Page Range | 51333-51548 | |
FR Document |
Page and Subject | |
---|---|
82 FR 51547 - National Veterans and Military Families Month, 2017 | |
82 FR 51543 - National Native American Heritage Month, 2017 | |
82 FR 51541 - National Family Caregivers Month, 2017 | |
82 FR 51539 - National Entrepreneurship Month, 2017 | |
82 FR 51537 - National Adoption Month, 2017 | |
82 FR 51535 - Critical Infrastructure Security and Resilience Month, 2017 | |
82 FR 51432 - Government in the Sunshine Act Meeting Notice | |
82 FR 51431 - Government in the Sunshine Act Meeting Notice | |
82 FR 51442 - Sunshine Act Meeting Notice | |
82 FR 51442 - Sunshine Act Meeting | |
82 FR 51418 - Notice of Final Issuance Adopting Administration for Native Americans Program Policies and Procedures | |
82 FR 51425 - Agency Information Collection Activities; Proposed Collection; Comment Request; Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act | |
82 FR 51363 - Naturally-Occurring and Accelerator-Produced Radioactive Materials | |
82 FR 51424 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals | |
82 FR 51475 - Notice of Open Public Event | |
82 FR 51417 - Notice of Agreements Filed | |
82 FR 51483 - Funding Availability Under Supportive Services for Veteran Families Program | |
82 FR 51358 - Migratory Bird Hunting; Approval of Corrosion-Inhibited Copper Shot as Nontoxic for Waterfowl Hunting | |
82 FR 51350 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Continuous Opacity Monitoring Requirements for Municipal Waste Combustors | |
82 FR 51398 - Notice of Availability of Draft Environmental Assessment on the Effects of Issuing an Incidental Take Permit No. 21293 | |
82 FR 51380 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Continuous Opacity Monitoring Requirements for Municipal Waste Combustors | |
82 FR 51349 - Air Plan Approval; New Hampshire; Rules for Open Burning and Incinerators; Withdrawal of Direct Final Rule | |
82 FR 51415 - New Chemicals Review Program Implementation and Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations Under the Amended Toxic Substances Control Act (TSCA); Notice of Public Meetings and Opportunity for Public Comment | |
82 FR 51355 - Formaldehyde, Polymer With 1,3-Benzenediol, Ethers With Polyethylene Glycol Mono-Me Ether; Exemption From the Requirement of a Tolerance | |
82 FR 51351 - Formaldehyde, Polymer With 1,3-Benzenediol, 2-Methyloxirane and Oxirane, Ethers With Polyethylene Glycol Mono-Me Ether; Exemption From the Requirement of a Tolerance | |
82 FR 51441 - NASA Advisory Council; Science Committee; Meeting. | |
82 FR 51440 - Centennial Challenges: 3D-Printed Habitat Challenge | |
82 FR 51421 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption | |
82 FR 51344 - Amendment of Multiple Restricted Areas; Vandenberg AFB, CA | |
82 FR 51433 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Medical Technology Enterprise Consortium | |
82 FR 51421 - Abbreviated New Drug Applications: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence); Draft Guidance for Industry; Availability | |
82 FR 51345 - Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry; Availability | |
82 FR 51381 - Fisheries Off West Coast States; Coastal Pelagic Species Fisheries; Amendment 16 to the Coastal Pelagic Species Fishery Management Plan | |
82 FR 51419 - Formal Dispute Resolution: Sponsor Appeals Above the Division Level; Guidance for Industry and Review Staff; Availability | |
82 FR 51442 - New Postal Products | |
82 FR 51433 - ChipRX, L.L.C., d/b/a City Center Pharmacy; Decision and Order | |
82 FR 51380 - National Emission Standards for Hazardous Air Pollutants From the Portland Cement Manufacturing Industry; Residual Risk and Technology Review | |
82 FR 51467 - Certification Pursuant to Section 7041(A)(L) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2017 | |
82 FR 51439 - Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation | |
82 FR 51401 - Request for Public Comment on a Commercial Availability Request Under the U.S.-Morocco Free Trade Agreement | |
82 FR 51400 - Request for Public Comment on a Commercial Availability Request Under the U.S.-Morocco Free Trade Agreement | |
82 FR 51472 - Renewal of Currently Approved Information Collection: Comment Request for Customer Satisfaction and Opinion Surveys, and Focus Group Interviews | |
82 FR 51476 - Homeless Providers Grant and Per Diem Program | |
82 FR 51429 - Draft Environmental Impact Report/Environmental Impact Statement for North Bay Water Recycling Program Phase 2, California | |
82 FR 51428 - Receipt of Application for Incidental Take Permit; Draft Low-Effect Habitat Conservation Plan for the California Tiger Salamander; Phillips 66 Line 300 Project, Santa Barbara County, California | |
82 FR 51386 - Utility Scale Wind Towers From the Socialist Republic of Vietnam: Preliminary Determination of No Shipments, and Preliminary Partial Rescission of Antidumping Duty Administrative Review; 2016-2017 | |
82 FR 51396 - Fine Denier Polyester Staple Fiber From the People's Republic of China: Preliminary Affirmative Countervailing Duty Determination | |
82 FR 51387 - Fine Denier Polyester Staple Fiber From India: Preliminary Affirmative Countervailing Duty Determination | |
82 FR 51471 - Public Availability of the Department of Transportation FY 2016 Service Contract Inventory | |
82 FR 51475 - Privacy Act of 1974; System of Records | |
82 FR 51389 - Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Final Results of the Expedited Fourth Sunset Review of the Antidumping Duty Order | |
82 FR 51393 - Stainless Steel Bar From Brazil, India, Japan, and Spain: Final Results of the Expedited Sunset Reviews of the Antidumping Duty Orders | |
82 FR 51392 - Certain Crystalline Silicon Photovoltaic Products From the People's Republic of China: Notice of Rescission of Countervailing Duty Administrative Review; 2016 | |
82 FR 51395 - Large Power Transformers From the Republic of Korea: Notice of Court Decision Not in Harmony With Final Results, Notice of Amended Final Results | |
82 FR 51394 - Continuation of Antidumping Duty Order: Fresh Garlic From the People's Republic of China | |
82 FR 51390 - Certain Lined Paper Products From India: Final Results of Expedited Second Sunset Review of Countervailing Duty Order | |
82 FR 51347 - Safety Zone, Delaware River; Pipeline Removal | |
82 FR 51411 - Notice of Availability of Government-Owned Inventions; Available for Licensing | |
82 FR 51400 - Western Pacific Fishery Management Council; Public Meetings; Cancellation | |
82 FR 51441 - Agency Information Collection Activities: Proposed Collection; Comment Request; Minority Depository Institution Preservation Program | |
82 FR 51414 - Agency Information Collection Activities; Comment Request; National Evaluation of the Investing in Innovation (i3) Program | |
82 FR 51482 - Agency Information Collection Activity: Notice of Waiver of VA Compensation or Pension To Receive Military Pay and Allowances | |
82 FR 51482 - Agency Information Collection Activity: VA Cooperative Studies Program | |
82 FR 51449 - Order Temporarily Exempting Certain Broker-Dealers From Specified Provisions of the Recordkeeping, Reporting, and Monitoring Responsibilities of Rule 13h-1 Under the Securities Exchange Act of 1934 | |
82 FR 51431 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest | |
82 FR 51430 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest | |
82 FR 51429 - Minor Boundary Revision at Obed Wild and Scenic River | |
82 FR 51461 - Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Rule 20.6, Nullification and Adjustment of Options Transactions Including Obvious Errors | |
82 FR 51453 - Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 1614 | |
82 FR 51444 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Establish a Special Segregation Account for a Participant or Pledgee That Is a Derivatives Clearing Organization or Futures Commission Merchant | |
82 FR 51455 - Self-Regulatory Organizations; Investors Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt New Rule 6.210 Related to Ex-Dates for Securities Listed or Traded on the Exchange | |
82 FR 51457 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change, as Modified by Amendments No. 1 and 2, To List and Trade Shares of the Calvert Ultra-Short Duration Income NextSharesTM | |
82 FR 51453 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To Amend Rule 4703(a) To Allow Members To Designate When an Order With a RTFY or SCAN Routing Order Attribute Will Be Activated | |
82 FR 51447 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Regarding Exchange Calculation of the Intraday Indicative Value for Specified Exchange-Traded Products | |
82 FR 51406 - Privacy Act of 1974; System of Records | |
82 FR 51402 - Privacy Act of 1974; System of Records | |
82 FR 51333 - Privacy Act Regulations | |
82 FR 51409 - Privacy Act of 1974; System of Records | |
82 FR 51443 - Product Change-Priority Mail Express, Priority Mail, & First-Class Package Service Negotiated Service Agreement | |
82 FR 51444 - Product Change-Priority Mail Express and Priority Mail Negotiated Service Agreement | |
82 FR 51404 - Privacy Act of 1974; System of Records | |
82 FR 51471 - Petition for Waiver of Compliance | |
82 FR 51384 - Notice of Public Meeting of the Tennessee Advisory Committee | |
82 FR 51384 - Notice of Public Meeting of the Georgia Advisory Committee | |
82 FR 51427 - National Institute of Mental Health; Notice of Closed Meeting | |
82 FR 51428 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
82 FR 51427 - Center for Scientific Review; Notice of Closed Meetings | |
82 FR 51470 - Thirty Sixth RTCA SC-213 Enhanced Flight Vision Systems/Synthetic Vision Systems (EFVS/SVS) Joint Plenary With EUROCAE Working Group 70 | |
82 FR 51470 - Fifty Third RTCA SC-224 Standards for Airport Security Access Control Systems Plenary | |
82 FR 51397 - Marine Mammals; File No. 20626 | |
82 FR 51468 - Applications for Inclusion on the Binational Panels Roster Under the North American Free Trade Agreement | |
82 FR 51413 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Federal Family Educational Loan Program (FFEL)-Administrative Requirements for States, Not-for-Profit Lenders, and Eligible Lenders Trustees | |
82 FR 51417 - Incentive Auction Task Force and Media Bureau Announce the Initial Reimbursement Allocation for Eligible Broadcasters and MVPDs | |
82 FR 51385 - Agenda and Notice of Public Meeting of the Colorado Advisory Committee | |
82 FR 51385 - Notice of Public Meeting of the Louisiana Advisory Committee To Discuss Hearing Preparations for Barriers to Voting Report | |
82 FR 51342 - Amendment of Class E Airspace; Seward, NE | |
82 FR 51364 - Airworthiness Directives; Fokker Services B.V. Airplanes | |
82 FR 51382 - Mitigation Policies of the U.S. Fish and Wildlife Service; Request for Comments | |
82 FR 51467 - Seminole Gulf Railway, L.P.-Abandonment Exemption-in Sarasota County, Fla. | |
82 FR 51369 - Group Registration of Newspapers | |
82 FR 51367 - Airworthiness Directives; Viking Air Limited Airplanes | |
82 FR 51492 - Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States; Essential Fish Habitat | |
82 FR 51526 - Federal Acquisition Regulation; Federal Acquisition Circular 2005-96; Small Entity Compliance Guide | |
82 FR 51527 - Federal Acquisition Regulation; Removal of Fair Pay and Safe Workplaces Rule | |
82 FR 51526 - Federal Acquisition Regulation; Federal Acquisition Circular 2005-96; Introduction | |
82 FR 51358 - Guidance for Executive Order 13673, “Fair Pay and Safe Workplaces” | |
82 FR 51335 - Airworthiness Directives; Bombardier, Inc., Airplanes | |
82 FR 51340 - Airworthiness Directives; Saab AB, Saab Aeronautics (Formerly Known as Saab AB, Saab Aerosystems) Airplanes | |
82 FR 51338 - Airworthiness Directives; Airbus Helicopters (Type Certificate Previously Held by Eurocopter France) |
International Trade Administration
National Oceanic and Atmospheric Administration
Navy Department
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
Fish and Wildlife Service
National Park Service
Reclamation Bureau
Antitrust Division
Drug Enforcement Administration
Copyright Office, Library of Congress
Federal Aviation Administration
Federal Railroad Administration
United States Mint
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.
Council of the Inspectors General on Integrity and Efficiency.
Interim final rule.
The Council of the Inspectors General on Integrity and Efficiency (CIGIE) is updating its regulations addressing procedures relating to access, maintenance, disclosure, and amendment of records that are in a CIGIE system of records under the Privacy Act of 1974 (Privacy Act) to implement changes in accordance with the Inspector General Empowerment Act of 2016 and to make minor typographical corrections.
This interim final rule is effective November 6, 2017. Written comments may be submitted by December 6, 2017.
You may submit comments by any of the following methods:
•
•
•
•
•
Atticus J. Reaser, General Counsel, CIGIE, (202) 292-2600.
CIGIE published its final rule to provide the procedures and guidelines under which CIGIE implements the Privacy Act in the
In order to conform to the IGEA and meet its obligations thereunder, CIGIE is amending its regulations implementing the Privacy Act. Specifically, CIGIE is amending 5 CFR 9801.102 to accurately reflect the changed custodianship of IC records and adding a new subpart D to address the exemptions necessary to maintain the Privacy Act system of records associated with IC records. CIGIE is also making three minor typographical corrections.
Pursuant to 5 U.S.C. 553(d)(3), CIGIE has found that good cause exists for waiving the general notice of proposed rulemaking and public comment procedures as to these amendments and for issuing this interim final rule without a delayed effective date. The notice and comment procedures are being waived because these amendments are being made in accordance with the mandates of the IGEA, which took effect without delay on December 16, 2016. Additionally, these amendments specify exemptions regarding the public's access to information about themselves maintained by CIGIE. The absence of well-defined exemptions to the Privacy Act regulations could impair confidentiality and privacy rights of those who submit sensitive information to CIGIE and the ability of CIGIE to use that information to carry out its statutory mission.
In promulgating this amended rule, CIGIE has adhered to the regulatory philosophy and the applicable principles of regulation set forth in section 1 of Executive Order 12866, Regulatory Planning and Review. The Office of Management and Budget (OMB) has determined that this rule is not “significant” under Executive Order 12866.
These amended regulations will not have a significant economic impact on a substantial number of small entities. Therefore, a regulatory flexibility analysis under the Regulatory Flexibility Act, as amended, is not required.
These amended regulations impose no additional reporting and recordkeeping requirements. Therefore, clearance by OMB is not required.
This amended rule does not have Federalism implications, as set forth in Executive Order 13132. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
Information, Privacy, Privacy Act, Records.
For the reasons set forth in the preamble, CIGIE amends part 9801 to title 5 of the Code of Federal Regulations as follows:
Section 11 of the Inspector General Act of 1978, as amended, 5 U.S.C. app.; 5 U.S.C. 301, 552a; 31 U.S.C. 9701.
(a)
(b)
(d) Maintain no system of records without public notice and notify appropriate CIGIE officials of the existence or development of any system of records that is not the subject of a current or planned public notice;
(i) Maintain and use records with care to prevent the unauthorized or inadvertent disclosure of a record to anyone. No record contained in a CIGIE system of records shall be disclosed to another person, or to another agency outside CIGIE, except pursuant to a written request by, or with the prior written consent of, the individual to whom the record pertains, unless the disclosure is otherwise authorized by the Privacy Act; and
(b) * * *
(2) The exact portion of the record the requester seeks to have amended should be indicated clearly. If possible, proposed alternative language should be set forth, or, at a minimum, the reasons why the requester believes the record is not accurate, relevant, timely, or complete should be set forth with enough particularity to permit CIGIE to not only understand the requester's basis for the request, but also to make an appropriate amendment to the record.
(a)
(b)
(1) Pursuant to the provisions of 5 U.S.C. 552a(j)(2), CIGIE-04 is exempt from the following provisions of the Privacy Act: 5 U.S.C. 552a(c)(3) and (c)(4); (d); (e)(1), (e)(2), (e)(3), (e)(4)(G)-(H), (e)(5), and (e)(8); (f); and (g).
(2) Pursuant to the provisions of 5 U.S.C. 552a(k)(1) and (2), CIGIE-04 is exempt from the following provisions of the Privacy Act: 5 U.S.C. 552a(c)(3); (d); (e)(1) and (e)(4)(G)-(H); and (f).
(3) Exemptions from the particular subsections are justified for the following reasons:
(i) From subsection (c)(3) because release of disclosure accounting could alert the subjects of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of the investigation and the fact that they are subjects of the investigation, and reveal investigative interest by not only CIGIE, through the IC, but also by external agencies such as the Public Integrity Section of the Department of Justice. Because release of such information to the subjects of an investigation would provide them with significant information concerning the nature of the investigation, release could result in the destruction of documentary evidence, improper influencing of witnesses, and other activities that could impede or compromise the investigation. In addition, accounting for each disclosure could result in the release of properly classified information which would compromise the national defense or disrupt foreign policy.
(ii) From subsection (c)(4) because this system is exempt from the access provisions of subsection (d) pursuant to subsections (j) and (k) of the Privacy Act.
(iii) From the access and amendment provisions of subsection (d) because access to the records contained in this system of records could inform the subjects of an investigation of an actual or potential criminal, civil, or regulatory violation of the existence of that investigation and of the nature and scope of the information and evidence obtained as to their activities. Such awareness by the subjects could prevent the successful completion of an investigation and/or lead to the improper influencing of witnesses, the destruction of evidence, or fabricated testimony. In addition, granting access to such information could disclose security-sensitive or confidential business information or information that would constitute an unwarranted invasion of the personal privacy of third parties. Finally, access to the records could result in the release of classified information which would compromise the national defense or disrupt foreign policy. Amendment of the records would interfere with ongoing investigations and law enforcement activities and impose an impossible administrative burden by requiring investigations to be continuously reinvestigated.
(iv) From subsection (e)(1) because the application of this provision could impair investigations and interfere with the law enforcement responsibilities of CIGIE through the IC for the following reasons:
(A) It is not possible to detect relevance or necessity of specific information in the early stages of a civil, criminal, or other law enforcement investigation, case, or matter, including investigations in which use is made of classified information. Relevance and necessity are questions of judgment and timing, and it is only after the information is evaluated that the relevance and necessity of such information can be established.
(B) During the course of any investigation, CIGIE, through the IC, may obtain information concerning actual or potential violations of laws other than those within the scope of its jurisdiction. In the interest of effective law enforcement, CIGIE should retain this information, as it may aid in establishing patterns of criminal activity and can provide valuable leads for Federal and other law enforcement agencies.
(C) In interviewing individuals or obtaining other forms of evidence during an investigation, information may be supplied to an investigator that relates to matters incidental to the primary purpose of the investigation but which may relate also to matters under
(v) From subsection (e)(2) because, in some instances, the application of this provision would present a serious impediment to law enforcement for the following reasons:
(A) The subjects of an investigation would be placed on notice as to the existence of an investigation and would therefore be able to avoid detection or apprehension, to improperly influence witnesses, to destroy evidence, or to fabricate testimony.
(B) In certain circumstances the subjects of an investigation cannot be required to provide information to investigators, and information relating to their illegal acts, violations of rules of conduct, or any other misconduct must be obtained from other sources.
(C) In any investigation it is necessary to obtain evidence from a variety of sources other than the subjects of the investigation.
(vi) From subsection (e)(3) because the application of this provision would provide the subjects of an investigation with substantial information which could impede or compromise the investigation.
(vii) From subsection (e)(4)(G)-(I) because this system of records is exempt from the access provisions of subsection (d).
(viii) From subsection (e)(5) because the application of this provision may prevent the collection of any data not shown to be accurate, relevant, timely, and complete at the moment it is collected. In the collection of information for law enforcement purposes, it is impossible to determine in advance what information is accurate, relevant, timely, and complete. Material which may seem unrelated, irrelevant, or incomplete when collected may take on added meaning or significance as an investigation progresses. The restrictions of this provision could interfere with the preparation of a complete investigative report, and thereby impede effective law enforcement.
(ix) From subsection (e)(8) because the application of this provision could prematurely reveal an ongoing criminal investigation to the subjects of an investigation and could reveal investigative techniques, procedures, or evidence.
(x) From subsection (f) because CIGIE's rules are inapplicable to those portions of the system that are exempt and would place the burden on CIGIE of either confirming or denying the existence of a record pertaining to a requesting individual, which might in itself provide an answer to that individual relating to an ongoing investigation. The conduct of a successful investigation leading to the indictment of a criminal offender precludes the applicability of established agency rules relating to verification of record, disclosure of the record to that individual, and record amendment procedures for this record system.
(xi) From subsection (g) to the extent that this system is exempt from the access and amendment provisions of subsection (d) pursuant to subsections (j)(2), (k)(1), and (k)(2) of the Privacy Act.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702), Model CL-600-2D15 (Regional Jet Series 705), Model CL-600-2D24 (Regional Jet Series 900), and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. This AD was prompted by a report indicating that a number of rubber bull gear (RBG) wheels installed in the horizontal stabilizer trim actuator (HSTA) were manufactured using an incorrect material specification. This AD requires replacement of the affected RBG wheels. We are issuing this AD to address the unsafe condition on these products.
This AD is effective December 11, 2017.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of December 11, 2017.
For service information identified in this final rule, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999; fax 514-855-7401; email
You may examine the AD docket on the Internet at
Aziz Ahmed, Aerospace Engineer, Airframe and Mechanical Systems Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7329; fax 516-794-5531.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702), Model CL-600-2D15 (Regional Jet Series 705), Model CL-600-2D24 (Regional Jet Series 900), and Model CL-600-2E25 (Regional Jet Series 1000). The NPRM published in the
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2016-22, dated June 24, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702), Model CL-600-2D15 (Regional Jet Series 705), Model CL-600-2D24 (Regional Jet Series 900), and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. The MCAI states:
An inspection by the vendor revealed that a number of Rubber Bull Gear (RBG) Wheels installed in the Horizontal Stabilizer Trim Actuator (HSTA) of the CL-600-2C10, CL-600-2D15, CL-600-2D24 and CL-600-2E25 aeroplanes were manufactured from the incorrect material specification. The use of the incorrect material specification has a direct impact on the RBG Wheels life limit. The teeth of these non-conforming RBG Wheels may experience premature wear out and if not corrected, this condition could result in difficulties in maneuvering the aeroplane.
This [Canadian] AD mandates replacement of the RBGs whose wheels have been made using an incorrect material specification.
You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. The following presents the comment received on the NPRM and the FAA's response.
Air Line Pilots Association, International (ALPA) requested that we review and revise the compliance times specified in the proposed AD to reflect flight hours rather than flight cycles, and to align the times with a previous AD, AD 2011-12-06, Amendment 39-16713 (76 FR 33982, June 10, 2011) (“AD 2011-12-06”). The commenter asserted that the compliance times in AD 2011-12-06 were more conservative than what is written in the proposed AD, and that for a component with a known material defect that is continuously used throughout the duration of any given flight, flight hours rather than flight cycles would be a more appropriate metric to measure compliance time.
We disagree with the commenter's proposed change. We reviewed TCCA's evaluation of the compliance times, and determined that they are appropriate to mitigate the unsafe condition. We have not received any data to demonstrate otherwise. In addition, the compliance times in AD 2011-12-06 are also based on flight cycles instead of flight hours. Therefore, have not changed this AD in this regard.
We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this AD as proposed, except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We reviewed Bombardier Service Bulletin 670BA-27-072, Revision A, dated October 26, 2016. This service information describes procedures for identification of affected HSTAs, and replacement if necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 544 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective December 11, 2017.
None.
This AD applies to the Bombardier, Inc., airplanes identified in paragraphs (c)(1) through (c)(4) of this AD, certificated in any category, equipped with horizontal stabilizer trim actuator (HSTA) part number 8489-7 or 8489-7R.
(1) Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes.
(2) Model CL-600-2D15 (Regional Jet Series 705) airplanes.
(3) Model CL-600-2D24 (Regional Jet Series 900) airplanes.
(4) Model CL-600-2E25 (Regional Jet Series 1000) airplanes.
Air Transport Association (ATA) of America Code 27, Flight controls.
This AD was prompted by a report indicating that a number of rubber bull gear (RBG) wheels installed in the HSTA were manufactured using an incorrect material specification. We are issuing this AD to prevent premature wear-out of the teeth of the RBG wheels, which could cause difficulties in maneuvering the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 600 flight hours after the effective date of this AD, inspect to determine whether the serial number (S/N) of the installed HSTA is listed in paragraph 1.A, “Effectivity,” of Bombardier Service Bulletin 670BA-27-072, Revision A, dated October 26, 2016. If the S/N of the installed HSTA is not listed in paragraph 1.A, “Effectivity,” of Bombardier Service Bulletin 670BA-27-072, Revision A, dated October 26, 2016, no further action is required by this AD, except as required by paragraph (j) of this AD. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number of the HSTA can be conclusively determined from that review.
For any HSTA with a S/N listed in paragraph 1.A, “Effectivity,” of Bombardier Service Bulletin 670BA-27-072, Revision A, dated October 26, 2016: Within the compliance times specified in figure 1 to paragraph (h) of this AD, as applicable, replace the affected HSTA, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 670BA-27-072, Revision A, dated October 26, 2016.
This paragraph provides credit for actions required by paragraphs (g) and (h) of this AD, if those actions were performed before the effective date of this AD using Bombardier Service Bulletin 670BA-27-072, dated April 26, 2016.
As of the effective date of this AD, no person may install, on any airplane, an HSTA having part number 8489-7 or 8489-7R, with a S/N listed in paragraph 1.A, “Effectivity,” of Bombardier Service Bulletin 670BA-27-072, Revision A, dated October 26, 2016, unless the S/N has a suffix “C” marked on the identification plate adjacent to the S/N.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2016-22, dated June 24, 2016, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For more information about this AD, contact Aziz Ahmed, Aerospace Engineer, Airframe and Mechanical Systems Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7329; fax 516-794-5531.
(3) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (m)(3) and (m)(4) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Bombardier Service Bulletin 670BA-27-072, Revision A, dated October 26, 2016.
(ii) Reserved.
(3) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999; fax 514-855-7401; email
(4) You may view this service information at the FAA, Transport Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are superseding Airworthiness Directive (AD) 2013-15-03 for Eurocopter France Model AS350B, AS350BA, AS350B1, AS350B2, AS350B3, AS350C, AS350D, and AS350D1 helicopters. AD 2013-15-03 required inspecting the hydraulic pump drive pulley bearing (bearing) for leaks, rust, overheating, and condition. This new AD adds a requirement to grease the bearing and inspect for bronze particles in the grease, and changes the inspection and inspection intervals of the bearing until it is replaced with an improved bearing. This AD was prompted by additional reports of hydraulic pump drive belt failure caused by bearing seizures. The actions of this AD are intended to prevent an unsafe condition on these products.
This AD is effective December 11, 2017.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of December 11, 2017.
For service information identified in this final rule, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
You may examine the AD docket on the Internet at
Stephen Barbini, Manager, Safety Management Section, Policy and Innovation Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to remove AD 2013-15-03, Amendment 39-17519 (78 FR 44422, July 24, 2013) and add a new AD. AD 2013-15-03 applied to Eurocopter France (now Airbus Helicopters) Model AS350B, AS350BA, AS350B1, AS350B2, AS350B3, AS350C, AS350D, and AS350D1 helicopters with a single hydraulic system and a hydraulic pump drive installed. AD 2013-15-03 required repetitively inspecting the bearing for leaks, rust, overheating, and condition. AD 2013-15-03 was prompted by six reports of hydraulic pump drive belt failure caused by bearing seizures. AD 2013-15-03 also was prompted by AD No. 2013-0044-E, dated February 27, 2013, issued by EASA, which is the Technical Agent for the Member States of the European Union. EASA advised that hydraulic pump drive belt failures caused by seizure of the bearing, for helicopters with a single hydraulic system, could lead to loss of hydraulic servo assistance and an increase in pilot workload to the point that the helicopter needs to land as soon as possible.
The NPRM published in the
As a result, the NPRM proposed to retain the inspection requirements in AD 2013-15-03, add a requirement to grease the bearing and inspect for bronze particles in the grease, and change the inspection and inspection intervals of the bearing until it is replaced with the improved bearing.
Since the NPRM was issued, the FAA's Aircraft Certification Service has changed its organizational structure. The new structure replaces product directorates with functional divisions. We have revised some of the office titles and nomenclature throughout this Final rule to reflect the new organizational changes. Additional information about the new structure can be found in the Notice published on July 25, 2017 (82 FR 34564).
After our NPRM was published, we received a comment from Airbus Helicopters.
Airbus Helicopters requested that we revise the Applicability section of the AD to eliminate confusion. Specifically, Airbus Helicopters requested we change the AD to apply to helicopters with “Single Hydraulics pre mod 079568 with Hydraulic pump drive assembly part number 350A35-0132-00 with bearing part number 704A33651243 installed.”
We do not agree. Airbus Helicopters' request does not make the Applicability section clearer because the unsafe condition lies with the bearing, which is also installed in hydraulic pump drive assembly part number 350A35-0132-00 V. Leaving the original Applicability language makes this point clear.
We have reviewed the relevant information and determined that an unsafe condition exists and is likely to exist or develop on other helicopters of these same type designs and that air safety and the public interest require adopting the AD requirements as proposed.
The EASA AD applies to Airbus Helicopters Model AS350BB helicopters, and this AD does not because the Model AS350BB has no FAA-issued type certificate. This AD applies to Model AS350D1 and AS350C helicopters, while the EASA AD does not.
We reviewed Airbus Helicopters ASB No. AS350-63.00.24, Revision 0, dated October 21, 2014 (ASB), for Model AS350B, AS350BA, AS350BB, AS350B1, AS350B2, AS350B3, AS350D, and military Model AS350L1 helicopters with a single hydraulic system and a hydraulic pump drive assembly P/N 350A35-0132-00. The ASB calls for mandatory replacement of bearing P/N 704A33651243 with bearing P/N 704A33651269 and introduces a preventative maintenance operation for bearing P/N 704A33651243 until it is replaced.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 729 helicopters of U.S. Registry and that labor costs average $85 per work hour. Based on these estimates, we expect the following costs:
• Greasing and visually inspecting the bearing requires 1.5 work hours and no parts are needed. We estimate a total cost of $128 per helicopter and $93,312 for the U.S. fleet per inspection cycle.
• Inspecting and manually rotating the bearing requires 2 work hours, and no parts are needed. We estimate a total cost of $170 per helicopter and $123,930 for the U.S. fleet per inspection cycle.
• Replacing the bearing requires 2 work hours and $1,571 for parts, for a total cost of $1,741 per helicopter and $1,269,189 for the U.S. fleet.
• Replacing the hydraulic pump drive assembly requires 2 work hours and $8,543 for parts, for a total cost of $8,713 per helicopter and $6,351,777 for the U.S. fleet.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska to the extent that a regulatory distinction is required, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD applies to Airbus Helicopters Model AS350B, AS350BA, AS350B1, AS350B2, AS350B3, AS350C, AS350D, and AS350D1 helicopters with a hydraulic pump drive bearing (bearing) part number (P/N) 704A33651243 installed, certificated in any category.
This AD defines the unsafe condition as the seizure of the bearing. This condition could result in hydraulic pump drive belt failure, loss of hydraulic servo assistance, and subsequent loss of control of the helicopter.
This AD supersedes AD 2013-15-03, Amendment 39-17519 (78 FR 44422, July 24, 2013).
This AD becomes effective December 11, 2017.
You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.
(1) For each bearing with less than 115 hours time-in-service (TIS), before accumulating 150 hours TIS, and for each bearing with 115 or more hours TIS, within 50 hours TIS, and for all helicopters thereafter at intervals not to exceed 150 hours TIS:
(i) Grease each bearing in accordance with the Accomplishment Instructions, paragraph 3.B.2.b., of Airbus Helicopters Alert Service Bulletin No. AS350-63.00.24, Revision 0, dated October 21, 2014 (ASB).
(ii) Perform a test ground run. Inspect all grease that comes out of the bearing during the ground run and all grease around the bearing for bronze particles.
(iii) If there are any bronze particles in the grease, before further flight, replace the bearing with bearing P/N 704A33651269. This constitutes terminating action for the inspections in this AD.
Hydraulic pump drive assembly P/N 350A35-0132-01 is fitted with bearing P/N 704A33651269.
(2) Within 600 hours TIS and thereafter at intervals not to exceed 600 hours TIS:
(i) Visually inspect the bearing for bronze particles in the grease. If there are any bronze particles in the grease, before further flight, replace the bearing with bearing P/N 704A33651269. This constitutes terminating action for the inspections in this AD.
(ii) Manually rotate the bearing and inspect for a friction point, brinelling, and a noise from the bearing. If there is a hard point, any brinelling, or any noise from the bearing, before further flight, replace the bearing with bearing P/N 704A33651269.
(3) Replacing bearing P/N 704A33651243 with bearing P/N 704A33651269, or replacing hydraulic pump drive assembly P/N 350A35-0132-00 with hydraulic pump drive assembly P/N 350A35-0132-01, constitutes terminating action for the inspections required by this AD.
(1) The Manager, Safety Management Section, FAA, may approve AMOCs for this AD. Send your proposal to: Stephen Barbini, Manager, Safety Management Section, Policy and Innovation Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office, before operating any aircraft complying with this AD through an AMOC.
The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2014-0233, dated October 23, 2014. You may view the EASA AD on the Internet at
Joint Aircraft Service Component (JASC) Code: 2913, Hydraulic Pump (Electric/Engine), Main.
(1) The Director of the Federal Register approved the incorporation by reference of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Airbus Helicopters Alert Service Bulletin No. AS350-63.00.24, Revision 0, dated October 21, 2014.
(ii) Reserved.
(3) For Airbus Helicopters service information identified in this AD, contact contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
(4) You may view this service information at FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for certain Saab AB, Saab Aeronautics Model SAAB 340B airplanes. This AD was prompted by reports of natural stall events in icing conditions, without prior stall warnings. This AD requires modifying the stall warning system, installing new stall warning computers, and activating the stall warning system. We are issuing this AD to address the unsafe condition on these products.
