| Page Range | 42437-42584 | |
| FR Document |
| Page and Subject | |
|---|---|
| 83 FR 42583 - National Employer Support of the Guard and Reserve Week, 2018 | |
| 83 FR 42526 - Sunshine Act Meeting | |
| 83 FR 42505 - Announcement of Intent To Issue one OPDIV-Initiated Supplement to BCFS Health and Human Services Under the Standing Announcement for Residential (Shelter) Services for Unaccompanied Children, HHS-2017-ACF-ORR-ZU-1132 | |
| 83 FR 42516 - National Vaccine Injury Compensation Program; List of Petitions Received | |
| 83 FR 42459 - Notice of Request for an Extension of Approval of an Information Collection; Qualitative Feedback on Agency Service Delivery | |
| 83 FR 42559 - Proposed Collection; Comment Request for Forms 990, 990 EZ SCH B (BR), (BR), 990-EZ SCH L (LP), 990-EZ, 990-PF, 990-SCH B, 990-C, 990-EZ, 990-EZ (BR), 990-N, OR 990-EZ (SCH A), 990-EZ (SCH C), 990-EZ (SCH E), 990-EZ (SCH G), 990-EZ (SCH L), 990-EZ (SCH N), 990-EZ (SCH N-1), 990-EZ (SCH O), 990-EZ(SCH O)(BR), 990-PF. 990-PF (BR), 990-SCH A (BR), 990-SCH D, 990-SCH D (BR), 990-SCH F, 990-SCH F-1, 990-SCH H, 990-SCH I, 990-SCH I (BR), 990-SCH I-1, 990-SCH J, 990-SCH J (BR), 990-SCH J-1, 990-SCH J-2, 990-SCH K, 990-SCH M, 990-SCH R, 990-SCH R (BR), 990-SCH R-1, 990-T, 990-T SCH M, 990-T (BR), 990-W, 1023, 990-(BR), 990-I, 1024, 1028, 1028-BR, 5578, 5884 C, 8038, 8038 B, 8038 CP, 8030 G, 8038 GC, 8038 R, 8038 T 8038 TC, 8328, 8718, 8282, 8453-E.O., 8453-X, 8868, 8868-(BR), 8870, 8871, 8872, 8879-E.O., 8886-T, 8899 | |
| 83 FR 42559 - Open Meeting of the Taxpayer Advocacy Panel Special Projects Committee; Correction | |
| 83 FR 42449 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; 2018 Commercial Accountability Measure and Closure for South Atlantic Blueline Tilefish | |
| 83 FR 42490 - Pacific Island Fisheries; Marine Conservation Plan for American Samoa; Western Pacific Sustainable Fisheries Fund | |
| 83 FR 42552 - Investor Advisory Committee Meeting | |
| 83 FR 42518 - Agency Information Collection Request. 60-Day Public Comment Request | |
| 83 FR 42455 - Fisheries of the Exclusive Economic Zone Off Alaska; Atka Mackerel in the Bering Sea and Aleutian Islands Management Area | |
| 83 FR 42450 - Magnuson-Stevens Act Provisions; Fisheries of the Northeastern United States; Atlantic Herring Fishery; Adjustment to 2018 Atlantic Herring Management Area Sub-Annual Catch Limits | |
| 83 FR 42456 - Federal Motor Carrier Safety Regulations (FMCSRs) Which May Be a Barrier to the Safe Integration of Automated Driving Systems in Commercial Vehicle Operations; Public Meeting | |
| 83 FR 42491 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS) Part 237, Service Contracting, Associated DFARS Clauses at DFARS 252.237, DD Form 2062, and DD Form 2063 | |
| 83 FR 42525 - Public Meeting of the National Geospatial Advisory Committee | |
| 83 FR 42492 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Information Collection in Support of DFARS Part 245, Government Property | |
| 83 FR 42499 - Submission for OMB Review; General Services Administration Acquisition Regulation; Identification of Products With Environmental Attributes | |
| 83 FR 42500 - Submission for OMB Review; General Services Administration Acquisition Regulation; Solicitation Provisions and Contract Clauses; Placement of Orders Clause; and Ordering Information Clause | |
| 83 FR 42501 - Submission for OMB Review; General Services Administration Acquisition Regulation; Contract Administration, Quality Assurance (GSA Forms 1678 and 308) | |
| 83 FR 42490 - North Pacific Fishery Management Council; Public Meeting | |
| 83 FR 42498 - Clean Water Act; Contractor Access to Confidential Business Information | |
| 83 FR 42505 - Administration for Native Americans; Notice of Meeting | |
| 83 FR 42437 - Safety Zones; Annual Events Requiring Safety Zones in the Captain of the Port Lake Michigan Zone-Corn Festival Fireworks | |
| 83 FR 42523 - Accreditation and Approval of AmSpec LLC (Mobile, AL) as a Commercial Gauger and Laboratory | |
| 83 FR 42523 - Accreditation and Approval of Saybolt LP (Linden, NJ) as a Commercial Gauger and Laboratory | |
| 83 FR 42531 - New Postal Products | |
| 83 FR 42499 - Notice of Agreements Filed | |
| 83 FR 42526 - Notice of Availability of Draft Programmatic Environmental Assessment for BSEE Permitted Activities in the Southern California Planning Area 189E1700D2, ET1EE0000.PSB000, EEJJ000000 | |
| 83 FR 42518 - Advisory Commission on Childhood Vaccines; Notice of Meeting | |
| 83 FR 42492 - Agency Information Collection Activities; Comment Request; A Study of Reliability and Consequential Validity of a Mathematics Diagnostic Assessment System in Georgia | |
| 83 FR 42496 - Contractor's Power Group, Inc.; American Falls Reservoir District No. 2; Notice of Application for Transfer of License and Soliciting Comments, Motions To Intervene, and Protests | |
| 83 FR 42494 - Brookfield White Pine Hydro LLC; Notice of Application Accepted for Filing, Soliciting Comments, Protests, and Motions To Intervene | |
| 83 FR 42493 - Enterprise TE Products Pipeline Company LLC; Notice of Petition for Declaratory Order | |
| 83 FR 42494 - Combined Notice of Filings | |
| 83 FR 42495 - Combined Notice of Filings #1 | |
| 83 FR 42452 - Extension of Emergency Measures To Address Overfishing of Atlantic Shortfin Mako Shark | |
| 83 FR 42461 - Additional Production Authority Not Approved; The Coleman Company, Inc.; Subzone 119I (Textile-Based Personal Flotation Devices); Sauk Rapids, Minnesota | |
| 83 FR 42461 - Small Diameter Graphite Electrodes From the People's Republic of China: Notice of Rescission of Antidumping Duty Administrative Review; 2017-2018 | |
| 83 FR 42552 - Certification Related to Foreign Military Financing for Colombia Under Section 7045(B)(6) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2018 | |
| 83 FR 42524 - Agency Information Collection Activities; Annual Certification of Hunting and Sport Fishing Licenses Issued | |
| 83 FR 42459 - Notice of Meeting; Board for International Food and Agricultural Development | |
| 83 FR 42462 - U.S. Department of Commerce Trade Finance Advisory Council | |
| 83 FR 42514 - Determination That DANOCRINE (Danazol) Capsules, 50 Milligrams, 100 Milligrams, and 200 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Except the Indication of Fibrocystic Breast Disease, Which Was Withdrawn From Sale for Reasons of Safety or Effectiveness | |
| 83 FR 42506 - Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control; Public Meeting | |
| 83 FR 42555 - Agency Information Collection Activities; Proposed Renewal; Comment Request; Renewal Without Change of Recordkeeping and Termination of Correspondent Accounts for Foreign Banks | |
| 83 FR 42558 - Agency Information Collection Activities; Proposed Renewal; Comment Request; Renewal Without Change of Anti-Money Laundering Programs for Money Services Businesses, Mutual Funds, and Operators of Credit Card Systems | |
| 83 FR 42556 - Agency Information Collection Activities; Proposed Renewal; Comment Request; Renewal Without Change of Suspicious Activity Reporting Requirements by Brokers or Dealers in Securities and Futures Commission Merchants and Introducing Brokers in Commodities | |
| 83 FR 42522 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0015 | |
| 83 FR 42515 - Meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry | |
| 83 FR 42509 - Agency Information Collection Activities; Proposed Collection; Comment Request; Sun Protection Factor Labeling and Testing Requirements for Over-the-Counter Sunscreen Drug Products | |
| 83 FR 42513 - The Food and Drug Administration's Comprehensive, Multi-Year Nutrition Innovation Strategy; Extension of the Comment Period | |
| 83 FR 42508 - Expanding Access to Effective Treatment for Opioid Use Disorder: Provider Perspectives on Reducing Barriers to Evidence-Based Care; Public Meeting | |
| 83 FR 42521 - National Offshore Safety Advisory Committee | |
| 83 FR 42527 - Sacramento Municipal Utility District; Rancho Seco Independent Spent Fuel Storage Installation; Renewal of Special Nuclear Materials License | |
| 83 FR 42530 - Meeting of the Advisory Committee on Reactor Safeguards (ACRS) Subcommittee on NuScale | |
| 83 FR 42535 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend FINRA Rule 1220(a)(4), Financial and Operations Principal and Introducing Broker-Dealer Financial and Operations Principal | |
| 83 FR 42532 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Codify the Definitions of the Protocols To Enter Quotes and Orders | |
| 83 FR 42534 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To Provide for the Listing of Exchange Traded Products With No Component NMS Stock Listed on the Exchange, Amend Its Rules Regarding Unlisted Trading Privileges, and Make Corresponding Changes | |
| 83 FR 42545 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend FINRA Rule 7620A Relating to Fees Applicable to the FINRA/Nasdaq Trade Reporting Facilities | |
| 83 FR 42538 - Self-Regulatory Organizations: Investors Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Definition of the Cross Price Constraint Utilized in the Opening Process for Non-IEX-Listed Securities Pursuant to Rule 11.231 | |
| 83 FR 42545 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Designation of a Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change To Modify the Listing Requirements Contained in Listing Rule 5635(d) To Change the Definition of Market Value for Purposes of the Shareholder Approval Rule and Eliminate the Requirement for Shareholder Approval of Issuances at a Price Less Than Book Value but Greater Than Market Value | |
| 83 FR 42541 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt Initial and Continued Listing Standards for Subscription Receipts and Fees for Their Listing | |
| 83 FR 42540 - Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Designation of Longer Period for Commission Action on Proposed Rule Change Relating to the Clearance of an Additional Credit Default Swap Contract | |
| 83 FR 42465 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the Mission Bay Ferry and Water Taxi Landing Project in San Francisco Bay, California | |
| 83 FR 42502 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 83 FR 42503 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 83 FR 42554 - Agency Information Collection Activities; Proposals, Submissions, and Approvals | |
| 83 FR 42464 - Export Trade Certificate of Review | |
| 83 FR 42519 - Center for Scientific Review; Notice of Closed Meetings | |
| 83 FR 42519 - National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings | |
| 83 FR 42520 - National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting | |
| 83 FR 42520 - National Institute of Environmental Health Sciences; Notice of Meeting | |
| 83 FR 42512 - Determination That DITROPAN XL (Oxybutynin Chloride) Extended Release Tablets, 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | |
| 83 FR 42448 - Federal Management Regulation; Annual Real Property Inventories | |
| 83 FR 42501 - Maximum Per Diem Reimbursement Rates for the Continental United States (CONUS) | |
| 83 FR 42437 - Cranberries Grown in States of Massachusetts, et al.; Establishment of Handler Diversion and Reporting Requirements and New Information Collection; Correction | |
| 83 FR 42460 - Information Collection Activity; Comment Request | |
| 83 FR 42440 - Hazardous Waste Management System; Identification and Listing of Hazardous Waste | |
| 83 FR 42552 - Parts and Accessories Necessary for Safe Operation; Application for an Exemption From Traditional Trucking Corporation | |
| 83 FR 42579 - Federal Acquisition Regulation: Federal Acquisition Circular 2005-100; Small Entity Compliance Guide | |
| 83 FR 42571 - Federal Acquisition Regulation; Technical Amendments | |
| 83 FR 42570 - Federal Acquisition Regulation: Non-Retaliation for Disclosure of Compensation Information | |
| 83 FR 42569 - Federal Acquisition Regulation; Paid Sick Leave for Federal Contractors | |
| 83 FR 42568 - Federal Acquisition Regulation: Federal Acquisition Circular 2005-100; Introduction | |
| 83 FR 42438 - Outdated or Superseded Regulations: Title I, Parts A through C; Christa McAuliffe Fellowship Program; and Empowerment Zone or Enterprise Community-Priority | |
| 83 FR 42456 - Petitions for Reconsideration of Action in Rulemaking Proceeding | |
| 83 FR 42497 - Release of Risk and Exposure Assessment Plan for the Secondary National Ambient Air Quality Standard for Oxides of Nitrogen, Oxides of Sulfur and Particulate Matter |
Agricultural Marketing Service
Animal and Plant Health Inspection Service
Rural Utilities Service
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Defense Acquisition Regulations System
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Children and Families Administration
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
U.S. Customs and Border Protection
Bureau of Safety and Environmental Enforcement
Fish and Wildlife Service
Geological Survey
Ocean Energy Management Bureau
Federal Motor Carrier Safety Administration
National Highway Traffic Safety Administration
Financial Crimes Enforcement Network
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents 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.
