang, North Korea; nationality Korea, North; Gender Male; Director, External Construction Bureau (individual) [DPRK2].
Designated pursuant to section 1(a)(ii) of E.O. 13687 for being an official of the Government of North Korea.
4. KU, Sung Sop (a.k.a. KU, Seung Sub; a.k.a. KU, Su'ng-so'p; a.k.a. KU, Young Hyok), Shenyang, China; DOB 07 Nov 1959; POB Pyongan-bukdo, North Korea; nationality Korea, North; Passport 321233 (Korea, North); Consul General, Shenyang, China (individual) [DPRK2].
Designated pursuant to section 1(a)(ii) of E.O. 13687 for being an official of the Government of North Korea.
5. KIM, Min Chol, Vietnam; DOB 21 Sep 1967; POB North Korea; nationality Korea, North; Diplomat at North Korean Embassy (individual) [DPRK2].
Designated pursuant to section 1(a)(ii) of E.O. 13687 for being an official of the Government of North Korea.
6. RI, Thae Chol (a.k.a. RI, Tae-Chol; a.k.a. RI, T'ae-Ch'o'l); DOB 01 Jan 1947 to 31 Dec 1947; nationality Korea, North; DPRK First Vice Minister of People's Security (individual) [DPRK2] (Linked To: KOREAN PEOPLE'S ARMY).
Designated pursuant to section 1(a)(ii) of E.O. 13687 for being an official of the Government of North Korea and the Worker's Party of Korea.
7. SIN, Yong Il (a.k.a. SHIN, Yong Il; a.k.a. SIN, Yo'ng Il), Korea, North; DOB 28 Feb 1948; nationality Korea, North; Passport PD654210116 (Korea, North); Deputy Director of the Military Security Command (individual) [DPRK2].
Designated pursuant to section 1(a)(ii) of E.O. 13687 for being an official of the Government of North Korea.
1. CH'OLHYO'N OVERSEAS CONSTRUCTION COMPANY, Kuwait; Algeria [DPRK3].
Identified as falling within the definition of the Government of North Korea as set forth in Section 9(d) of Executive Order 13722 of March 15, 2016, “Blocking Property of the Government of North Korea and the Workers' Party of Korea, and Prohibiting Certain Transactions With Respect to North Korea” (E.O. 13722) because it is an agency, instrumentality, or controlled entity of the Government of North Korea.
2. EXTERNAL CONSTRUCTION BUREAU (a.k.a. EXTERNAL CONSTRUCTION GENERAL COMPANY; a.k.a. EXTERNAL CONSTRUCTION GUIDANCE BUREAU), Korea, North; Kuwait; Qatar; United Arab Emirates; Oman [DPRK3].
Identified as falling within the definition of the Government of North Korea as set forth in Section 9(d) of E.O. 13722 because it is an agency, instrumentality, or controlled entity of the Government of North Korea.
3. MILITARY SECURITY COMMAND (a.k.a. KOREAN PEOPLE'S ARMY SECURITY BUREAU; a.k.a. MILITARY SECURITY BUREAU), Korea, North [DPRK3].
Identified as falling within the definition of the Government of North Korea as set forth in Section 9(d) of E.O. 13722 because it is an agency, instrumentality, or controlled entity of the Government of North Korea.
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of entities and one aircraft whose property and interests in property have been unblocked.
OFAC's actions described in this notice were taken on October 26, 2017.
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel.: 202-622-4855; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.
The Specially Designated Nationals and Blocked Persons List (SDN List) and additional information concerning OFAC sanctions programs are available from OFAC's Web site at
On October 26, 2017, OFAC removed from the SDN List the entities and aircraft listed below, whose property and interests in property were blocked pursuant to Executive Order 13581.
1. PACNET GROUP, Canada; Chile; United Kingdom; United States; Ireland; Brazil; France; Hong Kong; India; Malta; Switzerland; South Africa [TCO].
2. ACCU-RATE CORPORATION, 2573 Carling Ave., Ottawa, ON K2B 7H7, Canada; Web site
3. AEROPAY LIMITED (a.k.a. POINTS EAST LIMITED), D11 Glyme Court, Oxford Office Village, Langford Lane, Oxford Oxon OX5 1LQ, United Kingdom; 70 Empress Court, Woodin's Way, Oxford, Oxfordshire OX1 1HG, United Kingdom; Company Number 05648577 (United Kingdom) [TCO] (Linked To: PACNET SERVICES LTD.; Linked To: PACNET HOLDINGS LIMITED; Linked To: PACNET GROUP).