This AD is effective December 11, 2017.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of December 11, 2017.
For service information identified in this final rule, contact Saab AB, Saab Aeronautics, SE-581 88, Linköping, Sweden; telephone +46 13 18 5591; fax +46 13 18 4874; email
You may examine the AD docket on the Internet at
Shahram Daneshmandi, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1112; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Saab AB, Saab Aeronautics Model SAAB 340B airplanes. The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2017-0067, dated April 24, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Saab AB, Saab Aeronautics Model SAAB 340B airplanes. The MCAI states:
A few natural stall events, specifically when operating in icing conditions, have been experienced on SAAB 340 series aeroplanes, without receiving a prior stall warning.
This condition, if not corrected, could result in loss of control of the aeroplane.
To address this potential unsafe condition, SAAB developed a modified stall warning system, incorporating improved stall warning logic, and issued various Service Bulletins (SB) providing instructions to replace the Stall Warning Computer (SWC) with a new SWC, and instructions to activate the new SWC. The new system includes stall warning curves optimized for operation in icing conditions, which are activated by selection of Engine Anti-Ice.
Consequently, EASA issued AD 2014-0218 [which corresponds to FAA AD 2016-22-15, Amendment 39-18704 (81 FR 76843, November 4, 2016)] to require installation and activation of the improved SWC. That [EASA] AD excluded certain SAAB 340B aeroplanes by s/n [serial number].
Since EASA AD 2014-0218 was issued, SAAB developed a technical solution applicable for some of those previously excluded aeroplanes, and issued SB 340-27-117 and SB 340-27-118, providing instructions to modify and activate the new SWC.
For the reasons described above, this [EASA] AD requires installation and activation of the improved SWC.
You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.
We reviewed the relevant data and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
Saab AB, Saab Aeronautics has issued Service Bulletin 340-27-117, dated January 23, 2017. This service information describes procedures for modifying the stall warning system.
Saab AB, Saab Aeronautics has also issued Service Bulletin 340-27-118, dated January 23, 2017. This service information describes procedures for installing new stall warning computers and activating the modified stall warning system.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 4 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective December 11, 2017.
None.
This AD applies to Saab AB, Saab Aeronautics (formerly known as Saab AB, Saab Aerosystems) Model SAAB 340B airplanes, certificated in any category, serial numbers 362, 363, 385, and 405.
Air Transport Association (ATA) of America Code 27, Flight Controls.
This AD was prompted by reports of natural stall events in icing conditions, without prior stall warnings. We are issuing this AD to prevent a natural stall event in icing conditions without any stall warning, which could result in loss of control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 12 months after the effective date of this AD, do the actions specified in paragraphs (g)(1) and (g)(2) of this AD.
(1) Install a provision for a modified stall warning system, in accordance with the Accomplishment Instructions of Saab Service Bulletin 340-27-117, dated January 23, 2017.
(2) Install new stall warning computers and activate the modified stall warning system, in accordance with the Accomplishment Instructions of Saab Service Bulletin 340-27-118, dated January 23, 2017.
After modification of an airplane as required by paragraph (g) of this AD, no person may install a stall warning computer having part number (P/N) 20AK5 or P/N 0020AK5 on that airplane.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2017-0067, dated April 24, 2017, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For more information about this AD, contact Shahram Daneshmandi, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1112; fax 425-227-1149.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Saab Service Bulletin 340-27-117, dated January 23, 2017.
(ii) Saab Service Bulletin 340-27-118, dated January 23, 2017.
(3) For service information identified in this AD, contact Saab AB, Saab Aeronautics, SE-581 88, Linköping, Sweden; telephone +46 13 18 5591; fax +46 13 18 4874; email
(4) You may view this service information at the FAA, Transport Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
This action modifies Class E airspace extending upward from 700 feet above the surface at Seward Municipal Airport, Seward, NE, to accommodate new standard instrument approach procedures for instrument flight rules (IFR) operations at the airport. This action is necessary due to
Effective 0901 UTC, February 1, 2018. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Walter Tweedy, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5900.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace extending upward from 700 feet above the surface at Seward Municipal Airport, Seward, NE, to support IFR operations in standard instrument approach procedures at the airport.
The FAA published in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the
This amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 amends Class E airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Seward Municipal Airport, Seward, NE, to accommodate new standard instrument approach procedures for IFR operations at the airport. The segments within 4 miles each side of the 166° bearing from the Seward NDB extending from the 6.4-mile radius to 14 miles southeast of the NDB, and within 4 miles each side of the 359° bearing from the Seward NDB extending from the 6.4-mile radius to 13 miles north of the NDB, are removed due to the decommissioning of the Seward NDB and the NDB approach is cancelled. This action enhances the safety and management of the standard instrument approach procedures for IFR operations at the airport.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5. a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
The airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Seward Municipal Airport.
Federal Aviation Administration (FAA), DOT.
Final rule; technical amendment.
This action makes minor adjustments to the boundary descriptions of restricted areas R-2516, R-2517, R-2534A and R-2534B; Vandenberg AFB, CA. The changes are necessary as a result of the FAA using updated digital data that defines maritime limits and other geophysical features used in the boundary descriptions. This requires minor changes to certain latitude/longitude points in the boundary descriptions of the above restricted areas to match the updated digital data.
Effective date 0901 UTC, February 1, 2018.
Kenneth Ready, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority since it makes minor updates to certain boundary coordinates for restricted areas R-2516, R-2517, R-2534A and R-2534B; Vandenberg AFB, CA, to match updated digital shoreline data received from the National Oceanic and Atmospheric Administration (NOAA).
Some restricted area boundary descriptions use maritime limits, such as the shoreline of the U.S., to identify the shape of the area (
For a variety of reasons, maritime limits change over time. The FAA has received updated digital data for maritime limits from NOAA. Digital data is more precise than measurements used in the past. The FAA, through the implementation of its data-driven charting process, was able to utilize this new data to accurately update the U.S. maritime limit boundaries used for aeronautical charting. Prior to the update, the maritime limit boundary data used for charting were over 25 years old. In applying the updated data, FAA found that some restricted area boundary descriptions, that were based on the maritime limits, did not correspond to the updated shoreline data. Consequently, there are minor mismatches between some restricted area latitude/longitude coordinates and the actual shoreline position.
This rulemaking action updates the affected boundary coordinates of restricted areas R-2516, R-2517, R-2534A and R-2534B, in California to maintain the intended shape of the airspace in relation to the U.S. shoreline and to improve their representations on aeronautical charts.
This action amends Title 14 Code of Federal Regulations (14 CFR) part 73 to make minor adjustments to certain latitude/longitude coordinates in the descriptions of restricted areas R-2516, R-2517, R-2534A and R-2534B, in California. The changes are necessary as a result of the FAA using digital data for aeronautical charting. This more precise digital plotting of points revealed minor mismatches between some of the current restricted area boundary coordinates and the more accurate digital data for those points. The specific restricted area boundary updates are shown below:
These minor editorial changes update existing restricted area boundaries with more precise digital information. It does not affect the location, designated altitudes, or activities conducted within the restricted areas; therefore, notice and public procedure under 5 U.S.C. 553(b) are unnecessary.
The FAA has determined that this action only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5d, modification of the technical description of special use airspace (SUA) that does not alter the dimensions, altitudes, or times of designation of the airspace. This
Airspace, Prohibited areas, Restricted areas.
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 73, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
By removing the current boundaries and inserting the following:
to lat. 34°54′00″ N., long. 120°33′04″ W.;
to lat. 34°50′00″ N., long. 120°32′04″ W.;
to lat. 34°46′00″ N., long. 120°27′04″ W.;
to lat. 34°42′00″ N., long. 120°30′04″ W.;
to lat. 34°38′35″ N., long. 120°31′24″ W.;
to lat. 34°42′00″ N., long. 120°34′34″ W.;
to lat. 34°42′00″ N., long. 120°40′01″ W.;
thence 3 NM from and parallel to the shoreline to the point of beginning.
By removing the current boundaries and inserting the following:
to lat. 34°42′00″ N., long. 120°34′34″ W.;
to lat. 34°38′35″ N., long. 120°31′24″ W.;
to lat. 34°35′00″ N., long. 120°32′04″ W.;
to lat. 34°25′00″ N., long. 120°27′04″ W.;
to lat. 34°24′04″ N., long. 120°29′51″ W.;
thence 3 NM from and parallel to the shoreline to the point of beginning.
By removing the current boundaries and inserting the following:
to lat. 34°35′45″ N., long. 120°28′14″ W.;
to lat. 34°36′20″ N., long. 120°27′24″ W.;
to lat. 34°30′00″ N., long. 120°15′34″ W.;
to lat. 34°25′00″ N., long. 120°15′34″ W.;
thence 3 NM from and parallel to the shoreline
to lat. 34°24′39″ N., long. 120°19′13″ W.;
to the point of beginning.
By removing the current boundaries and inserting the following:
to lat. 34°24′39″ N., long. 120°19′13″ W.;
to lat. 34°25′00″ N., long. 120°27′04″ W.;
to lat. 34°35′00″ N., long. 120°32′04″ W.;
to the point of beginning.
Food and Drug Administration, HHS.
Notification of availability.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled “Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food.” The guidance announces that we do not intend to take enforcement action against a receiving facility that is a co-manufacturer and that is not in compliance with certain supply-chain program requirements in the “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” and “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” regulations (preventive controls regulations) for food manufactured for the brand owner, under certain circumstances, until November 6, 2019. Furthermore, we do not intend to take enforcement action under the Foreign Supplier Verification Programs (FSVP) regulation against an importer whose supply-chain program is subject to enforcement discretion under the preventive controls regulations until November 6, 2019.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances 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.”
• 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
You may submit comments on any guidance at any time (see 21CFR 10.115(g)(5)).
Submit written requests for single copies of the guidance to the Office of Food Safety, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the
We are announcing the availability of a guidance for industry entitled “Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry.” We are issuing this guidance consistent with our good guidance practices (GGP) regulation (§ 10.115 (21 CFR 10.115)). We are implementing this guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate (§ 10.115(g)(2)). We made this determination because the guidance represents a less burdensome policy consistent with the public health. Although this guidance document is immediately in effect, it remains subject to comment in accordance with FDA's GGP regulation. This guidance is not subject to Executive Order 12866.
The guidance is intended for persons who participate in certain “co-manufacturing” agreements in the production of human or animal food. By “co-manufacturing,” we mean a contractual arrangement whereby one party (the brand owner) arranges for a second party (the co-manufacturer) to manufacture/process human or animal food on behalf of the first party. The guidance concerns three regulations that we have established in Title 21 of the Code of Federal Regulations (21 CFR) as part of our implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353). (For more information on the Agency's implementation of FSMA, see
Under the FSVP regulation, importers are required to develop, maintain, and follow a foreign supplier verification program that, among other things, provides adequate assurance that foreign suppliers are producing food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350g) (which authorized the supply-chain programs in parts 117 and 507) (see § 1.502(a) (21 CFR 1.502(a)). An importer that is a receiving facility subject to section 418 of the FD&C Act is deemed to be in compliance with the requirements of the FSVP regulation, except the importer identification requirements in 21 CFR 1.509, if the importer has established and implemented a risk-based supply-chain program in compliance with part 117, subpart G or part 507, subpart E (§ 1.502(c)(3)).
Under the definition of “receiving facility” established in parts 117 and 507, co-manufacturers that are subject to the human food or the animal food preventive controls requirements and that manufacture/process a raw material or other ingredient received from a supplier are receiving facilities. Co-manufacturers that are receiving facilities that have identified a hazard in a raw material or ingredient requiring a supply-chain-applied control are required to approve their suppliers for those raw materials or other ingredients. However, the supply-chain provisions permit an entity other than the receiving facility (
Industry has expressed concerns that the requirements of the supply-chain program would require revisions to contracts between brand owners and their suppliers to allow brand owners to share certain information (
To provide time for contracts to be revised to allow co-manufacturers to review all necessary documentation from the brand owner, FDA is announcing that, under certain circumstances and on a temporary basis, we do not intend to take enforcement action against a receiving facility that is a co-manufacturer, and that is not in compliance with certain supply-chain program requirements (§§ 117.410(d) and 117.415(a)(3) or §§ 507.110(d) and 507.115(a)(3)) for food manufactured for the brand owner until November 6, 2019. Furthermore, we do not intend to take enforcement action under the FSVP regulation against an importer who is relying on § 1.502(c)(3) but whose supply-chain program is subject to enforcement discretion regarding §§ 117.410(d) and 117.415(a)(3) or §§ 507.110(d) and 507.115(a)(3).
The guidance represents the current thinking of FDA on this topic. 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 statues and regulations.
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 117 have been approved under OMB control number 0910-0751. The collections of information in part 507 have been approved under OMB control number 0910-0789.
Persons with access to the internet may obtain the document at
The following reference is on display in the Dockets Management Staff (see
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing temporary safety zones in the Mifflin Range on the Delaware River to facilitate pipeline removal in preparation for the deepening of the Delaware River. The safety zones will be established for the waters in the vicinity of the dredge, dredge equipment, dive operations, and pipe removal operations. This regulation is necessary to provide for the safety of life on navigable waters of the Delaware River in the vicinity of pipeline removal operations and to protect mariners from the hazards associated with dredging and pipeline removal operations. Entry of vessels or persons into these zones is prohibited unless specifically authorized by the Captain of the Port Delaware Bay.
This rule is effective from November 6, 2017, through December 4, 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 Petty Officer Edmund Ofalt, Waterways Management Branch, U.S. Coast Guard Sector Delaware Bay; telephone (215) 271-4814, 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 due to the short time period between when Sector Delaware Bay received complete details of this project, October 20, 2017, and the date when these safety zones needed to go into effect by. It is impracticable and contrary to the public interest to publish an NPRM to provide a notice and opportunity for comment period because the safety zones must be established by November 6, 2017 to ensure safety of life on navigable waters in the vicinity of dredging operations, underwater cutting operations, and pipeline removal operations and to protect mariners from hazards associated with the same.
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 Captain of the Port (COTP) Delaware Bay has determined that potential hazards associated with dredging, dive operations, and pipeline removal operations starting November 6, 2017, will be a safety concern for vessels attempting to transit the Delaware River along the Mifflin Range. This rule is needed to protect personnel, vessels, and the marine environment on the navigable waters within the safety zone while dredging, dive operations, and pipeline removal operations are being conducted.
This rule establishes two safety zones on a portion of the Mifflin Range, just upriver of the green 63 buoy, in the Delaware River from November 6, 2017, through December 4, 2017, unless cancelled earlier by the COTP, to facilitate dredging, dive operations, and pipeline removal. Dredging operations to expose the pipeline will commence on November 6, 2017. The hopper dredge 549 will be conducting the dredging operations and will be attended by the towing vessel SHELBY. Dive operations will commence approximately one week after the completion of dredging operations and will continue through completion of removal of the pipeline.
Safety zone one includes all navigable waters within 250 yards of the dredge barge 549 and associated pipeline removal equipment, to include any equipment located within Anchorage 9 near the entrance to Mantua Creek found in 33 CFR 110.157(a)(10).
Safety zone two includes all navigable waters within 250 yards of the dive barge 543 and all associated pipeline removal equipment, to include any equipment located within Anchorage 9 near the entrance to Mantua Creek Found in 33 CFR 110.157 (a)(10).
Vessels requesting to transit either safety zone must contact the towing vessel SHELBY on VHF-FM channel 13 or 65, at least 1 hour, as well as 30 minutes prior to arrival to arrange safe passage. Vessels may also contact the COTP for permission to enter or transit either safety zone on VHF-FM channel 16.
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, and duration of the safety zones. Although this regulation will restrict access to regulated areas, the effect of this rule will not be significant because there are a number of alternate anchorages available. Furthermore, vessels may be permitted to transit through the safety zone with the permission of the COTP or make satisfactory passing arrangements with the towing vessel SHELBY in accordance with this rule and the Rules of the Road (33 CFR subchapter E). Extensive notification of the safety zones to the maritime public will be made via maritime advisories allowing mariners to alter their plans accordingly.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian 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
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 a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone that encompasses all navigable waters within 250 yards of a dredge, diving operations, pipeline removal operations and all associated equipment. 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
Harbors, Marine Safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(1) Safety zone one includes all navigable waters within 250 yards of the dredge barge 549 and associated equipment operating in Mifflin Range and Anchorage 9 near the entrance to Mantua Creek, upriver of green buoy 63, on the Delaware River.
(2) Safety zone two includes all navigable waters within 250 yards of the dive barge 543 and associated equipment operating in Mifflin range and Anchorage 9 near the entrance to Mantua Creek, upriver of green buoy 63, on the Delaware River.
(b)
(2) Designated representative means any Coast Guard commissioned, warrant or petty officer who has been authorized by the Captain of the Port, Delaware Bay, to assist with the enforcement of safety zones described in paragraph (a) of this section.
(c)
(1) Entry into or transiting within either safety zone is prohibited unless vessels obtain permission from the Captain of the Port via VHF-FM channel 16, or make satisfactory passing arrangements via VHF-FM channels 13 or 65, with the towing vessel SHELBY per this section and the rules of the Road (33 CFR subchapter E). Vessels requesting to transit shall contact the towing vessel SHELBY on channel 13 or 65, at least 1 hour, as well as 30 minutes, prior to arrival.
(2) Vessels granted permission to enter and transit the safety zone must do so in accordance with any directions or orders of the Captain of the Port, his designated representative, or the towing vessel SHELBY. No person or vessel may enter or remain in a safety zone without permission from the Captain of the Port or the towing vessel SHELBY.
(3) At least one side of the main navigational channel will be kept clear for safe passage of vessels.
(4) This section applies to all vessels that intend to transit through the safety zone except vessels that are engaged in the following operations: Enforcement of laws; service of aids to navigation, and emergency response.
(d)
Environmental Protection Agency.
Withdrawal of direct final rule.
Due to the receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the September 6, 2017 direct final rule approving a State Implementation Plan (SIP) revision submitted by the State of New Hampshire. New Hampshire's SIP revision establishes emission standards and operating practices for incinerators and wood waste burners that are not regulated pursuant to federal incinerator standards. This action is being taken in accordance with the Clean Air Act.
The direct final rule was published on September 6, 2017 (82 FR 42037), and is withdrawn effective November 6, 2017.
Alison Simcox, Air Quality Planning Unit, U.S. Environmental Protection Agency, New England Regional Office, 5 Post Office Square—Suite 100, (Mail code OEP05-2), Boston, MA 02109—3912, telephone (617) 918-1684, facsimile (617) 918-0684, email
In the direct final rule, EPA stated that if adverse comments were submitted by October 6, 2017, the rule would be withdrawn and not take effect. EPA received an adverse comment prior to the close of the comment period and, therefore, is withdrawing the direct final rule. EPA will address the comment in a subsequent final action based upon the proposed rule also published on September 6, 2017 (82 FR 42054). EPA will not institute a second comment period on this action.
Environmental protection, Air pollution control, Carbon monoxide,
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the State of Maryland's Clean Air Act (CAA) section 111(d)/129 State Plan for municipal waste combustors (MWCs). The revisions contain Maryland's amendments to Regulations .07 and .08 under the Code of Maryland Regulations (COMAR) 26.11.08. These amendments update the MWC references to opacity compliance. The Maryland Department of the Environment (MDE)'s discontinued Technical Memorandum (TM 90-01) is no longer applicable and the regulations now refer to COMAR 26.11.31, which codifies quality assurance (QA) and quality control (QC) procedures for continuous opacity monitors (COMs). EPA is approving this revision to remove TM 90-01 from Maryland's CAA section 111(d)/129 State Plan in accordance with the requirements of the CAA.
This rule is effective on January 5, 2018 without further notice, unless EPA receives adverse written comment by December 6, 2017. If EPA receives such comments, it will publish a timely withdrawal of the direct final rule in the
Submit your comments, identified by Docket ID No. EPA-R03-OAR-2017-0484 at
Emily Linn, (215) 814-5273, or by email at
On May 10, 2016, the State of Maryland submitted a formal revision (MD Submittal #16-05) to its CAA section 111(d)/129 State Plan for MWCs. The revisions contain Maryland's amendments to COMAR 26.11.08.08, “Requirements for an Existing Large MWC with a Capacity Greater Than 250 Tons Per Day.” These amendments update the MWC references to opacity compliance previously made by MDE. MDE's discontinued technical memorandum which previously addressed QA/QC procedures for COMs, TM 90-01, is no longer state effective and the Maryland regulations therefore now refer to COMAR 26.11.31, which codifies similar QA and QC procedures for COMs.
EPA has reviewed Maryland's submittal to revise its CAA section 111(d)/129 State Plan for MWCs in the context of the requirements of 40 CFR part 60, subpart Eb. These amendments are largely administrative in nature. In this action, EPA is finalizing its determination that the submitted revision meets the above-cited requirements. EPA is revising 40 CFR part 62, subpart V (§ 62.5110 and § 61.5112) to reflect this approval.
EPA is approving the May 10, 2016 Maryland CAA section 111(d)/129 State Plan revision submittal as a revision to Maryland's CAA section 111(d)/129 State Plan for MWCs. EPA is publishing this rule without prior proposal because EPA views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of this
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
In reviewing Section 111(d)/129 plan submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a Section 111(d)/129 plan submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a Section 111(d)/129 plan submission, to use VCS in place of a Section 111(d)/129 plan submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 5, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of this
Environmental protection, Air pollution control, Carbon monoxide, Intergovernmental relations, Lead, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides.
For the reasons stated in the preamble, 40 CFR part 62 is amended as follows:
42 U.S.C. 7401
(c) On May 10, 2016, Maryland submitted a revised State Plan and related COMAR 26.11.08.08 amendments.
(c) The plan revision is effective January 5, 2018.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether (CAS Reg. No. 1998118-31-2) when
This regulation is effective November 6, 2017. Objections and requests for hearings must be received on or before January 5, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0362, is available at
Michael Goodis, Director Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0362 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 5, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0362, by one of the following methods.
•
•
•
In the
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and use in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . .” and specifies factors EPA is to consider in establishing an exemption.
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide
Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). Formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.
1. The polymer is a cationic or potentially cationic polymer with low cationic density (the percent of cationic or potentially cationic species with respect to the overall weight of polymer).
2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.
3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.
5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.
6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.
Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).
7. The polymer's minimum number average MW of 1,000,000 is greater than 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups.
Thus, formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether.
For the purposes of assessing potential exposure under this exemption, EPA considered that formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The minimum number average MW of formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether is 1,000,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether conforms to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”
EPA has not found formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether to share a common mechanism of toxicity with any other substances, and formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.
Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether.
An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with
The Codex has not established a MRL for formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether.
Accordingly, EPA finds that exempting residues of formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether from the requirement of a tolerance will be safe.
This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether (CAS Reg. No. 1998118-32-3) when used as an inert ingredient in a pesticide chemical formulation. Eco Verde Technologies, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether on food or feed commodities.
This regulation is effective November 6, 2017. Objections and requests for hearings must be received on or before January 5, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0363, is available at
Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0363 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 5, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0363, by one of the following methods.
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and use in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). Formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.
1. The polymer is a cationic or potentially cationic polymer with low cationic density (the percent of cationic or potentially cationic species with respect to the overall weight of polymer).
2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.
3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.
5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.
6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.
Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).
7. The polymer's minimum number average MW of 1,000,000 daltons is greater than 1,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups.
Thus, formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether.
For the purposes of assessing potential exposure under this exemption, EPA considered that formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The minimum number average MW of formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether is 1,000,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether conforms to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”
EPA has not found formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether to share a common mechanism of toxicity with any other substances, and formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.
Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to
An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether.
Accordingly, EPA finds that exempting residues of formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether from the requirement of a tolerance will be safe.
This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
Department of Labor.
Final guidance; rescission.
Under the Congressional Review Act, Congress has passed, and the President has signed, Public Law 115-11, a resolution of disapproval of the rule promulgated by the Department of Defense, General Services Administration, and National Aeronautics and Space Administration to implement Executive Order 13673, Fair Pay and Safe Workplaces, as amended (the “Order”). Additionally, the President has issued an Executive Order revoking the Order, and directing all executive departments and agencies, as appropriate and to the extent consistent with law, to consider promptly rescinding any orders, rules, regulations, guidance, guidelines, or policies implementing or enforcing the Order. Accordingly, the Department of Labor is rescinding its guidance on the Order, published on August 25, 2016.
Effective November 6, 2017.
Stephanie Swirsky, Deputy Assistant Secretary for Policy, U.S. Department of Labor, Room S-2312, 200 Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693-5959 (this is not a toll-free number). Copies of this notice may be obtained in alternative formats (large print, Braille, audio tape or disc), upon request, by calling (202) 693-5959 (this is not a toll-free number). TTY/TDD callers may dial toll-free [1-877-889-5627] to obtain information or request materials in alternative formats.
On July 31, 2014, President Barack Obama issued Executive Order 13673, Fair Pay and Safe Workplaces. 79 FR 45309. Executive Order 13673 was amended twice, first by section 3 of Executive Order 13683 on December 11, 2014, 79 FR 75041, and again by Executive Order 13738 on August 23, 2016, 81 FR 58807. The Order directed the Federal Acquisition Regulatory Council (“FAR Council”) to amend its regulations consistent with the Order's requirements, and directed the Secretary of Labor (“Secretary”) to develop guidance to assist agencies in implementing the Order. After notice and comment, the final rule and guidance were published on August 25, 2016. 81 FR 58562 (FAR Council's rule); 81 FR 58654 (Secretary's guidance). On October 24, 2016, the United States District Court for the Eastern District of Texas issued a preliminary injunction partially enjoining the FAR Council's rule and the Secretary's guidance.
On March 27, 2017, President Donald Trump signed Public Law 115-11, a resolution of disapproval of the FAR Council's rule under the Congressional Review Act, 5 U.S.C. 801
Fish and Wildlife Service, Interior.
Final rule.
Having completed our review of the application materials for corrosion-inhibited copper shot, the U.S. Fish and Wildlife Service (hereinafter Service or we) approves the shot for hunting waterfowl and coots. We have concluded that this type of shot left in terrestrial or aquatic environments is unlikely to adversely affect fish, wildlife, or their habitats. Approving this shot formulation would increase the nontoxic shot options for hunters.
This rule is effective on November 6, 2017.
You can view the final environmental assessment by one of the following methods:
•
• Request a copy by contacting the person listed under
Ron Kokel, Division of Migratory Bird Management, at 703-358-1967;
The Migratory Bird Treaty Act of 1918 (Act) (16 U.S.C. 703-712 and 16 U.S.C. 742 a-j) implements migratory bird treaties between the United States and Great Britain for Canada (1916 and 1996, as amended), Mexico (1936 and 1972, as amended), Japan (1972 and 1974, as amended), and Russia (then the Soviet Union, 1978). These treaties protect most migratory bird species from take, except as permitted under the Act, which authorizes the Secretary of the
Deposition of toxic shot and release of toxic shot components in waterfowl hunting locations are potentially harmful to many organisms. Research has shown that ingested spent lead shot causes significant mortality in migratory birds. Since the mid-1970s, we have sought to identify types of shot for waterfowl hunting that are not toxic to migratory birds or other wildlife when ingested. Following a process set forth at 50 CFR 20.134, we review applications for approval of nontoxic shot types and coatings and add those that we approve to the migratory bird hunting regulations at 50 CFR 20.21(j).
We addressed lead poisoning in waterfowl in an environmental impact statement (EIS) in 1976, and again in a 1986 supplemental EIS. The 1986 document provided the scientific justification for a ban on the use of lead shot and the subsequent approval of steel shot for hunting waterfowl and coots that began that year, with a complete ban of lead for waterfowl and coot hunting in 1991. We have continued to consider other potential nontoxic shot candidates for approval. We are obligated to review applications for approval of alternative shot types as nontoxic for hunting waterfowl and coots.
Many hunters believe that some nontoxic shot types compare poorly to lead and may damage some shotgun barrels. A small and decreasing percentage of hunters have not complied with nontoxic shot regulations. Allowing use of additional nontoxic shot types may encourage greater hunter compliance and participation with nontoxic shot requirements and discourage the use of lead shot. The use of nontoxic shot for waterfowl hunting increased after the ban on lead shot (Anderson
Environ-Metal, Inc., of Sweet Home, Oregon, seeks approval of corrosion-inhibited copper shot as nontoxic. We evaluated the impact of approval of this shot type in an environmental assessment (see
We have reviewed the shot under the criteria in Tier 1 of the nontoxic shot approval procedures at 50 CFR 20.134 for permanent approval of shot and coatings as nontoxic for hunting waterfowl and coots. We amend 50 CFR 20.21(j) to add the shot to the list of those approved for waterfowl and coot hunting. Details on the evaluations of the shot can be found in the environmental assessment.
Corrosion-inhibited copper shot (CIC shot) consists of commercially pure copper that has been surface-treated with benzotriazole (BTA) to obtain insoluble, hydrophobic films of BTA-copper complexes (CDA 2009). These films are very stable; are highly protective against copper corrosion in both salt water and fresh water; and are used extensively to protect copper, even in potable water systems. Other high-volume applications include deicers for aircraft and dishwasher detergent additives, effluents of which may be directly introduced into municipal sewer systems, indicative of the exceptionally low environmental impact of BTA. “The corrosion-inhibiting effectiveness of BTA-copper complex coating, based on actual testing conducted by the applicants and by others, is substantial.”
CIC shot will have an additional coating that will fluoresce under ultraviolet light. The coating is applied by a proprietary process and coats the shot so that the layers of coating are visible through the translucent shotshell. The coating is environmentally safe and is very long-lasting in the shotshells. The sole purpose of fluorescent-coating CIC shot is to provide a portable, non-invasive and affordable field-detection method for use by law enforcement officers to identify this non-magnetic shot type as approved for waterfowl and coot hunting.
ECO Pigments
Environ-Metal, Inc., will apply the pigment to metallic shot using a proprietary process to create a thin, adherent coating of a tough, resilient, fluorescent substance. The coating is visually detectable through the wall of a shotshell when ultraviolet light is applied to the exterior of the shell. To further aid field detection, after application of the nontoxic ultraviolet (UV) pigment to CIC shot, the shot is loaded into an uncolored (“clear”) hull, with a unique inner shot wad printed with the manufacturer and shot material type.
Law enforcement officers who have reason to suspect that a non-magnetic shotshell may contain unapproved shot (
Although the shot coating is inherently water-proof, it is further protected against environmental degradation by being sealed within two layers of polyethylene plastic—the wad and the hull or shell. Environ-Metal, Inc., has stated that “potential fading of the thermoplastic UV dye could not become significant until after both of the enveloping polyethylene cylinders had become embrittled/cracked by excessive exposure to direct sunlight, a condition which would essentially render the shotshell useless.”
Allowing use of additional nontoxic shot types may encourage greater hunter compliance and participation with nontoxic shot requirements and discourage the use of lead shot. Furnishing additional approved nontoxic shot types and nontoxic coatings likely would further reduce the use of lead shot. Thus, approving additional nontoxic shot types and coatings would likely result in a minor positive long-term impact on waterfowl and wetland habitats.
The impact on endangered and threatened species of approving corrosion-inhibited copper shot would be very small, but positive. Corrosion-inhibited copper shot is highly unlikely to adversely affect animals that consume the shot or habitats in which it might be used. We see no potential significant negative effects on endangered or threatened species due to approval of the shot type.
Further, we annually obtain a biological opinion pursuant to section 7 of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Previously approved shot types have been shown in test results to be nontoxic to the migratory bird resource, and that they cause no adverse impact on ecosystems. There is concern, however, about noncompliance with the prohibition on lead shot and potential ecosystem effects. The use of lead shot has a negative impact on wetland ecosystems due to the erosion of shot, causing sediment/soil and water contamination and the direct ingestion of shot by aquatic and predatory animals. Though noncompliance is of concern, approval of the shot type would have little impact on the resource, except the small positive impact of reducing the rate of noncompliance.
We foresee no negative cumulative impacts if we approve this shot type for waterfowl hunting. Its approval could help to further reduce the negative impacts of the use of lead shot for hunting waterfowl and coots. We conclude the impacts of the approval for waterfowl hunting in the United States should be positive.
On August 15, 2017, we published in the
Therefore, as stated in the proposed rule, we reviewed the subject shot under the criteria at 50 CFR 20.134, and we add this product to the list of those approved for hunting waterfowl and coots at 50 CFR 20.21(j).
This rule is effective upon publication in the
A list of the references cited in this rule may be found at
This rule is considered to be an Executive Order (E.O.) 13771 deregulatory action (82 FR 9339, February 3, 2017) because it would approve an additional type of nontoxic shot in our regulations at 50 CFR part 20.
Executive Order 12866 provides that OIRA will review all significant rules. OIRA has determined that this rule is not significant.
Executive Order 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 executive order 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.
Under the Regulatory Flexibility Act (5 U.S.C. 601
SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We have examined this rule's potential effects on small entities as required by the Regulatory Flexibility Act, and have determined that this action would not have a significant economic impact on a substantial number of small entities. The rule would allow small entities to improve their economic viability. However, the rule would not have a significant economic impact because it would affect only two companies. We certify that because this rule would not have a significant economic effect on a substantial number of small entities, a regulatory flexibility analysis is not required.
This rule is not a major rule under the SBREFA (5 U.S.C. 804(2)).
a. This rule would not have an annual effect on the economy of $100 million or more.
b. This rule would not cause a major increase in costs or prices for consumers; individual industries; Federal, State, Tribal, or local government agencies; or geographic regions.
c. This rule would 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.
In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501
a. This rule would not “significantly or uniquely” affect small governments. A small government agency plan is not required. Actions under the rule would not affect small government activities in any significant way.
b. This rule would not produce a Federal mandate of $100 million or greater in any year. It would not be a “significant regulatory action” under the Unfunded Mandates Reform Act.