Agricultural Marketing Service, USDA.
Final rule; correction.
The Agricultural Marketing Service is correcting a final rule that appeared in the
This correction is effective August 23, 2018.
Melissa Schmaedick, Marketing Order and Agreement Division, Specialty Crop Programs, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938 or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
In FR Doc. 2018-14939, beginning on page 32193 in the
1. On page 32196, in the second column, the sentence, “The five currently approved forms in 0581-0304 and one additional form will be merged with forms currently approved under OMB No. 0581-0189, Fruit Crops.” is corrected to read “The five currently approved forms in 0581-0304 and one additional form (Handler Withholding Final Report that OMB pre-approved under 0581-0313) will be finalized with the publishing of this rule.
The two collections, 0581-0304 and 0581-0313, will be merged with forms currently approved under OMB No. 0581-0189, Fruit Crops.”
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce a safety zone on the Illinois River in Morris, IL. This action is necessary and intended to protect the safety of life and property on navigable waters before, during, and immediately after a shore based firework display. During the enforcement period listed below, vessels and persons are prohibited from transiting through, mooring, or anchoring within this safety zone without approval from the Captain of the Port Lake Michigan or his or her designated representative.
The regulations in 33 CFR 165.929, Table 165.929, item (h)(1) will be enforced from 7:25 p.m. through 8:30 p.m. on September 29, 2018.
If you have questions about this notice of enforcement, call or email LT John Ramos, Waterways Management Division, Marine Safety Unit Chicago; telephone (630) 986-2155, email address
The Coast Guard will enforce the Safety Zone; Corn Festival Fireworks listed as item (h)(1) in Table 165.929 of 33 CFR 165.929. Section 165.929 lists annual events requiring safety zones in the Captain of the Port Lake Michigan zone. This safety zone will encompass all waters of the Illinois River within an 560 foot radius from approximate launch position at 41°21.173′ N, 88°25.101′ W (NAD 83). This safety zone will be enforced from 7:25 p.m. through 8:30 p.m. on September 29, 2018.
Pursuant to 33 CFR 165.929, entry into, transiting, or anchoring within the safety zone during an enforcement period is prohibited unless authorized by the Captain of the Port Lake Michigan, or his designated on-scene representative. Those seeking permission to enter the safety zone may request permission from the Captain of Port Lake Michigan via channel 16, VHF-FM. Vessels and persons granted permission to enter the safety zone shall obey the directions of the Captain of the Port Lake Michigan or his designated representative. While within a safety zone, all vessels shall operate at the minimum speed necessary to maintain a safe course.
This notice of enforcement is issued under authority of 33 CFR 165.929, Safety Zones; Annual events requiring safety zones in the Captain of the Port Lake Michigan zone, and 5 U.S.C. 552(a). In addition to this notice of enforcement in the
Office of Elementary and Secondary Education, Department of Education.
Final regulations.
The Secretary amends the Code of Federal Regulations (CFR) to remove outdated or superseded regulations. As a result of new legislation, absence of funding, and review in accordance with the President's regulatory reform initiative, the Secretary has determined that the regulations described below are no longer needed for the reasons discussed.
Effective August 22, 2018.
Anna Lieth, U.S. Department of Education, 400 Maryland Avenue SW, Room 3W337, Washington, DC 20202. Telephone: (202) 453-5682 or by email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
Consistent with Executive Order 13777, “Enforcing the Regulatory Reform Agenda,” the Department is evaluating all existing regulations and making recommendations to the Secretary regarding their repeal, replacement, or modification, consistent with applicable law. As part of that effort, we have determined it is appropriate to take three deregulatory actions in this document to remove regulations that are outdated or unnecessary in parts 200, 237, and 299.
The regulations being removed have been superseded by new legislation or were issued to implement a program that is no longer funded. Therefore, these deregulatory actions will have no effect on the current operation of the Department's grant programs. To the extent that amendments to existing regulations or new regulations are needed to implement new legislation, they will be issued separately from this document. Any determination to issue new regulations will be carefully considered to ensure that it is consistent with the President's regulatory reform efforts and the principles in Executive Orders 12866 and 13771.
The Department is continuing to review its other existing regulations thoroughly. To the extent the Secretary can identify further opportunities for regulatory reform, the Secretary will take appropriate action to revise or eliminate existing regulations, reduce burden, and increase flexibility.
In these final regulations, we take the following three deregulatory actions:
In 2015, the Every Student Succeeds Act (ESSA) reauthorized the Elementary and Secondary Education Act of 1965 (ESEA). Accordingly, some changes to the ESEA have rendered whole portions of the regulations in part 200 inconsistent with the statute. The superseded regulations in part 200 that the Department rescinds are: 34 CFR 200.7 (Disaggregation of Data); 200.12 (State Accountability System); 200.13-200.22 (Adequate Yearly Progress); 200.27-200.28 (Schoolwide Programs); 200.30-200.53 (LEA and School Improvement); 200.55-200.57 and 200.59-200.60 (Highly Qualified Teachers and Duties of Paraprofessionals); 200.81(d), 200.81(f), 200.81(g), and 200.81(h) (Migrant Education Program (MEP)); and 200.89(a) (Allocation of funds under the MEP for FY 2006 and subsequent years). In addition, the ESSA removed the authority for the Migrant Education Even Start Program. Accordingly, the Department rescinds 34 CFR 200.80 because it is no longer needed.
The Department rescinds the regulations governing the Christa McAuliffe Fellowship Program. We take this action because this program is no longer authorized under the Higher Education Act. The program was last funded in 1995.
The Department rescinds the regulations establishing the priority for activities in an Empowerment Zone or Enterprise Community. We take this action because the last Congressional extension of tax benefits to Empowerment Zones ended in 2017 and, thus, the program is no longer viable.
Under the Administrative Procedure Act (APA) (5 U.S.C. 553), the Department generally offers interested parties the opportunity to comment on proposed regulations. However, the APA provides that an agency is not required to conduct notice-and-comment rulemaking when the agency, for good cause, finds that the requirement is impracticable, unnecessary, or contrary to the public interest (5 U.S.C. 553(b)(B) and (d)(3)). There is good cause to waive rulemaking in this case because these final regulations merely remove existing regulations that are outdated, unnecessary, or superseded by recent statutory changes. This regulatory action adopts no new regulations and does not establish or affect substantive policy. Therefore, under 5 U.S.C. 553(b)(B), the Secretary has determined that proposed regulations are unnecessary and, thus, waives notice-and-comment rulemaking.
The APA also requires that regulations be published at least 30 days before their effective date, unless the agency has good cause to implement its regulations sooner (5 U.S.C. 553(d)(3)). Again, because the final regulations merely reflect statutory changes and remove outdated or unnecessary regulatory provisions, the Secretary also has good cause to waive the 30-day delay in the effective date of these regulatory changes under 5 U.S.C. 553(d)(3).
Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—
(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement grants, user fees,
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.
This regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.
Under Executive Order 13771, for each new regulation that the Department proposes for notice and comment or otherwise promulgates that is a significant regulatory action under Executive Order 12866 and that imposes total costs greater than zero, it must identify two deregulatory actions. For FY 2018, any new incremental costs associated with a new regulation must be fully offset by the elimination of existing costs through deregulatory actions. Because this final rule is not a significant regulatory action, the requirement to offset new regulations in Executive Order 13771 does not apply.
We have also reviewed these regulations under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—
(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);
(2) Tailor their regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things, and to the extent practicable—the costs of cumulative regulations;
(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);
(4) To the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and
(5) Identify and assess available alternatives to direct regulation, including providing economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”
We are issuing this regulatory action only upon a reasoned determination that it provides benefits and will not have any costs. In choosing among alternative regulatory approaches, we selected the approach that maximizes net benefits. Based on the analysis that follows, the Department believes that these regulations are consistent with the principles in Executive Order 13563.
We also have determined that this regulatory action would not unduly interfere with State, local, and Tribal governments in the exercise of their governmental functions.
This regulatory action is necessary to remove superseded, outdated, or unnecessary regulations from the Code of Federal Regulations (CFR).
This regulatory action is a benefit to the public, grant recipients, and the Department as the action will remove any confusion that might be caused by maintaining superseded, outdated, or unnecessary regulations in the CFR.
The Department has also analyzed the costs of this regulatory action and has determined that it will impose no additional costs ($0). As detailed earlier, this regulatory action reflects statutory changes and removes superseded, outdated, or unnecessary regulatory provisions.
Pursuant to 5 U.S.C. 601(2), the Regulatory Flexibility Act applies only to rules for which an agency publishes a general notice of proposed rulemaking. The Regulatory Flexibility Act does not apply to this rulemaking because there is good cause to waive notice and comment under 5 U.S.C. 553.
This rule does not contain any information collection requirements. The previously OMB-approved information collections that were associated with part 237 are no longer active information collections (OMB Control Numbers 1810-0532 and 1810-0537). The OMB-approved information collection associated with the sections of part 200 (Consolidated State Plans OMB 1810-0576) that this rule removes has been modified as necessary to align with the requirements of the ESSA.
Some of these programs are subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.
You may also access documents of the Department published in the
Education of disadvantaged, Elementary and secondary education, Grant programs—education, Indians—education, Infants and children, Juvenile delinquency, Migrant labor, Private schools, Reporting and recordkeeping requirements.
Elementary and secondary education, Grant programs—education, Scholarships and fellowships, Teachers.
Administrative practice and procedure, Elementary and secondary education, Grant programs—education, Private schools, Reporting and recordkeeping requirements.
For reasons discussed in the preamble, and under the authority at 20 U.S.C. 3474, 20 U.S.C. 1221e-3, Public Law 109-270, and Public Law 114-95, the Secretary amends Chapter II of title 34 of the Code of Federal Regulations as follows:
20 U.S.C. 6301 through 6576, unless otherwise noted.
20 U.S.C. 1221e-3(a)(1), 6511(a), and 7373(b), unless otherwise noted.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is granting a petition submitted by Blanchard Refining Company LLC—(Blanchard) to exclude (or delist) the residual solids generated from the reclamation of oil bearing hazardous secondary materials (OBSMs) on-site at Blanchard's Galveston Bay Refinery (GBR), located in Texas City, Texas from the lists of hazardous wastes. EPA used the Delisting Risk Assessment Software (DRAS) Version 3.0.35 in the evaluation of the impact of the petitioned waste on human health and the environment. The residual solids are listed as F037 (primary oil/water/solids separation sludge) when they are reclaimed from the OBSMs. After careful analysis and evaluation of comments submitted by the public, the EPA has concluded that the petitioned wastes are not hazardous waste when disposed of in Subtitle D landfills. This exclusion applies to the residuals solids generated at Blanchard's Galveston Bay Refinery (GBR), located in Texas City, Texas facility. Accordingly, this final rule excludes the petitioned waste from the requirements of hazardous waste regulations under the Resource Conservation and Recovery Act (RCRA) when disposed of in Subtitle D landfills but imposes testing conditions to ensure that the future-generated wastes remain qualified for delisting.
Effective August 22, 2018.
The EPA has established a docket for this action under Docket ID No. EPA-R06-RCRA-2017-0556. All documents in the docket are listed on the
For technical information regarding the Blanchard Refinery petition, contact Michelle Peace at 214-665-7430 or by email at
The information in this section is organized as follows:
The EPA is finalizing:
(1) the decision to grant GBR's petition to have its surface impoundment basin solids excluded, or delisted, from the definition of a hazardous waste, subject to certain continued verification and monitoring conditions; and
(2) to use the Delisting Risk Assessment Software to evaluate the potential impact of the petitioned waste on human health and the environment. The Agency used this model to predict the concentration of hazardous constituents released from the petitioned waste, once it is disposed.