4. CHEXX INC. (a.k.a. CHEXX AMERICAS; a.k.a. CHEXX INC. LIMITED), 4th Floor, 595 Howe St., Vancouver, BC V6C 2T5, Canada; Shannon Airport House, Shannon, Co. Clare V14E370, Ireland; Bishopbrook House, Cathedral Avenue, Wells, Somerset BA5 1FD, United Kingdom; nationality Canada; alt. nationality United Kingdom; alt. nationality Ireland; Web site
5. CHEXX ITALIA SRL, Largo San Giuseppe 3/32, Genova 16121, Italy; V.A.T. Number IT02326870991; Commercial Registry Number GE 477550 (Italy); Fiscal Code 02326870991 (Italy) [TCO] (Linked To: PACNET GROUP).
6. COUNTING HOUSE SERVICES LTD. (a.k.a. UK COUNTING HOUSE LTD.), 595 Howe Street, 4th Floor, Vancouver, BC V6C 2T5, Canada; 410-900 Howe Street, Vancouver, British Columbia V672M4, Canada; 4410-900 Howe Street, Vancouver, BC V6Z 2M4, Canada; 5 Kew Road, Richmond, Surrey TW9 2PR, United Kingdom; 43 Princeton Highstown Rd., Suite D, Princeton Junction, NJ 08550, United States; Tel Aviv, Israel; Web site
7. DEEPCOVE LABS (a.k.a. DEEPCOVE LABORATORIES LTD.), 4th Floor, 595 Howe Street, Vancouver, BC V6C 2T5, Canada; Web site
8. INDIAN RIVER (UK) LTD., D11 Glyme Court, Oxford Office Village, Langford Lane, Kidlington, Oxon OX5 1LQ, United Kingdom; Company Number 07927999 (United Kingdom) [TCO] (Linked To: PACNET CONNECTIONS LIMITED; Linked To: PACNET GROUP).
9. PACNET AIR (a.k.a. PACIFIC NETWORK AIR LTD.), Suite 3, 3rd Floor, Britannia House, St. Georges Street, Douglas, Isle of Man IM1 1JD, United Kingdom; Web site
10. PACNET BRAZIL (a.k.a. MMC CLUB; a.k.a. PACNET SERVICES DO BRASIL LTDA.; a.k.a. PACNET SERVICES DO BRASIL S S LTDA ME),
11. PACNET CHILE (a.k.a. THE PAYMENTS FACTORY CHILE LIMITADA), Av. Vicuna Mckenna 2598, Macul, Santiago de Chile, Chile [TCO] (Linked To: PACNET SERVICES LTD.; Linked To: PACNET GROUP).
12. PACNET CONNECTIONS LIMITED, Shannon Airport House, Shannon Free Zone, Co. Clare, Ireland; 4 Michael Street, Co. Limerick, Ireland; Registration ID 332576 (Ireland) [TCO] (Linked To: PACNET SERVICES LTD.; Linked To: PACNET GROUP).
13. PACNET EUROPE, Shannon Airport House, SFZ, Country Clare, Ireland; Web site
14. PACNET FRANCE (a.k.a. PACNET SERVICES (FRANCE) SARL), 17 rue de Teheran, 75008 Paris, France [TCO] (Linked To: PACNET SERVICES LTD.; Linked To: PACNET GROUP).
15. PACNET HOLDINGS LIMITED (f.k.a. COUNTING HOUSE (EUROPE) LIMITED), Shannon Airport House, Shannon Free Zone, Co. Clare, Ireland; Four Michael Street, Limerick, Ireland; Registration ID EO348346 (Ireland) [TCO] (Linked To: PACNET SERVICES LTD.; Linked To: PACNET GROUP).
16. PACNET HONGKONG (a.k.a. PACNET SERVICES (HK) LTD.), 2001 Central Plaza, 18 Harbour Road, Wanchai, Hong Kong [TCO] (Linked To: PACNET SERVICES LTD.; Linked To: PACNET GROUP).
17. PACNET INDIA (a.k.a. PACNET SERVICES (INDIA) PRIVATE LIMITED), 208, Rewa Chambers, 31 New Marine Lines, Mumbai 400 020, India; National ID No. U67190MH2005PTC15766 (India) [TCO] (Linked To: PACNET SERVICES LTD.; Linked To: PACNET GROUP).
18. PACNET MALTA (a.k.a. PACNET SERVICES (MALTA) LTD.), The Dixcart Suite, Level 11, Le Meridien, St. Julians, Malta; The Dixcart Suite, Level 11, LE, 39, Main Street, Balluta Bay, St. Julians STJ1017, Malta; Company Number C 52227 (Malta) [TCO] (Linked To: PACNET SERVICES LTD.; Linked To: PACNET GROUP).