In accordance with E.O. 12630, this rule would not have significant takings implications. A takings implication assessment is not required. This rule does not contain a provision for taking of private property.
This rule does not have sufficient Federalism effects to warrant preparation of a federalism summary impact assessment under E.O. 13132. It would not interfere with the ability of States to manage themselves or their funds.
In accordance with E.O. 12988, the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of E.O. 12988.
This rule does not contain any new collections of information that require approval by the Office of Management and Budget (OMB) under the PRA (44 U.S.C. 3501
Our environmental assessment is part of the administrative record for this rule. In accordance with the National Environmental Policy Act (NEPA, 42 U.S.C. 4321
In accordance with the President's memorandum of April 29 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), E.O. 13175, and 512 DM 2, we have evaluated potential effects on federally recognized Indian Tribes and have determined that there are no potential effects. This rule would not interfere with the ability of Tribes to manage themselves or their funds or to regulate migratory bird activities on Tribal lands.
E.O. 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This rule would not be a significant regulatory action under E.O. 12866, nor would it significantly affect energy supplies, distribution, or use. This action would not be a significant energy
Section 7 of the Endangered Species Act (ESA) of 1973, as amended (16 U.S.C. 1531
Exports, Hunting, Imports, Reporting and recordkeeping requirements, Transportation, Wildlife.
For the reasons discussed in the preamble, we amend part 20, subchapter B, chapter I of title 50 of the Code of Federal Regulations as follows:
16 U.S.C. 703-712, and 16 U.S.C. 742a-j.
The addition and revision read as follows:
(j)(1) * * *
Nuclear Regulatory Commission.
Petition for rulemaking; extension of comment period.
On August 23, 2017, the U.S. Nuclear Regulatory Commission (NRC) requested public comment on a Petition for Rulemaking (PRM) received from Matthew McKinley on behalf of the Organization of Agreement States (OAS, or the Petitioner). The public comment period is scheduled to close on November 6, 2017. The NRC has decided to extend the public comment period for 30 calendar days to allow more time for members of the public to develop and submit their comments.
The due date for comments requested in the
You may submit comments by any of the following methods:
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Robert D. MacDougall, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-5175, email:
Please refer to Docket ID NRC-2017-0159 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
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•
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Please include Docket ID NRC-2017-0159 in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
The NRC requested public comment on the OAS PRM on August 23, 2017. The purpose of the request was to obtain public input and responses to a set of four questions about the OAS petition and how the NRC should proceed. The public comment period was originally scheduled to close on November 6, 2017. The NRC has decided to extend the public comment period on this document until December 6, 2017, to allow more time for members of the public to submit their comments.
For the Nuclear Regulatory Commission.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Fokker Services B.V. Model F28 Mark 0100 airplanes. This proposed AD was prompted by a report that a jammed control cable prevented the full extension of the nose landing gear (LG). This proposed AD would require a general visual inspection of the LG handle teleflex cable conduit connector for the presence of a grease nipple, a maintenance records check of affected airplanes, and if necessary, a detailed inspection for corrosion and damage of the LG handle teleflex cable, replacement if found, and lubrication. This proposed AD would also require revising the maintenance or inspection program, as applicable. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by December 21, 2017.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
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For service information identified in this NPRM, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31 (0)88-6280-111; email
You may examine the AD docket on the Internet at
Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137; fax 425-227-1149.
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2017-0068, dated April 24, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Fokker Services B.V. Model F28 Mark 0100 airplanes. The MCAI states:
A report was received of an alledgedly post-SBF100-32-107 (introducing a teleflex cable conduit with a grease nipple and a stainless steel teleflex cable) Fokker 100 aeroplane landing with a nose landing gear (LG) that was not completely in the extended position, in spite of the application by the crew of the relevant normal and abnormal Airplane Flight Manual LG extension procedures. The investigation revealed that the failure of the nose LG to completely extend had been caused by a jammed teleflex cable of the LG control system, which resulted in a hydraulic lock in the nose LG extension/retraction actuator. The investigation also revealed that the teleflex cable conduit connector on the subject aeroplane did not have the grease nipple installed, so that the aeroplane was actually not in the full post-SBF100-32-107 configuration.
Based on an incorrect assumption with regard to full incorporation of SBF100-32-107 (
This condition, if not detected and corrected, could lead to further landings with the nose LG not in the fully extended position, possibly resulting in damage to the aeroplane and injury to occupants.
To address this potential unsafe condition, Fokker Services published SBF100-32-167 (hereafter referred to as `the SB' in this [EASA] AD) to provide inspection instructions.
For the reasons described above, this [EASA] AD requires a one-time [general visual] inspection of the LG handle teleflex cable conduit connector for the presence of the grease nipple and, depending on findings, [a maintenance records check and] accomplishment of applicable corrective action(s). This [EASA] AD also requires the reporting of findings to Fokker Services, and to ensure that the maintenance [or inspection] programme [as applicable] contains those instructions applicable to the aeroplane configuration.
Required actions also include a detailed inspection for corrosion and damage of the LG handle teleflex cable, replacement of the LG handle teleflex cable if any corrosion or damage is found, and lubrication of the LG handle teleflex cable. You may examine the MCAI in the AD docket on the Internet at
Fokker Services B.V. has issued Fokker Service Bulletin SBF100-32-167, dated December 14, 2016. This service information describes procedures for a one-time inspection of the nose LG control cable; a maintenance records check; detailed inspection, replacement, and lubrication of the LG handle teleflex cable; and revision of the maintenance program. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
We estimate that this proposed AD affects 8 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary on-condition actions that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need these actions:
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this proposed AD is 2120-0056. The paperwork cost associated with this proposed AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this proposed AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by December 21, 2017.
None.
This AD applies to Fokker Services B.V. Model F28 Mark 0100 airplanes, certificated in any category, serial numbers 11244 through 11481 inclusive, if maintenance records show that the airplane is in a post-Fokker Service Bulletin SBF100-32-107 configuration.
Air Transport Association (ATA) of America Code 32, Landing gear.
This AD was prompted by a report that lack of maintenance on a control system cable caused a hydraulic lock and difficult operation of the nose landing gear (LG) handle, preventing full extension of the nose LG when landing. We are issuing this AD to detect and correct erratic or hard-to-move LG handles, which could lead to the nose LG not being in the fully extended position during landing and consequent damage to the airplane and injury to the flight crew and passengers.
Comply with this AD within the compliance times specified, unless already done.
Within 3 months after the effective date of this AD: Do a general visual inspection of the LG handle teleflex cable conduit connector for the presence of a grease nipple, in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100-32-167, dated December 14, 2016.
If, during the inspection required by paragraph (g) of this AD, a grease nipple is not found installed: Within 3 months after the effective date of this AD, check the maintenance records of the affected airplane for the previous 3 months for reports of an erratic or hard-to-move LG handle, and check the maintenance records to determine the date of the most recent installation, or inspection/lubrication, as applicable, of the LG handle teleflex cable.
Based on results of the maintenance records check required by paragraph (h) of this AD: Within the applicable compliance times specified in Table 1 to paragraph (i) of this AD, do a detailed inspection for corrosion and damage of the LG handle teleflex cable, replace the LG handle teleflex cable if any corrosion or damage is found, and lubricate the LG handle teleflex cable, in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100-32-167, dated December 14, 2016.
Within 6 months after the effective date of this AD: Revise the maintenance or inspection program, as applicable, in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100-32-167, dated December 14, 2016, to incorporate the applicable tasks and associated thresholds and intervals, based on the airplane configuration (pre- or post-SBF100-32-107) determined in the inspection required by paragraph (g) of this AD.
Within 3 months after the effective date of this AD, or within 30 days after doing the
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2017-0068, dated April 24, 2017, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For more information about this AD, contact Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137; fax 425-227-1149.
(3) For service information identified in this AD, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31 (0)88-6280-111; email
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for Viking Air Limited Models DHC-6-1, DHC-6-100, DHC-6-200, DHC-6-300, and DHC-6-400 airplanes. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as aileron cable wear or fouling at the wing root rib, fuselage skin, and wing root rib fairlead, or fraying of the cable from the root rib fairlead. We are issuing this proposed AD to require actions to address the unsafe condition on these products.
We must receive comments on this proposed AD by December 21, 2017.
You may send comments by any of the following methods:
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For service information identified in this proposed AD, contact Viking Air Limited Technical Support, 1959 De Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; telephone: (North America) (866) 492-8527; fax: (250) 656-0673; email:
You may examine the AD docket on the Internet at
Erin Hulverson, Aerospace Engineer, FAA, Boston ACO Branch, 1200 District Avenue, Burlington, MA 01803; telephone: (781) 238-7655; fax: (781) 238-7199; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Transport Canada, which is the aviation authority for Canada, has issued AD Number CF-2017-20, dated June 7, 2017 (referred to after this as “the MCAI”), to correct an unsafe condition for Viking Air Limited Models DHC-6-1, DHC-6-100, DHC-6-200, DHC-6-300, and DHC-6-400 airplanes. The MCAI states:
There have been reports of accelerated aileron cable wear because of contact with the fuselage skin cut-out or the wing root rib. Wear that is not detected can lead to failure of the aileron cable and loss of control of the aeroplane.
The root cause of this problem has not yet been identified. This [Transport Canada] AD requires inspection of the aeroplane and reporting of the inspection results to Viking Air Ltd. This [Transport Canada] AD is considered an interim action and further AD action may follow.
Aileron cables are typically replaced at intervals of 60 months in accordance with the DHC-6 maintenance schedule.
You may examine the MCAI on the Internet at
Viking Air Limited has issued DHC-6 Twin Otter Service Bulletin Number: V6/0022, Revision B, dated June 13, 2014. The service information describes procedures for initial and repetitive inspections of the aileron cable for aileron cable wear or fouling at the wing root rib, fuselage skin, and wing root rib fairlead, or fraying of the cable from the root rib fairlead, and replacement of the aileron cables as necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.
We estimate that this proposed AD will affect 141 products of U.S. registry. We also estimate that it would take about 20 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour.
Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $239,700, or $1,700 per product.
In addition, the following is an estimate of possible necessary follow-on replacement actions. We have no way of determining the number of products that may need these actions.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this proposed AD is 2120-0056. The paperwork cost associated with this proposed AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this proposed AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591. ATTN: Information Collection Clearance Officer, AES-200.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes and domestic business jet transport airplanes to the Director of the Policy and Innovation Division.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by December 21, 2017.
None.
This AD applies to Viking Air Limited Models DHC-6-1, DHC-6-100, DHC-6-200, DHC-6-300, and DHC-6-400 airplanes, all serial numbers, certificated in any category.
Air Transport Association of America (ATA) Code 27: Flight Controls.
This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as aileron cable wear or fouling at the wing root rib, fuselage skin, and wing root rib fairlead, or fraying of the cable from the root rib fairlead. We are issuing this AD to identify and correct wear on the aileron cable fuselage skin cut-out and on the wing root rib fairlead, and any fraying of the cable from the root rib fairlead, which could lead to failure of the aileron cable and loss of control.
Unless already done, do the following actions in paragraphs (f)(1) through (5) of this AD:
(1) Within the next 50 hours time-in-service (TIS) after the effective date of this AD or before the aileron cables have accumulated 300 hours TIS, whichever occurs later, inspect the aileron cables following the Accomplishment Instructions in Viking Air Limited Service Bulletin V6/0022, Revision B, dated June 13, 2014 (SB V6/0022, Revision B). Inspect repetitively thereafter at intervals not to exceed 500 hours TIS, but not to exceed five inspections (the initial and four repetitives).
(2) If any discrepancies are found during any of the inspections required in paragraph (f)(1) of this AD, before further flight, replace the aileron cable(s) following the Accomplishment Instructions in SB V6/0022, Revision B.
(3) Upon completion of the initial and four repetitive inspections detailed in paragraph (f)(1) of this AD, resume the inspections specified in the maintenance program.
(4) Within 30 days after completion of each inspection detailed in paragraphs (f)(1) of this AD, report the results of each inspection to Viking Air Limited in accordance with the reporting instructions in SB V6/0022, Revision B.
(5) Installation of new aileron cables or re-installation of existing cables that have been removed for any reason re-starts the inspections required in paragraph (f)(1) of this AD.
The following provisions also apply to this AD:
(1)
(2)
(3)
Refer to MCAI Transport Canada AD Number CF-2017-20, dated June 7, 2017, for related information. You may examine the MCAI on the Internet at
U.S. Copyright Office, Library of Congress.
Notice of proposed rulemaking.
The U.S. Copyright Office is proposing to amend its regulation governing the group registration option for newspapers. The proposed rule will make a number of changes to reflect
Comments must be made in writing and must be received in the U.S. Copyright Office no later than December 6, 2017.
For reasons of government efficiency, the Copyright Office is using the regulations.gov system for the submission and posting of public comments in this proceeding. All comments are therefore to be submitted electronically through regulations.gov. Specific instructions for submitting comments are available on the Copyright Office Web site at
Robert J. Kasunic, Associate Register of Copyrights and Director of Registration Policy and Practice, or Erik Bertin, Deputy Director of Registration Policy and Practice, by telephone at 202-707-8040, or by email at
When Congress enacted the Copyright Act of 1976 (the “Act”), it authorized the Register of Copyrights (the “Register”) to specify by regulation the administrative classes of works for the purpose of seeking a registration, and the nature of the deposits required for each such class. In addition, Congress granted the Register the discretion to allow groups of related works to be registered with one application and one filing fee, a procedure known as “group registration.”
As the legislative history explains, allowing “a number of related works to be registered together as a group represent[ed] a needed and important liberalization of the law.” H.R. Rep. No. 94-1476, at 154 (1976); S. Rep. No. 94-473, at 136 (1975). Congress recognized that requiring applicants to submit separate applications for certain types of works may be so burdensome and expensive that authors and copyright owners may forgo registration altogether, since copyright registration is not a prerequisite to copyright protection.
To register a group of newspapers under the current regulation, the applicant must complete and submit a paper application using Form G/DN.
In addition to these regulatory requirements, the instructions for Form G/DN include three additional requirements: Each issue in the group must be an “essentially all-new collective work” that has not been previously published; each issue must be a work made for hire; and the author and the copyright claimant must be the same person or organization.
During the early 1990s, the Office became aware that applicants wished to use the group registration option to register newspapers that had
To reduce the number of applicants incurring such unnecessary costs in transferring non-selected newspapers to archival-quality microfilm, and to complement its existing regulation, the Office adopted an interim practice allowing applicants to use the group registration option for newspapers that have not been selected by the Library without submitting the works on microfilm. Specifically, the interim practice allows an applicant to submit: (i) Complete print copies of the earliest and most recent issues from the month specified in the application; (ii) print copies of the first section from the earliest and most recent issues in that month; or (iii) print copies of the first page from the earliest and most recent issues in that month. Although the Office's interim practice is not reflected in the current regulation, it is mentioned in the instructions for Form G/DN, in
The Office is proposing to amend the regulation governing the group registration option for newspapers (the “Proposed Rule”) to reflect current Office practices, promote efficiency, and where possible, reduce the burden on applicants.
As explained in greater detail below, the Proposed Rule will modify the eligibility requirements for this group option in several respects. First, it will make
Finally, the Proposed Rule will memorialize the Office's longstanding position regarding the scope of a registration for a group of newspaper issues (
This section discusses the proposed amendments to the eligibility requirements for the group option for newspapers. Applicants failing to satisfy these requirements will not be permitted to use this option.
The Proposed Rule will update the regulatory definition for the term “newspaper” in several respects.
As discussed above, the current regulation states that a newspaper is eligible for group registration if it is listed in “Newspapers Received Currently in the Library of Congress,” a policy document listing newspapers that have been selected to be received and retained by the Library. 37 CFR 202.3(b)(7)(ii). The Proposed Rule will make any newspaper eligible for a group registration, regardless of whether the Library has selected that title for its collections.
In addition, the Proposed Rule clarifies that for purposes of registration, a newspaper will be classified as a “periodical.” Under the current regulation, “newspapers” and “periodicals” are both subsets of “serials,” a broader category of works “issued or intended to be issued in successive parts bearing numerical or chronological designations and intended to be continued indefinitely.”
Defining a newspaper as a “periodical” is consistent with section 408(c)(3) of the Act, which indicates that “newspapers” are a subset of “periodicals.” 17 U.S.C. 408(c)(3) (directing the Register to create a group registration option for works “first published as contributions to periodicals, including newspapers”). Similarly, it is consistent with section 101 of the Act, which cites a “periodical issue” as an example of a collective work. 17 U.S.C. 101 (definition of “collective work”).
Finally, the Office will use the term “GR/NP,” which stands for “group newspapers,” instead of the term “G/DN” when referring to the group registration option for newspapers. As discussed below in Section III.B.1, the Office is proposing to eliminate Form G/DN and require applicants to submit their claims through the electronic registration system. Thus, the term G/DN will soon be obsolete. The term G/DN is also confusing, because the Office uses the same term when referring to the group option for daily newsletters.
The current regulation states that applicants may register newspaper issues “published with issue dates in one calendar month.” 37 CFR 202.3(b)(7)(i)(A). The Proposed Rule will clarify that all of the issues in the group must be published (
Under the Proposed Rule, each issue in the group must have been created as a work made for hire, with the same person or organization named as the author and copyright claimant. These requirements have appeared in
The Proposed Rule states that each newspaper issue in the group must be an all-new collective work that has not been previously published. This requirement has appeared in
A newspaper will be considered a collective work if it contains “a number of contributions” that constitute “separate and independent works in themselves,” and if the contributions are “assembled into a collective whole” “in such a way that the resulting work as a whole constitutes an original work of authorship.” 17 U.S.C. 101 (definitions of “collective work” and “compilation”). For example, a newspaper that contains multiple articles, photographs, illustrations, and advertisements could be considered a collective work if those contributions are selected, coordinated, and arranged in a sufficiently creative manner. By contrast, a work that contains a single article and a single photograph would not be considered a collective work, because it does not contain a sufficient number of contributions.
A newspaper issue may qualify as an “all-new” collective work if it contains a sufficient amount of compilation authorship. In other words, there must be a sufficient amount of new expression in the selection, coordination, and arrangement of the articles, photographs, or other content appearing in each issue. The fact that the content itself is entirely new is irrelevant to this determination. For example, an issue could be considered “all-new” if it contains a brand new selection, coordination, and arrangement of content, even if that individual content has been previously published in the newspaper—such as advertisements appearing in previous issues.
The Proposed Rule clarifies that a registration for a group of newspapers covers each issue in the group, and each issue will be registered as a separate collective work. As a general rule, a registration for a collective work covers the individual contributions contained within that work if they are fully owned by the copyright claimant and if they were first published in that work.
With respect to the information collected as part of a group registration and examination practices, the Office must balance the public interest in creating a meaningful record (
Accordingly, the Office's application to register a group of newspaper issues does not contain spaces where the applicant can expressly assert a claim in the individual contributions appearing within each issue, provide titles, authors, or other identifying information for each contribution, or identify component works created by a third party and transferred to the claimant by written agreement. When the examiner reviews each newspaper issue, he or she will examine the issue as a whole to determine if it contains sufficient compilation authorship to warrant registration. And the examiner will review the newspaper issue to determine whether it contains “a number of contributions” constituting “separate and independent works in themselves.” 17 U.S.C. 101. When the Office issues a group registration, the certificate will identify the title, author, and claimant for each newspaper issue in the group, but it will not identify the titles, authors, or claimants for the individual contributions appearing within those issues.
The scope of protection for a group registration issued under the Proposed Rule will have several consequences in infringement actions. First, a group registration may be used to satisfy the statutory requirements for instituting an infringement action involving any of the newspaper issues that were included within the group, or any of the individual contributions appearing within those issues—provided that the claimant fully owned those contributions at the time the application for registration is submitted, and provided that the contributions were first published in one of those issues.
Second, a group registration may also be used to satisfy the plaintiff's burden of proof by providing a presumption of validity for each registered issue. Specifically, a certificate of registration “constitute[s] prima facie evidence of the validity of the copyright and of the facts stated in the certificate.” 17 U.S.C. 410(c). A group registration issued under the Proposed Rule would thus create a presumption that the claimant owns the copyright in each newspaper issue listed in the certificate, and a presumption that the copyright law protects each issue as a whole.
Although the Proposed Rule does not require granular information concerning the individual component works within each newspaper issue, the Office foresees the future possibility of applicants submitting metadata for the component works appearing within each issue, and the possibility of the Office incorporating this information into the registration record. If this becomes feasible once the Office implements its next-generation registration system, it may require this type of information as a condition for using this group registration option.
Finally, the Proposed Rule also clarifies that the group as a whole is not considered a compilation, a collective work, or a derivative work. Instead, the group is merely an administrative classification created solely for the purpose of registering multiple collective works with one application and one filing fee. The chronological selection, coordination, and arrangement of the issues within the group is entirely dictated by the regulatory requirements for this option. Likewise, when a group of newspaper issues are combined for the purpose of facilitating registration, those works are not “recast, transformed, or adapted” in any way, and the group as a whole is not “a work based upon one or more preexisting works” because there is no copyrightable authorship in simply collecting a month of issues and arranging them in chronological order. 17 U.S.C. 101 (definition of “derivative work”).
The Proposed Rule clarifies that each newspaper issue in the group must be fixed and distributed as a discrete, self-contained collective work.
By contrast, a newspaper Web site would not satisfy this requirement. Newspaper Web sites typically add, archive, and/or replace content on a continuing basis. As such, they are not fixed and distributed as discrete, self-contained works. Moreover, these updates are rarely distributed on an established schedule, and rarely contain numerical or chronological designations distinguishing one update from the next. For this reason, Web sites are not considered “newspapers” for purposes of registration. As discussed above, “newspapers” and “periodicals” have historically been considered subsets of “serials,” a broader category of works “issued or intended to be issued in successive parts bearing numerical or chronological designations and intended to be continued indefinitely,” and under the Proposed Rule, newspapers will be categorized as a “periodical.”
Although the Proposed Rule does not extend to newspaper Web sites, the Office is aware of the need for establishing new and updated practices
The Office has allowed and encouraged applicants to register their works through the electronic registration system since 2007.
On December 14, 2012, the Office made some modifications to its electronic registration system to allow newspaper publishers to submit their claims with the online application. Under the Proposed Rule, applicants will be required to use the electronic application designated for a group of newspaper issues as a condition for seeking a group registration. The Office will no longer accept groups of newspaper issues submitted for registration on paper using Form G/DN. If, after the effective date of this rule, such paper applications are received, the Office will refuse registration and instruct the applicant to resubmit the claim through the electronic system. The Office invites comment on this proposal, including whether the Office should eliminate the paper application for newspaper issues, phase it out after a specified period of time, or continue to offer Form G/DN for applicants who prefer to use the paper-based system.
A supplementary registration is a special type of registration that may be used “to correct an error in a copyright registration or to amplify the information given in a registration,” including a registration for a group of related works. 17 U.S.C. 408(d). Specifically, it identifies an error or omission in an existing registration (referred to herein as a “basic registration”) and places the corrected information or additional information in the public record.
The Office recently issued a final rule that modified the regulation governing this procedure. 82 FR 27424 (June 15, 2017). This rule requires applicants to file an online application in order to correct or amplify the information set forth in a basic registration for any work capable of being registered through the electronic system, rather than filing a paper application. This online filing requirement will apply to supplementary registrations for groups of newspaper issues—even if the issues were originally registered using Form G/DN.
The Office's decision to offer a group option is entirely discretionary, and Congress gave the Office broad authority to establish the requirements for these types of claims. 17 U.S.C. 408(c)(1). Currently, the vast majority of the claims submitted on Form G/DN require correspondence or other action from the Office. Applicants routinely file claims that are not eligible for this group option, such as submitting a full year of issues instead of limiting the claim to one month, or submitting claims long after the deadline has expired (
Addressing these issues imposes significant burdens on the Office's limited resources, and has had an adverse effect on the examination of other types of works within the Literary Division of the Registration Program. Eliminating the paper application should mitigate many of these problems. Among other improvements, the online application contains automated validations that prevent applicants from submitting applications that fail to comply with the eligibility requirements for this group option, such as including too many issues in the group (
For these reasons, the Office believes that requiring applicants to submit online applications is necessary to avoid a significant fee increase and to improve the overall efficiency of the group registration process. Nonetheless, the Office invites comment on this aspect of the Proposed Rule.
The Proposed Rule will amend the deposit requirements for this group option by requiring applicants to submit their newspapers in digital form and upload each issue through the electronic system. Applicants will no longer be required to submit microfilm as a condition for using the group registration option—but they may do so voluntarily if the microfilm is received before December 31, 2019 (in addition to providing digital copies). After that, the microfilm requirement will be phased out. These proposals are discussed below.
To register a group of newspapers under the Proposed Rule, applicants will be required to submit a complete copy of each issue in the group, regardless of whether the Library has selected that newspaper for its collections. This will ensure that the
The Proposed Rule reiterates that applicants must submit the final edition of each issue that was published in the month specified in the application. The current regulation states that applicants may submit earlier editions of the same newspaper if they were published on the same date as the final edition. 37 CFR 202.3(b)(7)(i)(D). The Office is aware that most newspapers no longer publish multiple print editions throughout the day, such as the “morning,” “afternoon,” “evening,” or “late” edition of a particular newspaper.
In all cases, applicants will be required to submit a digital copy of each issue, rather than a physical copy. Under the Proposed Rule, the Office will no longer accept physical copies, such as a print copy or photocopy of each issue in the group (although, as discussed below, newspaper publishers may provide microfilm
In addition, the Office will have a number of technical requirements for the digital files. Specifically, applicants will be required to submit electronic files in Portable Document Format (“PDF”). Each newspaper issue in the group must be submitted to the Office as one discrete, self-contained collective work (
If the applicant's electronic files do not comply with the Office's technical requirements, the Copyright Acquisitions Division (“CAD”) will contact the publisher and ask for replacement files. If the publisher does not provide replacement files, CAD will notify the Literary Division of the Registration Program, which will review that publisher's future electronic submissions for similar deficiencies, and may refuse registration if there are similar defects. If an applicant is unable to comply with the application requirements at the time of filing the application, the applicant may request special relief from the deposit requirements under 37 CFR 202.20(d).
Requiring applicants to upload digital copies to the electronic system will increase the efficiency of the group registration process. The Office does not need physical copies to examine a newspaper for copyrightable authorship, or to determine whether the applicant satisfied the formal and legal requirements for this group option.
Requiring digital uploads may also provide newspaper publishers with certain legal benefits. When the Office registers a group of newspapers and issues a certificate of registration, the effective date of registration is the date on which the Office received the application, filing fee, and deposit in proper form. When an applicant uploads a digital copy of the deposit to the electronic system, the Office typically receives the application, filing fee, and deposit on the same date. By contrast, when an applicant sends physical copies to the Office the deposit may arrive long after the date that the application and filing fee were received—thereby establishing a later effective date of registration.
Moreover, if an applicant uploads a complete copy of the newspaper through the electronic registration system, the Office will retain a digital copy of those issues in its repository of electronic deposits. Digital copies are much easier to store and retrieve. This is critical if the copyright owner or other interested parties need to obtain a copy of a particular issue for use in litigation or another legitimate purpose. The current regulation assumes that a complete copy of each issue will be sent to the Library on microfilm, which may be used to identify the work, if necessary. But as discussed above, many
The Office recognizes that some publishers may not have a digital copy of their issues or may find it difficult to create a digital copy for the purpose of seeking a group registration. The Office will address these concerns on a case-by-case basis. If an applicant is unable to upload a particular newspaper to the electronic system, the applicant may request special relief from the deposit requirements under 37 CFR 202.20(d).
The current regulation states that the applicant must provide the Library with microfilm containing a complete copy of each issue as a condition for using the group registration option. As discussed in more detail below, microfilm will no longer be required when the Final Rule goes into effect—even if the Library has selected that newspaper for its collections. In addition to digital files, newspaper publishers may provide microfilm on a voluntary basis if the microfilm is received by December 31, 2019. After that, the microfilm option will be phased out.
The next few sections discuss the reasons for phasing out the microfilm requirement, as well as the procedure for submitting microfilm to the Office on a voluntary basis.
Section 408(c) of the Copyright Act authorizes the Register to create discretionary registration options for groups of related works, including the applicable deposit requirements. In administering the group registration option for newspapers, the Register must balance the Library's need for microfilm deposits against the potential impact on the newspaper publishing industry. On the one hand, the microfilm requirement has benefitted the Library and the public by providing newspapers in a format suitable for long-term preservation, and at no cost to the government. It benefits researchers accessing these copies at the Library or through interlibrary loan. The regulation also creates a potential supply of microfilm that otherwise might not exist, which may benefit local and regional libraries, assuming they are able to purchase microfilm from publishers for use in their own collections.
On the other hand, the current microfilm requirement does impose a burden on publishers if their newspapers have been selected for the Library's collections. This requirement appears to have been less burdensome when the newspaper group option was adopted in 1990. At that time, newspaper publishers apparently hired microfilm producers to transfer paper newspaper issues onto microfilm for their own archival preservation instead of keeping physical copies. Thus, newspaper publishers were creating microfilm copies in the ordinary course of business. Some publishers offered copies of their microfilm to libraries and other institutions, including the Library of Congress, to offset this cost.
Needless to say, the newspaper publishing industry has since changed dramatically, and the microfilm requirement may have become more burdensome over the past twenty-five years. Representatives of the newspaper industry have informed the Office that most publishers no longer preserve their works on microfilm, and instead make digital copies for archival purposes.
In addition, representatives of the newspaper industry have informed the Office that “many newspapers are no longer registering their works with the Copyright Office because the Library requires that newspaper deposits be in microfilm format.”
Because newspapers have turned increasingly to online publishing, the Library has been considering how to incorporate online publishing into its collections. As part of that effort, in February 2016, the Library initiated a pilot project with the News Media Alliance known as the “Newspaper ePrint Technical Pilot.” The pilot involved collecting electronic files from six newspapers over two phases, with the goal of “explor[ing] the technical feasibility of accepting electronic copies of newspapers in lieu of physical deposits.” Library of Congress and News Media Alliance (NMA) Technical Pilot project,
Based on the results of this pilot and the changes in the newspaper publishing industry, the Office is proposing to eliminate the microfilm requirement. Representatives of the newspaper industry have informed the Office that they generally support this proposal. But some publishers noted that they have entered into long-term contracts with microfilm producers that are still in effect. Others stated that they need time to develop internal procedures and quality assurance testing to ensure that their submissions contain a complete copy of each issue.
To give publishers an opportunity to exhaust their microfilm production contracts, and to ease the transition to the new model, the Proposed Rule will allow newspaper publishers to submit microfilm on a voluntary basis (in addition to the required digital deposits for registration). Specifically, publishers may continue to submit microfilm if the microfilm is received by December 31,
Under the Proposed Rule, if the applicant chooses to submit a microfilm copy in addition to the digital files discussed above in Section III.C.1, the applicant would have to provide positive 35mm silver halide microfilm containing the final edition of each issue that was published during the month specified in the application.
The Office requests comment on these proposals. The Office is particularly interested in knowing whether the proposed phase-out period will give publishers a sufficient amount of time to exhaust their current contracts or whether a longer period would be needed.
When the Office established the group registration option for newspapers, it implicitly recognized that publishers could satisfy their obligations under mandatory deposit by registering their issues with the Office and providing the Library with a copy of those issues on microfilm—although this was not explicitly stated in the regulation itself. The Proposed Rule codifies this understanding by stating that publishers may comply with mandatory deposit by registering their newspapers using the group registration option.
The Copyright Act provides that all copies deposited with the Office for mandatory deposit and registration purposes under sections 407 and 408 “are the property of the United States Government,” and that, in the case of published works, those copies “are available to the Library of Congress for its collections.” 17 U.S.C. 704(a)-(b). The Office has received digital files submitted by registration applicants under section 408 since it launched its electronic registration system in 2007. Although digital registration deposits submitted for registration are stored on Library-operated servers, the Library has to date not incorporated these digital deposits into its general collections or made them available to its patrons.
In addition, electronic works not published in physical formats are—with one exception—exempt from all mandatory deposit requirements under section 407.
With this notice of proposed rulemaking, the Office notes that, for the first time, the Library plans to incorporate digital copies of works submitted for registration under section 408 into the Library's collections, and provide public access to those digital copies. To regulate such public access, the Proposed Rule borrows and codifies the existing public access practices used for electronic serials obtained under section 407; specifically, the Proposed Rule establishes a new section 201.18, entitled “Access to electronic works.” That provision clarifies that the Library may make these digital files available to “authorized users,” meaning (i) Members, staff, and officers of the U.S. House of Representatives and the U.S. Senate, (ii) Library of Congress staff and its contractors, and (iii) registered researchers who use the Library's facilities in Washington, DC and Culpeper, Virginia. The limitation permitting access to two authorized users at any one time applies across all Library facilities. It also clarifies that the Library may not make these files available to the public over the Internet without the copyright owner's permission.
To be clear, while the Proposed Rule would permit public access to digital copies only to newspapers received by the Office under the group registration option, over time the Library would like to expand this new provision to address public access to digital registration deposits for other types of digital works. Before expanding such access, however, the Office will issue separate rulemakings to notify the public.
Under the Proposed Rule, the applicant will be required to pay the same filing fee currently set forth in the Office's fee schedule, namely $80 per claim. The Proposed Rule clarifies that this fee must be included with the application or charged to an active deposit account. Once the Proposed Rule has been implemented, the Office will monitor the cost of processing newspapers through the electronic system to determine if future fee adjustments may be warranted, and may use this information in conducting its next fee study.