After evaluating the petition, EPA proposed rule, on October 31, 2017, to exclude GBR's residuals from the treatment of OBSM waste from the lists of hazardous wastes under §§ 261.31 and 261.32. The comments received on this rulemaking will be addressed as part of this decision.
GBR's petition requests an exclusion from the F037 waste listing pursuant to 40 CFR 260.20 and 260.22. GBR does not believe that the petitioned waste meets the criteria for which EPA listed it. GBR also believes no additional constituents or factors could cause the waste to be hazardous. EPA's review of this petition included consideration of the original listing criteria and the additional factors required by the Hazardous and Solid Waste Amendments of 1984 (HSWA). See section 3001(f) of RCRA, 42 U.S.C. 6921(f), and 40 CFR 260.22 (d)(1) through (4) (hereinafter, all sectional references are to 40 CFR unless otherwise indicated). In making the initial delisting determination, EPA evaluated the petitioned waste against the listing criteria and factors cited in § 261.11(a)(2) and (3). Based on this review, EPA agrees with the petitioner that the waste is non-hazardous with respect to the original listing criteria. If EPA had found, based on this review, that the waste remained hazardous based on the factors for which the waste was originally listed, EPA would have proposed to deny the petition. EPA evaluated the waste with respect to other factors or criteria to assess whether there is a reasonable basis to believe that such additional factors could cause the waste to be hazardous. EPA considered whether the waste is acutely toxic, the concentration of the constituents in the waste, their tendency to migrate and to bioaccumulate, their persistence in the environment once released from the waste, plausible and specific types of management of the petitioned waste, the quantities of waste generated, and waste variability. EPA believes that the petitioned waste does not meet the listing criteria and thus should not be a listed waste. EPA's proposed decision to delist waste from GBR is based on the information submitted in support of this rule, including descriptions of the wastes and analytical data from the Texas City, Texas facility.
This exclusion applies to the waste described in the petition only if the requirements described in Table 1 of part 261, Appendix IX, and the conditions contained herein are satisfied. The exclusion applies to 20,000 cubic yards of residual solids.
Storage containers with OBSM residual solids will be transported to an authorized solid waste landfill (
This rule is effective August 22, 2018. The Hazardous and Solid Waste Amendments of 1984 amended Section 3010 of RCRA to allow rules to become effective in less than six months when the regulated community does not need the six-month period to come into compliance. That is the case here because this rule reduces, rather than increases, the existing requirements for persons generating hazardous wastes. These reasons also provide a basis for making this rule effective immediately, upon publication, under the Administrative Procedure Act, pursuant to 5 U.S.C. 553(d).
Because EPA is issuing this exclusion under the Federal RCRA delisting program, only states subject to Federal RCRA delisting provisions would be affected. This would exclude two categories of States: States having a dual system that includes Federal RCRA requirements and their own requirements, and States who have received our authorization to make their own delisting decisions.
Here are the details: We allow states to impose their own non-RCRA regulatory requirements that are more stringent than EPA's, under section 3009 of RCRA. These more stringent requirements may include a provision that prohibits a federally issued exclusion from taking effect in the State. Because a dual system (that is, both Federal (RCRA) and State (non-RCRA) programs) may regulate a petitioner's waste, we urge petitioners to contact the State regulatory authority to establish the status of their wastes under the State law.
EPA has also authorized some States (for example, Louisiana, Georgia, Illinois) to administer a delisting program in place of the Federal program, that is, to make State delisting decisions. Therefore, this exclusion does not apply in those authorized States. If Blanchard transports the petitioned waste to or manages the waste in any State with delisting authorization, Blanchard must obtain delisting authorization from that State before they can manage the waste as nonhazardous in the State.
A delisting petition is a request from a generator to EPA or another agency with jurisdiction to exclude from the list of hazardous wastes, wastes the generator does not consider hazardous under RCRA.
Under 40 CFR 260.20 and 260.22, facilities may petition the EPA to remove their wastes from hazardous waste control by excluding them from the lists of hazardous wastes contained in §§ 261.31 and 261.32. Specifically, § 260.20 allows any person to petition the Administrator to modify or revoke any provision of parts 260 through 266, 268 and 273 of Title 40 of the Code of Federal Regulations. Section 260.22 provides generators the opportunity to petition the Administrator to exclude a waste on a “generator-specific” basis from the hazardous waste lists.
Petitioners must provide sufficient information to EPA to allow the EPA to determine that the waste to be excluded does not meet any of the criteria under which the waste was listed as a hazardous waste. In addition, the Administrator must determine, where he/she has a reasonable basis to believe that factors (including additional constituents) other than those for which the waste was listed could cause the waste to be a hazardous waste, that such factors do not warrant retaining the waste as a hazardous waste.
In June 2017, Blanchard petitioned EPA to exclude from the lists of hazardous wastes contained in §§ 261.31 and 261.32, residual solids (F037) generated during reclamation activities conducted at its GBR facility located in Texas City, Texas. The waste falls under the classification of listed
The 40 CFR part 261 Appendix VII hazardous constituents which are the basis for listing can be found in Table 1.
To support its petition, Blanchard conducted individual sampling events on residual solids resulting from the reclamation of Blanchard's three (3) identified categories of OBSMs. Each separate sampling event consisted of four (4) composite samples taken during a 24-hour period of representative operation. Each composite sample was comprised of individual grab samples (
The EPA received fifteen anonymous public comments on the October 31, 2017, proposed rule via regulations.gov. There were ten comments which had no bearing on the delisting of hazardous waste for Blanchard Refining. Two comments: EPA-R06-RCRA-2017-0556-0003 and EPA-R06-RCRA-2017-0556-0005 were submitted in favor of the issuance of the petition. Comments and responses to the three adverse comments (EPA-R06-RCRA-2017-0556-0009) are addressed below.
General Comment: EPA Region 6 received ten comments through regulations.gov to which no responses are required. These comments are numbered: EPA-R06-RCRA-2017-0556-0002, EPA-R06-RCRA-2017-0556-0004, EPA-R06-RCRA-2017-0556-0006, EPA-R06-RCRA-2017-0556-0007, EPA-R06-RCRA-2017-0556-0009, EPA-R06-RCRA-2017-0556-0010, EPA-R06-RCRA-2017-0556-0011, EPA-R06-RCRA-2017-0556-0012, EPA-R06-RCRA-2017-0556-0013, and EPA-R06-RCRA-2017-0556-0015 in this rulemaking docket. These commenters expressed concerns regarding wildfires, wind turbines, climate change, car lithium batteries, and opinions on Lead leaching into drinking water which are not appropriately addressed as part of the Hazardous Waste delisting program. Some comments reflect differences in opinions or preferred outcomes, to which an agency response is not appropriate. The EPA acknowledges the submission of these comments but notes the comments are out of the scope of the current final action regarding the delisting of hazardous waste residuals generated at Blanchard Refining.
Comment 1 (EPA-R06-RCRA-2017-0556-0009): “I am writing in representation of the over 150,000 members of TinyTimmy.org. We are against delisting these Blanchard solid hazardous wastes because they do not meet the standards stated clearly by the EPA for such delisting activity. Many of their own test results show a much higher than acceptable levels of some of the most toxic chemicals known to man. This attempt to delist byproducts such as Appendix VII inorganic constituents of concern, lead and chromium, and Appendix VII organic constituents of concern benzene, benzo(a)pyrene and chrysene. The levels found by Blanchard's testing does not meet the EPA criteria for delistment. Further, doing so violates human safety, groundwater, environment and worker health. We strongly urge the EPA to reconsider and follow its actual mission of protecting the health of both humans and the environment and stop giving out favors to the fossil fuel industry on our backs.”
Response 1 (EPA-R06-RCRA-2017-0556-0009). The Delisting Program requires extensive waste sampling and a risk assessment is performed to assess a wastes potential harm to human health and the environment. The program is designed to insure that the wastes which are deemed excluded will not be managed in a manner to harm human health or the environment. This waste will be managed in a Subtitle D industrial waste landfill as solid waste to prevent releases to groundwater and air pathways.
Comment 2 (EPA-R06-RCRA-2017-0556-0014). “I oppose the petition for delisting and believe delisting would pose a threat to the public.”
Response 2 (EPA-R06-RCRA-2017-0556-0014). The Delisting Program requires extensive waste sampling and a risk assessment is performed to assess a wastes potential harm to human health and the environment. The program is designed to insure that the wastes which are deemed excluded will not be managed in a manner to harm human health or the environment. This waste will be managed in a Subtitle D industrial waste landfill as solid waste to prevent releases to groundwater and air pathways.
Comment 3 (EPA-R06-RCRA-2017-0556-0016). “I'd like to say thank you for opportunity to comment. My concern is regarding the delisting mandate of the Blanchard Refinery residual solid waste stream with chemicals that are classifiable as known carcinogenicity to human. The EPA is basing the ruling on the results from DRAS (Hazardous Waste Delisting Risk Assessment Software). Per the EPA, “the DRAS is a risk assessment tool and, therefore, can only provide risk analyses based on the information input into the program.” Therefore, this software is not a dynamic simulation of the site's actual contaminates level but rather a “subjective” user input simulation.
Also, the criteria for demonstration of health-based levels is the Maximum Toxicity Characteristic Leaching Procedure (TCLP) delisting level. Does this limit cover worksite exposure limits? Will rate of evaporation affect the TCLP concentration? If so, will there be continuous monitoring at the site? For example, Cobalt meets the Maximum TCLP delisting level criteria of 0.902 (mg/L); however, per a New Jersey Department of Health and Senior Services Hazardous Substance Fact Sheet, it does not meet the workplace exposure limits.1
The average airborne permissible exposure limits (PEL) according to:
Based on these limits, the maximum TCLP is, using the most conservative case, 900% higher. Also, according to the same study, it is stated that cobalt maybe a carcinogen in humans and there may be no safe level of exposure of exposure to a carcinogen.
Within the delisted chemicals, I have identified multiple chemicals in addition to Cobalt that are classifiable as known carcinogenicity to human, such as benzene and toluene. Since a landfill is considered a worksite, the chemicals should be reconsidered or the PEL considered in the criteria for demonstration of health-based levels.”
Response 3 (EPA-R06-RCRA-2017-0556-0016). The requirements of the Federal regulations defined in 40 CFR part 260.20, and 260.22, describe the process by which wastes may be removed from the list of hazardous waste. In addition to extensive quality assurance and quality control data for the samples taken, EPA performs a risk assessment using the Delisting Risk Assessment Software to ensure that our decision is protective of human health and the environment. The constituent concentrations found in the residual solids are below the concentrations that would pose harm to human health and the environment. A waste is eligible for delisting only if that waste, as generated at a particular facility, does not meet any of the criteria under which the waste was listed as a hazardous waste. In addition, the waste may not contain any other Appendix VIII constituents that would cause the waste to be hazardous. RCRA § 3001(f) and 40 CFR 260.22. A delisting is only intended to address a specific waste stream generated at a specific site. Since individual waste streams may vary depending on raw materials, industrial processes, and other factors, it may be appropriate not to list a specific waste from a specific site. Therefore, while a waste described in the regulations or resulting from the operation of the mixture or derived-from rules generally is hazardous, a specific waste from an individual facility may not be hazardous. For this reason, 40 CFR
Under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), this rule is not of general applicability and therefore, is not a regulatory action subject to review by the Office of Management and Budget (OMB). This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Similarly, because this rule will affect only a particular facility, this rule does not have tribal implications, as specified in Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). Thus, Executive Order 13175 does not apply to this rule. This rule also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. The basis for this belief is that the Agency used DRAS, which considers health and safety risks to children, to calculate the maximum allowable concentrations for this rule. This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)), because it is not a significant regulatory action under Executive Order 12866. This rule does not involve technical standards; thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988, “Civil Justice Reform”, (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct.
The Congressional Review Act, 5 U.S.C. 801
EPA has determined that this rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. The Agency's risk assessment did not identify risks from management of this material in an authorized, solid waste landfill (
Environmental protection, Hazardous Waste, Recycling, Reporting and record-keeping requirements.
Sec. 3001(f) RCRA, 42 U.S.C. 6921(f).
For the reasons set out in the preamble, 40 CFR part 261 is amended as follows:
42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y) and 6938.
Office of Government-wide Policy (OGP), General Services Administration (GSA).
Direct final rule; request for comments.