19. PACNET SERVICES (IRELAND) LIMITED, 222 Shannon Airport House, Shannon, Co. Clare, Ireland; Registration ID 452666 (Ireland) [TCO] (Linked To: PACNET HOLDINGS LIMITED; Linked To: PACNET GROUP).
20. PACNET SERVICES LTD. (a.k.a. PACIFIC NETWORK SERVICES LTD.; a.k.a. PACNET AMERICAS; a.k.a. PACNET CANADA; a.k.a. PACNET SERVICES AMERICAS LTD.), Fourth Floor, 595 Howe St, Vancouver, BC V6C 2T5, Canada; Parkshot House, 5 Kew Road, Richmond, Surrey, England TW9 2PR, United Kingdom; Registration ID M08842780 (Canada); Company Number BC0469083 (Canada); License 15128950 (Canada) [TCO] (Linked To: PACNET GROUP).
21. PACNET SUISSE (a.k.a. PACNET SERVICES (SUISSE) SA), Carrefour du Rive 1, Geneva, Switzerland; Alpenstrasse 15, 6304, Zug, Switzerland; Identification Number CHE-109.623.231 (Switzerland); alt. Identification Number CH66012280021 (Switzerland) [TCO] (Linked To: PACNET SERVICES LTD.; Linked To: PACNET GROUP).
22. PACNET UK (a.k.a. PACIFIC NETWORK SERVICES (UK) LTD.), The Old Mill, Park Road, Shepton Mallet, Somerset IK BA4 5BS, United Kingdom [TCO] (Linked To: PACNET SERVICES LTD.; Linked To: PACNET GROUP).
23. PACNET ZAR (f.k.a. GOLDEN DIVIDEND 234 (PTY) LTD.; a.k.a. PACNET SERVICES ZAR (PROPRIETARY) LTD.), 13 Wellington Road, Parktown, Johannesburg 2193, South Africa; 22 Wellington Road, Parktown, Western Cape 2193, South Africa; Private Bag X60500, Houghton, Guateng 2041, South Africa; Registration ID 200503498307 (South Africa); Tax ID No. 9871659141 (South Africa) [TCO] (Linked To: PACNET SERVICES LTD.; Linked To: PACNET GROUP).
24. THE PAYMENTS FACTORY LTD. (f.k.a. RUMENO SONCE 60 D.O.O.; a.k.a. THE PAYMENTS FACTORY D.O.O.; a.k.a. THE PAYMENTS FACTORY LLC; a.k.a. THE PAYMENTS FACTORY LLC—PERU; a.k.a. THE PAYMENTS FACTORY PERU LLC), 69 Buchanan Street, Glasgow, Scotland G1 3HL, United Kingdom; 4th Floor, 595 Howe Street, Vancouver, BC V6C 2T5, Canada; Suite 3, 3rd Floor, Britannia House, St. Georges Street, Douglas, Isle of Man IM1 1JD, United Kingdom; 1521 Concord Pike, #303, Wilmington, DE 19803, United States; Pasaje Retiro 574 of. 201, Ciudad Satelite, Santa Rosa, Provincia Callao, Peru; 2-22-7, Shibuya, Shibuya-ku, Tokyo 150-0002, Japan; Jr. Retiro No. 574, Dpto. 201, Callao 01, Peru; 3 Independent Dr., Jacksonville, FL 32202-5004, United States; Tehnoloski park 24, Ljubljana 1000, Slovenia; Shannon Airport House SFZ, County Clare V14 E370, Ireland; 89/247 Soi Ruammit Phatthana Yeak 1, Tharang Sub-District, Bang Kehn District, Bangkok Province, Thailand; Web site
1. N840PN; Aircraft Model 690c; Aircraft Operator Pacnet Air; Aircraft Manufacturer's Serial Number (MSN) 11679; Aircraft Tail Number N840PN (aircraft) [TCO] (Linked To: PACNET AIR; Linked To: PACNET GROUP).
U.S. persons are permitted to engage in all lawful transactions with the persons listed above.
Department of the Treasury.
Notice of members of the Legal Division Performance Review Board (PRB).
This notice announces the appointment of members of the Legal Division PRB. The purpose of this Board is to review and make recommendations concerning proposed performance appraisals, ratings, bonuses, and other appropriate personnel actions for incumbents of SES positions in the Legal Division.
Office of the General Counsel, Department of the Treasury, 1500 Pennsylvania Avenue NW., Room 3000, Washington, DC 20220, Telephone: (202) 622-0283 (this is not a toll-free number).