The current regulation states that newspaper publishers must submit their claims within three months after the publication of the most recent issue in the group. 37 CFR 202.3(b)(7)(i)(F). The Proposed Rule maintains the three-month deadline, but will require applicants to submit their claims within three months after the publication of the
Compliance with this requirement may provide newspaper publishers with certain legal benefits. Publishers must
By contrast, the current regulation allows an applicant to submit a claim up to four months after the publication of the earliest issue in the group, which may limit the remedies that a publisher may seek in an infringement action. For instance, in the previous example, the applicant could wait until September 30th to register issues published in the month of June, rather than submitting the claim on September 1st. The publisher would be able to seek statutory damages and attorney's fees for infringement involving the June 30th issue occurring after the effective date of registration (
Under the Proposed Rule, the date that optional microfilm copies are received by the Office would be irrelevant. This represents a significant improvement compared to the current process, in which the Office routinely receives microfilm between four to six months after the publication of the most recent issue in the group. On some occasions the Office has received microfilm one or two years after the deadline has expired. Representatives of the newspaper industry have informed the Office that these delays are due to the high cost of producing microfilm. Many publishers cannot afford to send their newspapers to a microfilm producer until they have a sufficient number of issues to justify the cost, which delays the production and delivery of the microfilm. Given these obstacles, it is unreasonable to penalize publishers for failing to transfer their newspapers onto microfilm within three months after publication.
The Proposed Rule will move the regulation governing the newspaper group option from section 202.3 to section 202.4. Going forward, the Office intends to move all regulations governing the various group options implemented under section 408(c) of the Copyright Act to section 202.4. This change is intended to improve the readability of existing regulations and does not represent a substantive change in policy.
In addition, the Proposed Rule incorporates the regulatory definitions from sections 202.3 and 202.20 into section 202.4, to apply to the various group registration options.
The Proposed Rule also confirms that an application for a group of newspaper issues may be submitted by any of the parties listed in section 202.3(c)(1), namely, (i) the author or copyright claimant of those works, (ii) the owner of any of the exclusive rights in those works, or (iii) a duly authorized agent of any author, claimant, or owner of exclusive rights.
Finally, the Proposed Rule contains an unrelated technical amendment, which removes the terms “single application” and “single registration” and replaces them with the terms “application” and “group registration.” 37 CFR 202.3(b)(7)(i). This is intended to avoid potential confusion with the “single application,” a special application that may be used to register “a single work by a single author that is owned by the person who created it.” 37 CFR 202.3(b)(2)(i)(B).
The Proposed Rule will encourage broader participation in the registration system, and increase the efficiency of the process for both the Office and copyright owners alike, while providing the Library with a means for adding newspapers to its collections in an archival-quality format. The Office invites public comment on each of these proposed changes, including:
1. The proposed definition of “newspaper issues,” including making the group registration option to all newspapers, regardless of whether they have been selected to be received and retained by the Library, and classifying a newspaper as a “periodical.”
2. The clarification that all issues in the group must be published and bear issue dates within the same calendar month.
3. The proposed authorship, ownership, and work made for hire requirements.
4. The proposed requirement that each newspaper issue in the group must be an all-new collective work that has not been previously published.
5. The proposed clarifications for the scope of protection for newspaper issues, versus individual contributions appearing within those issues.
6. The clarification that each newspaper issue in the group must be fixed and distributed as a discrete, self-contained collective work.
7. The proposed requirement that applicants use the electronic application designated for a group of newspaper issues as a condition for seeking a group registration, and whether the current online filing requirement for supplementary registrations relating to groups of newspaper issues should be retained.
8. The proposed requirement that applicants submit a complete digital copy of the final edition of each issue in the group, regardless of whether the newspaper was selected to be received and retained by the Library, as well as any of the proposed file submission requirements.
9. The proposed phase-out of the practice of accepting microfilm deposits by December 31, 2019.
10. The proposed parameters for public access to digital deposits of newspaper issues, including the Library making digital copies available to two authorized users at a time at the Library's facilities, and considerations related to secure storage of and access to such digital deposits.
11. The proposed requirement that applicants submit their claims within three months after the publication of the earliest issue in the group.
Copyright, General provisions.
Copyright, Preregistration and registration of claims to copyright.
For the reasons set forth in the preamble, the Copyright Office proposes amending 37 CFR parts 201 and 202 as follows:
17 U.S.C. 702.
(c) * * *
(6)
(c) * * *
17 U.S.C. 408(f), 702.
The revision reads as follows:
(a) * * *
(2) For the purposes of this section, the term
The addition and revisions read as follows:
(b)
(2) For purposes of this section, the term
(3) For purposes of this section, a
(e)
(1) All the issues in the group must be newspapers. For purposes of this section, a newspaper is a periodical (as defined in paragraph (b)(3) of this section) that is mainly designed to be a primary source of written information on current events, either local, national, or international in scope. A newspaper contains a broad range of news on all subjects and activities and is not limited to any specific subject matter. Newspapers are intended either for the general public or for a particular ethnic, cultural, or national group.
(2) Each issue in the group must be an all-new collective work that has not been previously published (except where earlier editions of the same newspaper are included in the deposit together with the final edition), each issue must be fixed and distributed as a discrete, self-contained collective work, and the claim in each issue must be limited to the collective work.
(3) Each issue in the group must be a work made for hire, and the author and claimant for each issue must be the same person or organization.
(4) All the issues in the group must be published under the same continuing title, and they must be published within the same calendar month and bear issue dates within that month. The applicant must include the final edition of each issue published within that month, and must identify the earliest and latest date that the issues were published. The applicant may include earlier editions of the same newspaper, provided that they were published on the same date as the final edition. The applicant also may include local editions of the newspaper that were published within the same metropolitan area, but may not include national or regional editions that were distributed outside that metropolitan area.
(5)
(6)
(ii)(A) The issues must be submitted in a digital form, and each issue must be contained in a separate electronic file. The applicant must use the file-naming convention and submit digital files in accordance with instructions specified on the Copyright Office's Web site. The files must be submitted in Portable Document Format (PDF), they must be assembled in an orderly form, and they must be uploaded to the electronic registration system as individual electronic files (
(B) The applicant may also submit the issues on positive 35mm silver halide
(7) The application, the filing fee, and files specified in paragraph (e)(7)(ii)(A) of this section must be received by the Copyright Office within three months after the date of publication for the earliest issue in the group.
(m)
(a) Access to electronic works received under § 202.4(e) will be available only to authorized users at Library of Congress facilities in accordance with the policies listed below. Library staff may access such content off-site as part of their assigned duties via a secure connection.
(b) Access to each individual electronic work received under § 202.4(e) will be limited, at any one time, to two Library of Congress authorized users via a secure server over a secure network that serves Library of Congress facilities.
(c) The Library of Congress will not make electronic works received under § 202.4(e) available to the public over the Internet without rightsholders' permissions.
(d) “Authorized user” means Library of Congress staff, contractors, and registered researchers, and Members, staff and officers of the U.S. House of Representatives and the U.S. Senate for the purposes of this section.
(e) “Library of Congress facilities” means all Library of Congress facilities in Washington, DC, and the Library of Congress Packard Campus for Audio-Visual Conservation in Culpeper, VA.
(d) * * *
(2) * * *
(ix) In the case of published newspapers, a deposit submitted pursuant to and in compliance with the group registration option under § 202.4(e) shall be deemed to satisfy the mandatory deposit obligation under this section.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) proposes to approve the Clean Air Act (CAA) section 111(d)/129 State Plan revision submitted by the State of Maryland for the purpose of updating municipal waste combustor (MWC) references to opacity monitor quality assurance and quality compliance requirements in Regulations .07 and .08 under the Code of Maryland Regulations (COMAR) 26.11.08. In the Final Rules section of this
Comments must be received in writing by December 6, 2017.
Submit your comments, identified by Docket ID No. EPA-R03-OAR-2017-0484 at
Emily Linn, (215) 814-5273, or by email at
For further information, please see the information provided in the direct final action, with the same title, that is located in the “Rules and Regulations” section of this
Environmental Protection Agency (EPA).
Extension of comment period.
On September 21, 2017, the Environmental Protection Agency (EPA) proposed a rule titled, “National Emission Standards for Hazardous Air
The public comment period for the proposed rule published in the
The EPA has established a docket for the proposed rulemaking (available at
For additional submission methods, the full EPA public comment policy, and general guidance on making effective comments, please visit
For additional information on this action, contact Brian Storey, Sector Policies and Programs Division, Office of Air Quality Planning and Standards (D243-04), Environmental Protection Agency, Research Triangle Park, NC 27711; telephone number: (919) 541-1103; email address:
To allow additional time for stakeholders to provide comments, the EPA has decided to extend the public comment period until November 21, 2017.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Availability of fishery management plan amendment; request for comments.
NMFS announces that the Pacific Fishery Management Council (Council) has submitted Amendment 16 to the Coastal Pelagic Species (CPS) Fishery Management Plan (FMP) for review by the Secretary of Commerce. Amendment 16 would add a description to the CPS FMP of a very small sector of the CPS fishery that is not part of the primary commercial directed fishery and harvests minor amounts of CPS finfish. Total landings from this sector typically make up less than one percent of the total landings of any particular CPS stock. Currently, when directed fishing closures are enacted, these very small-scale fisheries have been precluded from fishing and/or harvesting these minor amounts because they do not fall under the existing exemptions during closures for incidental harvest or for harvesting CPS to be sold as live bait. The intent of Amendment 16 is to allow this sector to continue targeting CPS finfish after a directed fishery closure, while keeping the aggregate catch level within the applicable annual catch limit (ACL).
Comments on Amendment 16 must be received by January 5, 2018.
You may submit comments on this document, identified by NOAA-NMFS-2017-0135, by any of the following methods:
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Copies of the draft CPS FMP as amended through Amendment 16, with notations showing how Amendment 16 would change the FMP, if approved, are available via the Federal eRulemaking Portal:
Joshua B. Lindsay, Sustainable Fisheries Division, NMFS, at 562-980-4034; or Kerry Griffin, Pacific Fishery Management Council, at 503-820-2280.
The CPS fishery in the U.S. exclusive economic zone (EEZ) off the West Coast is managed under the CPS FMP, which was developed by the Council pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (MSA), 16 U.S.C. 1801
The MSA requires each regional fishery management council to submit any amendment to a FMP to NMFS for review and approval, disapproval, or partial approval. The MSA also requires that NMFS, upon receiving an amendment to a FMP, publish
In recent years the primary directed fishery for Pacific sardine has experienced extremely shortened fishing seasons or complete fishing year closures. However, the CPS FMP allows incidental catch of CPS and live bait fishing to continue when directed fisheries are closed, provided the Pacific sardine stock is not overfished or experiencing overfishing. These small allowances continue to be subject to ACLs and comport with the conservation goals of the CPS FMP. Management measures for incidental landing allowances are typically expressed as allowable percentages of that species in a landing of the dominant species catch. However, during the directed fishing closures some other very small-scale fisheries have been precluded from fishing and/or harvesting even
At the April 2017 Council meeting, the Council adopted Amendment 16 to the CPS FMP to allow minor directed fishing to continue after a directed fishery is closed. Minor directed fishing would be allowed unless otherwise specified, or if an applicable ACL is anticipated to be exceeded. As a further restriction, to ensure the minor directed landing provision is not exploited to make large aggregate harvests, Amendment 16 limits this directed fishing exemption so that landings cannot exceed 1 metric ton (mt) per day per vessel or person, and which is limited to one fishing trip per day by any vessel. The intent of distinguishing between a “vessel” and “person” is that some participants in this small sector of the CPS fishery fish from a platform other than a vessel (
Public comments on Amendment 16 must be received by January 5, 2018. The Council has also submitted proposed regulations to implement Amendment 16 for Secretarial review and approval. NMFS expects to publish and request public comment on the proposed regulation to implement Amendment 16 in the near future. Public comments on Amendment 16 must be received by the end of the comment period to be considered in the approval/disapproval decision on Amendment 16. All comments received by the end of the comment period on Amendment 16, whether specifically directed to Amendment 16 or the proposed rule, will be considered in the approval/disapproval decision. Comments received after that date will not be considered in the approval/disapproval decision of Amendment 16. To be considered, comments must be received by close of business on the last day of the comment period; that does not mean postmarked or otherwise transmitted by that date.
16 U.S.C. 1801
Fish and Wildlife Service, Interior.
Policy review; request for comments.
We, the U.S. Fish and Wildlife Service (Service), are requesting public comment on portions of our existing Mitigation Policy and Endangered Species Act Compensatory Mitigation Policy (ESA-CMP). We specifically request comment on the policies' mitigation planning goals. Based on comments received, the Service will decide whether and how to revise the policies.
We will accept comments from all interested parties until January 5, 2018. Please note that if you are using the Federal eRulemaking Portal (see A
•
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We will post all comments on
Craig Aubrey, U.S. Fish and Wildlife Service, Division of Environmental Review, 5275 Leesburg Pike, Falls Church, VA 22041-3803, telephone 703-358-2442.
The Mitigation Policy (81 FR 83440, November 21, 2016) and the ESA-CMP (81 FR 95316, December 27, 2016) were developed to ensure consistency with existing directives in effect at the time of issuance, including former President Obama's Memorandum on Mitigating Impacts on Natural Resources From Development and Encouraging Related Private Investment (November 3, 2015). The Presidential Memorandum directed all Federal agencies that manage natural resources to avoid and then minimize harmful effects to land, water, wildlife, and other ecological resources (natural resources) caused by land- or water-disturbing activities, and to ensure that any remaining harmful effects are effectively addressed, consistent with existing mission and legal authorities. Also, under the memorandum, all Federal mitigation policies were directed to clearly set a net-benefit goal or, at minimum, a no-net-loss goal for natural resources, wherever doing so is allowed by existing statutory authority and is consistent with agency mission and established natural resource objectives. The Presidential Memorandum was subsequently rescinded by Executive Order 13783, “Promoting Energy Independence and Economic Growth” (March 28, 2017).
The 2016 policies also described their consistency with the Secretary of the Interior's Order 3330 on Improving Mitigation Policies and Practices of the Department of the Interior (October 31, 2013), which established a Department-wide mitigation strategy to ensure consistency and efficiency in the review and permitting of infrastructure-development projects and in conserving natural and cultural resources. The Secretary's Order was subsequently revoked by Secretary of the Interior's Order 3349 on American Energy Independence (March 29, 2017). It directed Department of the Interior bureaus to reexamine mitigation policies and practices to better balance conservation strategies and policies with job creation for American families.
The Mitigation Policy articulated general policy and principles intended to guide Service-recommended mitigation across Service programs. These principles were in turn adopted by the ESA-CMP. Included among the principles was an overall mitigation planning goal of net conservation gain:
The Service's mitigation planning goal is to improve (
When the Service published both the draft Mitigation Policy and draft ESA-CMP for public comment, many commenters addressed the policies' mitigation planning goals. Comments on the proposed Mitigation Policy may be viewed here:
This document announces the Service's intent to solicit additional input regarding whether to retain or remove net conservation gain as a mitigation planning goal within our mitigation policies.
We ask that comments specifically address the advisability of retaining or removing references to net conservation gain from the Service's overall mitigation planning goal within each policy. We further ask that commenters submit comments to one or the other docket based on the specific policy of concern (the Mitigation Policy or the ESA-CMP).
We will consider information and recommendations from all interested parties. We therefore invite comments, information, and recommendations from governmental agencies, Indian Tribes, the scientific community, industry groups, environmental interest groups, and any other interested parties. All comments and materials received by the date listed above in
If you submit information via
After the comment period closes, we will determine whether and how to revise the policies in response to the public input regarding the requested information. We will also update the policies to remove specific references to the Presidential Memorandum that was rescinded by Executive Order 13783 and to Secretary of the Interior's Order 3330 that was revoked by the subsequent Order 3349.
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 Georgia Advisory Committee will hold a meeting on Monday, November 20, 2017, for continuing discussion of a public hearing on the civil rights implications of the Olmstead Act.
The meeting will be held on Monday, November 20, 2017, at 11:00 a.m. EST.
Jeff Hinton, 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: 888-466-4442, conference ID: 3266197. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are also entitled to submit written comments; the comments must be received in the regional office by November 17, 2017. Written comments may be mailed to the Southern Regional Office, U.S. Commission on Civil Rights, 61 Forsyth Street, Suite 16T126, Atlanta, GA 30303. They may also be faxed to the Commission at (404) 562-7005, or emailed to Regional Director, Jeffrey Hinton at
Records generated from this meeting may be inspected and reproduced at the Southern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Tennessee Advisory Committee will hold a meeting on Wednesday, December 6, 2017 to review, discuss, and update the draft report on civil rights issues related to civil asset forfeiture in the state.
The meeting will be held on Wednesday, December 6, 2017, at 12:30 p.m. EST.
Jeff Hinton, 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: 888-297-0357, conference ID: 7237688. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are also entitled to submit written comments; the comments must be received in the regional office by December 1, 2017. Written comments may be mailed to the Southern Regional Office, U.S. Commission on Civil Rights, 61 Forsyth Street, Suite 16T126, Atlanta, GA 30303. They may also be faxed to the Commission at (404) 562-7005, or emailed to Regional Director, Jeffrey Hinton at
Records generated from this meeting may be inspected and reproduced at the Southern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Louisiana Advisory Committee (Committee) will hold a meeting on Tuesday, November 7, 2017, at 10:00:00 a.m. Central for a discussion on Barriers to Voting in Louisiana.
The meeting will be held on Tuesday, November 7, 2017, at 10:00 a.m. Central.
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: 888-726-2418, conference ID: 9008728. 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
Commission on Civil Rights.
Announcement of meetings.
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 (FACA), thata planning meeting of the Colorado Advisory Committee to the Commission will by teleconference at 3:00 p.m. (MST) on Friday, November 17, 2017. The purpose of the meeting is to continue to discuss next steps after briefing meeting on the Blaine Amendment in Denver on July 2017.
Friday, November 17, 2017, at 3:00 p.m. MST.
Evelyn Bohor, at
Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-888-857-6931 and conference call 1528884. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-977-8339 and providing the operator with the toll-free conference call-in number: 1-888-857-6931 and conference call 1528884.
Members of the public are invited to make statements during the open comment period of the meeting or submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written
Records and documents discussed during the meeting will be available for public viewing as they become available at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on utility scale wind towers (wind towers) from the Socialist Republic of Vietnam (Vietnam). This review covers respondent CS Wind Group. The period of review (POR) is February 1, 2016, through January 31, 2017. We preliminarily find no evidence of any shipments of subject merchandise by CS Wind Group during the POR, and are therefore issuing a preliminary no shipments determination.
Applicable November 6, 2017.
Trisha Tran, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4852.
The merchandise covered by this order are certain wind towers, whether or not tapered, and sections thereof. Merchandise covered by the order is currently classified in the Harmonized Tariff System of the United States (HTSUS) under subheadings 7308.20.0020
The Department is conducting this review in accordance with section 751(a)(2) of the Tariff Act of 1930, as amended (the Act). For a full description of the methodology underlying our conclusions,
Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if a party that requested the review withdraws its request within 90 days of the date of publication of the notice of initiation of the requested review. The petitioner, Wind Tower Trade Coalition, timely withdrew its requests for an administrative review of Vina Halla Heavy Industries Ltd. and UBI Tower Sole Member Company Ltd. within 90 days of the
Based on information CS Wind Group submitted after the initiation of this administrative review, and due to the fact that we have not received any information from U.S. Customs and Border Protection (CBP) indicating that CS Wind Group had entries where CS Wind Group was (1) the producer but not the exporter, or (2) the exporter but not the producer during the POR, the Department has preliminarily determined that the record evidence indicates that CS Wind Group had no shipments of subject merchandise during the POR.
Consistent with an announced refinement to its assessment practice in non-market economy cases, the Department is not rescinding this review but intends to complete the review with respect to CS Wind Group for which it has preliminarily found no shipments and issue appropriate instructions to CBP based on the final results of the review.
Upon issuance of the final results, the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.
Additionally, for the companies for which this review is rescinded, antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(l)(i). The Department intends to issue appropriate assessment instructions to CBP 15 days after publication of this notice.
Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs no later than 30 days after the date of publication of this notice.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS, within 30 days after the date of publication of this notice.
The Department intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, unless extended, pursuant to section 751(a)(3)(A) of the Act.
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that countervailable subsidies are being provided to producers and exporters of fine denier polyester staple fiber (fine denier PSF) from India. The period of investigation is January 1, 2016, through December 31, 2016.
Applicable November 6, 2017.
Trisha Tran or Eli Lovely, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4852 or (202) 482-1593, respectively.
This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on June 27, 2017.
The product covered by this investigation is fine denier PSF from India. 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 701 of the Act. For each of the subsidy programs found countervailable, the Department preliminarily determines that there is a subsidy,
The Department notes that, in making these findings, it relied, in part, on facts available and, because it finds that one or more respondents did not act to the best of their ability to respond to the Department's requests for information, it drew an adverse inference where appropriate in selecting from among the facts otherwise available.
Sections 703(d) and 705(c)(5)(A) of the Act provide that in the preliminary determination, the Department shall determine an estimated all-others rate for companies not individually examined. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually examined, excluding any zero and
In this investigation, the Department calculated individual estimated countervailable subsidy rates for Bombay Dyeing & Manufacturing Company Limited (Bombay Dyeing) and Reliance Limited Industries (Reliance) that are not zero,
The Department preliminarily determines that the following estimated countervailable subsidy rates exist:
In accordance with section 703(d)(1)(B) and (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 the scope of the investigation section 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 its public announcement, or if there is no public announcement, within five days of the date 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.
In accordance with section 703(f) of the Act, the Department will notify the International Trade Commission (ITC) of its 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.
This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).
The merchandise covered by this investigation is fine denier polyester staple fiber (fine denier PSF), not carded or combed, measuring less than 3.3 decitex (3 denier) in diameter. The scope covers all fine denier PSF, whether coated or uncoated. The following products are excluded from the scope:
(1) PSF equal to or greater than 3.3. decitex (more than 3 denier, inclusive) currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheadings 5503.20.0045 and 5503.20.0065.
(2) Low-melt PSF defined as a bicomponent fiber with a polyester core and anouter, polyester sheath that melts at a significantly lower temperature than its inner polyester core currently classified under HTSUS subheading 5503.20.0015.
Fine denier PSF is classifiable under the HTSUS subheading 5503.20.0025. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of this sunset review, the Department of Commerce (the Department) finds that revocation of the antidumping duty (AD) order on tapered roller bearings and parts thereof, finished and unfinished (TRBs) from the People's Republic of China (PRC) would be likely to lead to continuation or recurrence of dumping. The magnitude of the dumping margin likely to prevail is indicated in the “Final Results of Sunset Review” section of this notice.
Applicable November 6, 2017.
Whitley Herndon; Office II, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-6274.
On June 15, 1987, the Department published the AD order on TRBs from the PRC.
The merchandise covered by the
All issues raised in this sunset review are addressed in the Decision Memorandum. The issues discussed in the Decision Memorandum include the likelihood of continuation or recurrence of dumping and the magnitude of the dumping margin likely to prevail if the
The Decision Memorandum is a public document and is on file electronically
Pursuant to sections 751(c)(1) and 752(c)(1) and (3) of the Act, the Department determines that revocation of the
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. Timely notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these results and notice in accordance with sections 751(c), 752, and 777(i)(1) of the Act and 19 CFR 351.281 and 19 CFR 351.221(c)(5)(ii).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On July 3, 2017, the Department of Commerce (the Department) initiated a sunset review of the countervailing duty (CVD) order on certain lined paper products from India pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). The Department has conducted an expedited sunset review of this order pursuant to the Act and 19 CFR 351. As a result of this sunset review, the Department finds that revocation of the CVD order is likely to lead to continuation or recurrence of a countervailable subsidy at the levels indicated in the “Final Results of Review” section of this notice.
Applicable November 6, 2017.
John Conniff, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: 202-482-1009.
The CVD order on certain lined paper products from India was published in the
The scope of this order includes certain lined paper products, typically school supplies,
Specifically excluded from the scope of this order are:
• Unlined copy machine paper;
• writing pads with a backing (including but not limited to products commonly known as “tablets,” “note pads,” “legal pads,” and “quadrille pads”), provided that they do not have a front cover (whether permanent or removable). This exclusion does not apply to such writing pads if they consist of hole-punched or drilled filler paper;
• three-ring or multiple-ring binders, or notebook organizers incorporating such a ring binder provided that they do not include subject paper;
• index cards;
• printed books and other books that are case bound through the inclusion of binders board, a spine strip, and cover wrap;
• newspapers;
• pictures and photographs;
• desk and wall calendars and organizers (including but not limited to such products generally known as “office planners,” “time books,” and “appointment books”);
• telephone logs;
• address books;
• columnar pads & tablets, with or without covers, primarily suited for the recording of written numerical business data;
• lined business or office forms, including but not limited to: Pre-printed business forms, lined invoice pads and paper, mailing and address labels, manifests, and shipping log books;
• lined continuous computer paper;
• boxed or packaged writing stationary (including but not limited to products commonly known as “fine business paper,” “parchment paper,” and “letterhead”), whether or not containing a lined header or decorative lines;
• Stenographic pads (“steno pads”), Gregg ruled,
Also excluded from the scope of this order are the following trademarked products:
• Fly
• Zwipes
• FiveStar®Advance
• FiveStar Flex
Merchandise subject to this order is typically imported under headings 4810.22.5044, 4811.90.9050, 4811.90.9090, 4820.10.2010, 4820.10.2020, 4820.10.2030, 4820.10.2040, 4820.10.2050, 4820.10.2060, and 4820.10.4000 of the Harmonized Tariff Schedule of the United States (HTSUS). The HTSUS headings are provided for convenience and customs purposes; however, the written description of the scope of the order is dispositive.
All issues raised in this review are addressed in the Issues and Decision Memorandum, which is dated concurrently with, and hereby adopted by, this notice.
As a result of this review, the Department determines that revocation of the CVD order would likely lead to continuation or recurrence of a countervailable subsidy at the rates listed below:
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. Timely notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
We are issuing and publishing the final results of this review in accordance with sections 751(c), 752, and 777(i) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) is rescinding the administrative review of the countervailing duty (CVD) order on certain crystalline silicon photovoltaic products (solar products) from the People's Republic of China (PRC) for the period January 1, 2016, through December 31, 2016.
Applicable November 6, 2017.
Gene H. Calvert, 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) 482-3586.
On April 10, 2017, 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 party that requested a review withdraws its request within 90 days of the date of publication of the notice of initiation of the requested review. In this case, the petitioner timely withdrew its request for review within the 90-day deadline, and no other party requested an administrative review of the CVD order. Therefore, in accordance with 19 CFR 351.213(d)(1), we are rescinding the administrative review of the CVD order on solar products from the PRC covering the period January 1, 2016, through December 31, 2016, in its entirety.
The Department will instruct U.S. Customs and Border Protection (CBP) to assess countervailing duties on all appropriate entries of solar products
This notice serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under an APO, in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
This notice is issued and published in accordance with section 751(a)(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.
As a result of these sunset reviews, the Department of Commerce (the Department) finds that revocation of the antidumping duty orders on stainless steel bar (SSB) from Brazil, India, Japan, and Spain would be likely to lead to continuation or recurrence of dumping at the levels indicated in the “Final Results of Sunset Reviews” section of this notice.
Applicable November 6, 2017.
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) 482-4798.
On July 3, 2017, the Department published the notice of initiation of the fourth sunset reviews of the antidumping duty orders on SSB from Brazil, India, Japan, and Spain, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).
On August 2, 2017, we received complete substantive responses for each review from the domestic interested parties within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i). We received no substantive responses from respondent interested parties with respect to any of the orders covered by these sunset reviews, nor was a hearing requested. The Department received no comments on the adequacy of responses in these sunset reviews. Pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2), the Department is conducting expedited (120-day) sunset reviews of these orders.
The merchandise subject to the orders is SSB. For a complete description of the scope of these orders, including variances in the Japan order,
All issues raised in these reviews, including the likelihood of continuation or recurrence of dumping in the event of revocation and the magnitude of the margins likely to prevail if the orders were revoked, are addressed in the accompanying Issues and Decision Memorandum. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Pursuant to sections 751(c)(1) and 752(c)(1), (2) and (3) of the Act, we determine that revocation of the antidumping duty orders on SSB from Brazil, India, Japan, and Spain would likely lead to continuation or recurrence of dumping up to the following weighted-average margin percentages:
This notice serves as the only reminder to parties subject to an 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. Timely notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act and 19 CFR 351.218.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Department) and the U.S. International Trade Commission (ITC) determined that revocation of the antidumping duty order
Applicable November 6, 2017.
Jacqueline Arrowsmith, 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) 482-5255.
On November 16, 1994, the Department of Commerce published in the
The Department conducted this sunset review 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, timely, and adequate response from a domestic interested party but no substantive responses from respondent interested parties. As a result of this sunset review, the Department determined that revocation of the
On October 24, 2017, the ITC published its determination that revocation of the
The products subject to the
The scope of the
The subject merchandise is used principally as a food product and for seasoning. The subject garlic is currently classifiable under subheadings 0703.20.0000, 0703.20.0005, 0703.20.0015, 0703.20,0010, 0703.20.0020, 0703.20.0090, 0710.80.7060, 0710.80.9750, 0711.90.6000, 0711.90.6500, 2005.90.9500, 2005.90.9700 and 2005.99.9700 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the order is dispositive. In order to be excluded from the
As a result of the determinations by the Department and the ITC that revocation of the
CBP will continue to collect antidumping duty cash deposits at the rates in effect at the time of entry for all imports of subject merchandise. The effective date of the continuation of this order will be the date of publication in the
The sunset review 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).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On October 10, 2017, the Court of International Trade (CIT or Court) sustained the final remand results pertaining to the administrative review of the antidumping duty order on large power transformers (LPTs) from the Republic of Korea (Korea) covering the period February 16, 2012, through July 31, 2013. The Department of Commerce (the Department) is notifying the public that the final judgment in this case is not in harmony with the final results, notice of amended final results, and notice of second amended final results of the administrative review and that the Department is amending the second amended final results with respect to the dumping margins assigned to Hyosung Corporation (Hyosung), Hyundai Heavy Industries Co., Ltd. (Hyundai), and the companies not selected for individual examination (ILJIN, ILJIN Electric Co., Ltd., and LSIS Co., Ltd.).
Applicable October 20, 2017.
Moses Song, 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) 482-5041.
On March 31, 2015, the Department issued the
On October 7, 2016, the CIT remanded various aspects of the
Pursuant to the
In its decision in
Because there is now a final court decision, the Department is amending the
In the event that the CIT's rulings are not appealed or, if appealed, are upheld by a final and conclusive court decision, the Department will instruct Customs and Border Protection (CBP) to assess antidumping duties on unliquidated entries of subject merchandise based on the revised dumping margins listed above.
Since the
This notice is issued and published in accordance with sections 516A(e)(1), 751(a)(1), and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that countervailable subsidies are being provided to producers and exporters of fine denier polyester staple fiber (fine denier PSF) from the People's Republic of China (PRC). The period of investigation is January 1, 2016, through December 31, 2016.
Applicable November 6, 2017.
Yasmin Bordas or Davina Friedmann, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3813 or (202) 482-0698, respectively.
This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on June 27, 2017.
The product covered by this investigation is fine denier PSF from the PRC. 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 701 of the Act. For each of the subsidy programs found countervailable, the Department preliminarily determines that there is a subsidy,
The Department notes that, in making these findings, it relied, in part, on facts available and, because it finds that one or more respondents did not act to the best of their ability to respond to the Department's requests for information, it drew an adverse inference where appropriate in selecting from among the facts otherwise available.
Sections 703(d) and 705(c)(5)(A) of the Act provide that in the preliminary determination, the Department shall determine an estimated all-others rate for companies not individually examined. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually examined, excluding any zero and
The Department preliminarily determines that the
In accordance with section 703(d)(1)(B) and (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 the scope of the investigation section 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 its public announcement, or if there is no public announcement, within five days of the date 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, 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.
In accordance with section 703(f) of the Act, the Department will notify the International Trade Commission (ITC) of its 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.
This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).
The merchandise covered by this investigation is fine denier polyester staple fiber (fine denier PSF), not carded or combed, measuring less than 3.3 decitex (3 denier) in diameter. The scope covers all fine denier PSF, whether coated or uncoated. The following products are excluded from the scope:
(1) PSF equal to or greater than 3.3. decitex (more than 3 denier, inclusive) currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheadings 5503.20.0045 and 5503.20.0065.
(2) Low-melt PSF defined as a bi-component fiber with a polyester core and an outer, polyester sheath that melts at a significantly lower temperature than its inner polyester core currently classified under HTSUS subheading 5503.20.0015.
Fine denier PSF is classifiable under the HTSUS subheading 5503.20.0025. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the investigations is dispositive.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that James H.W. Hain, Ph.D., Box 721, Woods Hole, MA 02543, has applied in due form for a permit to conduct research on North Atlantic right (
Written, telefaxed, or email comments must be received on or before December 6, 2017.
The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page,
These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to
Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Carrie Hubard or Shasta McClenahan, (301) 427-8401.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The applicant requests a five-year permit to conduct aerial and vessel surveys for North Atlantic right whales (NARW) off South Carolina, Georgia, and Florida. The primary study area is in Florida from St. Augustine to Canaveral National Seashore. Research would mainly occur in coastal waters. Survey platforms include boats, airplanes, aerostats, blimps, and unmanned aircraft systems. Up to 160 NARW could be approached annually (100 via aerial surveys, 60 via vessel surveys) for behavioral observations, photo-identification, counts, and passive acoustic recordings. Up to 10 humpback whales may be encountered annually and would be studied in the same manner as NARW. Bottlenose (
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability of a Draft Environmental Assessment; request for comments.