The General Services Administration (GSA) is issuing a direct final rule to remove and reserve regulations regarding the Federal Management Regulation (FMR). The regulations contain ambiguous and outdated provisions regarding reporting requirements, as well as references to systems and forms that are no longer used by agencies or GSA. The regulations are also unnecessary as a result of the Federal Assets Sale and Transfer Act of 2016 and the Federal Property Management Reform Act of 2016, which require executive agencies to report real property data annually to GSA.
Submit comments in response to FMR Case 2018-102-8 by any of the following methods:
•
•
For clarification of content, contact Ms. Aluanda Drain, Director, Real Property Policy Division, Office of Government-wide Policy, at 202-501-1624, or
Federal agencies annually reported real property assets as a result of the Senate Committee on Appropriations request that the Government maintain an Annual Real Property Inventory. Executive Order (E.O.) 12411, Government Work Space Management Reforms, dated March 29, 1983 (48 FR 13391, 3 CFR, 1983 Comp., p. 155), requires Executive agencies to produce and maintain a total inventory of work space and related furnishings, and declare excess to the Administrator of General Services all such holdings that are not necessary to satisfy existing or known and verified planned programs. It further requires agencies to establish information systems, implement inventory controls and conduct surveys in accordance with procedures established by the Administrator of General Services, so that a government-wide reporting system may be developed.
E.O. 13327, Federal Real Property Asset Management, dated February 4, 2004 (69 FR 5897), required that the Administrator of General Services, in consultation with the Federal Real Property Council, establish and maintain a single, comprehensive and descriptive database of all real property under the custody and control of all executive branch agencies, except when otherwise required for reasons of national security. This E.O. authorized the Administrator to collect from each Executive agency such descriptive information, except for classified information, as the Administrator considers will best describe the nature, use, and extent of real property holdings of the Federal Government.
Since the last part 102-84 regulatory update in January 2008 to incorporate the guidance of E.O. 13327, the E.O. has been amended. More recently two laws were enacted, the Federal Assets Sales and Transfer Act of 2016 (Pub. L. 114-287) and the Federal Property Management Reform Act of 2016 (Pub. L. 114-318) that create a statutory requirement for a publicly accessible federal real property database and require executive agencies to report real property data annually to GSA.
Therefore, part 102-84, Annual Real Property Inventories, is unnecessary and outdated, and under the authority of 40 U.S.C. 121(c), GSA is removing part 102-84, Annual Real Property Inventories, and reserving it.
E.O.s 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. GSA has determined that this direct final rule is not a significant regulatory action and is not subject to review under section 6(b) of E.O. 12866. GSA has further determined that this direct final rule is not a major rule under 5 U.S.C. 804.
This direct final rule is not subject to the requirements of E.O. 13771 because it is related to agency organization, management, or personnel.
This direct final rule will not have a significant economic impact on a substantial number of entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601
The Paperwork Reduction Act does not apply because the changes to the FMR do not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public that require the approval of the
This direct final rule is exempt from Congressional review under 5 U.S.C. 801 since it relates solely to agency management and personnel.
Federal buildings and facilities, Government property management.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS implements an accountability measure (AM) for commercial blueline tilefish in the exclusive economic zone (EEZ) of the South Atlantic. Commercial landings of blueline tilefish are projected to reach the commercial annual catch limit (ACL) by August 22, 2018. Therefore, NMFS is closing the commercial sector for blueline tilefish in the South Atlantic EEZ at 12:01 a.m., local time, on August 22, 2018, and it will remain closed until the start of the next fishing year on January 1, 2019. This closure is necessary to protect the blueline tilefish resource.
This temporary rule is effective at 12:01 a.m., local time, on August 22, 2018, until 12:01 a.m., local time, on January 1, 2019.
Mary Vara, NMFS Southeast Regional Office, telephone: 727-824-5305, email:
The snapper-grouper fishery of the South Atlantic includes blueline tilefish and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The South Atlantic Fishery Management Council and NMFS prepared the FMP, and the FMP is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.
As specified at 50 CFR 622.193(z)(1)(i), the commercial ACL for blueline tilefish is 87,521 lb (39,699 kg), round weight. The commercial AM for blueline tilefish requires NMFS to close the commercial sector when the commercial ACL is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register (50 CFR 622.193(z)(1)(i)). NMFS has projected that the commercial ACL for South Atlantic blueline tilefish will be reached by August 22, 2018. Accordingly, the commercial sector for South Atlantic blueline tilefish is closed effective at 12:01 a.m., local time, on August 22, 2018, until 12:01 a.m., local time, on January 1, 2019.
The operator of a vessel with a valid Federal commercial vessel permit for South Atlantic snapper-grouper having blueline tilefish on board must have landed and bartered, traded, or sold such blueline tilefish prior to August 22, 2018. During the commercial closure, all sale or purchase of blueline tilefish is prohibited. The harvest or possession of blueline tilefish in or from the South Atlantic EEZ is limited to the bag and possession limits specified in 50 CFR 622.187(b)(2) and 622.187(c)(1), respectively, while the recreational sector for blueline tilefish is open. These bag and possession limits apply in the South Atlantic on board a vessel with a valid Federal commercial or charter vessel/headboat permit for South Atlantic snapper-grouper, and apply to the harvest of blueline tilefish in both state and Federal waters.
The Regional Administrator for the NMFS Southeast Region has determined this temporary rule is necessary for the conservation and management of blueline tilefish and the South Atlantic snapper-grouper fishery and is consistent with the Magnuson-Stevens Act and other applicable laws.
This action is taken under 50 CFR 622.193(z)(1)(i) and is exempt from review under Executive Order 12866.
These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.
This action responds to the best scientific information available. The Assistant Administrator for NOAA Fisheries (AA) finds that the need to immediately implement this action to close the commercial sector for blueline tilefish constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such prior notice and opportunity for public comment are unnecessary and contrary to the public interest. Such procedures are unnecessary because the regulations at 50 CFR 622.193(z)(1)(i) have already been subject to notice and comment, and all that remains is to notify the public of the closure. Prior notice and opportunity for public comment are contrary to the public interest because there is a need to immediately implement this action to protect blueline tilefish, since the capacity of the fishing fleet allows for rapid harvest of the commercial ACL. Prior notice and opportunity for public comment would require time and would potentially result in a harvest well in excess of the established commercial ACL.
For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Interim final rule; request for comments.
This interim final rule reduces the sub-annual catch limits for the four Atlantic Herring Management Areas (including Area 1A, 1B, 2, and 3). This action is necessary to address Atlantic herring population decline due to poor recruitment into the population. The reduction is intended to mitigate herring population declines and lead to more available herring biomass and higher catch limits in 2019 and beyond.
This action is effective August 22, 2018 through December 31, 2018. Comments must be received on or before September 21, 2018.
You may submit comments on this document, identified by NOAA-NMFS-2018-0094, by either of the following methods:
•
•
Daniel Luers, Fishery Management Specialist, 978-282-8457.
Regulations implementing the Atlantic Herring Fishery Management Plan (FMP) for herring appear at 50 CFR part 648, subpart K. We implemented 2016-2018 herring specifications (November 1, 2016; 81 FR 75731) in November 2016 as recommended by the Council. The specifications included overfishing limits (OFLs) of 138,000 mt, 117,000 mt, and 111,000 mt for 2016, 2017, and 2018, respectively. The resulting acceptable biological catch (ABC) based on the New England Fishery Management Council's ABC control rule was 111,000 mt in 2018, an amount equal to the OFL and that had no greater than a 50-percent probability that overfishing would occur. This ABC was consistent with the Council Scientific and Statistical Committee's advice. The current ACL for the herring fishery is 100,969 mt, and the sub-ACLs for the four management areas are: Area 1A-31,789 mt; Area 1B-3,552 mt; Area 2-31,137 mt; and Area 3-43,763 mt.
In June of 2018, a new Northeast Regional Stock Assessment Workshop (SAW) and review by the Stock Assessment Review Committee (SARC) for Atlantic herring was completed. The assessment concluded that although Atlantic herring was not overfished and overfishing was not occurring in 2017, the stock is declining due to poor recruitment of herring into the population. The stock assessment estimated that recruitment has been at historic lows during the most recent 5 years (2013-2017). The final assessment summary report is available on the Northeast Fisheries Science Center website (
The assessment projects that poor recruitment of Atlantic herring will likely result in a substantial decline in biomass, but that the biomass should increase after reaching a low in 2019 if recruitment returns to historic average levels. The SAW/SARC estimated that if the entire 2018 acceptable biological catch (ABC) (111,000 mt) is harvested, the 2019 overfishing limit (OFL) would need to be reduced by nearly 90 percent, to 13,700 mt. The SAW/SARC also estimated that if the 2018 catch is half of the ABC (55,000 mt), the OFL in 2019 would need to be 28,900 mt.
The herring specification regulations provide us with the authority to make in-season adjustments to the specifications and sub-ACLs to achieve conservation and management objectives after we have consulted with the Council. Any adjustments must be consistent with the Atlantic Herring FMP objectives and other FMP provisions. After receiving preliminary SAW/SARC results, we consulted with the Council on potential sub-ACL adjustments during the Council's June 2018 meeting.
At its June 2018 meeting, based on the SAW/SARC preliminary stock assessment projections, the Council recommended capping the sub-ACLs for herring Management Areas 1A, 1B, and 3 at 2017 catch levels, and to set the Area 2 sub-ACL at 8,200 mt. The Council recommended a slightly different approach for Area 2 because the 2017 harvest level had been surpassed, and they wanted to allow for a fall fishery for the bottom trawl fleet, who have consistently relied upon fall herring catch in that area. The Council recommendation was intended to provide some conservation benefits for herring in 2018 and thereby mitigate the impacts of estimated 2019 reductions on the herring industry. After the June Council meeting, additional catch projections completed at the SARC meeting indicated the Council's recommended level of catch has a 69-percent chance of resulting in overfishing in 2018. The Northeast Fisheries Science Center subsequently provided us with an additional projection based on a 50-percent probability of overfishing. This projection resulted in catch equal to 49,900 mt.
To lessen the risk of overfishing occurring in 2018, we are reducing the 2018 total allowable catch to 49,900 mt, which is 3,775 mt less than the Council's recommended 53,655 mt. This action only reduces the sub-ACLs for the four herring management areas and does not alter any other limits in the 2016-2018 specifications. We chose to reduce the Council's recommended catch so that the new area sub-ACLs provide at least a 50-percent probability of preventing overfishing in 2018. We set levels based on the newly projected OFL for 2018 out of precaution to prevent overfishing while allowing the fishery to achieve optimum yield. As explained below, projections based on current catch rates show a low probability that the fishery will catch
We are relying on the SAW/SARC's report and the Northeast Fisheries Science Center's additional projection to set reduced 2018 management area sub-ACLs for the fishery. The SAW/SARC used the most recent and best available data to make projections for future biomass. Although the estimates of future biomass are projections, they represent the best available scientific data for NMFS to act upon to mitigate both further biomass reductions and adverse economic impacts to the herring fishery. Based on this information, we are setting sub-ACLs consistent with projection probabilities that were used to set OFLs for the 2016-2018 specifications.
The herring specification regulations provide that the OFL must be equal to catch resulting from applying the maximum fishing mortality threshold to a current or projected estimate of stock size. When the stock is not overfished and overfishing is not occurring, this is usually the fishing rate supporting maximum sustainable yield (F
The 2016-2018 specifications included an ABC that was equal to the OFL for 2018 and was based on a projection showing there was no greater than a 50 percent probability that overfishing would occur at that level. Further, the SSC determined there was a near zero chance the stock would become overfished at that level based on the scientific information available to it at the time. The sub-ACLs were slightly reduced from the ABC to account for management uncertainty in the New Brunswick weir fishery.
We do not anticipate that the fishery will catch the reduced limits for each of the four management areas. The herring fishery caught 49,500 mt in 2017, and catch rates to date in 2018 are substantially below those for 2017. The largest catch limit reduction in 2018 would occur in Area 3, where we would reduce the sub-ACL by over 30,000 mt. However, catch in Area 3 has dropped sharply in the past 3 years. The fishery caught 33.3k mt in 2015, 18.8k mt in 2016, and 14.1k mt in 2017. The 2018 catch through July 20 is only about 1.2k mt. This is below the catch level through July 20 for 2017, which was the previous lowest catch level for that time series. Similarly, the fishery has failed to catch the Area 1B sub-ACL in two of the previous three years, and the current catch level is less than the lowest of those years (2015), suggesting that it may be difficult for the fishery to catch this area's sub-ACL. Additionally, the vast majority of Area 2 is closed to the midwater trawl fishery due to a river herring/shad catch cap closure, which greatly reduces the likelihood that any more than a small portion of the remaining sub-ACL would be harvested. Finally, even if catch rates increase this year and catch amounts approach the new catch limits set in this action, we are required to close the directed fisheries once 92 percent of the sub-ACL is projected to be caught. This would allow us to constrain catch below the limit that is expected to prevent overfishing.