The names and titles of the PRB members are as follows:
Paul Ahern, Assistant General Counsel (Enforcement & Intelligence);
Brian Callanan, Deputy General Counsel;
Himamauli Das, Counselor;
Eric Froman, Principal Deputy Assistant General Counsel (Banking and Finance);
Jean Gentry, Chief Counsel, U.S. Mint
Anthony Gledhill, Chief Counsel, Alcohol Tobacco, Tax, and Trade Bureau;
Elizabeth Horton, Deputy Assistant General Counsel (Ethics);
Jimmy Kirby, Chief Counsel, Financial Crimes Enforcement Network;
Jeffrey Klein, Deputy Assistant General Counsel (International Affairs);
Steven D. Laughton, Assistant General Counsel (Banking and Finance);
Robert Neis, Benefits Tax Counsel;
Martha M. Pacold, Deputy General Counsel;
Douglas Poms, Deputy International Tax Counsel;
Joel Pulliam, Deputy Assistant General Counsel (Banking and Finance);
Sidney Rocke, Chief Counsel, Bureau of Engraving and Printing;
Bradley Smith, Chief Counsel, Office of Foreign Assets Control;
Brian Sonfield, Assistant General Counsel (General Law, Ethics and Regulation);
David Sullivan, Assistant General Counsel (International Affairs);
Drita Tonuzi, Deputy Chief Counsel (Operations), Internal Revenue Service;
Heather Trew, Deputy Assistant General Counsel (Enforcement & Intelligence);
Krishna Vallabhaneni, Deputy Tax Legislative Counsel;
Thomas West, Tax Legislative Counsel and;
Paul Wolfteich, Chief Counsel, Bureau of the Fiscal Service.
Veterans Health Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Health Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before November 30, 2017.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Office of Quality, Privacy and Risk (OQPR), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-5870 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that the Advisory Committee on Disability Compensation (Committee) will meet on December 5 and 6, 2017. The Committee will meet at 1722 Eye Street NW., Washington, DC 20006, in the third-floor training complex. The sessions are open to the public and will begin at 8:30 a.m. and end at 4:30 p.m. EST each day.
The purpose of the Committee is to advise the Secretary of Veterans Affairs on the maintenance and periodic readjustment of the VA Schedule for Rating Disabilities. The Committee is to assemble and review information relating to the nature and character of disabilities arising during service in the Armed Forces, provide an ongoing assessment of the effectiveness of the rating schedule, and give advice on the most appropriate means of responding to the needs of Veterans with service-connected disabilities.
The Committee will receive briefings on issues related to compensation for Veterans and on other VA benefits programs. The Committee will allocate time for receiving public comments, which are limited to three minutes each. Individuals wishing to make oral statements before the Committee will be accommodated on a first-come, first-
The public may submit written statements for the Committee's review to Stacy Boyd, Department of Veterans Affairs, Veterans Benefits Administration, Compensation Service, Policy Staff (211A), 810 Vermont Avenue NW., Washington, DC 20420, or via email
Because the meeting is being held in a government building, the screening process requires individuals to present a photographic identification at the Guard's desk. Due to an increase in security protocols, you should allow an additional 30 minutes before the meeting begins. Routine escort will be provided until 9:00 a.m. each day. Any member of the public wishing to attend the meeting or seeking additional information should email Stacy Boyd or call her at (202) 461-9580.
Veterans Health Administration, Department of Veterans Affairs.
Notice.
Veterans Health Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before January 2, 2018.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Brian McCarthy at (202) 461-6345.
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VHA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VHA's functions, including whether the information will have practical utility; (2) the accuracy of VHA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
10-1465-1—160 hours.
10-1465-2—18,000 hours.
10-1465-3—160 hours.
10-1465-4—120 hours.
10-1465-5—48,000 hours.
10-1465-6—8,000 hours.
10-1465-7—80 hours.
10-1465-8—120 hours.
10-1465-9—30,000 hours.
10-1465-10—72,000 hours.
10-1465-1—20 minutes.
10-1465-2—15 minutes.
10-1465-3—20 minutes.
10-1465-4—15 minutes.
10-1465-5—10 minutes.
10-1465-6—20 minutes.
10-1465-7—10 minutes.
10-1465-8—15 minutes.
10-1465-9—15 minutes.
10-1465-10—15 minutes.
10-1465-1—480.
10-1465-2—72,000.
10-1465-3—480.
10-1465-4—480.
10-1465-5—288,000.
10-1465-6—24,000.
10-1465-7—480.
10-1465-8—480.
10-1465-9—120,000.
10-1465-10—288,000.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
Veterans Benefits Administrations, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before January 2, 2018.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Cynthia Harvey-Pryor at (202) 461-5870.
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
Public Law 104-13; 44 U.S.C. 3501-3521.
By direction of the Secretary.
(b) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
(d) The Secretary of Health and Human Services is hereby authorized and directed to publish this memorandum in the
| 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 |