NMFS announces the availability of the “Draft Environmental Assessment (EA) on the Effects of Issuing an Incidental Take Permit (ITP) (No. 21293) to Mr. Jack Rudloe, Gulf Specimen Marine Laboratories, Inc. (GSML), pursuant to the Endangered Species Act of 1973, as amended (ESA). Publication of this notice begins the official public comment period for this draft EA. Per the National Environmental Policy Act (NEPA), the purpose of the draft EA is to evaluate the potential direct, indirect, and cumulative impacts caused by the issuance of Permit No. 21293 to GSML for the incidental take of Gulf sturgeon (
Written comments must be received at the appropriate address or fax number (see
The EA is available for download and review at
You may submit comments, identified by “NOAA-NMFS-2017-0132”, by any of the following methods:
•
•
•
Ron Dean or Angela Somma, (301) 427-8403.
Section 9 of the ESA and Federal regulations prohibits the `taking' of a species listed as endangered or threatened. The ESA defines “take” to mean harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct. NMFS may issue permits, under limited circumstances to take listed species incidental to, and not the purpose of, otherwise lawful activities. Section 10(a)(1)(B) of the ESA provides for authorizing incidental take of listed species. The regulations for issuing incidental take permits for threatened and endangered species are promulgated at 50 CFR 222.307.
NMFS received a permit application from GSML on February 4, 2016. Based on our review of the application, we requested further information and clarification. On July 22, 2016, GSML submitted supplemental information to its application. NMFS and GSML held further discussions on amount and extent of anticipated takes and clarifications of gear type to be used. On March 16, 2017, NMFS notified GSML of this approach, and GSML confirmed the updated approach on March 21, 2017.
On April 12, 2017, we published a notice of application receipt and requested review and comment on the application and conservation plan in the
Through this notice, we are making the Draft EA available for comment and review. The EA analyzes the effects to the human and natural environment caused by the issuance of ITP No. 21293 to GSML for the incidental take of Gulf sturgeon
• The impact which will likely result from the taking;
• How the applicant will minimize and mitigate those impacts, and the funding available to implement;
• What alternative actions the applicant considered, and why those actions are not being pursued;
• Other measures the Secretary of Commerce may require; and
• All sources of data relied on in preparing the plan.
The conservation plan prepared by GSML describes measures designed to monitor, minimize, and mitigate the incidental take of ESA-listed species.
In preparing the Draft EA, NMFS considered the following 2 alternatives for the action:
Alternative 1—No Action. Under the No Action alternative no ITP would be issued for the incidental take of Gulf sturgeon
Alternative 2—(Proposed) Issue ITP as Requested in Application. Under Alternative 2, an ITP would be issued to exempt GSML from the ESA prohibition on taking ESA listed species.
The Draft EA presents the scientific and analytic basis for comparison of the direct, indirect, and cumulative effects of the alternatives. Regulations for implementing NEPA (42 U.S.C. 4331
NMFS would not issue an ITP under the No Action Alternative (Alternative 1). Because no incidental take permit would be issued, GSML would not receive an exemption from the ESA prohibitions against take; therefore, any incidental takes of ESA listed species under NMFS' jurisdiction would not be exempted. Because this alternative would affect GSML's ability to engage in marine education, research, and coastal conservation, the No Action Alternative would have more of a socio-economic impact than the other alternative.
The issuance of the Permit as Requested in the Application (Alternative 2 Proposed Action) would allow GSML to continue to engage in marine education, research, and coastal conservation. This would result in less socio-economic costs than the No Action alternative (Alternative 1).
This notice is provided pursuant to section 10(c) of the ESA. The application, supporting documents, public comments, and views already received by the agency, as well as those submitted in response to this notice, will be fully considered and evaluated as we prepare the final EA and determine whether to issue a Finding of No Significant Impact. The final NEPA document and ITP determinations will not be completed until after the 30-day comment period ends. NMFS will publish a record of its final action in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of cancellation of public meeting.
The Western Pacific Fishery Management Council (Council) has cancelled its 172nd meeting that was scheduled between 2 p.m. and 5 p.m. (Hawaii Standard Time (HST)) and between 1 p.m. and 4 p.m. (American Samoa Standard Time (ASST)) on Wednesday, November 15, 2017 and between 10 a.m. and 1 p.m. (Marianas Standard Time (MST)) on Thursday, November 16, 2017.
Kitty M. Simonds, Executive Director; telephone: (808) 522-8220.
The initial notice for this public meeting published in the
16 U.S.C. 1801
Committee for the Implementation of Textile Agreements (CITA).
Request for public comments concerning a request for modification of the U.S.-Morocco Free Trade Agreement (USMFTA) rules of origin for certain knit apparel made from certain knit fabrics.
The Government of the United States received a request from the Government of Morocco on October 10, 2017, on behalf of SALSABILE to initiate consultations under Article 4.3.3 of the USMFTA. The Government of Morocco is requesting that the United States and Morocco (“the Parties”) consider revising the rules of origin for certain knit apparel to address availability of supply of certain knit fabrics in the territories of the Parties. The President of the United States may proclaim a modification to the USMFTA rules of origin for textile and apparel products after the United States reaches an agreement with the Government of Morocco on a modification under Article 4.3.6 of the USMFTA to address issues of availability of supply of fibers, yarns, or fabrics in the territories of the Parties. CITA hereby solicits public comments on this request, in particular with regard to whether certain knit fabrics can be supplied by the U.S. domestic industry in commercial quantities in a timely manner.
Comments must be submitted by January 5, 2018 to the Chairman, Committee for the Implementation of Textile Agreements, Room 30003, United States Department of Commerce, Washington, DC 20230.
Linda Martinich, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-3588.
The Government of the United States received a request from the Government of Morocco on October 10, 2017, on behalf of SALSABILE, requesting that the United States consider whether the USMFTA rule of origin for certain knit apparel should be modified to allow the use of certain knit fabrics that are not originating under the USMFTA. The fabrics subject to this request, according to the fabric number in the request and organized by specific apparel end-use, are:
Fabric 7: Dyed knit fabric of cotton (51-60%), rayon (30-40%), and nylon (4-10%), classified in subheading 6006.22 of the HTSUS.
Fabric 8: Knit fabric of rayon (50-84%), polyester (14-49%), and elastomeric (1-10%), classified in subheadings 6004.10, 6005.41, 6005.42, 6005.43, 6005.44, 6006.41, 6006.42, 6006.43, and 6006.44 of the HTSUS;
Fabric 9: Knit fabric of polyester (50-65%), rayon (30-49%), and elastomeric (1-10%), classified in subheadings 6004.10, 6005.36, 6005.37, 6005.38, 6005.39, 6006.31, 6006.32, 6006.33, and 6006.34 of the HTSUS;
Fabric 10: Knit fabric of rayon (90-99%) and elastomeric (1-10%), classified in subheadings 6004.10, 6005.41, 6005.42, 6005.43, 6005.44, 6006.41, 6006.42, 6006.43, and 6006.44 of the HTSUS;
Fabric 11: Knit fabric of rayon (51-84%) and polyester (16-49%), classified in subheadings 6005.41, 6005.42, 6005.43, 6005.44, 6006.41, 6006.42, 6006.43, and 6006.44 of the HTSUS;
Fabric 12: Knit fabric of polyester (51-65%) and rayon (35-49%), classified in subheadings 6005.36, 6005.37, 6005.38,
Fabric 13: Knit fabric of synthetic fiber (90-99%) and elastomeric (1-10%), classified in subheadings 6004.10, 6005.37, 6005.38, 6005.39, 6006.32, 6006.33, and 6006.34 of the HTSUS.
Fabric 19: Slub jersey fabric, other than warp knit, of rayon (92-98%), polyester (2-3%), and elastomeric (2-5%), weighing 150-200 g/m2, classified in subheadings 6004.10 and 6006.42 of the HTSUS.
Fabric 17: Knit fabric of cotton (51-70%), rayon (33-49%), and elastomeric (2-7%), weighing up to 275 g/m2, classified in subheadings 6004.10, 6006.21, 6006.22, and 6006.24 of the HTSUS.
Fabric 14: Knit jersey fabric, other than warp knit, of lyocell (44-50%), rayon (44-50%), and elastomeric (3-9%), weighing 150-220 g/m2, classified in subheadings 6004.10 and 6006.42 of the HTSUS;
Fabric 15: Slub jersey fabric of cotton (51-65%) and rayon (35-49%), weighing 120-225 g/m2, classified in subheading 6006.22 of the HTSUS;
Fabric 16: Knit jersey fabric, other than warp knit, of rayon (30-36%), acrylic (19-35%), polyester (27-33%), and elastomeric (3-8%), weighing 125-250 g/m2, classified in subheadings 6004.10 and 6006.32 of the HTSUS; and
Fabric 18: Knit jersey fabric, other than warp knit, of polyester (43-46%), rayon (43-45%), flax (5-9%), and elastomeric (4-5%), weighing 125-250 g/m2, classified in subheadings 6004.10 and 6006.32 of the HTSUS.
Fabric 5: Dyed knit fabric of cotton (50-56%), acrylic (34-40%), and polyester (7-13%), classified in subheadings 6006.22 and 6006.32 of the HTSUS.
Fabric 1: Knit fleece fabric of acrylic (67-73%) and viscose (27-33%), weighing 200-280 g/m2, classified in subheading 6001.22 of the HTSUS;
Fabric 2: Dyed knit fabric of nylon (52-58%), wool (27-33%), and acrylic (12-18%), classified in subheading 6006.32 of the HTSUS;
Fabric 3: Dyed knit fabric of nylon (42-48%), viscose (37-43%), and wool (12-18%), classified in subheading 6006.32 of the HTSUS;
Fabric 4: Dyed knit fabric of nylon (41-47%), wool (18-24%), acrylic (18-24%), and mohair (11-17%), classified in subheading 6006.32 of the HTSUS; and
Fabric 6: Dyed knit fabric of polyester (57-63%), wool (27-33%), and nylon (7-13%), classified in subheading 6006.32 of the HTSUS.
CITA is soliciting public comments regarding this request, particularly with respect to whether the fabrics described above can be supplied by the U.S. domestic industry in commercial quantities in a timely manner. Comments must be received no later than January 5, 2018. Interested persons are invited to submit such comments or information electronically to
If comments include business confidential information, commenters must submit a business confidential version in hard copy to the Chairman of CITA, and also provide a public version, either in hard copy or electronically. CITA will protect any information that is marked business confidential from disclosure to the full extent permitted by law. All public versions of the comments will be posted on OTEXA's Web site for Commercial Availability proceedings under the Morocco FTA:
Committee for the Implementation of Textile Agreements (CITA).
Request for public comments concerning a request for modification of the U.S.-Morocco Free Trade Agreement (USMFTA) rules of origin for certain pants, skirts, and jackets made from certain woven fabrics.
The Government of the United States received a request from the Government of Morocco on October 10, 2017, on behalf of MODALINE HOLDING to initiate consultations under Article 4.3.3 of the USMFTA. The Government of Morocco is requesting that the United States and Morocco (“the Parties”) consider revising the rules of origin for certain pants, skirts, and jackets to address availability of supply of certain woven fabrics in the territories of the Parties. The President of the United States may proclaim a modification to the USMFTA rules of origin for textile and apparel products after the United States reaches an agreement with the Government of Morocco on a modification under Article 4.3.6 of the USMFTA to address issues of availability of supply of fibers, yarns, or fabrics in the territories of the Parties. CITA hereby solicits public comments on this request, in particular with regard to whether certain woven fabrics can be supplied by the U.S. domestic industry in commercial quantities in a timely manner.
Comments must be submitted by January 5, 2018 to the Chairman, Committee for the Implementation of Textile Agreements, Room 30003, United States Department of Commerce, Washington, DC 20230.
Maria D'Andrea-Yothers, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-1550.
The Government of the United States received a request from the Government of Morocco on October 10, 2017, on behalf of MODALINE HOLDING, requesting that the United States consider whether the USMFTA rule of origin for pants classified in HTSUS 6204.61.8010; skirts classified in HTSUS 6204.51.0010; and jackets classified in HTSUS 6204.31.2010 should be modified to allow the use of 83-94% wool/4%-15% nylon/1%-7% spandex woven fabric classified in subheading 5112.19 and 5112.20 of the HTSUS that is not originating under the USMFTA.
CITA is soliciting public comments regarding this request, particularly with respect to whether the fabrics described above can be supplied by the U.S. domestic industry in commercial quantities in a timely manner. Comments must be received no later than January 5, 2018. Interested persons are invited to submit such comments or information electronically to
If comments include business confidential information, commenters must submit a business confidential version in hard copy to the Chairman of CITA, and also provide a public version, either in hard copy or electronically. CITA will protect any information that is marked business confidential from disclosure to the full extent permitted by law. All public versions of the comments will be posted on OTEXA's Web site for Commercial Availability proceedings under the Morocco FTA:
Council of the Inspectors General on Integrity and Efficiency.
Notice of a new system of records.
The Council of the Inspectors General on Integrity and Efficiency (CIGIE) proposes to establish a system of records that is subject to the Privacy Act of 1974. Specifically, the Correspondence Tracking system of records will enable CIGIE to more efficiently track correspondence received from and sent to entities and individuals, both within and external to the Federal government. CIGIE also proposes to establish routine uses for the proposed system of records. In this notice, CIGIE provides the required information on the system of records and routine uses for such system.
This action will be effective without further notice on December 6, 2017 unless comments are received that would result in a contrary determination.
You may submit comments by any of the following methods:
•
•
•
•
•
Atticus J. Reaser, General Counsel, CIGIE, (202) 292-2600.
In 2008, Congress established CIGIE as an independent entity within the executive branch in order to address integrity, economy, and effectiveness issues that transcend individual Government agencies; and increase the professionalism and effectiveness of personnel by developing policies, standards, and approaches to aid in the establishment of a well-trained and highly skilled workforce in the offices of the Inspector General. CIGIE's membership is comprised of all Inspectors General whose offices are established under the Inspector General Act of 1978, as amended, 5 U.S.C. app, as well as the Controller of the Office of Federal Financial Management, a designated official of the Federal Bureau of Investigation, the Director of the Office of Government Ethics, the Special Counsel of the Office of Special Counsel, the Deputy Director of the Office of Personnel Management, the Deputy Director for Management of the Office of Management and Budget (OMB), and the Inspectors General of the Office of the Director of National Intelligence, Central Intelligence Agency, Library of Congress, Capitol Police, Government Publishing Office, Government Accountability Office, and the Architect of the Capitol. The Deputy Director for Management of OMB serves as the Executive Chairperson of CIGIE.
The new system of records described in this notice, CIGIE—1—Correspondence Tracking, will enable CIGIE to more efficiently track correspondence received from and sent to entities and individuals, both within and external to the Federal government. In accordance with 5 U.S.C. 552a(r), CIGIE has provided a report of this new system of records to OMB and to Congress. The new system of records reads as follows:
Correspondence Tracking—CIGIE-1.
None.
The principal location of paper records contained within the system is the headquarters of the Council of the Inspectors General on Integrity and Efficiency (CIGIE), 1717 H Street NW., Suite 825, Washington, DC 20006. Paper records within the system may also be
Executive Director, Council of the Inspectors General on Integrity and Efficiency, 1717 H Street NW., Suite 825, Washington, DC 20006.
Section 11 of the Inspector General Act of 1978, as amended, 5 U.S.C. app (IG Act); 5 U.S.C. 301; 44 U.S.C. 3101.
The information is used to track and record the incoming correspondence to determine whether the matter is appropriate for CIGIE to handle and prepare a response, whether CIGIE should refer it to another Federal agency for handling, and whether CIGIE should decline to take any action.
Individuals who submit correspondence to CIGIE, who have correspondence submitted on their behalf to CIGIE, who are the subject of correspondence to CIGIE, or who request to receive correspondence from CIGIE, as well as CIGIE employees responsible for processing, reviewing, and/or responding to such correspondence.
The system maintains information about correspondence that CIGIE receives from Members and Committees of Congress; Federal, state, and local agencies; private entities; and private citizens, regarding significant issues that do or may fall within CIGIE's jurisdiction under the IG Act. The system also contains information about responses to such correspondence, as well as referrals of the complaints/correspondence to the various Offices of Inspector General and other Federal agencies for response. The system may contain personal information relating to the sender and individuals (both public officials and private citizens) who are named in or related to the correspondence, such as names, addresses, phone numbers, and email addresses. This system does not contain all correspondence received or sent by CIGIE. For example, most routine email correspondence is not included in this system and some correspondence is maintained in other CIGIE systems of record.
The information is provided by Members and Committees of Congress; Federal, State, and local agencies; private entities; and private citizens.
In addition to those disclosures generally permitted under the Privacy Act (5 U.S.C. 552a(b)), the records or information contained in this system of records may specifically be disclosed outside of CIGIE as a routine use pursuant to the Privacy Act (5 U.S.C. 552a(b)(3)) as follows:
A. To a Member of Congress in response to an inquiry from that Member made at the request of the individual. In such cases, however, the Member's right to a record is no greater than that of the individual.
B. If the disclosure of certain records to the Department of Justice (DOJ) is relevant and necessary to litigation and is compatible with the purpose for which the records were collected, CIGIE may disclose those records to the DOJ. CIGIE may make such a disclosure if one of the following parties is involved in the litigation or has an interest in the litigation:
1. CIGIE or any component thereof; or
2. Any employee or former employee of CIGIE in his or her official capacity; or
3. Any employee or former employee of CIGIE in his or her individual capacity when the DOJ has agreed to represent the employee; or
4. The United States, if CIGIE determines that litigation is likely to affect CIGIE or any of its components.
C. If disclosure of certain records to a court, adjudicative body before which CIGIE is authorized to appear, individual or entity designated by CIGIE or otherwise empowered to resolve disputes, counsel or other representative, party, or potential witness is relevant and necessary to litigation and is compatible with the purpose for which the records were collected, CIGIE may disclose those records to the court, adjudicative body, individual or entity, counsel or other representative, party, or potential witness. CIGIE may make such a disclosure if one of the following parties is involved in the litigation or has an interest in the litigation:
1. CIGIE or any component thereof; or
2. Any employee or former employee of CIGIE in his or her official capacity; or
3. Any employee or former employee of CIGIE in his or her individual capacity when the DOJ has agreed to represent the employee; or
4. The United States, if CIGIE determines that litigation is likely to affect CIGIE or any of its components.
D. To the appropriate Federal, state, local, tribal, or foreign agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order, if the information is relevant to a violation or potential violation of civil or criminal law or regulation within the jurisdiction of the receiving entity.
E. To officials and employees of any Federal agency to the extent the record contains information that is relevant to that agency's decision concerning the hiring, appointment, or retention of an employee; issuance of a security clearance; execution of a security or suitability investigation; or classification of a job.
F. To the National Archives and Records Administration (NARA) pursuant to records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906.
G. To contractors, grantees, consultants, volunteers, or other individuals performing or working on a contract, interagency agreement, service, grant, cooperative agreement, job, or other activity for CIGIE and who have a need to access the information in the performance of their duties or activities for CIGIE.
H. To appropriate agencies, entities, and persons when: CIGIE suspects or has confirmed that there has been a breach of the system of records; CIGIE has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, CIGIE (including its information systems, programs, and operations), the Federal Government, or national security; and the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with CIGIE's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
I. To another Federal agency or Federal entity, when: CIGIE determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in responding to a suspected or confirmed breach; or preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national
J. To Federal agencies and independent certified public accounting firms that have a need for the information in order to audit the financial statements of CIGIE.
K. To an organization or an individual in the public or private sector if there is reason to believe the recipient is or could become the target of a particular criminal activity or conspiracy, or to the extent the information is relevant to the protection or life or property.
L. To officials, members, and employees of CIGIE who have need of the information in the performance of their duties.
M. To the Office of Personnel Management (OPM) in accordance with OPM's responsibility for evaluation and oversight of Federal personnel management.
N. To appropriate agencies, entities, and persons, to the extent necessary to respond to or refer correspondence.
Information in this system is maintained in paper and/or electronic form.
These records are retrieved by the name or other programmatic identifier assigned to the individual on whom they are maintained.
The information is retained and disposed of in accordance with the General Records Schedule or the CIGIE records schedule applicable to the record and/or as otherwise required by the Federal Records Act and implementing regulations. Destruction is by shredding or electronic deletion.
Paper records are located in locked file storage areas or in specified areas to which only authorized personnel have access. Electronic records are protected from unauthorized access through password identification procedures, limited access, firewalls, and other system-based protection methods.
Individuals seeking notification and access to any record contained in this system of records, or seeking to contest its content, may inquire in writing to the System Manager listed above. CIGIE has published a rule, entitled “Privacy Act Regulations,” to establish its procedures relating to access, maintenance, disclosure, and amendment of records which are in a CIGIE system of records under the Privacy Act, promulgated at 5 CFR part 9801.
See “Record Access Procedures” above.
See “Record Access Procedures” above.
None.
Council of the Inspectors General on Integrity and Efficiency.
Notice of a new system of records.
The Council of the Inspectors General on Integrity and Efficiency (CIGIE) proposes to establish a system of records that is subject to the Privacy Act of 1974. Specifically, the Integrity Committee Management System (ICMS) will enable CIGIE to track complaints made to CIGIE's Integrity Committee (IC) and information related thereto. CIGIE also proposes to establish routine uses for the proposed system of records. In this notice, CIGIE provides the required information on the system of records and routine uses for such system.
This action will be effective without further notice on December 6, 2017 unless comments are received that would result in a contrary determination.
You may submit comments by any of the following methods:
•
•
•
•
•
Atticus J. Reaser, General Counsel, CIGIE, (202) 292-2600.
In 2008, Congress established CIGIE as an independent entity within the executive branch in order to address integrity, economy, and effectiveness issues that transcend individual Government agencies; and increase the professionalism and effectiveness of personnel by developing policies, standards, and approaches to aid in the establishment of a well-trained and highly skilled workforce in the offices of the Inspector General (OIG). CIGIE's membership is comprised of all Inspectors General whose offices are established under the Inspector General Act of 1978, as amended, 5 U.S.C. app (IG Act), as well as the Controller of the Office of Federal Financial Management, a designated official of the Federal Bureau of Investigation (FBI), the Director of the Office of Government Ethics, the Special Counsel of the Office of Special Counsel, the Deputy Director of the Office of Personnel Management, the Deputy Director for Management of the Office of Management and Budget (OMB), and the Inspectors General of the Office of the Director of National Intelligence, Central Intelligence Agency, Library of Congress, Capitol Police, Government Publishing Office, Government Accountability Office, and the Architect of the Capitol. The Deputy Director for Management of OMB serves as the Executive Chairperson of CIGIE.
The IG Act established the IC in order to receive, review, and refer for investigation allegations of wrongdoing that are made against Inspectors General and certain staff members of the various OIGs. With the enactment of the Inspector General Empowerment Act of 2016 on December 16, 2016, the IG Act was amended to require the Chairperson of CIGIE to maintain the records of the IC. Previously, such records were required by the IG Act to be maintained by the official of the FBI serving in CIGIE. The new system of records described in this notice, the ICMS (CIGIE-4), will enable CIGIE to track complaints made to the IC and information related thereto. In accordance with 5 U.S.C. 552a(r), CIGIE has provided a report of this new system of records to OMB and to Congress. The new system of records reads as follows:
Integrity Committee Management System (ICMS)—CIGIE-4.
The vast majority of the information in the system is Controlled Unclassified Information. However, there is some classified information as well.
The principal location of paper records contained within the ICMS is the headquarters of the Council of the Inspectors General on Integrity and Efficiency (CIGIE), 1717 H Street NW., Suite 825, Washington, DC 20006. Records maintained in electronic form are principally located in contractor-hosted data centers in the United States. Records within the system may also be temporarily located at a Federal Bureau of Investigation (FBI) location in the system location specified in the current System of Record Notice associated with The FBI Central Records System, Justice/FBI-002. Contact the System Manager identified below for additional information.
Executive Director, Council of the Inspectors General on Integrity and Efficiency, 1717 H Street NW., Suite 825, Washington, DC 20006.
Section 11 of the Inspector General Act of 1978, as amended, 5 U.S.C. app (IG Act); Section 3 of the Inspector General Empowerment Act of 2016, Public Law 114-317, 130 Stat. 1595 (IGEA); 5 U.S.C. 301; 44 U.S.C. 3101.
CIGIE maintains this system of records in order to carry out its responsibilities pursuant to the IG Act, as further amended by section 3 of the IGEA. Pursuant to section 11(d)(1) of the IG Act, CIGIE is statutorily directed to establish the Integrity Committee (IC), which shall receive, review, refer for investigation, or otherwise act on allegations of wrongdoing that are made against Inspectors General and certain staff members of various Offices of Inspector General (OIGs), as well as the Special Counsel and Deputy Special Counsel, and make appropriate recommendations regarding confirmed or verified allegations. Furthermore, pursuant to section 11(d)(13) of the IG Act, as further amended by the IGEA, the Chairperson of CIGIE is statutorily obligated to maintain the records of the IC. Accordingly, the records in this system are used in the course of responding to complaints made to or referred to the IC, investigating individuals suspected of wrongdoing falling within the authority of the IC, referring matters to the Department of Justice (DOJ) or the Office of Special Counsel (OSC), as appropriate, and making recommendations to the President or head of the relevant agency, as appropriate.
In connection with its investigative and other duties, the IC maintains records on the following categories of individuals:
A. Individuals who relate in any manner to official IC matters, including, but not limited to, individuals who are or have been the subject, complainant, victim, witness, or close relative or associate of a subject, complainant, victim, or witness in a complaint made or referred to the IC. Such individuals include, but are not necessarily limited to, Inspectors General, the Special Counsel, the Deputy Special Counsel, and those staff members of the OIGs specified in section 11(d)(4)(B) of the IG Act, as well as other individuals identified in such complaints.
B. Individuals identified in reports of investigation and other materials received from the DOJ or the OSC pursuant to section 11(d)(7)(E) of the IG Act or received from other entities that submit materials to the IC, such as Inspectors General who conduct investigations on behalf of the IC.
C. Individuals identified in correspondence or records that are related to the general administration of the IC.
Information relating to complaints and investigations, including:
A. Letters, memoranda, and other documents describing complaints or alleged criminal, civil, or administrative misconduct.
B. Investigative files, which include reports of investigations and related exhibits, statements, affidavits, and records obtained during investigations.
C. General administrative materials, including minutes, reports, case-tracking logs, and Congressional and other correspondence.
D. Records relating to referrals and recommendations to and from external entities, including, but not limited to the DOJ, the OSC, OIGs, and others.
The subjects of investigations and inquiries; individuals and entities with which the subjects of investigations and inquiries are associated; Federal, state, local, and foreign law enforcement and non-law enforcement agencies and entities; private citizens; witnesses; complainants; and public and/or commercially available source materials.
In addition to those disclosures generally permitted under the Privacy Act (5 U.S.C. 552a(b)), the records or information contained in this system of records may specifically be disclosed outside of CIGIE as a routine use pursuant to the Privacy Act (5 U.S.C. 552a(b)(3)) as follows:
A. To a Member of Congress in response to an inquiry from that Member made at the request of the individual. In such cases, however, the Member's right to a record is no greater than that of the individual.
B. If the disclosure of certain records to the DOJ is relevant and necessary to litigation and is compatible with the purpose for which the records were collected, CIGIE may disclose those records to the DOJ. CIGIE may make such a disclosure if one of the following parties is involved in the litigation or has an interest in the litigation:
1. CIGIE or any component thereof; or
2. Any employee or former employee of CIGIE in his or her official capacity; or
3. Any employee or former employee of CIGIE in his or her individual capacity when the DOJ has agreed to represent the employee; or
4. The United States, if CIGIE determines that litigation is likely to affect CIGIE or any of its components.
C. If disclosure of certain records to a court, adjudicative body before which CIGIE is authorized to appear, individual or entity designated by CIGIE or otherwise empowered to resolve disputes, counsel or other representative, party, or potential witness is relevant and necessary to litigation and is compatible with the purpose for which the records were collected, CIGIE may disclose those records to the court, adjudicative body, individual or entity, counsel or other representative, party, or potential witness. CIGIE may make such a disclosure if one of the following parties is involved in the litigation or has an interest in the litigation:
1. CIGIE or any component thereof; or
2. Any employee or former employee of CIGIE in his or her official capacity; or
3. Any employee or former employee of CIGIE in his or her individual capacity when the DOJ has agreed to represent the employee; or
4. The United States, if CIGIE determines that litigation is likely to affect CIGIE or any of its components.
D. To the appropriate Federal, state, local, tribal, or foreign agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order, if the information is relevant to a violation or potential violation of civil or criminal law or regulation within the jurisdiction of the receiving entity, including, but not limited to, the DOJ or the OSC pursuant to section 11(d)(5) of the IG Act, as further amended by the IGEA.
E. To officials and employees of any Federal agency to the extent the record contains information that is relevant to that agency's decision concerning the hiring, appointment, or retention of an employee; issuance of a security clearance; execution of a security or suitability investigation; or classification of a job.
F. To the National Archives and Records Administration (NARA) pursuant to records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906.
G. To contractors, grantees, consultants, volunteers, or other individuals performing or working on a contract, interagency agreement, service, grant, cooperative agreement, job, or other activity for CIGIE (including, but not limited to, representatives of the DOJ and the OSC reviewing complaints made to the IC pursuant to section 11(d)(5) of the IG Act, as further amended by the IGEA, the Chief of the Public Integrity Section of the Criminal Division of the DOJ, or his designee, who serves as legal advisor to the IC, and officials at the FBI involved with the maintenance of IC-related records) and who have a need to access the information in the performance of their duties or activities for CIGIE.
H. To appropriate agencies, entities, and persons when: CIGIE suspects or has confirmed that there has been a breach of the system of records; CIGIE has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, CIGIE (including its information systems, programs, and operations), the Federal Government, or national security; and the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with CIGIE's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
I. To another Federal agency or Federal entity, when: CIGIE determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in responding to a suspected or confirmed breach; or preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
J. To Federal agencies and independent certified public accounting firms that have a need for the information in order to audit the financial statements of CIGIE.
K. To an organization or an individual in the public or private sector where there is reason to believe the recipient is or could become the target of a particular criminal activity or conspiracy, or to the extent the information is relevant to the protection or life or property.
L. To officials, members, and employees of CIGIE and members of the IC who have need of the information in the performance of their duties.
M. To any individual or entity when necessary to elicit information that will assist an IC investigation.
N. To the President or the head of a designated Federal entity, as appropriate, for resolution after assessment and final disposition of reports by the IC to the extent required to comply with section 11(d) of the IG Act or as otherwise required by law.
O. To Members of Congress and appropriate congressional committees of jurisdiction to the extent required to comply with section 11(d) of the IG Act or as otherwise required by law.
Information in this system is maintained in paper and/or electronic form.
These records are retrieved by the name or other programmatic identifier assigned to the individual on whom they are maintained.
The information is retained and disposed of in accordance with the General Records Schedule or the CIGIE records schedule applicable to the record and/or as otherwise required by the Federal Records Act and implementing regulations. Destruction is by shredding or electronic deletion.
Paper records are located in locked file storage areas or in specified areas to which only authorized personnel have access. Electronic records are protected from unauthorized access through password identification procedures, limited access, firewalls, and other system-based protection methods.
Part of this system is exempt from notification and access requirements pursuant to 5 U.S.C. 552a(j)(2), (k)(1), and (k)(2). To the extent that this system is not subject to exemption, it is subject to notification and access requirements. Individuals seeking notification and access to any record contained in this system of records, or seeking to contest its content, may inquire in writing to the System Manager listed above. CIGIE has published a rule, entitled “Privacy Act Regulations,” to establish its procedures relating to access, maintenance, disclosure, and amendment of records which are in a CIGIE system of records under the Privacy Act, promulgated at 5 CFR part 9801.
See “Record Access Procedures” above.
See “Record Access Procedures” above.
CIGIE has exempted this system of records from the following provisions of the Privacy Act pursuant to the general authority in 5 U.S.C. 552a(j)(2): 5 U.S.C. 552a(c)(3) and (c)(4); (d); (e)(1), (e)(2), (e)(3), (e)(4)(G)-(H), (e)(5), and (e)(8); (f); and (g). Additionally, CIGIE has exempted this system from the following provisions of the Privacy Act pursuant to the general authority in 5 U.S.C. 552a(k)(1) and (k)(2): 5 U.S.C. 552a(c)(3); (d); (e)(1) and (e)(4)(G)-(H); and (f). See 5 CFR part 9801.
Council of the Inspectors General on Integrity and Efficiency.
Notice of a new system of records.
The Council of the Inspectors General on Integrity and Efficiency (CIGIE) proposes to establish a system of
This action will be effective without further notice on December 6, 2017 unless comments are received that would result in a contrary determination.
You may submit comments by any of the following methods:
•
•
•
•
•
Atticus J. Reaser, General Counsel, CIGIE, (202) 292-2600.
In 2008, Congress established CIGIE as an independent entity within the executive branch in order to address integrity, economy, and effectiveness issues that transcend individual Government agencies; and increase the professionalism and effectiveness of personnel by developing policies, standards, and approaches to aid in the establishment of a well-trained and highly skilled workforce in the offices of the Inspector General. CIGIE's membership is comprised of all Inspectors General whose offices are established under the Inspector General Act of 1978, as amended, 5 U.S.C. app, as well as the Controller of the Office of Federal Financial Management, a designated official of the Federal Bureau of Investigation, the Director of the Office of Government Ethics, the Special Counsel of the Office of Special Counsel, the Deputy Director of the Office of Personnel Management, the Deputy Director for Management of the Office of Management and Budget (OMB), and the Inspectors General of the Office of the Director of National Intelligence, Central Intelligence Agency, Library of Congress, Capitol Police, Government Publishing Office, Government Accountability Office, and the Architect of the Capitol. The Deputy Director for Management of OMB serves as the Executive Chairperson of CIGIE.