The NMFS Assistant Administrator has determined that this interim final rule is consistent with the Atlantic Herring FMP, national standards and other provisions of the Magnuson-Stevens Fishery Conservation and Management Act, and other applicable law.
This interim final rule is exempt from the procedures of Executive Order (E.O.) 12866 because this action contains no implementing regulations.
This interim final rule does not introduce any new reporting, recordkeeping, or other compliance requirements.
This interim final rule does not contain policies with Federalism or “takings” implications as those terms are defined in E.O. 13132 and E.O. 12630, respectively.
Pursuant to 5 U.S.C. 553(b)(B), the Assistant Administrator for Fisheries (AA) finds it is impracticable and contrary to the public interest to provide for prior notice and an opportunity for public comment. Additionally, the AA finds there is good cause under 5 U.S.C. 553(d)(1) and (3) to waive the 30-day delay in effectiveness so that the purpose of this rule is not undermined. This action reduces the herring catch limits to reduce the risk of overfishing in 2018 with a goal of increasing herring biomass and future fishery opportunity. This rule must be in effect as soon as practicable to realize these intended benefits.
Before taking this action, we consulted with the New England Council at is June 2018 meeting, at which the Council recommended that we reduce the 2018 sub-ACLs for each herring management area. This consultation was scheduled after preliminary results from the 2018 stock assessment became available indicating that herring biomass is likely to decline substantially in 2019. At this meeting, the Council discussed the preliminary stock assessment results, measures likely necessary in 2019, and took public comment on its recommendation to reduce the 2018 sub-ACLs. As a result of these discussions and input from the public, including the herring industry, the Council recommended reducing 2018 catch to mitigate the economic harm to the herring industry that is
A delay in implementing the new catch limits will increase the likelihood that 2018 catch will exceed these new limits. The 2018 catch reductions in this action are based on the new benchmark assessment, which was just recently completed in June 2018. Based on this new scientific information, the reductions in this action would result in a 50-percent probability of preventing overfishing in 2018. Exceeding the new harvest limits would result in a lower biomass and negative economic impacts to the herring industry due to a lower allowable catch in 2019 and beyond. Because herring is a critical bait source for the lobster fishery, these negative economic impacts are also expected to extend to the lobster fishery due to a reduction in bait supply.
Additionally, we are required to implement a 2,000-lb possession limit for each management area through the end of the current fishing year once 92 percent of the area sub-ACL is projected to be caught. We are also required to implement the 2,000-lb possession limit for the whole fishery (all areas) when 95-percent of the total herring ACL is harvested. If a delay in implementing this action results in catch approaching, or exceeding, the new 2018 catch limits, the closure of the directed fishery is more likely. An inseason closure of the directed fishery would be counter to the goals and objectives of this action, which is intended to reduce 2018 catch, but also continue to provide fishing opportunities for the remainder of the 2018 fishing year.
Input from the public at the June 2018 Council meeting was nearly all supportive of reducing 2018 catch limits, and the fishing industry and the public generally are expecting new limits to be set as soon as practicable. The lack of catch to date in 2018 has tempered the industry's expectations, and they no longer anticipate reaching even the reduced ACL. Herring industry members were concerned about the economic impact to the fishery in 2019 if we do not ensure reduced catch this year. Representatives from fishing advocacy and environmental groups also supported reducing 2018 catch limits, suggesting it could improve the projected stock estimates and expedite growth of the stock to previous high levels. The Council recommended we implement this action with the goal of conserving herring biomass and allowing for higher fishery catch limits in the 2019-2021 specifications. We expect the 2018 sub-ACL reductions to increase the estimated herring biomass in 2019 and provide for more catch for the fishery.
This interim final rule is exempt from the procedures of the Regulatory Flexibility Act because the rule is issued without opportunity for prior notice and opportunity for public comment.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; emergency action extended.
This rule extends the measures in an emergency interim final rule for the North Atlantic shortfin mako shark fishery published on March 2, 2018. This extension is necessary to maintain measures that address overfishing of shortfin mako sharks while long-term measures are developed and to meet requirements of a recommendation of the International Commission for the Conservation of Atlantic Tunas (ICCAT). The rule is expected to reduce fishing mortality to address overfishing, consistent with ICCAT Recommendation 17-08, by continuing to reduce landings and increase live releases in the recreational and commercial HMS fisheries, but is not expected to result in significant economic impacts.
The end of the effective period for the amendments to 50 CFR 635.20, 635.21, 635.24, and 635.71, as published on March 2, 2018 (83 FR 8946), is extended from August 29, 2018, to March 3, 2019.
Copies of the Environmental Assessment (EA) and other supporting documents for the emergency action are available from the Highly Migratory Species (HMS) Management Division website at
Tobey Curtis at (978) 281-9273 or Guy DuBeck or Lauren Latchford at (301) 427-8503.
On March 2, 2018, NMFS implemented an interim final rule using emergency authority under the Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1855(c), to implement measures in HMS recreational and commercial fisheries to address overfishing consistent with ICCAT Recommendation 17-08 (83 FR 8946). The interim final rule noted that the measures may be extended for up to an additional 186 days if needed while longer-term measures were developed through an FMP amendment. This temporary rule extends the emergency interim final measures for North Atlantic shortfin mako sharks (
Section 305(c) of the Magnuson-Stevens Act allows for the extension of an emergency regulation or interim measure, which is otherwise effective for up to 180 days, for up to another 186 days, provided that the public has had an opportunity to comment on the emergency regulation. NMFS accepted public comment on the initial emergency measures in the interim final rule through May 7, 2018; comments and responses are summarized below. This extension does not alter the emergency measures already in place. NMFS is not accepting additional public comment on this extension.
NMFS has determined that all the necessary criteria for extending the emergency measures have been met and, therefore, NMFS is extending these emergency measures through March 3, 2019. NMFS has proposed long-term management measures for the North Atlantic shortfin mako shark stock through Draft Amendment 11 to the 2006 Consolidated HMS Fishery Management Plan (FMP), 83 FR 35590 (July 27, 2018), which are expected to replace these emergency measures before the expiration date.
NMFS is extending the original emergency regulations without change. The management measures in the emergency rule that are being extended are as follows:
• Commercial fishermen on vessels deploying pelagic longline gear, which are required to have a functional electronic monitoring system on board under current regulations, must release all live shortfin mako sharks with a minimum of harm, while giving due consideration to the safety of crew members. Commercial fishermen using pelagic longline gear can only retain a shortfin mako shark if it is dead at haulback;
• Commercial fishermen using gear other than pelagic longline commercial gear (
• Recreational fishermen (fishermen with HMS Angling or Charter/Headboat permits, and fishermen with Atlantic Tunas General category and Swordfish General Commercial permits when participating in a registered HMS tournament) must release any shortfin mako sharks smaller than the minimum size of 83 inches (210 cm) fork length (FL).
Public comments were accepted on the original interim final rule through May 7, 2018, and one public hearing was held in conjunction with the HMS Advisory Panel meeting in Silver Spring, MD, on March 7, 2018. During the comment period, NMFS received a total of 65 individual written comments on the interim final rule from fishermen, states, and other interested parties and the members of the public. NMFS also received comments related to the emergency interim final rule during the four public scoping meetings associated with Draft Amendment 11 to the 2006 Consolidated HMS FMP. We also included the following comments on Draft Amendment 11 that were relevant to the emergency measures or to our decision to extend them. All written comments can be found at
The Assistant Administrator for Fisheries has determined that the emergency measures extended by this temporary rule are necessary to address overfishing of the North Atlantic shortfin mako shark fishery and are consistent with the Magnuson-Stevens Act and other applicable law.
Under 5 U.S.C. 553(d)(1), the Assistant Administrator for Fisheries finds good cause to waive the 30-day delayed effectiveness of this action. These emergency measures were
This action is being taken pursuant to the emergency provision of the Magnuson-Stevens Act and is exempt from OMB review.
This rule is exempt from the otherwise applicable requirement of the Regulatory Flexibility Act to prepare a regulatory flexibility analysis because the rule is issued without opportunity for prior public comment.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for Atka mackerel in the Central Aleutian district (CAI) of the Bering Sea and Aleutian Islands management area (BSAI) by vessels participating in the BSAI trawl limited access fishery. This action is necessary to prevent exceeding the 2018 total allowable catch (TAC) of Atka mackerel in this area allocated to vessels participating in the BSAI trawl limited access fishery.
Effective 1200 hours, Alaska local time (A.l.t.), August 17, 2018, through 2400 hours, A.l.t., December 31, 2018.
Steve Whitney, 907-586-7228.
NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2018 TAC of Atka mackerel, in the CAI, allocated to vessels participating in the BSAI trawl limited access fishery was established as a directed fishing allowance of 1,868 metric tons by the final 2018 and 2019 harvest specifications for groundfish in the BSAI (83 FR 8365, February 27, 2018).
In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Atka mackerel in the CAI by vessels participating in the BSAI trawl limited access fishery.
While this closure is effective the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA) finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such a requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of the Atka mackerel directed fishery in the CAI for vessels participating in the BSAI trawl limited access fishery. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 16, 2018. The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Federal Communications Commission.
Petitions for reconsideration.
The National Association of Telecommunications Officers and Advisors (NATOA) requests reconsideration of the Order's finding that deployments of small wireless facilities, as defined in the Order, are not subject to review under the National Historic Preservation Act (“NHPA”) and the National Environmental Policy Act of 1969 (“NEPA”). PTA-FLA, Inc. requests that the Commission also determine that structures between 50 feet and 199 feet are not subject to review under NEPA and NHPA. PTA-FLA also requests changes to Commission's procedures for notifying tribal governments of proposed structures. Various petitioners seek reconsideration of the Order because they assert that small cell facilities must complete review under the NHPA and NEPA.
Oppositions to the Petition must be filed on or before September 6, 2018. Replies to an opposition must be filed on or before September 17, 2018.
Federal Communications Commission, 445 12th Street SW, Washington, DC 20554.
Leon Jackler, Wireless Telecommunications Bureau, at: (202) 418-0946; email:
This is a summary of the Commission's document, Report No. 3099, released July 24, 2018. The full text of the Petitions is available for viewing and copying at the FCC Reference Information Center, 445 12th Street SW, Room CY-A257, Washington, DC 20554. It also may be accessed online via the Commission's Electronic Comment Filing System at:
Petitions for Reconsideration (Petitions) have been filed in the Commission's Rulemaking proceeding by Elaine R Unger, Cynthia Baughman, Lisa Cline and Rebecca Carol Smith. William Kenny Now, on behalf of Friends of Merrymeeting Bay, Mary Beth Brangan, Laura Allred, Joann Fox, Chuch Matzker, John M. Unger, Sue Present, Jacqueline J Shrontz, Sue Present, John Dankowski, Molly P Hauck. Pacia J. Harper, Ronald A. Fisher, Donna Desanto Ott PT, DPT, MS, FMCHC, Evelyn Savarin, Thomas Maslar, Naveen Albert, Jaclyn and David Kramer, Lucy Hackett, Andrew Hackett, Sarah Kendall, Allan D. Sikorski, Michael Kendall, Gary Swittel, Mary Kay Swittel, Leah Spitzer, Susan L. Benson, Daniel Kleiber, Susan B. Flemming, Catherine Kleiber, Molly Perkings, Hauck, Debra Albus, Michele Hertz, Alexandra Ansell, Cynthia Franklin, Michael Lipa, Rita Lipa, Victoria Sievers. Kate Kheel, Jonathan Mirin, Susan Riedeman and Pamela J. Ericson. Matt Huck, on behalf of Truth &Facts Never Lie, Becky Huck and Olemara Peters. Nancy L. Werner, on behalf of NATOA. Donald J. Evans, on behalf of PTA-FLA, Inc., and B Golomb.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Announcement of public listening session.
FMCSA announces a public listening session on Friday, August 24, 2018, to solicit information on issues relating to the design, development, testing, and integration of automated driving systems (ADS) equipped commercial motor vehicles (CMVs) on our Nation's roadways. The listening session is the third in a series held in 2018 with the first occurring on June 19 in Ann Arbor, MI, and the second occurring on July 12 in San Francisco, CA. The meeting will provide interested parties an opportunity to share their views on the FMCSRs as they relate to the development and safe integration of ADS. Attendees are also encouraged to share any data or analysis on this topic with Agency representatives.