The new system of records described in this notice, CIGIE—2—Freedom of Information Act—Privacy Act System, will enable CIGIE to better track and index record access requests and administrative appeals under the FOIA, as well as access, notification, and amendment requests and administrative appeals under the Privacy Act. In accordance with 5 U.S.C. 552a(r), CIGIE has provided a report of this new system of records to OMB and to Congress. The new system of records reads as follows:
Freedom of Information Act—Privacy Act System—CIGIE-2.
None.
The principal location of paper records contained within the system is the headquarters of the Council of the Inspectors General on Integrity and Efficiency (CIGIE), 1717 H Street NW., Suite 825, Washington, DC 20006. Paper records within the system may also be located at CIGIE's Inspector General Criminal Investigator Academy, Federal Law Enforcement Training Center, 384 Marana Circle, Glynco, Georgia 31524. Records maintained in electronic form are principally located in contractor-hosted data centers in the United States. Records within this system may also be located at the offices of entities performing Freedom of Information Act (FOIA), 5 U.S.C. 552, and Privacy Act of 1974 (Privacy Act), 5 U.S.C. 552a, request processing on behalf of CIGIE. Contact the System Manager identified below for additional information.
Executive Director, Council of the Inspectors General on Integrity and Efficiency, 1717 H Street NW., Suite 825, Washington, DC 20006.
Section 11 of the Inspector General Act of 1978, as amended, 5 U.S.C. app (IG Act); 5 U.S.C. 301; 5 U.S.C. 552; 5 U.S.C. 552a; 44 U.S.C. 3101.
To assist CIGIE in carrying out its responsibilities under FOIA and the Privacy Act.
Individuals who have requested access to information pursuant to FOIA or the Privacy Act; individuals who have made a request to access or correct records pertaining to themselves; persons who, on behalf of another individual, have made a request to access or correct that individual's records; and individuals whose requests and/or records have been referred to CIGIE by other agencies.
The system maintains records received, created, or compiled in processing FOIA and Privacy Act requests or appeals, including, but not limited to, correspondence or internal memoranda related to the processing of these requests and documents relevant to administrative appeals and litigation under FOIA and the Privacy Act. Records will also contain such data as the name of requester, address of requester, and subject of request.
Information is derived from the individuals and entities making requests, the records searched in the process of responding to requests, and other agencies referring requests for access to or correction of records.
In addition to those disclosures generally permitted under the Privacy Act (5 U.S.C. 552a(b)), the records or information contained in this system of records may specifically be disclosed outside of CIGIE as a routine use pursuant to the Privacy Act (5 U.S.C. 552a(b)(3)) as follows:
A. To a Member of Congress in response to an inquiry from that Member made at the request of the individual. In such cases, however, the Member's right to a record is no greater than that of the individual.
B. If the disclosure of certain records to the Department of Justice (DOJ) is relevant and necessary to litigation and is compatible with the purpose for which the records were collected, CIGIE may disclose those records to the DOJ. CIGIE may make such a disclosure if one of the following parties is involved in the litigation or has an interest in the litigation:
1. CIGIE or any component thereof; or
2. Any employee or former employee of CIGIE in his or her official capacity; or
3. Any employee or former employee of CIGIE in his or her individual
4. The United States, if CIGIE determines that litigation is likely to affect CIGIE or any of its components.
C. If disclosure of certain records to a court, adjudicative body before which CIGIE is authorized to appear, individual or entity designated by CIGIE or otherwise empowered to resolve disputes, counsel or other representative, party, or potential witness is relevant and necessary to litigation and is compatible with the purpose for which the records were collected, CIGIE may disclose those records to the court, adjudicative body, individual or entity, counsel or other representative, party, or potential witness. CIGIE may make such a disclosure if one of the following parties is involved in the litigation or has an interest in the litigation:
1. CIGIE or any component thereof; or
2. Any employee or former employee of CIGIE in his or her official capacity; or
3. Any employee or former employee of CIGIE in his or her individual capacity when the DOJ has agreed to represent the employee; or
4. The United States, if CIGIE determines that litigation is likely to affect CIGIE or any of its components.
D. To the appropriate Federal, state, local, tribal, or foreign agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order, if the information is relevant to a violation or potential violation of civil or criminal law or regulation within the jurisdiction of the receiving entity.
E. To officials and employees of any Federal agency to the extent the record contains information that is relevant to that agency's decision concerning the hiring, appointment, or retention of an employee; issuance of a security clearance; execution of a security or suitability investigation; or classification of a job.
F. To the National Archives and Records Administration (NARA) pursuant to records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906.
G. To contractors, grantees, consultants, volunteers, or other individuals performing or working on a contract, interagency agreement, service, grant, cooperative agreement, job, or other activity for CIGIE and who have a need to access the information in the performance of their duties or activities for CIGIE.
H. To any appropriate Federal, state, or local agency or entity to:
1. Permit a decision as to access, amendment or correction of records to be made in consultation with or by that agency; or
2. Verify the identity of an individual or the accuracy of information submitted by an individual who has requested access to or amendment or correction of records.
I. To NARA, Office of Government Information Services (OGIS), to the extent necessary to fulfill its responsibilities in 5 U.S.C. 552(h), to review administrative agency policies, procedures, and compliance with the FOIA, and to facilitate OGIS's offering of mediation services to resolve disputes between persons making FOIA requests and administrative agencies.
J. To appropriate agencies, entities, and persons when: CIGIE suspects or has confirmed that there has been a breach of the system of records; CIGIE has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, CIGIE (including its information systems, programs, and operations), the Federal Government, or national security; and the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with CIGIE's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
K. To another Federal agency or Federal entity, when: CIGIE determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in responding to a suspected or confirmed breach; or preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
L. To Federal agencies and independent certified public accounting firms that have a need for the information in order to audit the financial statements of CIGIE.
M. To an organization or an individual in the public or private sector if there is reason to believe the recipient is or could become the target of a particular criminal activity or conspiracy, or to the extent the information is relevant to the protection or life or property.
N. To officials, members, and employees of CIGIE who have need of the information in the performance of their duties.
O. To the Office of Management and Budget for the purpose of obtaining its advice regarding CIGIE obligations under the Privacy Act.
P. To a submitter or subject of a record or information in order to obtain assistance to CIGIE in making a determination as to access or amendment.
Q. To the DOJ Office of Information Policy for the purpose of obtaining its advice regarding CIGIE obligations under the FOIA.
Information in this system is maintained in paper and/or electronic form.
These records are retrieved by the name or other programmatic identifier assigned to the individual on whom they are maintained.
The information is retained and disposed of in accordance with the General Records Schedule or the CIGIE records schedule applicable to the record and/or as otherwise required by the Federal Records Act and implementing regulations. Destruction is by shredding or electronic deletion.
Paper records are located in locked file storage areas or in specified areas to which only authorized personnel have access. Electronic records are protected from unauthorized access through password identification procedures, limited access, firewalls, and other system-based protection methods.
Individuals seeking notification and access to any record contained in this system of records, or seeking to contest its content, may inquire in writing to the System Manager listed above. CIGIE has published a rule, entitled “Privacy Act Regulations,” to establish its procedures relating to access, maintenance, disclosure, and amendment of records which are in a CIGIE system of records under the Privacy Act, promulgated at 5 CFR part 9801.
See “Record Access Procedures” above.
See “Record Access Procedures” above.
To the extent that copies of exempt records from other systems of records
Council of the Inspectors General on Integrity and Efficiency.
Notice of a new system of records.
The Council of the Inspectors General on Integrity and Efficiency (CIGIE) proposes to establish a system of records that is subject to the Privacy Act of 1974. Specifically, the Employee-related Records System system of records will enable CIGIE to more efficiently track current, former, and prospective employee-related records. CIGIE also proposes to establish routine uses for the proposed system of records. In this notice, CIGIE provides the required information on the system of records and routine uses for such system.
This action will be effective without further notice on December 6, 2017 unless comments are received that would result in a contrary determination.
You may submit comments by any of the following methods:
•
•
•
•
•
Atticus J. Reaser, General Counsel, CIGIE, (202) 292-2600.
In 2008, Congress established CIGIE as an independent entity within the executive branch in order to address integrity, economy, and effectiveness issues that transcend individual Government agencies; and increase the professionalism and effectiveness of personnel by developing policies, standards, and approaches to aid in the establishment of a well-trained and highly skilled workforce in the offices of the Inspector General. CIGIE's membership is comprised of all Inspectors General whose offices are established under the Inspector General Act of 1978, as amended, 5 U.S.C. app, as well as the Controller of the Office of Federal Financial Management, a designated official of the Federal Bureau of Investigation, the Director of the Office of Government Ethics, the Special Counsel of the Office of Special Counsel, the Deputy Director of the Office of Personnel Management, the Deputy Director for Management of the Office of Management and Budget (OMB), and the Inspectors General of the Office of the Director of National Intelligence, Central Intelligence Agency, Library of Congress, Capitol Police, Government Publishing Office, Government Accountability Office, and the Architect of the Capitol. The Deputy Director for Management of OMB serves as the Executive Chairperson of CIGIE.
The new system of records described in this notice, CIGIE—3—Employee-related Records System, will enable CIGIE to more efficiently track current, former, and prospective employee-related records. In accordance with 5 U.S.C. 552a(r), CIGIE has provided a report of this new system of records to the OMB and to Congress. The new system of records reads as follows:
Employee-related Records System—CIGIE-3.
None.
The principal location of paper records contained within the system is the headquarters of the Council of the Inspectors General on Integrity and Efficiency (CIGIE), 1717 H Street NW., Suite 825, Washington, DC 20006. Paper records within the system may also be located at CIGIE's Inspector General Criminal Investigator Academy, Federal Law Enforcement Training Center, 384 Marana Circle, Glynco, Georgia 31524. Records maintained in electronic form are principally located in contractor-hosted data centers in the United States. Contact the System Manager identified below for additional information.
Executive Director, Council of the Inspectors General on Integrity and Efficiency, 1717 H Street NW., Suite 825, Washington, DC 20006.
Section 11 of the Inspector General Act of 1978, as amended, 5 U.S.C. app (IG Act); 5 U.S.C. 301; 44 U.S.C. 3101.
This system of records is primarily maintained to perform agency functions related to general management of CIGIE personnel, including, but not limited to, employee training, leave, attendance, and payments, including determinations relating to the amounts to be paid to employees, the distribution of pay according to employee directions (for allotments, to financial institutions, and for other authorized purposes), and for tax withholdings and other authorized deductions. The system is also used to facilitate communication between CIGIE employees, initiate personnel actions, counsel employees on their performance, and propose disciplinary action.
Current and former employees of CIGIE, individuals detailed to CIGIE, and applicants for employment at CIGIE.
This system of records includes personnel information regarding current CIGIE employees, former CIGIE employees, prospective CIGIE employees, and individuals detailed to CIGIE. Such personnel information may include: Name; addresses; telephone numbers; Social Security number; duty location; position data; time, attendance, and leave information; payroll information; awards and bonus information; professional registrations; qualifications; training history; employment history; counseling; reprimands; grievances; work assignments; and injuries.
The system's records contain but are not limited to the following information about the individual's time, attendance, and leave: The number and type of hours worked; overtime information, including compensatory or credit time earned and used; compensatory travel earned; leave requests, balances, and credits; leave charge codes; and medical records as they pertain to employee medical leave.
The system's records contain but are not limited to the following information about an individual's payroll: Marital
The system does not include records covered by government-wide systems of record, including, but not limited to, applicable government-wide systems of record established by the U.S. Office of Personnel Management (OPM), U.S. Department of Labor (DOL), U.S. Equal Employment Opportunity Commission (EEOC), General Services Administration (GSA), U.S. Merit Systems Protection Board (MSPB), U.S. Office of Government Ethics, and U.S. Office of Special Counsel (OSC). Additionally, the system does not include CIGIE current and former employee records maintained by GSA and covered by GSA's GSA/Agency-1: Employee-Related Files system of record as a result of GSA's provision of payroll and other services to CIGIE. When records in the custody of CIGIE are covered in a record system published by another Federal agency as a government-wide record system, or by GSA/Agency-1, they are considered part of that system.
The sources for the information are individuals themselves; other employees; other personnel records; Federal, State, and local agencies; private entities; and private citizens.
In addition to those disclosures generally permitted under the Privacy Act (5 U.S.C. 552a(b)), the records or information contained in this system of records may specifically be disclosed outside of CIGIE as a routine use pursuant to the Privacy Act (5 U.S.C. 552a(b)(3)) as follows:
A. To a Member of Congress in response to an inquiry from that Member made at the request of the individual. In such cases, however, the Member's right to a record is no greater than that of the individual.
B. If the disclosure of certain records to the Department of Justice (DOJ) is relevant and necessary to litigation and is compatible with the purpose for which the records were collected, CIGIE may disclose those records to the DOJ. CIGIE may make such a disclosure if one of the following parties is involved in the litigation or has an interest in the litigation:
1. CIGIE or any component thereof; or
2. Any employee or former employee of CIGIE in his or her official capacity; or
3. Any employee or former employee of CIGIE in his or her individual capacity when the DOJ has agreed to represent the employee; or
4. The United States, if CIGIE determines that litigation is likely to affect CIGIE or any of its components.
C. If disclosure of certain records to a court, adjudicative body before which CIGIE is authorized to appear, individual or entity designated by CIGIE or otherwise empowered to resolve disputes, counsel or other representative, party, or potential witness is relevant and necessary to litigation and is compatible with the purpose for which the records were collected, CIGIE may disclose those records to the court, adjudicative body, individual or entity, counsel or other representative, party, or potential witness. CIGIE may make such a disclosure if one of the following parties is involved in the litigation or has an interest in the litigation:
1. CIGIE or any component thereof; or
2. Any employee or former employee of CIGIE in his or her official capacity; or
3. Any employee or former employee of CIGIE in his or her individual capacity when the DOJ has agreed to represent the employee; or
4. The United States, if CIGIE determines that litigation is likely to affect CIGIE or any of its components.
D. To the appropriate Federal, state, local, tribal, or foreign agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order, if the information is relevant to a violation or potential violation of civil or criminal law or regulation within the jurisdiction of the receiving entity.
E. To officials and employees of any Federal agency to the extent the record contains information that is relevant to that agency's decision concerning the hiring, appointment, or retention of an employee; issuance of a security clearance; execution of a security or suitability investigation; or classification of a job.
F. To the National Archives and Records Administration (NARA) pursuant to records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906.
G. To contractors, grantees, consultants, volunteers, or other individuals performing or working on a contract, interagency agreement, service, grant, cooperative agreement, job, or other activity for CIGIE and who have a need to access the information in the performance of their duties or activities for CIGIE.
H. To appropriate agencies, entities, and persons when: CIGIE suspects or has confirmed that there has been a breach of the system of records; CIGIE has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, CIGIE (including its information systems, programs, and operations), the Federal Government, or national security; and the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with CIGIE's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
I. To another Federal agency or Federal entity, when: CIGIE determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in responding to a suspected or confirmed breach; or preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
J. To Federal agencies and independent certified public accounting firms that have a need for the information in order to audit the financial statements of CIGIE.
K. To an organization or an individual in the public or private sector if there is reason to believe the recipient is or could become the target of a particular criminal activity or conspiracy, or to the extent the information is relevant to the protection or life or property.
L. To officials, members, and employees of CIGIE who have need of the information in the performance of their duties.
M. To the OPM in accordance with OPM's responsibility for evaluation and oversight of Federal personnel management.
N. To the OPM, MSPB, Federal Labor Relations Authority, OSC, or EEOC when requested in the performance of their respective authorized duties.
O. To an individual's prospective or current employer to the extent necessary to determine employment eligibility.
P. To an authorized appeal or grievance examiner, formal complaints examiner, equal employment opportunity investigator, arbitrator, or other duly authorized official engaged in investigation or settlement of a
Information in this system is maintained in paper and/or electronic form.
These records are retrieved by the name or other programmatic identifier assigned to the individual on whom they are maintained.
The information is retained and disposed of in accordance with the General Records Schedule or the CIGIE records schedule applicable to the record and/or as otherwise required by the Federal Records Act and implementing regulations. Destruction is by shredding or electronic deletion.
Paper records are located in locked file storage areas or in specified areas to which only authorized personnel have access. Electronic records are protected from unauthorized access through password identification procedures, limited access, firewalls, and other system-based protection methods.
Individuals seeking notification and access to any record contained in this system of records, or seeking to contest its content, may inquire in writing to the System Manager listed above. CIGIE has published a rule, entitled “Privacy Act Regulations,” to establish its procedures relating to access, maintenance, disclosure, and amendment of records which are in a CIGIE system of records under the Privacy Act, promulgated at 5 CFR part 9801.
See “Record Access Procedures” above.
See “Record Access Procedures” above.
None.
Department of the Navy, DoD.
Notice of availability for licensing.
The Department of the Navy (DoN) announces the availability of the inventions listed below, assigned to the United States Government, as represented by the Secretary of the Navy, for domestic and foreign licensing by the Department of the Navy.
Requests for copies of the inventions should be directed to Naval Postgraduate School, Research and Sponsored Programs Office, NPS Code 41, 699 Dyer Road, Bldg. HA, Room 226, Monterey, CA 93943.
Ms. Deborah Buettner, Director, Research and Sponsored Programs Office, NPS Code 41, 699 Dyer Road, Bldg. HA, Room 226, Monterey, CA 93943, telephone 831-656-7893. Due to U.S. Postal delays, please fax 831-656-2038, email:
The inventions listed below are available for licensing: U.S. Patent Number 6,664,915 entitled “Identification Friend or Foe System Including Short Range UV Shield” issued on December 16, 2003; U.S. Patent Number 7,661,271 entitled “Integrated Electric Gas Turbine” issued on February 16, 2010; U.S. Patent Number 6,600,694 entitled “Digital Signal Processor Based Torpedo Counter-measure” issued on July 29, 2003; U.S. Patent Number 6,820,025 entitled “Method and Apparatus for Motion Tracking of an Articulated Rigid Body” issued on November 16, 2004; U.S. Patent Number 6,717,525 entitled “Tactical Vectoring Equipment (TVE)” issued on April 6, 2004; U.S. Patent Number 6,624,780 entitled “False Target Radar Image Generator for Countering wideband and Imaging Radars” issued on September 23, 2003; U.S. Patent Number 7,725,595 entitled “Embedded Communications System and Method” issued on May 25, 2010; U.S. Patent Number 8,443,101 entitled “Method for Identifying and Blocking Embedded Communications” issued on May 14, 2013; U.S. Patent Number 7,675,198 entitled “Inductive Pulse Forming Network for High-current, High-power Applications” issued on March 9, 2010; U.S. Patent Number 8,018,096 entitled “Inductive Pulse Forming Network for High-current, High-power Applications” issued September 13, 2011; U.S. Patent Number 7,074,697 entitled “Doping-assisted Defect Control in Compound Semiconductors” issued on July 11, 2006; U.S. Patent Number 7,089,148 entitled “Method and Apparatus for Motion Tracking of an Articulated Rigid Body” issued August 8, 2006; U.S. Patent Number 7,627,003 entitled “Automatic Clock Synchronization and Distribution Circuit for Counter Clock Flow Pipelined Systems” issued on December 1, 2009; U.S. Patent Number 8,085,817 entitled “Automatic Clock Synchronization and Distribution Circuit for Counter Clock Flow Pipelined Systems” issued December 27, 2011; U.S. Patent Number 8,019,090 entitled “Active Feedforward Noise Vibration Control System” issued September 13, 2011; U.S. Patent Number 8,064,541 entitled “Hyperphase Shift Keying” issued November 22, 2011; U.S. Patent Number 8,050,849 entitled “Method to Reduce Fuel Consumption by Naval Vessels that Operate in Mixed Propulsion Modes” issued November 1, 2011; U.S. Patent Number 8,006,937 entitled “Spacecraft Docking Interface Mechanism” issued October 12, 2010; U.S. Patent Number 7,811,918 entitled “Electric Current Induced Liquid Metal Flow and Metallic Conformal Coating of Conductive Templates” issued on August 30, 2011; U.S. Patent Number 8,467,548 entitled “Miniature Directional Sound Sensor Using Micro-Electro-Mechanical-System (MEMS)” issued on June 18, 2013; U.S. Patent Number 8,579,535 entitled “Micro-coupling Active Release Mechanism” issued on November 12, 2013; U.S. Patent Number 9,003,627 entitled “Micro-coupling Active Release Mechanism” issued on April 14, 2015; U.S. Patent Number 8,654,672 entitled “Method for Optimal Transmitter Placement in Wireless Mesh Networks” issued on February 18, 2014; U.S. Patent Number 8,473,826 entitled “Hybrid Soft Decision Hard Decision Reed-Solomon Decoding” issued June 25, 2013; U.S. Patent Number 8,433,959 entitled “Method for Determining Hard Drive Contents Through Statistical Drive Sampling” issued on April 30, 2013; U.S. Patent Number 8,446,096 entitled “Terahertz (THz) Reverse Micromagnetron” issued on May 21, 2013; U.S. Patent Number 8,624,497 entitled “Terahertz (THz) Reverse Micromagnetron” issued on January 7, 2014; U.S. Patent Number 8,724,598 entitled “Method for Energy-efficient, Traffic-adaptive, Flow-specific Medium Access For Wireless Networks” issued on May 13, 2014; U.S. Patent Number
U.S. Patent Application Number 15/188,505 filed on June 21, 2016, entitled “Method and Apparatus for Guidance and Control of Uncertain Dynamical Systems”; U.S. Patent Application Number 14/833,728 filed on August 24, 2015, entitled “Method and Apparatus for Rapid Acoustic Analysis”; U.S. Patent Application Number 14/810,026 filed on July 27, 2015, entitled “Method and Apparatus for Detection of Hazardous Environmental Conditions and Initiation of Alarm Devices”; U.S. Patent Application Number 14/883,384 filed on October 14, 2015, entitled “Wireless Signal Localization and Collection from an Airborne Symmetric Line Array Network”; U.S. Patent Application Number 14/852,734 filed on September 14, 2015, entitled “Network Monitoring Method Using Phantom Nodes”; U.S. Patent Application Number 14/939,032 filed on November 12, 2015, entitled “Method and Apparatus for Computer Vision Analysis of Spin Rate of Marked Projectiles”; U.S. Patent Application Number 15/208,784 filed on July 13, 2016, entitled “Unscented Optimization and Control Allocation”; U.S. Patent Application Number 15/082,225 filed on March 28, 2016, entitled “Automated Multi-plane Propulsion System”; U.S. Patent Application Number 15/131,733 filed on April 18, 2016, entitled “Multiple Unmanned Aerial Vehicle Launcher System”; U.S. Patent Application Number 15/137,090 filed on April 25, 2016, entitled “Device and Method for Applying Internal Pressure to a Hollow Cylinder”; U.S. Patent Application Number 15/093,047 filed on April 7, 2016, entitled “Light Activated Rotor”; U.S. Patent Application Number 15/207,128 filed on July 11, 2016, entitled “AIGaAs/GaAs Solar Cell with Back-surface Alternating Contacts (GaAs BAC Solar
35 U.S.C. 207, 37 CFR part 404.7
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Interested persons are invited to submit comments on or before December 6, 2017.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that
Institute of Education Sciences (IES), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Interested persons are invited to submit comments on or before January 5, 2018.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Tracy Rimdzius, 202-245-7283.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Environmental Protection Agency (EPA).
Notice.
EPA is holding two meetings to discuss implementation activities under the Toxic Substances Control Act as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (TSCA). The first meeting is to update and engage with the public on the Agency's progress in implementing changes to the New Chemicals Review Program as a result of the 2016 amendments to TSCA, including discussion of EPA's draft New Chemicals Decision-Making Framework. EPA will describe its review process for new chemical substances under the amended statute and interested parties will have the opportunity to provide input and to ask questions. The Agency plans to utilize the feedback it receives from the public meeting and comments received to improve policy and processes relating to the review of new chemicals under TSCA. The second meeting will focus on possible approaches for identifying potential candidate chemical substances for EPA's prioritization process under TSCA. As amended, TSCA required that EPA establish processes for prioritizing and evaluating risks from existing chemical substances. EPA will describe and take comment on a number of possible approaches that could guide the Agency in the identification of potential candidate chemical substances for prioritization.
The New Chemicals Review Program Implementation meeting will be held on December 6, 2017 from 9:00 a.m. to 5:00 p.m. The meeting regarding approaches for identifying potential candidates for prioritization will be held on December 11, 2017 from 9:00 a.m. to 5:00 p.m. EPA will accept questions from the public in advance of the meetings, and the Agency will respond to these questions at each meeting as time allows, if such questions are received by November 20, 2017 (see Unit III under
Members of the public who register to speak at either meeting may make comments and may ask additional questions. Online requests to participate in either meeting must be received on or before December 5, 2017. On-site registration will be permitted, but seating and speaking priority will be given to those who pre-register by the deadline.
To request accommodation of a disability, please contact the meetings logistics person listed under
EPA will hear oral comments at these meetings. EPA will accept written comments and materials submitted to the docket for the New Chemicals Review Program Implementation meeting on or before January 20, 2018. EPA will accept written comments and materials submitted to the docket for the meeting regarding approaches for identifying potential candidates for prioritization on or before January 25, 2018. The dockets will remain open to receive comments and materials until these dates. When submitting comments to the dockets, please be as specific as possible, and please include any supporting data or other information.
The meetings will both be held at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue NW., Washington, DC 20004. The meetings will also be available by remote access for registered participants. For further information, see Unit III under
To participate in the New Chemicals Review Program Implementation meeting on December 6 (identified by docket identification (ID) number EPA-HQ-OPPT-2017-0585) you may register online (preferred) or in person at the meeting. To register online, go to
To participate in the meeting regarding approaches for identifying potential candidates for prioritization on December 11 (identified by docket ID number EPA-HQ-OPPT-2017-0586) you may register online (preferred) or in person at the meeting. To register online, go to
Written comments, identified by the docket ID number EPA-HQ-OPPT-2017-0585 (for the New Chemicals Review Program meeting) or EPA-HQ-OPPT-2017-0586 (for the meeting regarding approaches for identifying potential candidates for prioritization), can be submitted by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets in general is available at
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including chemical manufacturers, processors and
The docket for the New Chemical Program Implementation meeting (identified by docket ID number EPA-HQ-OPPT-2017-0585) and the docket for the meeting regarding approaches for identifying potential candidates for prioritization (identified by docket ID number EPA-HQ-OPPT-2017-0586) are available at
The Frank R. Lautenberg Chemical Safety for the 21st Century Act, amending the Toxic Substances Control Act of 1976, was signed into law on June 22, 2016. The amendments have enhanced EPA's authority to evaluate chemical substances.
EPA's New Chemicals Review Program has and will continue to support innovation while managing potential risks to human health and the environment from chemical substances new to the marketplace. Under section 5 of TSCA, anyone who plans to manufacture (including import) a new chemical substance for a non-exempt commercial purpose is required to provide EPA with notice before initiating the activity.
Additionally, EPA must also be notified before chemical substances are manufactured or processed for a use that the Agency has designated, by rule, as a significant new use. Under the amended law, EPA is now required to make one of several determinations regarding whether the new use or new chemical presents an unreasonable risk of injury to health or the environment, whether there is insufficient information to allow for a reasoned evaluation of the health and environmental effects of the chemical substance, or whether the substance is produced in substantial quantities and may either enter into the environment in substantial quantities or have significant or substantial human exposure.
The amended statute has resulted in significant changes for both the EPA's New Chemicals Review Program and those manufacturers submitting notices prior to commercialization. EPA has worked to keep stakeholders informed of its efforts to implement the statutory changes and will continue this dialogue during the meeting on December 6, 2017. Information obtained during this meeting and collected in the docket will be considered as the Agency works to increase efficiency in its review process under TSCA. An agenda for the meeting and supporting materials will be made available in the docket and on the Agency's Web site in advance of the meeting.
TSCA, as amended, also required that EPA establish procedures for prioritizing and evaluating risks from existing chemical substances. EPA announced its final procedures on June 22, 2017 (see
The purpose of the second meeting is to describe and take comment on a number of possible approaches that could guide the Agency in the identification of potential candidate chemical substances for prioritization. More information on these possible approaches will be made available in the docket and on EPA's Web site prior to the meeting. EPA is fully committed to further dialogue on best practices for these activities, and to carrying out these activities in a transparent, science-based manner, to ensure successful implementation of the prioritization and risk evaluation processes required by section 6 of TSCA.
Additional information on the TSCA amendments can be found at
The meetings will both be accessible remotely for registered participants. Registered participants will receive information on how to connect to the meetings prior to their start.
Members of the public may register to attend either or both the New Chemicals Review Program Implementation meeting and or the meeting regarding approaches for identifying potential candidates for prioritization as observers and may also register to provide oral comments and ask questions on the day of the respective meetings, using one of the registration methods described under
To attend the meetings in person or to receive remote access, you must register online no later than December 5, 2017, using one of the methods described under
Members of the public may register to attend as observers or to speak if planning to offer oral comments during the scheduled public comment periods. To register for the meetings online, you must provide your full name, organization or affiliation, and contact information.
15 U.S.C. 2601
Federal Communications Commission.
Notice.
In this document the Incentive Auction Task Force and the Media Bureau of the Federal Communications Commission (Commission) announce the issuance of an initial allocation of the TV Broadcaster Relocation Fund (Fund) in the amount of $1 billion to begin to reimburse eligible television broadcasters and multichannel video programming distributors (MVPDs), for reasonably incurred expenses related to the post-incentive auction repacking.
November 6, 2017.
Raphael Sznajder at (202) 418-1648 or
The Spectrum Act requires the Commission to “reimburse costs reasonably incurred” by broadcast television licensees that are involuntarily reassigned to new channels as a result of the repacking process and by MVPDs in order to continue carrying the signals of licensees reassigned to new channels as a result of the incentive auction and repacking process (together, Eligible Entities). The
The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the
S
By Order of the Federal Maritime Commission.
Administration for Native Americans, ACF, HHS.
Issuance of final policies.
Administration for Native Americans (ANA) is issuing final interpretive rules, general statements of policy and rules of agency organization, procedure, or practice relating to the following six proposed FY2018 Funding Opportunity Announcements (FOAs): Environmental Regulatory Enhancement (HHS-2018-ACF-ANA-NR-1344); Native American Language Preservation and Maintenance—Esther Martinez Immersion (HHS-2018-ACF-ANA-NB-1343); Native American Language Preservation and Maintenance (HHS-2018-ACF-NA-NL-1342); Social and Economic Development Strategies (HHS-2018-ACF-ANA-NA-1339); Social and Economic Development Strategies—Alaska (HHS-2018-ACF-ANA-NK-1340); and Native Youth Initiative for Leadership, Empowerment, and Development (HHS-2018-ACF-ANA-NC-1341).
The policies described in the Notice for Public Comment (NOPC), as amended in this notice if applicable, are effective immediately upon publication of this notice.
Carmelia Strickland, Director, Division of Program Operations, Administration for Native Americans, (877) 922-9262,
Section 814 of the Native American Programs Act of 1974 (NAPA), as amended, requires ANA to provide notice and allow for comment on its proposed interpretive rules and general statements of policy. On August 14, 2017, ANA published a NOPC with proposed policy and program clarifications for the FY 2018 FOAs. ANA also follows the ACF Tribal Consultation Policy, and sent a Dear Tribal Leader letter informing tribes of the NOPC and made them aware of the September 15 deadline for comment submission. This Notice responds to comments regarding ANA's August 14, 2017, NOPC (82 FR 37861) and the tribal consultation afforded through the Dear Tribal Leader letter issued August 14, 2017. In addition, this notification includes a clarification in a new administrative policy, a modification to the project start date for Native Language programs, and a notification regarding the application period for FY 2018 FOAs.
ANA published a NOPC in the
ANA did not receive any feedback on the FOA changes from tribal governments. ANA received one response to the NOPC from the Sisseton-Wahpeton Oyate Dakotah Language Institute. Comments expressed concerns or made suggestions about some of the changes. ANA considered the comments and determined there to be none that required changes to any of the FOAs. The following includes comments from the Sisseton-Wahpeton Oyate Dakotah Language Institute and responses provided by ANA:
When changing the application criteria, please make the changes effective two grant cycles from the adoption date. Sometimes the application due dates are changed because there are upcoming changes to the Funding Opportunity Announcement and a comment period has to be allowed. And then, the grant start dates are pushed back and then the entire timeline developed in the project planning is no longer applicable.
Each hour spent on a grant application is one less hour that can be spent working on our endangered language, especially for a small program like ours. A more accurate Paperwork Reduction Notice may have weight in deciding whether it is actually worth it to invest the amount of time it takes to complete the process with very little chance of success.
If you are putting in new terms that are common terms to those working in a federal program accepting grant applications, please make sure the new terms are adequately explained. How can a person comment about changing from “results” and “benefits” to
ANA has edited the description of this policy since it was published in the
Prioritized Funding for Community-based Native American Organizations:
ANA reserves the right to prioritize funding to community-based Native American organizations serving their local communities and populations. Applications from non-local, national, and regional organizations that propose projects to serve multiple communities, or to be performed in a different geographic location, must clearly demonstrate that the need for the project was originated by the each community being served, and that the community and/or tribal government supports the proposed project. They must also describe how each community was selected, identify and describe the intended beneficiaries, demonstrate community involvement in the development of the project, and discuss a community-based delivery strategy for the project. The proposed project goals, objectives, and outcomes must address goals of the community being served. National and regional organizations must describe their membership, and define how the organization operates. The type of community to be served will determine the type of documentation necessary to support the project.