The meeting will be held on Friday, August 24, 2018, from 1-2:30 p.m. Central Daylight Time (CDT) at the Great American Trucking Show (GATS), Kay Bailey Hutchison Convention Center, 650 S Griffin Street, Dallas, TX 75202. If all interested participants have had an opportunity to comment, the session may conclude early.
Ms. Shannon L. Watson, Senior Advisor to the Associate Administrator for Policy, Federal Motor Carrier Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590, at (202) 385-2395, or via email:
On September 12, 2017, the Department published the
• Encouraging new entrants and ideas that deliver safer vehicles;
• Making the Departmental regulatory processes nimbler to help match the pace of private sector innovation; and
• Supporting industry innovation and encouraging open communication with the public and with stakeholders.
The Voluntary Guidance is rooted in the Department's view that ADS-equipped vehicles hold enormous potential benefits for safety, mobility, and the efficiency of our transportation system. The primary focus of the Voluntary Guidance is on levels of ADS that can take full control of the driving tasks in at least some circumstances. Portions of the Voluntary Guidance also apply to lower levels of automation, including some of the driver assistance systems already being deployed by automakers today. The full document can be found at:
The Voluntary Guidance adopts the SAE International (SAE) J3016 standard's definitions for levels of automation. The SAE definitions divide vehicles into levels based on “who does what, when.” Generally:
•
•
•
•
•
•
Using the SAE levels described above, the Department draws a distinction between Levels 0-2 and 3-5 based on whether the human driver or the automated system is primarily responsible for monitoring the driving environment. For the purposes of this
FMCSA encourages the development of these advanced safety technologies for use on CMVs, and at the same time, recognizes the need to work with the States to ensure that, from an operations standpoint, all testing and use of these advanced safety systems is conducted in a manner that ensures the safe operation of ADS-equipped commercial vehicles.
FMCSA is responsible for the safety oversight of motor carriers operating CMVs in interstate commerce, the drivers of CMVs, and the vehicles. The Agency works with its State partners to deliver programs intended to prevent CMV crashes, and the associated injuries and fatalities.
The FMCSRs provide rules to ensure the safe operation of CMVs, as defined in 49 CFR 390.5, which includes vehicles with a gross vehicle weight/gross combination weight or gross vehicle weight rating/gross combination weight rating, whichever is greater, of 10,001 pounds or more; passenger-carrying vehicles designed or used to transport 9 to 15 passengers for direct compensation; passenger-carrying vehicles designed or used to transport 16 or more passengers; and any size vehicle transporting hazardous materials in a quantity requiring placards.
On March 26, 2018, FMCSA published “Request for Comments Concerning Federal Motor Carrier Safety Regulations (FMCSRs) Which May Be a Barrier to the Safe Testing and Deployment of Automated Driving Systems-Equipped Commercial Motor Vehicles on Public Roads.” (83 FR 12933) The document solicited public comments on existing Federal Motor Carrier Safety Regulations (FMCSRs) that may need to be updated, modified, or eliminated to facilitate the safe introduction of automated driving systems (ADS) equipped commercial motor vehicles (CMVs) onto our Nation's roadways. The Agency indicated that it had commissioned the U.S. Department of Transportation's John A. Volpe National Transportation Systems Center (Volpe) to conduct a preliminary review of the FMCSRs to identify regulations that may relate to the development and safe introduction of ADS. The Agency requested comments on this report, including whether any of FMCSA's current safety regulations may hinder the testing and safe integration of ADS-equipped CMVs. Further, FMCSA requested comment on certain specific regulatory requirements that are likely to be affected by an increased integration of ADS-equipped CMVs.
In addition, to support FMCSA's effort to understand future impacts on the FMCSRs, FMCSA requested information, including from companies engaged in the design, development, testing, and integration of ADS-equipped CMVs into the fleet. Specifically, the Agency requested information about: (1) The scenarios and environments where entities expect that ADS will soon be tested and integrated into CMVs operating on public roads or in interstate commerce; (2) the operational design domains (ODD) in which these systems are being operated or would be tested and eventually deployed; and, (3) measures they believe are required to ensure the protection of any proprietary or confidential business information they intend to share with the Agency. The comment period ended on May 10, 2018. Interested parties may view the comments the Agency received at
Subsequent to the publication of the March 28 notice, FMCSA and other surface transportation agencies have begun planning for the initiation of rulemakings concerning ADS technology. The agencies have been assigned Regulation Identification Numbers (RINs) for their respective Advance Notices of Proposed Rulemakings (ANPRMs). To that end, the public listening session is intended to provide FMCSA the opportunity to engage stakeholders before the Agency begins drafting its ANPRM.
Oral comments from the public will be heard throughout the meeting. Members of the public may submit written comments to public docket referenced at the beginning of this notice using any of the following methods:
•
•
•
•
Pursuant to the Federal Advisory Committee Act, notice is hereby given of the public meeting of the Board for International Food and Agricultural Development (BIFAD). The meeting will be held from 9:30 a.m. to 1:00 p.m. EDT on Wednesday, September 12, 2018, at the Murrow/White/Lisagor Room, 13th Floor, National Press Club, 529 14th Street NW, Washington, DC. Participants may attend in person or join via livestream. The link to the global live stream as well as registration information can be found on BIFAD's home page and online at
The central theme of this public meeting will be the new
Through the Learning Agenda, the U.S. Government seeks to improve the effectiveness and efficiency of the Feed the Future initiative by generating, synthesizing, communicating and applying evidence related to key questions. Evidence from the Learning Agenda will inform the design of Feed the Future-related strategies, programs, projects and activities. The Learning Agenda will also serve to address requirements laid out in section 8(a)(14) of the Global Food Security Act on sharing lessons learned from implementation of the Global Food Security Strategy.
This Feed the Future Learning Agenda will focus on eight areas: (1) Gender and women's empowerment, (2) Market systems, (3) Policy systems, (4) Nutrition, (5) Risk and resilience, (6) Youth, (7) Water and Water Sanitation and Hygiene (WASH), and (8) Scaling technologies and practices. These areas reflect work and research being carried out under the Feed the Future initiative. Analytical outputs from the work in these areas will feed into the answering Learning Agenda questions. BIFAD is taking this opportunity to welcome public input on these focus areas, the types of questions to be examined, and research under way that might help contribute.
Beginning at 12:30 p.m. EDT, Chairman Keenum will moderate a half-hour public comment period. The public meeting will adjourn at 1:00 p.m. EDT with Dr. Keenum's closing remarks.
Those wishing to attend the meeting or obtain additional information about BIFAD should contact Clara Cohen, Designated Federal Officer for BIFAD in the Bureau for Food Security at USAID. Interested persons may write to her in care of the U.S. Agency for International Development, Ronald Reagan Building, Bureau for Food Security, 1300 Pennsylvania Avenue NW, Washington, DC 20523-2110 or telephone her at (202) 712-0119.
Animal and Plant Health Inspection Service, USDA.
Extension of approval of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with qualitative customer and stakeholder feedback on service delivery by the Animal and Plant Health Inspection Service.
We will consider all comments that we receive on or before October 22, 2018.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
For more detailed information on this information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, MRPBS, APHIS, 4700 River Road Unit 123, Riverdale, MD 20737; (301) 851-2483.
By qualitative feedback, we mean information that provides useful insights on perceptions and opinions, but not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences, and expectations; provide an early warning of issues with service; or focus attention on areas where communication, training, or changes in operations might improve delivery of products or services. This collection will allow for ongoing, generic collaborative and actionable communications between APHIS and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.
The solicitation of feedback will target areas such as: Timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on APHIS' services will be unavailable.
APHIS will only submit a collection for approval under this generic clearance if it meets the following conditions:
• The collection is voluntary;
• The collection is low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden hours per respondent) and is low cost for both the respondents and the Federal Government;
• The collection is non-controversial and does not raise issues of concern to other Federal agencies;
• The collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future;
• Personally identifiable information is collected only to the extent necessary and is not retained;
• Information gathered is intended to be used only internally for general service improvement and program management purposes and is not intended for release outside of APHIS (if released, APHIS must indicate the qualitative nature of the information);
• Information gathered will not be used for the purpose of substantially informing influential policy decisions; and
• Information gathered will yield qualitative information (
As a general matter, this information collection will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.
We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies;
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Rural Utilities Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, the Rural Utilities Service, an agency of the U.S. Department of Agriculture (USDA), invites comments on this information collection for which approval from the Office of Management and Budget (OMB) will be requested.
Comments on this notice must be received by October 22, 2018.
Michele Brooks, Team Lead, Rural Development Innovation Center—Regulatory Team, USDA, 1400 Independence Ave., SW, STOP 1522, Room 5162 South Building, Washington, DC 20250-1522. Telephone: (202) 690-1078. Email:
The Office of Management and Budget's (OMB) regulation (5 CFR 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that will be submitted to OMB for approval.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including
The term of the loan is based on the expected composite economic life based on the depreciation rates of the facilities financed. The term of the loan can be as high as 35years. These loans are secured by a first lien on the borrower's broadband system. In the interest of protecting loan security and accomplishing the statutory objective of a sound program of rural broadband service access, Title VI of the RE Act further requires that RUS make or guarantee a loan only if there is reasonable assurance that the loan, together with all outstanding loans and obligations of the borrower, will be repaid in full within the time agreed.
Copies of this information collection can be obtained from MaryPat Daskal, Rural Development Innovation Center-Regulatory Team, at (202) 720-7853. Email:
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) is rescinding the administrative review of the antidumping duty order on small diameter graphite electrodes from the People's Republic of China (China) for the period February 1, 2017, through January 31, 2018, based on the timely withdrawal of the requests for review.
Applicable August 22, 2018.
Dennis McClure or John Anwesen, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5973 or (202) 482-0131, respectively.
On February 26, 2009, Commerce published in the
On February 28, 2018, Tokai Carbon GE LLC (the petitioner)
Pursuant to 19 CFR 351.213(d)(1), the Secretary will rescind an administrative review, in whole or in part, if the 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. In this case, the petitioner and Fushun Jinly timely withdrew their review requests by the 90-day deadline. No other parties requested an administrative review of the antidumping duty order on small diameter graphite electrodes from China. Therefore, we are rescinding the administrative review of the antidumping duty order on small diameter graphite electrodes from China for the period February 1, 2017, through January 31, 2018.
Commerce will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries. 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)(1)(i). Commerce intends to issue appropriate assessment instructions to CBP 15 days after publication of this notice in the
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of the antidumping duties occurred and the subsequent assessment of doubled antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(d)(4).
International Trade Administration, U.S. Department of Commerce.
Notice of renewal of the U.S. Department of Commerce Trade Finance Advisory Council and solicitation of nominations for membership.
Pursuant to provisions of the Federal Advisory Committee Act, as amended, the Department of Commerce (the Department) announces the renewal of the U.S. Department of Commerce Trade Finance Advisory Council. This advisory committee advises the Secretary on the development of strategies and programs that would help expand access to finance for U.S. exporters. The renewal of this federal advisory committee is necessary to provide input to the Secretary regarding the challenges faced by U.S. exporters in accessing capital, innovative solutions that can address these challenges, and recommendations on strategies that can expand access to finance and educate U.S. exporters on available resources.
Nominations for members must be received on or before 5:00 p.m. Eastern Daylight Time (EDT) Monday, October 15, 2018. After that date, the Department will continue to accept applications under this notice for a period of up to two years from the deadline to fill any vacancies that may arise.
All nominations should be submitted by email to
Ericka Ukrow, Office of Finance and Insurance Industries, Room 18002, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0405, email:
Pursuant to provisions of the Federal Advisory Committee Act, as amended, 5 U.S.C. App., the Department of Commerce announces the renewal of the U.S. Department of Commerce Trade Finance Advisory Council (TFAC). The TFAC advises the Secretary on matters related to access to finance for U.S. exporters.
The Department of Commerce, International Trade Administration, Office of Finance and Insurance Industries, is accepting nominations for membership on the TFAC. The TFAC functions solely as an advisory committee. The TFAC shall advise the Secretary in identifying effective ways to help expand access to finance for U.S. exporters, including small- and medium-sized enterprises (SMEs), and their foreign buyers.
The TFAC shall provide a forum to facilitate the discussion between a diverse group of stakeholders such as banks, non-bank financial institutions, other trade finance related organizations, and exporters to gain a better understanding regarding current challenges facing U.S. exporters in accessing capital.
The TFAC shall draw upon the experience of its members to identify how new technologies and other innovative solutions can expand access to trade finance for U.S. exporters.
The TFAC shall develop recommendations on programs or activities that the Department of Commerce could incorporate as part of its export promotion and trade finance education efforts.
The TFAC shall report to the Secretary on its activities and recommendations. In creating its reports, the TFAC shall: (1) Evaluate current credit conditions and specific financing challenges faced by U.S. exporters, including SMEs, and their foreign buyers, (2) identify emerging financing sources that would address these gaps, (3) examine how new financial technologies and other innovations could impact the availability and affordability of trade finance solutions, (4) highlight developments from international standard setting bodies that may affect the provision of trade finance, and (5) address any other noteworthy issues raised by stakeholders represented by the membership or the public.
The TFAC shall consist of no more than twenty-five members appointed by the Secretary. Members may be drawn from:
• U.S. companies that are exporters of goods and services;
• U.S. commercial banks that provide trade finance products, cross-border
payment services, or foreign exchange solutions;
• Non-bank U.S. financial institutions that provide trade finance products, cross-border payment services, or foreign exchange solutions;
• Associations that represent: (a) U.S. exporters; and (b) U.S. commercial banks or non-bank financial institutions or other professionals that facilitate international trade transactions;
• U.S. companies or entities whose business includes trade-finance-related activities or services;
• U.S. scholars, academic institutions, or public policy organizations with expertise in global business, trade finance, and international banking related subjects; and
• Economic development organizations and other U.S. regional, state and local governmental and non-governmental organizations whose missions or activities include the analysis, provision, or facilitation of trade finance products/services.
Membership shall include a broad range of companies and organizations in terms of products and services, company size, and geographic location of both the source and destination of trade finance. Members will be selected based on their ability to carry out the objectives of the TFAC, in accordance with applicable Department of Commerce guidelines and in a manner that ensures that the TFAC is balanced in terms of points of view.
Members, with the exception of those that serve as experts from academia and public policy organizations, serve in a representative capacity and representing their own views and interests and those of their particular sector, not as special government employees. The members that serve as experts (rather than as representatives) from academia and public policy organizations are Special Government employees (SGEs), pursuant to 18 U.S.C. 202, are required to comply with certain ethics laws and rules, including filing a Confidential Financial Disclosure form. Additionally, a member serving as an expert must not be a Federally Registered Lobbyist. Prospective nominees should designate the capacity in which they are applying to serve and identify either their area of expertise or the U.S. industry sector they wish to represent. Each member shall be appointed for a term of two years and will serve at the pleasure of the Secretary. The Secretary may at his/her discretion reappoint any member to an additional term or terms, provided that the member proves to work effectively on the TFAC and his/her knowledge and advice is still needed.
In addition, the Chairman of the U.S. Export Import Bank (EXIM), and the Administrator of the Small Business Administration (SBA) (or their respective designees), will serve on the TFAC as
The members term of service will not exceed the duration of this charter and they may be reselected for additional periods should the charter be renewed and should they remain on the TFAC.
Members will not be paid for their engagement in the performance of their duties as members of the Council. Members will not receive per diem and travel expenses.
The Department of Commerce will consider nominations of all qualified individuals to ensure that the TFAC includes representatives of the viewpoint areas of subject matter expertise noted above (see ”Structure, Membership and Operation”). Individuals may nominate themselves or a company, institution, trade association, or organization may nominate a qualified representative for membership on the TFAC.
Applications for immediate consideration must be received by 5:00 p.m. EDT Monday, October 15, 2018.
All applicants must submit the following:
1. Name and title of the individual requesting consideration.
2. The applicant's personal resume and short biography (less than 300 words).
3. A brief statement describing how the applicant will contribute to the work of the TFAC based on his/her unique experience and perspective (not to exceed 100 words).
4. All relevant contact information, including mailing address, fax, email, phone number, and support staff information where relevant.
5. An affirmative statement that the applicant meets all eligibility criteria, including an affirmative statement that the applicant is not required to register as a foreign agent under the Foreign Agents Registration Act of 1938, as amended.
6. For applicants to serve in a representative capacity, also submit:
a. A sponsor letter on the sponsoring entity's letterhead containing a brief statement of why the applicant should be considered for membership on the TFAC. This sponsor letter should also address the applicant's experience and leadership related to trade finance;
b. A brief description of the company, institution, trade association, or organization to be represented and its business activities and export market(s) served, if applicable;
c. Information regarding the ownership and control of the sponsoring entity, including the stock holdings as appropriate; and
d. The sponsoring entity's size (number of employees and annual sales), place of incorporation, product or service line, major markets in which the entity operates, and the entity's export or import experience.
7. For applicants to serve as experts (
a. A statement that the applicant is not a Federally registered lobbyist and that the applicant understands that, if appointed, the applicant will not be allowed to continue to serve as a Committee member if the applicant becomes a Federally registered lobbyist.
Notice of Application for an Amended Export Trade Certificate of Review by Alaska Longline Cod Commission, Application No. 10-4A001.
The Secretary of Commerce, through the International Trade Administration, Office of Trade and Economic Analysis (“OTEA”), received an application for an amended Export Trade Certificate of Review (“Certificate”) from Alaska Longline Cod Commission. This notice summarizes the proposed amendment and seeks public comments on whether the amended Certificate should be issued.
Joseph Flynn, Director, Office of Trade and Economic Analysis, International Trade Administration, by telephone at (202) 482-5131 (this is not a toll-free number) or email at
Title III of the Export Trading Company Act of 1982 (15 U.S.C. 4001-21) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. Section 302(b)(1) of the Export Trading Company Act of 1982 and 15 CFR 325.6(a) require the Secretary to publish a notice in the
Interested parties may submit written comments relevant to the determination whether an amended Certificate should be issued. If the comments include any privileged or confidential business information, it must be clearly marked and a nonconfidential version of the comments (identified as such) should be included. Any comments not marked as privileged or confidential business information will be deemed to be nonconfidential.
An original and five (5) copies, plus two (2) copies of the nonconfidential version, should be submitted no later than 20 days after the date of this notice to: Office of Trade and Economic Analysis, International Trade Administration, U.S. Department of Commerce, Room 21028, Washington, DC 20230.
Information submitted by any person is exempt from disclosure under the Freedom of Information Act (5 U.S.C. 552). However, nonconfidential versions of the comments will be made available to the applicant if necessary for determining whether or not to issue the amended Certificate. Comments should refer to this application as “Export Trade Certificate of Review, application number 10-4A001.”
A summary of the current application follows.
1. Add the following companies as new Members of the Certificate within the meaning of section 325.2(l) of the Regulations (15 CFR 325.2(l)):
2. Delete the following companies as Members of the Certificate:
3. Change/correct the name or location of the following Members of the Certificate:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; proposed incidental harassment authorization; request for comments on proposed authorization and possible renewal.
NMFS has received a request from the Port of San Francisco for authorization to take marine mammals incidental to the Mission Bay Ferry and Water Taxi Landing Project in San Francisco Bay, California. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-year renewal that could be issued under certain circumstances and if all requirements are met, as described in
Comments and information must be received no later than September 21, 2018.
Comments should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service. Physical comments should be sent to 1315 East-West Highway, Silver Spring, MD 20910 and electronic comments should be sent to
Gray Redding, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the application and supporting documents, as well as a list of the references cited in this document, may be obtained online at:
The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable [adverse] impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. The definitions of all applicable MMPA statutory terms cited above are included in the relevant sections below.
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
This action is consistent with categories of activities identified in Categorical Exclusion B4 (incidental harassment authorizations with no anticipated serious injury or mortality) of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has preliminarily determined that the issuance of the proposed IHA qualifies to be categorically excluded from further NEPA review.
We will review all comments submitted in response to this notice prior to concluding our NEPA process or making a final decision on the IHA request.
On November 2, 2017, NMFS received a request from the Port of San Francisco for an IHA to take marine mammals incidental to pile driving and drilling in San Francisco Bay. NMFS determined that a revised version of the Port's application was adequate and complete on June 22, 2018. The Port of San Francisco's request is for take of seven species of marine mammals by Level B harassment only. Neither the Port of San Francisco nor NMFS expects serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.
The port of San Francisco proposes to construct the Mission Bay Ferry Landing (MBFL) and Water Taxi Landing (WTL) on San Francisco Bay, within the Port of San Francisco's Southern Waterfront in the Mission Bay/Central Waterfront area (see Figure 1 of IHA Application). The project's proposed activities that have the potential to take marine mammals include vibratory and impact pile driving, vibratory pile removal, and down the hole drilling. In addition, the project will include dredging, however authorization of take from this activity is neither requested nor proposed for authorization.
The Mission Bay Ferry Landing, a single‐float, two‐berth ferry landing will provide critical regional ferry service to and from the Mission Bay neighborhood, one of the fastest growing neighborhoods in San Francisco, as well as the Dogpatch, Potrero Hill, Pier 70, and the Central Waterfront neighborhoods. The separate single float, two‐berth Water Taxi Landing will provide local water taxi access to the Mission Bay area and surrounding neighborhoods.
The Port of San Francisco's construction, including dredging, vibratory and impact pile driving, and drilling for installation of the pier and floating docks will occur from June through November of 2019 (environment working windows for dredging in this region of the San Francisco Bay established by the San Francisco Bay Long Term Management Strategy (LTMS Agencies, 2001). The maximum number of construction days possible, including dredging and all other activities, is 55 days. The maximum total number of days for pile installation and removal are 15 days.
As stated, the project is located in San Francisco Bay within the Port of San Francisco's Southern Waterfront in the Mission Bay/Central Waterfront area. The specific geographic location for the project is provided in Figures 1 and 2 of the IHA Application. The project site is approximately three kilometers south of the San Francisco-Oakland Bay Bridge, on the western side of San Francisco Bay in the Central Basin. The nearby waterfront is an active recreational and commercial port and shipyard.
Based on preliminary bathymetric surveys and historic information, The Port anticipates that buried remnants of concrete and wood debris from Pier 64-66 apron may be encountered within the Ferry Landing dredge boundary. All debris encountered during dredging operations will be removed and disposed of at an approved upland location.
In addition, existing piles will be pulled with a cable choker or removed with a vibratory hammer and every effort will be made to remove the entire pile length. If it is necessary to utilize vibratory hammer to remove a pile the process will consist of approximately 1-2 minutes of initial vibratory use while pulling the pile up to loosen it from the sediment. The barge/crane then moves to the next pile to loosen. The operator will do this for five to eight piles then remove the vibratory driver and go back to dead pull the loosened piles and place them on a debris barge for disposal at a permitted facility. The vibratory use is minimal to just loosen the pile. Noise generated from the operation of the vibratory hammer is expected to result in the behavioral disturbance of marine mammals and, therefore, take authorization is requested, and accounted for in the “Take Calculation and Estimation” section below.
Dredging of approximately 129,374 cubic yards will be conducted to a depth of −15 feet (ft) MLLW +2 ft of overdepth within the Ferry Landing dredge boundary, and to a depth of −8ft MLLW +1 ft overdepth within the Water Taxi Landing dredge boundary.
Best Management Practices (BMPs) will be detailed in a Dredge Operations Plan (DOP) submitted to the regulatory agencies for approval before dredging begins, and implemented. Dredging will be performed from a barge‐mounted crane with a clam shell bucket. Sediment will be transferred into adjacent barges for transport to permitted placement site(s). All debris encountered during dredging operations will be removed and disposed of at an approved upland location. Noise measurements of dredging activities are rare in the literature, but dredging is considered to be a low-impact activity for marine mammals, producing non-pulsed sound and being substantially quieter in terms of acoustic energy output than sources such as seismic airguns and impact pile driving. Noise produced by dredging operations has been compared to that produced by a commercial vessel travelling at modest speed (Robinson et al., 2011). Further discussion of dredging sound production may be found in the literature (
A total of 28 permanent piles will be installed as part of this project. Four 24-inch concrete piles will be installed on land above the mean highwater (MHW)
Concrete piles used for in‐water construction of the pier structure for the Mission Bay Ferry Landing will involve the temporary installation of a steel caisson sleeve followed by drilling of the rock socket, with this installation and drilling process outlined below. Four 14-inch steel H piles will be driven with a vibratory driver to provide support for a 30-inch steel caisson sleeve, a large tubular steel pile. The steel sleeve will also be installed using a vibratory driver until refusal. Once the caisson is in place, sediment/soil/rock within the caisson will be drilled out using a Bauer BG18 drill or similar. All drilled sediment/soil/rock will be collected for disposal and transported to an appropriate permitted facility. The concrete piles are then inserted after the hole has been drilled. The 24-inch concrete piles will then be placed/seated in bedrock for grouting then the outer caisson and four H‐piles will be pulled. Figure 3 in the IHA Application provides a depiction of this process. This method of construction creates less overall noise and turbidity during installation than driven piles. Drilling also is beneficial as it reduces the stress and therefore chance of breakage or damage to the pile during installation. Overall, ten 24-inch octagonal concrete piles will be driven using these methods, including down the hole drilling. Authorization of take by Level B harassment was requested and is proposed for authorization by NMFS for drilling activities associated with 24-inch concrete piles.