Through continued discussions with ANA grantees and stakeholders, ANA has determined that moving the start date from August 1 to July 1 for projects funded under the Native Language Preservation and Maintenance and the Native Language Esther Martinez Immersion programs will align reporting requirements to reduce the number of required federal financial reports, thereby reducing the reporting burden for grantees. In addition, an earlier start date will provide projects with additional time for planning and start up prior to the start of the school year, which marks the beginning of instruction for many Native Language projects. Therefore, ANA intends to implement a July 1 start date for all projects funded under the Native Language Preservation and Maintenance and Native Language Esther Martinez Immersion FOAs for FY 2018.
ANA would like to notify potential applicants that the open application period to respond to FOAs has been updated to a minimum of 60 days to support the timely award of new grants.
For information on the types of projects funded by ANA, please refer to ANA's Web site for information on our program areas and FOAs:
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry and review staff entitled “Formal Dispute Resolution: Sponsor Appeals Above the Division Level.” This guidance provides recommendations for industry and review staff on the procedures in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for resolving scientific and/or medical disputes between CDER or CBER and sponsors that cannot be resolved at the division level. This guidance describes the formal dispute resolution procedures for sponsors that wish to appeal a scientific and/or medical issue to the office or center level and provides a structured process for resolving disputes. This guidance finalizes the revised draft guidance entitled “Formal Dispute Resolution: Appeals Above the Division Level” issued September 9, 2015, and replaces the guidance of the same name issued February 2000.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances 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.”
• 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
You may submit comments on any guidance at any time (see 21 CDR 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, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Khushboo Sharma, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6486, Silver Spring, MD 20993-0002, 301-796-0700; or, Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is announcing the availability of a guidance for industry and review staff entitled “Formal Dispute Resolution: Sponsor Appeals Above the Division Level.” During the course of review of an investigational new drug application, new drug application, biologics license application, or abbreviated new drug application, a wide variety of important scientific and/or medical issues are considered that are central to product development. Sometimes, a sponsor may disagree with the Agency on a matter, and a dispute arises. Because these disputes often involve complex scientific and/or medical matters, it is critical to have procedures in place to help ensure open and prompt discussion. The procedures and policies described in this guidance are intended to promote rapid and fair resolution of scientific and/or medical disputes between a sponsor and CDER or CBER.
This guidance finalizes the revised draft guidance entitled “Formal Dispute Resolution: Appeals Above the Division Level” issued September 9, 2015, and replaces the guidance of the same name issued February 2000. Based on the docket comments for the revised draft guidance, FDA made clarifications to this guidance. The guidance was also clarified to reflect that it describes the formal dispute resolution procedures only for sponsors that wish to appeal a scientific and/or medical issue regarding their applications regulated by CDER or CBER and does not apply to other individuals or entities. In addition, the guidance was updated to reflect the changes under the 2017 reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA) regarding timelines for reviewing disputes involving drug applications covered by GDUFA.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on formal dispute resolution requests for appeals above the division level. 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.
This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in this guidance have been approved under OMB control number 0910-0430. This guidance finalizes a revision of an earlier version of the guidance. This version contains no additional information collections; therefore, it continues to be covered under OMB control number 0910-0430.
Persons with access to the internet may obtain the guidance at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by December 6, 2017.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Under section 403A(b) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343-1(b)), States may petition FDA for exemption from Federal preemption of State food labeling and standard-of-identity requirements. Section 100.1(d) (21 CFR 100.1(d)) sets forth the information a State is required to submit in such a petition. The information required under § 100.1(d) enables FDA to determine whether the State food labeling or standard-of-identity requirement satisfies the criteria of section 403A(b) of the FD&C Act for granting exemption from Federal preemption.
In the
FDA estimates the burden of this collection of information as follows:
The reporting burden for § 100.1(d) is minimal because petitions for exemption from preemption are seldom submitted by States. In the last 3 years, we have received one new petition for exemption from preemption; therefore, we estimate that one or fewer petitions will be submitted annually.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled “ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence).” FDA is revising the draft guidance because, after issuance of the original draft guidance, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) was amended by the FDA Reauthorization Act of 2017, which resulted in changes to the pre-submission of facility information. Pre-submitting facility information enables the Agency to determine whether inspection of a facility is necessary and, if so, to begin inspection planning in advance of an abbreviated new drug application (ANDA) receipt.
Submit either electronic or written comments on the draft guidance by February 5, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit either electronic or written comments concerning the collection of information proposed in the draft guidance by January 5, 2018.
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.”
• 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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Nikhil Thakur, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 4161, Silver Spring, MD 20993, 301-796-5536.
FDA is announcing the availability of a revised draft guidance for industry entitled “ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence).” The first draft of this document, entitled “ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions,” was issued pursuant to 21 CFR 10.115 in June 2017. The docket number has not changed since the first draft of this document was issued, and it is not necessary to resubmit comments already submitted to the docket. The Agency will consider comments submitted with respect to the first draft of this document in finalizing the revised document.
The Agency is issuing this revised draft guidance to describe the process through which prospective generic drug applicants submit facility information in advance of an original ANDA, prior approval supplement (PAS), PAS amendment, or ANDA amendment (hereafter collectively referred to as ANDA). FDA is revising the draft guidance because, after issuance of the original draft guidance, section 505(j)(11) of the FD&C Act (21 U.S.C. 355(j)(11)) as added by section 801 of the FDA Reauthorization Act of 2017 (FDARA) resulted in changes to the pre-submission of facility information.
In 2016 and 2017, FDA, regulated industry, and public stakeholders conducted negotiations concerning reauthorization of the Generic Drug User Fee Amendments (GDUFA II). A chief product of these congressionally mandated discussions was the “GDUFA Reauthorization Performance Goals and Program Enhancements, FYs 2018-2022” (GDUFA II Commitment Letter) available at:
On August 18, 2017, FDARA, which reauthorized the Generic Drug User Fee Amendments (Title III) as well as other provisions related to generic drugs (Title VIII), was signed into law. In particular, section 801 of the FDARA added section 505(j)(11) to the FD&C Act to address priority review of generic drugs. One of the enhancements specified in both Title VIII, section 801 of FDARA, and the GDUFA II Commitment Letter is a mechanism to enable a shorter review goal (priority review goal) for certain priority original ANDAs, PASs, PAS amendments, and ANDA amendments through the pre-submission of facility information, including sections of the ANDA determined to be relevant by FDA. Specifically, this guidance describes:
• The content and format of the facility information that should be submitted to enable FDA's assessment of facilities listed in the pre-submission.
• Timeframes for pre-submitting sections of the ANDA containing complete, accurate information, and the intersection of these timeframes with submission of the ANDA.
• The possible outcomes of the Agency's assessment of pre-submitted ANDA sections containing facility information.
• When and how the Agency notifies an applicant about the status of the pre-submitted ANDA sections containing facility information.
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 ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence). 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.
Under the Paperwork Reduction Act of 1995 (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 comment 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 draft guidance document refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the PRA. Existing regulations at 21 CFR 314.94 provide the content and format of an ANDA, and consistent with GDUFA II, this draft guidance describes the relevant sections of an ANDA that should be submitted as part of the pre-submission of facility information. The information collections associated with the submission of these ANDA sections are approved under OMB control number 0910-0001.
There are information collections proposed in the draft guidance that are not already addressed under the approved control numbers covering ANDA submissions. Section IV of the draft guidance describes the information that should be included in the pre-submission of facility information to enable FDA's facility assessment:
A. The planned ANDA pre-assigned number to be submitted with the pre-submission, which the applicant must request from FDA before submitting the pre-submission;
B. Cover letter accompanying the pre-submission, which includes a statement of justification for the expedited review request, a statement of inspection readiness, a statement identifying the Reference Listed Drug, and the anticipated date of the applicant's ANDA submission; and
C. Certification statement to be submitted with the applicant's ANDA stating either that the applicant has made no changes to the pre-submitted facility information, or that the only change was made to exclude a facility as described in 505(j)(11)(B) of the FD&C Act. (Changes other than those permitted under 505(j)(11)(B) of the FD&C Act should be identified in the ANDA cover letter. The applicant will also need to confirm the accuracy of the information provided in the Form FDA 356h submitted with the ANDA, and update accordingly.)
Section VI of the draft guidance describes the format used to submit the pre-submission of facility information, which is the electronic Common Technical Document (eCTD) format. Further, as explained in section V of the draft guidance, the pre-submission must be submitted not later than 60 days prior to the planned ANDA submission.
We estimate that a total of approximately 220 applicants (“number of respondents” in table 1) will submit annually approximately 275 pre-submissions as described above and in the draft guidance (“total annual responses” in table 1). We estimate that preparing and submitting the portion of each pre-submission that is not already addressed under approved control numbers covering ANDA submissions will take approximately 1.1 hours (“average burden per response” in table 1). This includes time spent preparing and submitting a cover letter accompanying the pre-submission of facility information. We estimate that approximately 10 percent of applicants will submit statements notifying the Agency that the applicant has decided not to submit an ANDA, and we have incorporated the estimated time to prepare and submit such a statement in table 1.
We estimate that approximately 198 applicants will submit annually approximately 248 certifications (“total annual responses” in table 1) verifying either that the applicant has made no changes to the pre-submitted facility information, or that the only change was made to exclude a facility as described in 505(j)(11)(B) of the FD&C Act. We estimate that preparing and submitting each certification will take approximately 4 hours (“average burden per response” in table 1).
We base our estimates for the number of applicants and the number of pre-submissions on information from our database of annual ANDA submissions, on the criteria set forth in the Agency's Manual of Policies and Procedures 5240.3,
Persons with access to the internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or 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 5, 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 5, 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
Ila Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
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 Agency regulations and associated guidance. Specifically, section 403(r)(6) of the FD&C Act (21 U.S.C. 343(r)(6)) requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have substantiation that the claim is truthful and not misleading. A nutritional deficiency claim states a benefit related to a classical nutrient deficiency disease and states how often the disease occurs in the United States. A structure/function claim describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or characterizes how a nutrient or dietary ingredient acts to maintain such structure or function. A general well-being claim describes general well-being from consumption of a nutrient or dietary ingredient.
The guidance document entitled “Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act” provides our recommendations to manufacturers about the amount, type, and quality of evidence they should have to substantiate a claim under section 403(r)(6) of the FD&C Act. The guidance does not discuss the types of claims that can be made concerning the effect of a dietary supplement on the structure or function of the body, nor does it discuss criteria to determine when a statement about a dietary supplement is a disease claim. The guidance document is intended to assist manufacturers in their efforts to comply with section 403(r)(6) of the FD&C Act. Persons with access to the internet may obtain the guidance at
Dietary supplement manufacturers collect the necessary substantiating information for their product as required by section 403(r)(6) of the FD&C Act. The guidance provides information to manufacturers to assist them in doing so. The recommendations contained in the guidance are voluntary. Dietary supplement manufacturers will only need to collect information to substantiate their product's nutritional deficiency, structure/function, or general well-being claim if they choose to place a claim on their product's label.
The standard discussed in the guidance for substantiation of a claim on the labeling of a dietary supplement is consistent with standards set by the Federal Trade Commission for dietary supplements and other health-related products that the claim be based on competent and reliable scientific evidence. This evidence standard is broad enough that some dietary supplement manufacturers may only need to collect peer-reviewed scientific journal articles to substantiate their claims; other dietary supplement manufacturers whose products have properties that are less well documented may have to conduct studies to build a body of evidence to support their claims. It is unlikely that a dietary supplement manufacturer will attempt to make a claim when the cost of obtaining the evidence to support the claim outweighs the benefits of having the claim on the product's label. It is likely that manufacturers will seek substantiation for their claims in the scientific literature.
The time it takes to assemble the necessary scientific information to support their claims depends on the product and the claimed benefits. If the product is one of several on the market making a particular claim for which there is adequate publicly available and widely established evidence supporting the claim, then the time to gather supporting data will be minimal; if the product is the first of its kind to make a particular claim or the evidence supporting the claim is less publicly available or not widely established, then gathering the appropriate scientific evidence to substantiate the claim will be more time consuming.
FDA estimates the burden of this collection of information as follows:
We have retained the currently approved burden estimate for the information collection. Based on our experience with the collection, we estimate that it will take 44 hours to assemble information needed to substantiate a claim on a particular dietary supplement when the claim is widely known and established. We believe it will take closer to 120 hours to assemble supporting scientific information when the claim is novel or when the claim is preexisting but the scientific underpinnings of the claim are not widely established. These are claims that may be based on emerging science, where conducting literature searches and understanding the literature takes time. It is also possible that references for claims made for some dietary ingredients or dietary supplements may primarily be found in foreign journals and in foreign languages or in the older, classical literature where it is not available on computerized literature databases or in the major scientific reference databases, such as the National Library of Medicine's literature database, all of which increases the time of obtaining substantiation.
In the
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.
Fish and Wildlife Service, Interior.
Notice of availability; request for comments.
We, the U.S. Fish and Wildlife Service (Service), have received an application from Phillips 66 Pipeline, LLC for an incidental take permit under the Endangered Species Act of 1973, as amended. The permit would authorize take of the federally endangered California tiger salamander (Santa Barbara distinct population segment), incidental to otherwise lawful activities associated with the Phillips 66 Line 300 Project draft low-effect habitat conservation plan. We invite public comment.
Written comments should be received on or before December 6, 2017.
•
•
Rachel Henry, Fish and Wildlife Biologist, 805-677-3312 (phone), or at the Ventura address in
We have received an application from Phillips 66 Pipeline, LLC (applicant) for an incidental take permit under the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
The Santa Barbara distinct population segment (DPS) of the California tiger salamander was listed by the Service as endangered on September 21, 2000 (65 FR 57242). Section 9 of the ESA and its implementing regulations prohibit the “take” of fish or wildlife species listed as endangered or threatened. “Take” is defined under the ESA to include the following activities: “[T]o harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct” (16 U.S.C. 1532); however, under section 10(a)(1)(B) of the ESA, we may issue permits to authorize incidental take of listed species. “Incidental take” is defined by the ESA as take that is incidental to, and not the purpose of, carrying out of an otherwise lawful activity. Regulations governing incidental take permits for threatened and endangered species are in the Code of Federal Regulations (CFR) at 50 CFR 17.32 and 17.22, respectively. Under the ESA, protections for federally listed plants differ from the protections afforded to federally listed animals. Issuance of an incidental take permit also must not jeopardize the existence of federally listed fish, wildlife, or plant species. The permittee would receive assurances under our “No Surprises” regulations (50 CFR 17.22(b)(5) and
The applicant has applied for a permit for incidental take of the California tiger salamander. The potential take will occur in association with activities necessary for the reconditioning of approximately 2,430 linear feet of the existing 300 Line. The site includes 2.9 acres of suitable upland habitat for the California tiger salamander. The HCP includes avoidance and minimization measures for the covered species and mitigation for unavoidable loss of occupied upland habitat through the purchase of mitigation credits at a Service-approved conservation bank.
The Service has made a preliminary determination that issuance of the incidental take permit is neither a major Federal action that will significantly affect the quality of the human environment within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4321
If you wish to comment on the permit application, draft HCP, and associated documents, you may submit comments by one of the methods in
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public view, we cannot guarantee that we will be able to do so.
We provide this notice under section 10 of the ESA (16 U.S.C. 1531
National Park Service, Interior.
Notification of boundary revision.
Notice is hereby given that the boundary of the Obed Wild and Scenic River is modified to include an additional 63.01 acres of land identified as Tract 101-63. The tract is located north of the Obed River and south of Hardwick Road in Morgan County, Tennessee. The boundary revision is depicted on Map No. 179/135,074 dated April 2017.
The date of this boundary revision is November 6, 2017.
The map is available for inspection 8 a.m. to 4 p.m. at the following locations: National Park Service, Southeast Region Land Resources Program Center, 1924 Building, 100 Alabama Street SW., Atlanta, Georgia 30303 and National Park Service, Department of the Interior, Washington, DC 20240.
National Park Service, Jeannie Whitler, Acting Chief, Southeast Region Land Resources Program Center, 1924 Building, 100 Alabama Street SW., Atlanta, Georgia 30303, telephone 404-507-5657.
Specifically, 54 U.S.C. 100506(c)(1) provides that, after notifying the House Committee on Natural Resources and the Senate Committee on Energy and Natural Resources, the Secretary of the Interior is authorized to make this boundary revision upon publication of notice in the
Bureau of Reclamation, Interior.
Notice of intent; request for comments.
The Sonoma County Water Agency, acting as administrator for the North Bay Water Reuse Authority and the lead State agency, and the Bureau of Reclamation, the lead Federal agency, will prepare a joint Environmental Impact Report/Environmental Impact Statement for Phase 2 of the North Bay Water Recycling Program. The purpose of the Phase 2 Program is to build upon the existing regional wastewater reuse network developed under the Program's Phase 1 to provide additional opportunities for recycled water for agricultural, urban, and environmental uses as an alternative to discharging treated wastewater to San Pablo Bay.
Submit written comments on the scope of the Environmental Impact Report/Environmental Impact Statement (EIR/EIS) on or before December 6, 2017.
Send written comments on the scope of the EIR/EIS to Anne Crealock, Sonoma County Water Agency, 404 Aviation Boulevard, Santa Rosa, CA 95403, or email to
Ms. Anne Crealock, Sonoma County Water Agency, at (707) 547-1948, or via email at
Recognizing the continuing need for an integrated and regional approach to water management, wastewater and potable water agencies in the North San Pablo Bay region of California have joined together to propose expansion of existing recycled water use in the region. The North Bay Water Reuse Authority (NBWRA), established under a Memorandum of Understanding (MOU) in August 2005, now comprises 11 wastewater and potable water utilities as members, and associate
NBWRA developed the regional North Bay Water Recycling Program for expanding cooperative water reuse within the North San Pablo Bay region. The SCWA, as the California Environmental Quality Act (CEQA) Lead Agency and the Bureau of Reclamation (Reclamation), as the Lead Agency under the National Environmental Policy Act (NEPA), completed a Draft EIR/EIS for Phase 1 of the North Bay Water Recycling Program Project (Phase 1 Project). SCWA certified the EIR in December 2009. Reclamation released a Final EIS in June 2010 and signed a Record of Decision in January 2011 for the Phase 1 Project. Reclamation provided funding assistance for Phase 1 under of Title XVI of Public Law 102-575, which provides a mechanism for Federal participation and cost-sharing in approved water reuse projects.
The Phase 2 Program now proposed by NBWRA seeks to increase the beneficial use of recycled water in the North Bay Region beyond Phase 1. Reclamation may also provide funding assistance under Title XVI of Public Law 102-575. The proposed Phase 2 Program would consist of distribution facilities, treatment capacity improvements, and storage (seasonal and operational) to make between 5,039 and 6,516 acre-feet per year of recycled water available for environmental, agricultural, and municipal reuse, consistent with the California Code of Regulations, Title 22, pertaining to the use of tertiary-treated recycled water.
At this time, there are no known Indian trust assets or environmental justice issues associated with the Proposed Action.
NBWRA filed a Notice of Preparation (California State Clearinghouse no. 2017072051) on July 20, 2017, pursuant to the California Environmental Quality Act (CEQA) (P.R.C. section 21092, C.C.R. section 15082) and held four public scoping meetings in August 2017. To avoid duplication with State and local procedures, we plan to use the scoping process initiated by NBWRA under CEQA. No additional public scoping meetings are planned at this time. However, Reclamation will fully consider all input received on this notice of intent. The CEQA Notice of Preparation is available at
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Self-Anchoring Beverage Containers,
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at
General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission (USITC) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Mighty Mug, Inc. on October 31, 2017. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of self-anchoring beverage containers. The complaint names as respondents Calvert Retail, Inc. of Montchanin Mills, DE; U.S. Imprints, Inc. of Franklin, TN; RushKing Promotions, Inc. of Brooklyn, NY; GOImprints, Inc. of Franklin, TN; Artful Home, Inc. of Madison, WI; Swag Brokers, LLC of Phoenix, AZ; 4AllPromos, Inc. of Centerbrook, CT; Hirsch Gift, Inc. of Houston, TX; Telebrands, Corp. of Fairfield, NJ; Sunrise Gifts, Inc. of Orlando, FL; Sunrise Gifts and Souvenirs, Inc. of Foley, AL; Motivators, Inc. of Westbury, NY; AnyPromo.com, Inc. of Ontario, CA; Quality Logo Products, Inc. of Aurora, IL; and Shenzhen Smartop Industrial Co., Ltd. of China. The complainant requests that the Commission issue an exclusion order and cease and desist orders.
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) Identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) Identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) Indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) Explain how the requested remedial orders would impact United States consumers.
Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3271”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
United States International Trade Commission.
November 8, 2017 at 11:00 a.m.
Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1.
2. Minutes.
3. Ratification List.
4. Vote in Inv. Nos. 731-TA-1387-1391 (Preliminary) (Polyethylene Terephthalate (PET) Resin from Brazil, Indonesia, Korea, Pakistan, and Taiwan). The Commission is currently scheduled to complete and file its determinations on November 13, 2017; views of the Commission are currently scheduled to be completed and filed on November 20, 2017.
5.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at
General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission (USITC) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Netlist, Inc. on October 31, 2017. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain memory modules and components thereof. The complaint names as respondents SK hynix Inc. of Korea; Sk hynix America Inc. of San Jose, Ca; and Sk hynix memory solutions Inc. of San Jose, CA. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders, and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) Identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) Identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) Indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) Explain how the requested remedial orders would impact United States consumers.
Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3272”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
United States International Trade Commission.
November 9, 2017 at 9:30 a.m.
Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1.
2. Minutes.
3. Ratification List.
4. Vote in Inv. Nos. 701-TA-588 and 731-TA-1392-1393 (Preliminary) (Polytetrafluoroethylene (PTFE) Resin from China and India). The Commission is currently scheduled to complete and file its determinations on November 13, 2017; views of the Commission are currently scheduled to be completed and filed on November 20, 2017.
5.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission:
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
Also, Applied Medical Device Institute (aMDI)—Grand Valley State University, Grand Rapids, MI; Aptus, LLC, Clemson, SC; Ellipsis Technologies, Inc., Greenville, SC; Johns Hopkins University, Baltimore, MD; Longeveron LLC, Miami, FL; Lovelace Biomedical and Environmental Research Institute, Albuquerque, NM; MicroCures, Inc., Santa Cruz, CA; New York Institute of Technology, Old Westbury, NY; NGT-VC 2012 Limited Partnership (NGT3), Nazareth, ISRAEL; and Otologic Pharmaceutics Inc., Oklahoma City, OK, 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 MTEC intends to file additional written notifications disclosing all changes in membership.
On May 9, 2014, MTEC 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 23, 2017. A notice was published in the
On August 19, 2016, the former Acting Administrator issued an Order to Show Cause and Immediate Suspension of Registration to ChipRX, L.L.C., d/b/a City Center Pharmacy (hereinafter, Registrant), of Hamlin, West Virginia. The Show Cause Order proposed the revocation of Registrant's DEA Certificate of Registration and the denial of any pending application to renew or modify its registration, on the ground that its “continued registration is inconsistent with the public interest.” Show Cause Order, at 1 (citing 21 U.S.C. 824(a)(4) and 823(f)).
As to the Agency's jurisdiction, the Show Cause Order alleged that Registrant is registered as a pharmacy with authority to dispense schedule II-V controlled substances under Registration No. FC3015915, at the registered address of 8119 Court Avenue, Hamlin, West Virginia.
As to the substantive grounds for the proceeding, the Show Cause Order alleged that Registrant is owned by George “Chip” Chapman and Summer Chapman, and that George Chapman is Registrant's Pharmacist-in-Charge (PIC).
With respect to the interview of PIC Chapman, the Show Cause Order alleged that he made various material false statements to the Investigators.
The Show Cause Order then alleged that in a subsequent interview conducted on July 22, 2016, Chapman “admitted that during the past year, he diverted oxycodone or hydrocodone pills equivalent to ‘200-300 mg every day,’ a total of approximately 25,000 pills.”
The Show Cause Order also alleged that from January 12, 2015
In addition to the above, the Show Cause Order alleged that Chapman “repeatedly deleted [p]harmacy video surveillance footage of his unlawful removal of controlled substances from the [p]harmacy,” that “Chapman frequently exhibits signs of impairment or intoxication while at work,” and that “[w]hile impaired, [he] has incorrectly filled prescriptions.”
Next, the Show Cause Order alleged that “[d]espite knowing . . . that DEA was actively investigating” his pharmacy, Chapman diverted oxycodone and other drugs “on least [five] occasions between June 30, 2016 and August 5, 2016.”
The Show Cause Order further alleged that “Chapman was hospitalized for complications related to overdose on at least three recent occasions, including . . . on approximately April 6, 2016, June 17, 2016, and July 18, 2016.”
Finally, the Show Cause Order alleged that “[o]ther [p]harmacy personnel have seen . . . Chapman using marijuana via [a] vaporizer while working at” Registrant.
Based on his “preliminary finding that controlled substances were diverted from [Registrant] on numerous occasions in connection with serious misconduct involving concealment, falsification of inventory records, circumvention of security controls, and misuse of [its] [r]egistration to order controlled substances for purposes other than the conduct of lawful business or professional practice,” the former Acting Administrator concluded that Registrant's registration “is inconsistent with the public interest.”
The Show Cause Order notified Registrant of its right to request a hearing on the allegations or to submit a written statement while waiving its right to a hearing, the procedures for electing either option, and the consequence of failing to elect either option.
According to the Government, since the date of service of the Order, Registrant has neither requested a hearing nor submitted a written statement while waiving its right to a hearing. Request for Final Agency Action, at 1-2. Based on the Government's representation, I find that more than 30 days have now passed and Registrant has neither requested a hearing nor submitted a written statement while waiving its right to a hearing. I therefore find that Registrant has waived its right to a hearing or to submit a written statement and issue this Decision and Order based on reliable and probative evidence submitted by the Government.
Registrant is a limited liability company organized under the laws of West Virginia; it owns and operates City Center Pharmacy, a retail pharmacy located at 8119 Court Avenue, Hamlin, West Virginia. GX1; GX 3, at 1.
Registrant previously held DEA Certificate of Registration No. FC3015915, pursuant to which it was authorized to dispense controlled substances in schedules II through V as a retail pharmacy at the above address. GX 1. This registration expired on August 31, 2017.
In 2009, Chapman, who was then employed at a hospital pharmacy, was convicted of a misdemeanor offense of embezzling controlled substances from his employer and placed on probation.
In June 2016, a DEA Diversion Investigator (DI) assigned to the Charleston, West Virginia Resident Office received “multiple tips” that George Chapman “often appeared impaired at work.” GX 3, at 2. The DI initiated an investigation and determined that Chapman had previously pled guilty in state court “to embezzling and abusing approximately 800 hydrocodone and oxycodone pills from approximately June through October 2009.”
The DI obtained an Administrative Inspection Warrant (AIW), and on June 30, 2016, he, accompanied by other Investigators, executed the AIW at Registrant.
The DI further stated that during the inspection, “several [p]harmacy [employees] uniformly reported to [him] that . . . Chapman regularly came to work impaired” and “[s]everal employees also reported that pills were regularly missing from the [p]harmacy during the last year.”
One pharmacy employee told the DI that on occasions when a “per diem [p]harmacist” was working at Registrant, Chapman came to the pharmacy, “asked to use” the employee's computer, after which he “open[ed] the locked cabinet” in which the oxycodone was kept and [took] a 100 count wholesale bottle of oxycodone 15 mg” out of the cabinet, then “went to his office” and subsequently “left the pharmacy.”
The same employee told the DI “that the [p]harmacy regularly experiences inventory losses” and had been experiencing them “for more than a year.”
The employee further told the DI that Chapman was impaired at work on an almost daily basis and that he would “spend the majority of his day asleep in his office.”
According to the DI, following the AIW, the same employee “reported to [him] multiple other instances where . . . Chapman had stolen oxycodone” from Registrant; the employee stated that these incidents occurred on July 18 and 23, as well as August 3, 2016.
During the AIW, the DI also interviewed Chapman. GX 3, at 3. During the interview, Chapman stated that the “[p]harmacy had destroyed approximately 70 Percocet pills sometime in the past and that . . . he had adjusted the `inventory book' so that the records would reflect the physical inventory.”
During the interview, “Chapman denied that he was abusing prescriptions drugs” and stated “that his fill-in pharmacists were previous drug abusers he had hired from a West Virginia Pharmacy Board facilitated drug rehabilitation program.”
During the June 30 interview, Chapman also admitted that he “us[ed] marijuana illegally.”
On July 19, 2016, the DI and a TFO served a search warrant on the Cabell-Huntington Hospital for Chapman's records.
According to the DI, he queried the West Virginia Prescription Monitoring Program (PMP) to determine what prescriptions Chapman had been issued. GX 3, at 5. The query showed that “Chapman had filled prescriptions for Tramadol and one prescription for hydrocodone in March 2016.”
On July 21, 2016, the DI received another report from a pharmacy employee that Chapman had again taken oxycodone from the pharmacy.
On July 23, 2016, the DI received another report from the employee that Chapman had taken drugs from the pharmacy, in particular, a 100-count bottle of oxycodone.
The DI also attempted to conduct an audit of the pharmacy.
The DI also obtained a search warrant for the pharmacy's video surveillance records; these videos were submitted as part of the record.
Finally, the DI stated that “[i]f Chapman had been candid about his role in the diversion of controlled substances during the June 30 AIW, I and my DEA colleagues would have pursued immediate criminal action against Chapman. We would also have been able to take additional steps—including seeking immediate administrative sanctions—to prevent additional diversion of controlled substances from the [p]harmacy.”
As found above, the registration at issue in this proceeding expired on August 31, 2017. According to the registration records of the Agency, Chapman has not filed either a renewal application or a new application for the pharmacy. Accordingly, there is neither a registration to revoke nor an application to act upon.
While ordinarily these facts would render this proceeding moot,
Under section 824(f), “[u]pon a revocation order becoming final, all such controlled substances” which have been seized or placed under seal “shall be forfeited to the United States” and “[a]ll right, title, and interest in such controlled substances shall vest in the United States upon a revocation order becoming final.” 21 U.S.C. 824(f). DEA has previously held that a registrant, who has been issued an immediate suspension order, cannot defeat the effect of this provision by allowing its registration to expire.
Under the CSA, “[a] registration pursuant to section 823 of this title to manufacture, distribute, or dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render [its] registration under section 823 of this title inconsistent with the public interest as determined under such section.” 21 U.S.C. 824(a)(4). In the case of a retail
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing or conducting research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
“[T]hese factors are . . . considered in the disjunctive.”
Also, pursuant to section 824(d), “[t]he Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to the public health or safety.” 21 U.S.C. 824(d)(1). Congress has defined “the phrase `imminent danger to the public health or safety' [to] mean[ ] that, due to the failure of the registrant to maintain effective controls against diversion or otherwise comply with the obligations of a registrant under [the CSA], there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration.”
Under the Agency's regulation, “[a]t any hearing for the revocation or suspension of a registration, the Administration shall have the burden of proving that the requirements for such revocation or suspension pursuant to . . . 21 U.S.C. 824(a) . . . are satisfied.” 21 CFR 1301.44(e). In this matter, I have considered all of the factors and find that the Government's evidence with respect to factors four and five,
In its Request for Final Agency Action, the Government did not address the applicability of Factor Two (the Registrant's experience in dispensing controlled substances) to the various acts of misconduct that were alleged and proved. As explained in this Decision, the record establishes that Registrant engaged in the unlawful distribution of controlled substances and committed various recordkeeping violations. These acts of misconduct are relevant in assessing both Registrant's compliance with applicable laws related to controlled substances as well as its experience in dispensing controlled substances.
As found above, the evidence shows that Chapman, Registrant's PIC, was diverting narcotic controlled substances from the pharmacy's stock for his own misuse. This evidence includes: (1) The videos showing him unlocking the cabinet in which controlled substances were stored, removing a bottle of medication, and leaving the pharmacy; (2) the statements of a pharmacy employee to the DI as to various instances in which oxycodone went missing, including the July 18, 2016 incident, when he passed out at his desk and was hospitalized; (3) the UDS results for the various hospitalizations including the July 18, 2016 positive result for oxycodone (which was also positive for cocaine); (4) his subsequent admission to Investigators during the July 21, 2016 interview that he had been diverting 200 to 300 milligrams every day of oxycodone or hydrocodone for approximately one year; (5) the DI's finding that at least 20,000 dosage units of oxycodone 30 mg and hydrocodone 10 mg could not be accounted for; and (6) the DI's statement that his query of the state PMP showed that Chapman had filled only prescriptions for tramadol and one hydrocodone prescription in March 2016.
Under the Controlled Substances Act, it is “unlawful for any person knowingly or intentionally to possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, from a practitioner, while acting in the course of his professional practice, or except as otherwise authorized by this subchapter.” 21 U.S.C. 844(a). While Chapman, as the PIC of a registered pharmacy, was authorized to order controlled substances for the pharmacy and to possess controlled substances in his capacity as the Registrant's PIC, he was generally authorized to do so only for the purpose of dispensing the controlled substances to patients “pursuant to the lawful order of a practitioner,”
The evidence also shows that Registrant (and Chapman) violated the CSA by failing maintain “a complete and accurate” record of each such [controlled] substance . . . received, sold, delivered or otherwise disposed of . . . .” 21 U.S.C. § 827(a)(3). Specifically, Chapman admitted that he shredded invoices from suppliers.
Moreover, Chapman admitted that he destroyed both schedule II order forms and CSOS (Controlled Substance Ordering System) electronic records. Chapman's admission establishes that Registrant violated 21 U.S.C. 828(c)(2), which requires that a purchaser of a schedule II controlled substance retain a duplicate copy of a DEA Order Form “if such order is accepted” by a supplier and “preserve such duplicate for a period of two years and make it available for inspection or copying.” Chapman's admission also establishes that Registrant violated section 828(c)(2) by failing to maintain CSOS records.
Thus, the evidence with respect to Registrant's compliance with applicable laws related to controlled substances establishes that Registrant committed numerous violations of the CSA by unlawfully distributing controlled substances to Chapman in violation of 21 U.S.C. 841(a)(1); it also shows that Registrant and Chapman violated the recordkeeping provisions of 21 U.S.C. 827(a)(3), as well as provisions requiring the maintenance of schedule II order forms. 21 U.S.C. 828(a)(2). Finally, the evidence also shows that Registrant's principal and PIC violated 21 U.S.C. 844(a) by obtaining controlled substances other than by means “pursuant to a valid prescription . . . from a practitioner, while acting in the course of his professional practice, or except as otherwise authorized by” the CSA.
The Agency has also long held that self-abuse of a controlled substance constitutes such other conduct which may threaten public health and safety.
The Government also alleged that Chapman made several materially false statements to agency Investigators. As recognized by the Sixth Circuit,”[c]andor during DEA investigations, regardless of the severity of the violations alleged, is considered by the DEA to be an important factor when assessing whether a [practitioner's] registration is consistent with the public interest.”
As the Supreme Court has explained, a false statement is material if it “ `has a natural tendency to influence, or was capable of influencing the decision of the decisionmaking body to which it was addressed.' ”
The evidence establishes that Chapman made several materially false statements to the Investigators. First, Chapman told the Investigators during the June 30, 2016 interview that “10 to 15 oxycodone or hydrocodone pills would be missing from the [p]harmacy . . . perhaps 15-20 times in the prior year” and that Registrant had “a total loss of perhaps 300 oxycodone and hydrocodone pills.” Second, during the June 30, 2016 interview, Chapman “denied that he was abusing prescription drugs” and attributed the diversion to fill-in pharmacists he employed who were previous drug abusers and were hired through a State Board rehabilitation program. He also “denied knowing anything further about the nature of the [p]harmacy's losses” of controlled substances.
Chapman's statements regarding the scope of the diversion of drugs from Registrant were false because the diversion was far more extensive than what he claimed during the June 30 interview, as he ultimately admitted during the July 22, 2016 interview, when he acknowledged diverting 200 to 300 milligrams per day of oxycodone or hydrocodone for personal use. So too, his statements during the June 30 interview in which he denied that he was abusing drugs, as well as that he knew anything further about the nature of the pharmacy's losses, were also false as he ultimately admitted during the July 22 interview that he was abusing narcotic prescription drugs and was diverting large quantities on a daily basis.
I further conclude that these statements were capable of influencing the decisionmaking process of the Agency because Chapman attempted to minimize the scope of the criminal conduct that was occurring at
Accordingly, I conclude that the evidence with respect to Factor Five establishes that Registrant's principal was abusing controlled substances and that he made several materially false statements to DEA investigators. I also conclude that these acts constitute actionable misconduct which may threaten public health and safety.
As found above, the Government's evidence establishes that Registrant unlawfully distributed controlled substances to Chapman and failed to maintain required records. The evidence also establishes that Registrant's principal and pharmacist in charge unlawfully possessed controlled substances, destroyed records that Registrant was required to maintain, abused controlled substances and made materially false statements to DEA Investigators. I therefore find that Registrant has committed such acts as to render its registration inconsistent with the public interest. 21 U.S.C. 824(a)(4).
For purposes of the imminent danger inquiry, these findings also support the conclusion that Registrant has “fail[ed] . . . to maintain effective controls against diversion or otherwise comply with the obligations of a registrant under” the CSA. 21 U.S.C. 824(d)(2). Also, the evidence that Chapman was diverting 200 to 300 milligrams of narcotics per day, which he then abused (along with the evidence showing that he was hospitalized for an overdose on multiple occasions), establishes that there was “a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance [would] occur in the absence of the immediate suspension of [Registrant'] registration.”
Pursuant to 21 U.S.C. 824(f), “[u]pon a revocation order becoming final, all . . . controlled substances” seized pursuant to a suspension order “shall be forfeited to the United States” and “[a]ll right, title, and interest in such controlled substances shall vest in the United States upon a revocation order becoming final.” As the Agency has previously held, a registrant cannot defeat the effect of this provision by allowing its registration to expire.”
Accordingly, I will order that the controlled substances seized pursuant to the Immediate Suspension Order be forfeited to the United States. 21 U.S.C. 824(f). I will also declare that “[a]ll, right, title, and interest in” the controlled substances that were seized pursuant to the Suspension Order have vested in the United States.
Pursuant to the authority vested in me by 21 U.S.C. 824(a) and (d), as well as 28 CFR 0.100(b), I order that the Order of Immediate Suspension issued to Chip RX d/b/a City Center Pharmacy be, and it hereby is, affirmed. Pursuant to the authority vested in me by 21 U.S.C. 824(f), I order that all controlled substances seized pursuant to the Order of Immediate Suspension be, and they hereby are, forfeited to the United States. Pursuant to the authority vested in me by 21 U.S.C. 824(f), I also declare that all right, title, and interest in all controlled substances seized pursuant to the Order of Immediate Suspension be, and they hereby are, vested in the United States. This Order is applicable December 6, 2017.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 5, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on May 23, 2017, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665-2402 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacture small quantities of the listed controlled substances to make reference standards which will be distributed to its customers.
National Aeronautics and Space Administration (NASA).
Notice of Centennial Challenges 3D-Printed Habitat Challenge Phase 3: On-Site Habitat Competition.
The 3D-Printed Habitat (3DPH) Challenge Phase 3 On-Site Habitat Competition is open, and teams that wish to compete may now register. Centennial Challenges is a program of prize competitions to stimulate innovation in technologies of interest and value to NASA and the nation. The 3DPH Challenge Phase 3 On-Site Habitat Competition is a prize competition with a $2,000,000 total prize purse to develop and demonstrate capabilities to autonomously manufacture through 3D-printing technologies a habitat on another planetary body using mission recycled materials and/or local indigenous materials. The Phase 3 competition consists of 5 levels. This technology demonstration competition has great potential value for terrestrial applications.
Challenge registration opens November 7, 2017, and will remain open until February 15, 2018. Early and Late registrations are available with discount or late fee respectively. Competitors will be allowed the option to participate in the Virtual Construction competitions levels 1 & 4 only with a reduced registration fee.
Other important dates:
The Level 5 On-Site Subscale Habitat Head-to-Head challenge competition will take place at: Caterpillar Edwards Demonstration and Learning Center, 5801 N. Smith Rd., Edwards, IL 61528.
To register for or get additional information regarding the 3D Printed Habitat Challenge, please visit:
The 3DPH Challenge Phase 3 Competition (On-Site Habitat) follows earlier phases of the Challenge as described below.
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The current competition, Phase 3 (On-Site Habitat), will focus on the technology for autonomous 3D-printing and construction of a complete 1:3 sub-scale habitat (~10 m
A Phase 4 competition (Full-Scale Habitat), calling for the development of an autonomous 3D-printed construction of a full-scale habitat (~93 m
The 3D Printed Habitat Challenge Phase 3 On-Site Habitat Competition purse is $2,000,000 (two million dollars) to be disbursed as follows:
These awards will be made based on scoring, as articulated in the competition rules.
To be eligible to win a prize, competitors must:
(1) Register and comply with all requirements in the rules and Team Agreement;
(2) In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States; and
(3) Not be a Federal entity or Federal employee acting within the scope of their employment.
The complete rules for the 3D-Printed Habitat Challenge Phase 3 competition can be found at:
This notice is issued in accordance with 51 U.S.C. 20144(c).
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The meeting will be held for the purpose of soliciting, from the scientific community and other persons, scientific and technical information relevant to program planning.
Tuesday, November 28, 2017, 8:30 a.m.-5:00 p.m.; and Wednesday, November 29, 2017, 8:30 a.m.-12:00 p.m., Local Time.
NASA Headquarters, MIC-5A (Room 5H41-A), 300 E Street SW., Washington, DC 20546.
Ms. KarShelia Henderson, Science Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-2355, fax (202) 358-2779, or
The meeting will be open to the public up to the capacity of the room. This meeting will also be available telephonically and by WebEx. You must use a touch-tone phone to participate in this meeting. Any interested person may dial the toll free number 1-888-592-9603 or toll number 1-312-470-7407, passcode 5588797, on both days, to participate in this meeting by telephone. The WebEx link is
National Credit Union Administration (NCUA).
Notice and request for comment.
The National Credit Union Administration (NCUA), as part of a continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the following renewal of a currently approved collection, as required by the Paperwork Reduction Act of 1995.
Written comments should be received on or before January 5, 2018 to be assured 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 or telephone 703-548-2279.
By Gerard Poliquin, Secretary of the Board, the National Credit Union Administration, on November 1, 2017.
9:30 a.m., Tuesday, November 28, 2017
NTSB Conference Center, 429 L'Enfant Plaza SW., Washington, DC 20594.
The one item is open to the public.
57233 Highway Accident Report—
Telephone: (202) 314-6100.
The press and public may enter the NTSB Conference Center one hour prior to the meeting for set up and seating.
Individuals requesting specific accommodations should contact Rochelle McCallister at (202) 314-6305 or by email at
The public may view the meeting via a live or archived webcast by accessing a link under “News & Events” on the NTSB home page at
Schedule updates, including weather-related cancellations, are also available at
Candi Bing at (202) 314-6403 or by email at
Terry Williams at (202) 314-6100 or by email at
Weeks of November 6, 13, 20, 27, December 4, 11, 2017.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
There are no meetings scheduled for the week of November 6, 2017.
There are no meetings scheduled for the week of November 13, 2017.
There are no meetings scheduled for the week of November 20, 2017.
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of December 4, 2017.
This meeting will be webcast live at the Web address—
The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0681 or via email at
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or email
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The November 8, 2017 comment due date applies to Docket Nos. CP2018-37; CP2018-38; CP2018-39; MC2018-18 and CP2018-40; MC2018-19 and CP2018-41.
The November 9, 2017 comment due date applies to Docket Nos. CP2016-128 and CP2017-77.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's Web site (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.
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This notice will be published in the
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 31, 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 31, 2017, it filed with the Postal Regulatory Commission a
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The proposal would add new Rule 37 (Segregated Accounts for Customer Property) to provide that a Participant
In its filing with the Commission, DTC 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. DTC has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The proposal would add new Rule 37 (Segregated Accounts for Customer Property) to provide that a Participant or Pledgee may establish a specifically designated Account to which Eligible Securities may be credited that the Participant or Pledgee wishes to segregate as Customer Property subject to the Customer Property Segregation Rules. Based on this segregation structure and the representations and warranties made by the Participant or Pledgee under the proposed Rule, DTC would, upon the request of the Participant or Pledgee, provide an acknowledgment of the segregation of such Customer Property, as further described below.
DTC maintains omnibus Accounts for its Participants and Pledgees.
Participants, in many cases, are themselves securities intermediaries, maintaining securities accounts for the benefit of their customers, crediting a portion of the amount of any issue of a Security held in their Account(s) to one or more customers, as securities entitlements of their customers against them. That is, their customers are entitlement holders, holding the rights and property interest represented by the amount of the security credited to their account(s) vis a vis the Participant. Some customers of a Participant may also be securities intermediaries, holding on behalf of, and maintaining securities accounts for, their own customers, and so forth. DTC does not know whether a Participant is holding interest in the Securities for itself or on behalf of its customers, as their securities intermediary.
This tiered system of intermediaries holding interests in securities for their respective customers is generally described as the “indirect holding
The Rules provide for Segregated Accounts that Participants have typically used to separate Securities held for their customers. The characteristics of a Segregated Account are, chiefly, that DTC has no lien on or claim to the Securities credited thereto to secure any obligation of the Participant to DTC.
The Rules also provide that Securities Pledged to a Pledgee (when credited to the Account of the Pledgee in a Free Pledge or, in a Pledge Versus Payment), are held free of any lien or other interest of DTC.
If a Participant or Pledgee holds Segregated or Pledged Securities on behalf of customers, that would be reflected in the accounts maintained by the Participant or Pledgee for its customers. DTC has no knowledge of whether Securities credited in that manner are held by the Participant or Pledgee for customers. It is the sole responsibility of the Participant or Pledgee to maintain appropriate records on its own books to identify customer Securities separately.
Because DTC is agnostic as to whether, when and how any Participant or Pledgee may be utilizing its Account for the benefit of customers, DTC cannot independently verify that any particular Securities are “customer securities”
The Customer Property Segregation Rules require that each FCM and DCO separately account for, and segregate from its own proprietary funds, all money, securities, or other property deposited by futures customers
Each Acknowledgment Letter must be executed in the form specified in the Customer Property Segregation Rules with no additions, deletions or modifications permitted.
(1) That the FCM/DCO has opened or will open the subject account for the purpose of depositing, Customer Property, as required by Customer Property Segregation Rules, including Regulation 1.20, as amended;
(2) that the Customer Property held by the depository after being deposited into the subject account will be separately accounted for and segregated on the depository's books from the FCM/DCO's own funds and from any other funds or accounts held by the FCM/DCO in accordance with the Customer Property Segregation Rules;
(3) that such Customer Property may not be used by the depository or by the FCM/DCO to secure or guarantee any obligations that the FCM/DCO might owe the depository, and they may not be used by FCM/DCO to secure or obtain credit from the depository; and
(4) that the Customer Property in the subject account shall not be subject to any right of offset or lien for or on account of any indebtedness, obligations or liabilities the FCM/DCO has or may have owing to the depository.
An FCM Acknowledgment Letter has additional examination, connectivity, and information requirements.
DTC would, pursuant to the proposed rule change, establish an Account type that a Participant or Pledgee could use to segregate its Customer Property and provide DTC with the representations needed in order for DTC to execute FCM and DCO Acknowledgment Letters for such Accounts, as may be requested. Because DTC does not have independent knowledge of whether a Participant or Pledgee is utilizing an
The proposed rule change would add Rule 37 to the Rules, to provide for:
(1) The establishment and maintenance by a Participant or Pledgee that is a DCO or FCM (respectively, “DCO Party” and “FCM Party”) of one or more segregated Accounts (respectively, a “Segregated DCO Account” or “Segregated FCM Account”) for the purpose of holding interests in Customer Property;
(2) credits to and debits from Segregated DCO Accounts and Segregated FCM Accounts in the manner otherwise provided by in the Rules and Procedures;
(3) the representation of each DCO Party to DTC:
i. That the only interests in property that such DCO Party shall cause or allow to be credited to its Segregated DCO Account (or Accounts) shall be interests in Deposited Securities that constitute Customer Property;
ii. that interests in Customer Property credited to its Segregated DCO Account (or Accounts) shall not be used by such DCO Party to secure or otherwise guarantee any obligations that such DCO Party might owe to DTC;
iii. that interests in Customer Property credited to its Segregated DCO Account (or Accounts) shall not be subject to any right of offset or lien for or on account of any indebtedness, obligations or liabilities that such DCO Party may have owing to DTC; and
iv. that DTC shall be entitled to rely on the representations of such DCO Party in connection with any acknowledgment that DTC may be required to provide to such DCO Party and/or the CFTC pursuant to the Customer Property Segregation Rules or for any other purpose;
(4) the representation of each FCM Party to DTC:
i. That the only interests in property that such FCM Party shall cause or allow to be credited to its Segregated FCM Account (or Accounts) shall be interests in Deposited Securities that constitute Customer Property;
ii. that interests in Customer Property credited to its Segregated FCM Account (or Accounts) shall not be used by such FCM Party to secure or otherwise guarantee any obligations that such FCM Party might owe to DTC;
iii. that interests in Customer Property credited to its Segregated FCM Account (or Accounts) shall not be subject to any right of offset or lien for or on account of any indebtedness, obligations or liabilities that such FCM Party may have owing to DTC; and
iv. that DTC shall be entitled to rely on the representations of such FCM Party in connection with any acknowledgment that DTC may be required to provide to such FCM Party and/or the CFTC pursuant to the Customer Property Segregation Rules or for any other purpose;
(5) the representation of DTC to each DCO Party that interests in Customer Property credited to the Segregated DCO Account (or Accounts) of such DCO Party:
i. May not be used by DTC to secure or guarantee any obligations that such DCO Party might owe to DTC;
ii. may not be used by such DCO Party to secure or obtain credit from DTC; and
iii. shall not be subject to any right of offset or lien for or on account of any indebtedness, obligations or liabilities such DCO Party may have owing to DTC; provided, however, that this prohibition does not affect the right of DTC to recover funds advanced in the form of cash transfers, lines of credit, repurchase agreements or other liquidity arrangements DTC makes in lieu of liquidating non-cash assets held in the Segregated DCO Account (or Accounts) of such DCO Party or in lieu of converting cash held in the Segregated DCO Account (or Accounts) of such DCO Party to cash in a different currency;
(6) the representation of DTC to each FCM Party that interests in Customer Property credited to the Segregated FCM Account (or Accounts) of such FCM Party:
i. May not be used by DTC to secure or guarantee any obligations that such FCM Party might owe to DTC;
ii. may not be used by such FCM Party to secure or obtain credit from DTC; and
iii. shall not be subject to any right of offset or lien for or on account of any indebtedness, obligations or liabilities such FCM Party may have owing to DTC; provided, however, that this prohibition does not affect the right of DTC to recover funds advanced in the form of cash transfers, lines of credit, repurchase agreements or other liquidity arrangements DTC makes in lieu of liquidating non-cash assets held in the Segregated FCM Account (or Accounts) of such FCM Party or in lieu of converting cash held in the Segregated FCM Account (or Accounts) of such FCM Party to cash in a different currency;
(7) DTC's disclaimer of liability:
i. To any DCO Party or FCM Party as a result of DTC acting on an instruction from such DCO Party or FCM Party to credit to or debit from interests in Customer Property from a Segregated DCO Account or Segregated FCM Account, respectively;
ii. to any DCO Party or FCM Party as a result of (x) any loss or liability suffered or incurred by such DCO Party or FCM Party arising out of or relating to the matters subject to proposed Rule 37, unless caused directly by the gross negligence or willful misconduct of DTC or by a violation of Federal securities law by DTC for which there is a private right of action, or (y) any force majeure, market disruption or technical malfunction that prevents DTC from performing its obligations to such DCO Party or FCM Party pursuant to proposed Rule 37; and
iii. to any third party (including without limitation any customer of any DCO Party or FCM Party) for any reason; and a provision stating that in the event of a conflict between proposed Rule 37 and the provisions of any other Rule, the provisions of Proposed Rule 37 would govern.
The proposed rule change would be implemented 30 days after the date of filing, or such shorter time as the Commission may designate.
DTC believes that the proposed rule change is consistent with the requirements of the Act, and the rules and regulations thereunder applicable to DTC, in particular section 17A(b)(3)(F) of the Act
Section 17A(b)(3)(F) of the Act requires,
Rule 17Ad-22(e)(21) requires,
DTC does not believe that the proposed rule change would have any impact, or impose any burden, on competition because the proposed Rule and its features would be available to all Participants and Pledgees equally on a non-discriminatory basis. Participants and Pledgees will be charged fees applicable to the maintenance of Accounts and transaction fees that are not different from established published fees.
DTC has not solicited and does not intend to solicit comments regarding the proposed rule change. DTC has not received any unsolicited written comments from interested parties. To the extent DTC receives written comments on the proposed rule change, DTC will forward such comments to the Commission.
Because the foregoing proposed rule change does not:
(i) Significantly affect the protection of investors or the public interest;
(ii) impose any significant burden on competition; and
(iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-DTC-2017-020 and should be submitted on or before November 27, 2017.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to section 19(b)(1)
The Exchange proposes to modify representations made in proposed rule changes previously filed with the Securities and Exchange Commission (“Commission”) regarding Exchange calculation of the “Intraday Indicative Value” (or comparable intra-day value) for specified exchange-traded products. 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.
Exchange rules relating to listing of certain exchange-traded products (“ETPs”) require that an “Intraday Indicative Value” (“IIV”) or comparable intra-day value be disseminated at least every 15 seconds during the Exchange's Core Trading Session as defined in Rule 7.34-E (a) (normally 9:30 a.m. to 4:00 p.m. Eastern Time).
The Exchange proposes to revise the representations made in the Exhibit 3 Filings that state that the Exchange will calculate the IIV for a particular ETP to state that the IIV will be calculated and widely disseminated by one or more major market data vendors. This proposed change is consistent with representations the Exchange has made in other filing [sic] relating to ETP listings.
The basis under the Act for this proposed rule change is the requirement under section 6(b)(5)
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. The Exchange's proposal to revise the representations made in the Exhibit 3 Filings that state that the Exchange will calculate the IIV for a particular ETP to state that the IIV will be calculated and widely disseminated by one or more major market data vendors is consistent with representations the Exchange has made in other filings relating to ETP listings.
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 [sic] of the Act. The Exchange believes the proposed rule change will enhance competition among ETP issuers by providing each issuer with additional flexibility to change its IIV calculation agent promptly based on business needs.
No written comments were solicited or received with respect to the proposed rule change.
Because the proposed rule change does not (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, the proposed rule change has become effective pursuant to section 19(b)(3)(A) of the Act
The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Commission believes that waiver of the 30-day operative delay is consistent with the protection of investors and the public interest because it will allow ETP issuers for the Exhibit 3 Filings to choose to use a calculation agent other than the Exchange, provided that such IIV is calculated and widely disseminated by
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On July 27, 2011, the Securities and Exchange Commission (“Commission”) adopted Rule 13h-1 (“Rule 13h-1” or the “Rule”) under the Securities Exchange Act of 1934 (“Exchange Act”)
The Financial Information Forum (“FIF”) and Securities Industry and Financial Markets Association (“SIFMA,” and, together with FIF, the “Industry Organizations”) have asked the Commission to eliminate Phase Three of the Rule, which would impose the remaining requirements on all broker-dealers and all large trader customers.
For the reasons discussed below, the Commission believes that it is consistent with the purposes of the Exchange Act to grant a limited extension of the compliance date for Phase Three by temporarily exempting broker-dealers until November 15, 2018 from the recordkeeping and reporting obligations of the Rule that would otherwise have been implemented in Phase Three on November 1, 2017. As discussed below, the Commission approved the Consolidated Audit Trail (“CAT NMS Plan”)
Rule 13h-1 defines a large trader as a person who “directly or indirectly, including through other persons controlled by such person, exercises investment discretion over one or more accounts and effects transactions for the purchase or sale of any National Market System (NMS) security for or on behalf of such accounts, by or through one or more registered broker-dealers, in an aggregate amount equal to or greater than the
The Rule requires large traders to self-identify to the Commission on Form 13H and to periodically update their Form 13H submission,
Under Rules 13h-1(d) and (e), registered broker-dealers are responsible for, among other things, maintaining records of certain transaction information and information relating to Unidentified Large Traders and then reporting such information to the Commission upon request. Specifically, Rule 13h-1 requires that every registered broker-dealer maintain records of information specified in paragraphs (d)(2) and (d)(3) of the Rule (“Transaction Data”), including, among other things, the applicable LTID(s) and execution time of each trade, for all transactions effected directly or indirectly by or through: (1) An account such broker-dealer carries for a large trader or an Unidentified Large Trader; or (2) if the broker-dealer is a large trader, any proprietary or other account over which such broker-dealer exercises investment discretion. Additionally, where a non-broker-dealer carries an account for a large trader or an Unidentified Large Trader under the Rule, the broker-dealer effecting transactions directly or indirectly for such large trader or Unidentified Large Trader must maintain records of all Transaction Data.
The Rule also requires that, upon Commission request, every registered broker-dealer that is itself a large trader or carries an account for a large trader or an Unidentified Large Trader must electronically report Transaction Data to the Commission through the Electronic Blue Sheets (“EBS”) system for all transactions effected directly or indirectly by or through accounts carried by such broker-dealer for large traders or Unidentified Large Traders equal to or greater than the reporting activity level.
Rule 13h-1(f) provides a safe harbor that is designed to reduce broker-dealers' recordkeeping and reporting burdens with respect to Unidentified Large Traders by, among other things, providing relief for when a broker-dealer shall be deemed to know or have reason to know that a person is a large trader and thus subject to reporting obligations related to Unidentified Large Traders under Rule 3h-1. Under the safe harbor, a registered broker-dealer is deemed not to know or have reason to know that a person is a large trader if the broker-dealer does not have actual knowledge that a person is a large trader and it establishes policies and procedures reasonably designed to identify customers whose transactions effected through an account or group of accounts carried by such broker-dealer or through which such broker-dealer executes transactions, as applicable, equal or exceed the identifying activity level and, if so, to treat such persons as Unidentified Large Traders and notify them of their potential reporting obligations under this Rule.
When the Commission adopted the Rule, it characterized the large trader reporting requirements as “relatively modest steps” to “address the Commission's near-term need for access to more information about large traders and their trading activities. . . .”
In Phase One, which began on November 30, 2012, the Commission temporarily exempted from the Recordkeeping and Reporting Responsibilities all broker-dealers, except clearing brokers for large traders (including the large trader itself if it is a self-clearing broker-dealer), with respect to large trader transactions that were either (1) proprietary trades by a U.S. registered broker-dealer, or (2) effected through a “sponsored access” arrangement.
Phase Three, scheduled to commence on November 1, 2017, would require compliance with the entirety of the Recordkeeping and Reporting Responsibilities for all broker-dealers, covering the remaining types of large traders and transactions not covered by Phases One and Two.
The Commission adopted Rule 613 to create a CAT that would allow regulators to more efficiently and accurately track activity in NMS securities.
When the Commission adopted Rule 613 it stated that, while certain aspects of Rule 13h-1 are not addressed by Rule 613, Rule 613 may supersede certain of the broker-dealer Recordkeeping and Reporting Responsibilities of Rule 13h-1.
Pursuant to Section 13(h)(6) of the Exchange Act and Rule 13h-1(g) thereunder,
As noted above, the Industry Organizations have requested that the Commission eliminate Phase Three of the implementation of the Rule.
The Commission notes that there has been significant progress on the implementation of the CAT since it issued the Phase Three Extension Order on October 30, 2015. As noted above, the Commission approved the CAT NMS Plan submitted by the SROs on November 15, 2016,
In light of the fact that the CAT NMS Plan has now been approved and the CAT is being built and implemented, the Commission believes that it is appropriate to issue this temporary exemption so that broker-dealer resources can be focused on CAT.
Accordingly, the Commission finds that it is consistent with the purposes of the Exchange Act to extend the compliance date for Phase Three by temporarily exempting broker-dealers until November 15, 2018 from compliance with specified provisions of the Rule. Thus, the Recordkeeping and Reporting Responsibilities under Rule 13h-1 will continue to apply with respect to: (1) The clearing broker-dealer for a large trader, with respect to (a) proprietary transactions by a large trader broker-dealer; (b) transactions effected pursuant to a “sponsored access” arrangement; and (c) transactions effected pursuant to a “direct market access” arrangement; and (2) broker-dealers that carry an account for a large trader for Transaction Data other than execution time.
By the Commission.
On August 30, 2017, The Nasdaq Stock Market LLC (“Nasdaq”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds that it is appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Rule 1614, entitled “Imposition of Fines for Minor Rule Violations,” to make a non-substantive, clarifying change to the rule. [sic]
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange is proposing to amend Rule 1614, entitled “Imposition of Fines for Minor Rule Violations,” to make a non-substantive, clarifying change to the rule.
The Exchange is proposing to amend Rule 1614, entitled “Imposition of Fines for Minor Rule Violations,” to make a non-substantive, clarifying change to the rule.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. As discussed above, the Exchange's proposal is a non-substantive, technical amendment to Rule 1614(d)(2), and is merely intended to add further clarification to the Exchange's rules and alleviate potential confusion.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative before 30 days from the date of the filing. However, pursuant to Rule 19b-4(f)(6)(iii),
The Exchange has asked the Commission to waive the 30-day operative delay. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. Clarification of how a FOCUS Report will be handled for purposes of assessing a fine that is 90 calendar days late will reduce confusion caused by the ambiguity of the Rule as written before the Exchange filed this proposed rule change. The Commission believes no purpose is served in delaying such clarification. Therefore, the Commission hereby waives the 30-day operative delay and designates the proposed rule change to be operative upon filing with the Commission.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
Pursuant to the provisions of Section 19(b)(1) under the Securities Exchange Act of 1934 (“Act”),
The text of the proposed rule change is available at 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 these statement may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
On June 17, 2016 the Commission granted IEX's application for registration as a national securities exchange under Section 6 of the Act including approval of rules applicable to the qualification, listing and delisting of companies on the Exchange. The Exchange plans to begin a listing program in early 2018 and is proposing to adopt Rule 6.210 related to ex-dates for securities listed on IEX.
IEX Rule 2.160(c)(4) requires in substance that an Exchange Member must be a Member of a registered clearing agency registered with the Commission pursuant to Section 17A of the Act or clear transactions executed on the Exchange through another Member that is a Member of a registered clearing agency. In addition, IEX Rule 6.110(a) provides that every Exchange Member who is a Member of a registered clearing agency shall implement comparison and settlement procedures under the rules of such entity. Further, IEX Rule 11.250(a) provides that the Exchange maintains connectivity and access to the Universal Trade Capture of the National Securities Clearing Corporation (“NSCC”) for the transmission of executed transactions. Pursuant to these provisions, all IEX Members are either Members of the NSCC or clear transactions executed on the Exchange through another Member that is a Member of NSCC. Thus, IEX Members must comply with NSCC comparison and settlement procedures for all transactions executed on the Exchange.
NSCC and other listing exchanges have rules related to securities settlement which specify the requirements and process for designation of so-called “ex-dates” in the event that the issuer of a security enters into certain types of corporate actions, including declaration of a dividend, and issuance of rights or warrants (
Thus, to provide certainty as to which security holder will receive the corporate action consideration it is necessary to establish “ex-dates” that denote the date on and after which a security will no longer trade with the corporate action consideration. Most listing exchanges, as well as the Financial Industry Regulatory Authority (“FINRA”) have such rules, which specify that generally a security will trade “ex” two [sic] business days [sic] prior to the record date. In the example above, XYZ would trade “ex-dividend” beginning on December 18, 2017.
Accordingly, in connection with the planned launch of its listing program, the Exchange proposes to adopt Rule 6.210 to specify when transactions in securities traded “regular” shall be “ex-dividend” or “ex-rights” as the case may be. As proposed, Rule 6.210 provides that transactions in securities traded “regular” shall be “ex-dividend” or “ex-rights” as the case may be, on the business day preceding the record date fixed by the company or the date of the closing of transfer books, except when the Board of Directors rules otherwise.
As proposed, Rule 6.210 is substantially identical to NYSE Arca Rule 7.4-E with only a minor difference in that proposed Rule 6.210 refers to “securities” rather than “stocks” to be inclusive of listed securities that are not strictly speaking characterized as stocks (
In connection with their “ex-date” rules, other listing exchanges disseminate relevant information regarding such corporate actions by their listed companies to market participants.
IEX believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
Further, the Exchange believes that the proposed rule change is consistent with the protection of investors and the public interest because it provides authority to the Exchange to determine ex-dates in circumstances warranting a different ex-date than the business day preceding the record date fixed by the company or the date of closing of transfer books.
Finally, the Exchange believes that the proposed rule change will serve to promote clarity and consistency among market participants thereby facilitating investor protection and the public interest.
IEX does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. The proposed rule change is not designed to address any competitive issues but rather to provide for the appropriate determination and dissemination of ex-dates, to provide certainty as to which security holder will receive the corporate action consideration. The Exchange also believes that the proposed rule change will serve to promote clarity and consistency, as noted in the Statutory Basis section, thereby reducing burdens on competition and facilitating investor protection.
Written comments were neither solicited nor received.
Because the proposed rule change does not (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate 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 August 30, 2017, The NASDAQ Stock Market LLC (“Nasdaq” or “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 of the Fund under Nasdaq Rule 5745, which governs the listing and trading of Exchange-Traded Managed Fund Shares, as defined in Nasdaq Rule 5745(c)(1). The Fund is a series of the Calvert Management Series (“Trust”). The Exchange represents that the Trust is registered with the Commission as an open-end investment company and that it has filed a registration statement on Form N-1A
Foreside Fund Services, LLC will be the principal underwriter and distributor of the Fund's Shares. State Street Bank and Trust Company will act as the accounting agent, custodian, and transfer agent to the Fund. ICE Data Services will be the intraday indicative value (“IIV”) calculator to the Fund.
The Exchange has made the following representations and statements in describing the Fund.
The investment objective of the Fund is to seek to maximize income, to the extent consistent with preservation of capital, through investment in bonds and income-producing securities. The Fund will seek to achieve its investment objective by investing, under normal circumstances, at least 80% of its net assets (including borrowings for investment purposes) in a portfolio of floating-rate debt securities (
Consistent with the disclosure requirements that apply to traditional open-end investment companies, a complete list of the Fund's current portfolio positions will be made available at least once each calendar quarter, with a reporting lag of not more than 60 days. The Fund may provide more frequent disclosures of portfolio positions at its discretion.
As defined in Nasdaq Rule 5745(c)(3), the “Composition File” is the specified portfolio of securities and/or cash that the Fund will accept as a deposit in issuing a creation unit of Shares, and the specified portfolio of securities and/or cash that the Fund will deliver in a redemption of a creation unit of Shares. The Composition File will be disseminated through the National Securities Clearing Corporation once each business day before the open of trading in Shares on that day and also will be made available to the public each day on a free Web site.
An estimated value of an individual Share, defined in Nasdaq Rule 5745(c)(2) as the IIV, will be calculated and disseminated at intervals of not more than 15 minutes throughout the Regular Market Session
Because Shares will be listed and traded on the Exchange, Shares will be available for purchase and sale on an intraday basis. Shares will be purchased and sold in the secondary market at prices directly linked to the Fund's next-determined NAV using a trading protocol called “NAV-Based Trading.” All bids, offers, and execution prices of Shares will be expressed as a premium/discount (which may be zero) to the