For the remaining piles, noise generated by vibratory and/or impact hammers is expected to result in the disturbance of marine mammals and, therefore, authorization of incidental take is proposed. Eight 36-inch steel piles for the MBFL guide piles and donut fenders and two 16-inch steel piles for the WTL platform will be installed with a combination of vibratory driver and/or impact hammer. The four remaining 20-inch square concrete piles to be installed in-water will be installed with an impact hammer.
The Port estimates a production rate for pile driving of two to six piles per day, resulting in a 15 days of pile driving and removal as outlined in Table 1. Piles installed using an impact hammer will use a Delmag D36/D46/D62 or similar diesel hammer. An overview of the sound source levels for this pile installation can be found in Table 3. It should be noted that the contractor will be instructed to implement vibratory installation as much as possible.
All pile driving will be performed in compliance with the “U.S. Army Corps of Engineers Proposed Procedures for Permitting Projects that will Not Adversely Affect Selected Listed Species in California” and the associated USFWS and NMFS section 7 consultation documents associated with these procedures.
Installation of the pier deck, pier canopy, float, and gangway would be conducted from land and water-based vessels. This work would include the use of generators, cranes, and other heavy equipment but is not expected to result in any harassment of marine mammals. Therefore, no take is requested or proposed for authorization for these activities.
Proposed mitigation, monitoring, and reporting measures are described in detail later in this document (please see
Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior
Table 2 lists all species with expected potential for occurrence in the Mission Bay/Central Waterfront area of San Francisco Bay and summarizes information related to the population or stock, including regulatory status under the MMPA and ESA and potential biological removal (PBR), where known. For taxonomy, we follow the Committee on Taxonomy (2017). PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS's SARs). While NMFS neither anticipates nor proposes to authorize mortality here, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species and other threats.
Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS's stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS's U.S. 2017 SARs (Carretta
All species that could potentially occur in the Port's proposed project area in San Francisco Bay are included in Table 2. However, the temporal and/or spatial occurrence of humpback whale and Guadalupe fur seal is such that take is not expected to occur, and they are not discussed further beyond the explanation provided here. Humpback whales are rare visitors to the interior of San Francisco Bay. A recent, seasonal influx of humpback whales inside San
Harbor seals are found from Baja California to the eastern Aleutian Islands of Alaska. The species primarily hauls out on remote mainland and island beaches and reefs, and estuary areas. Harbor seals tend to forage locally within 53 miles (mi) (85 kilometers (km)) of haul-out sites (Harvey and Goley 2011). Harbor seal is the most common marine mammal species observed in the Bay and individuals are commonly seen near the San Francisco-Oakland Bay Bridge east span (CalTrans 2013b, 2013c). Tagging studies have shown that most seals tagged in the Bay remain in the Bay (Harvey and Goley 2011; Manugian 2013). Foraging often occurs in the Bay, as noted by observations of seals exhibiting foraging behavior (short dives less than five minutes, moving back and forth in an area, and sometimes tearing up prey at the surface).
Gray whales are large baleen whales. They grow to approximately 50 ft in length and weigh up to 40 tons. They are one of the most frequently seen whales along the California coast, easily recognized by their mottled gray color and lack of dorsal fin. Adult whales carry heavy loads of attached barnacles, which add to their mottled appearance. Gray whales are divided into the Eastern North Pacific and Western North Pacific stocks. Both stocks migrate each year along the west coast of continental North America and Alaska. The Eastern North Pacific stock is much larger and is more likely to occur in the San Francisco Bay area. Western North Pacific Gray whales have summer and fall feeding grounds in the Okhotsk Sea off northeast Sakhalin Island, Russia, and off southeastern Kamchatka in the Bering Sea (NMFS 2017c), so they would not be expected to occur in San Francisco Bay during construction activity for this project. With the exception of an unusual mortality event in 1999 and 2000, the population of Eastern North Pacific stock has increased over the last 20 years and has been stable since the 1990s (NMFS 2015c).
Gray whales are the only baleen whale known to feed on the sea floor, where they scoop up bottom sediments to filter out benthic crustaceans, mollusks, and worms (NMFS 2015c). They feed in northern waters primarily off the Bering, Chukchi, and western Beaufort Seas during the summer. Between December and January, late-stage pregnant females, adult males, and immature females and males migrate southward to breeding areas around Mexico. The northward migration occurs between February and March. Coastal waters just outside San Francisco Bay are considered a migratory Biologically Important Area for the northward progression of gray whales (Calambokidis
Bottlenose dolphins are distributed world-wide in tropical and warm-temperate waters. In many regions, including California, separate coastal and offshore populations are known (Walker 1981; Ross and Cockcroft 1990; Van Waerebeek
Harbor porpoise are seldom found in waters warmer than 62.6 degrees Fahrenheit (17 degrees Celsius) (Read 1990) or south of Point Conception, and occurs as far north as the Bering Sea (Barlow and Hanan 1995; Carretta
Occasional sightings of harbor porpoises in the Bay, including near the Yerba Buena Island harbor seal haul‐out site, were reported by the Caltrans marine mammal monitoring program beginning in 2008 (Caltrans 2018). Continued sightings from Caltrans and the Golden Gate Cetacean Research (GGCR) Organization suggests that the species is returning to San Francisco Bay after an absence of approximately 65 years (GGCR 2010). This re‐immergence is not unique to San Francisco Bay, but rather indicative of the harbor porpoise in general along the west coast. GGCR has been issued a scientific research permit from NMFS for a multi‐year assessment to document the population abundance and distribution in the Bay (82 FR 60374). Recent observations of harbor porpoises have been reported by GGCR researchers off Cavallo Point, outside Raccoon Strait between Tiburon and Angel Island, off Fort Point and as far into the Bay as Carquinez Strait (Perlman 2010). Based on the Caltrans and GGCR monitoring, over 100 porpoises were seen at one time entering San Francisco Bay; and over 600 individual animals have been documented in a photo‐ID database. Reported sightings are concentrated in the vicinity of the Golden Gate Bridge and Angel Island, with lesser numbers sighted south of Alcatraz and west of Treasure Island (AECOM 2017).
California sea lions breed on the offshore islands of California from May through July (Heath and Perrin 2009). During the non-breeding season, adult and sub-adult males and juveniles migrate northward along the coast, to central and northern California, Oregon, Washington, and Vancouver Island (Jefferson
In San Francisco Bay, California sea lions have been observed at Angel Island and occupying the docks near Pier 39 which is the largest California sea lion haul‐out in San Francisco Bay. A maximum of 1,706 sea lions were counted at Pier 39 in 2009. However, since then the population has averaged at about 50-300 depending upon the season (TMMC 2017). This group of sea lions has decreased in size in recent years, coincident with a fluctuating decrease in the herring population in the Bay. There are no known breeding sites within San Francisco Bay. Their primary breeding site is in the Channel Islands (USACE 2011). The sea lions appear at Pier 39 after returning from the Channel Islands at the beginning of August (Bauer 1999). No other sea lion haul‐out sites have been identified in the Bay and no pupping has been observed at the Pier 39 site or any other site in San Francisco Bay under normal conditions (USACE 2011). Although there has been documentation of pupping on docks in the Bay, this event was during a domoic acid event. The Port does not anticipate that any domoic events will occur during the project construction activities.
The project site is approximately four miles away from Pier 39. Although there is little information regarding the foraging behavior of the California sea lion in southern San Francisco Bay, they have been observed foraging on a regular basis in the shipping channel south of Yerba Buena Island.
Foraging grounds have also been identified for pinnipeds, including sea lions, between Yerba Buena Island and Treasure Island, as well as off the Tiburon Peninsula (Caltrans, 2006). The California sea lions that use the Pier 39 haul‐out site may be feeding on Pacific herring (
Northern elephant seal is common on California coastal mainland and island sites, where the species pups, breeds, rests, and molts. The largest rookeries are on San Nicolas and San Miguel islands in the northern Channel Islands. Near the Bay, elephant seals breed, molt, and haul out at Año Nuevo Island, the Farallon Islands, and Point Reyes National Seashore.
Northern elephant seals haul out to give birth and breed from December through March. Pups remain onshore or in adjacent shallow water through May. Both sexes make two foraging migrations each year: One after breeding and the second after molting (Stewart 1989; Stewart and DeLong 1995). Adult females migrate to the central North Pacific to forage, and males migrate to the Gulf of Alaska to forage (Robinson
Generally, only juvenile elephant seals enter the Bay and do not remain long. The most recent sighting near the project area was in 2012, on the beach at Clipper Cove on Treasure Island, when a healthy yearling elephant seal hauled out for approximately 1 day. Approximately 100 juvenile northern elephant seals strand in or near the Bay each year, including individual strandings at Yerba Buena Island (YBI) and Treasure Island (less than 10 strandings per year).
Northern fur seal breeds on the offshore islands of California and in the Bering Sea from May through July. Two stocks of Northern fur seals may occur near the Bay, the California and Eastern Pacific stocks. The California stock breeds, pups, and forages off the California coast. The Eastern Pacific stock breeds and pups on islands in the Bering Sea, but females and juveniles move south to California waters to forage in the fall and winter months.
Both the California and Eastern Pacific stocks forage in the offshore waters of California, but only sick, emaciated, or injured fur seals enter the Bay. The Marine Mammal Center (TMMC) occasionally picks up stranded fur seals around YBI and Treasure Island.
Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Current data indicate that not all marine mammal species have equal hearing capabilities (
• Low-frequency cetaceans (mysticetes): Generalized hearing is estimated to occur between approximately 7 Hz and 35 kHz;
• Mid-frequency cetaceans (larger toothed whales, beaked whales, and most delphinids): Generalized hearing is estimated to occur between approximately 150 Hz and 160 kHz;
• High-frequency cetaceans (porpoises, river dolphins, and members of the genera Kogia and Cephalorhynchus; including two members of the genus Lagenorhynchus, on the basis of recent echolocation data and genetic data): Generalized hearing is estimated to occur between approximately 275 Hz and 160 kHz.
• Pinnipeds in water; Phocidae (true seals): Generalized hearing is estimated to occur between approximately 50 Hz to 86 kHz;
• Pinnipeds in water; Otariidae (eared seals): Generalized hearing is estimated to occur between 60 Hz and 39 kHz.
The pinniped functional hearing group was modified from Southall
For more detail concerning these groups and associated frequency ranges,
This section includes a summary and discussion of the ways that components of the specified activity may impact marine mammals and their habitat. The “Estimated Take” section later in this document includes a quantitative analysis of the number of individuals that are expected to be taken by this activity. The “Negligible Impact Analysis and Determination” section considers the content of this section, the “Estimated Take” section, and the “Proposed Mitigation” section, to draw conclusions regarding the likely impacts of these activities on the reproductive success or survivorship of individuals and how those impacts on individuals are likely to impact marine mammal species or stocks.
Sound travels in waves, the basic components of which are frequency, wavelength, velocity, and amplitude. Frequency is the number of pressure waves that pass by a reference point per unit of time and is measured in Hz or cycles per second. Wavelength is the distance between two peaks of a sound wave; lower frequency sounds have longer wavelengths than higher frequency sounds. Amplitude is the height of the sound pressure wave or the `loudness' of a sound and is typically measured using the dB scale. A dB is the ratio between a measured pressure (with sound) and a reference pressure (sound at a constant pressure, established by scientific standards). It is a logarithmic unit that accounts for large variations in amplitude; therefore, relatively small changes in dB ratings correspond to large changes in sound pressure. When referring to sound pressure levels (SPLs; the sound force per unit area), sound is referenced in the context of underwater sound pressure to one microPascal (μPa). One pascal is the pressure resulting from a force of one newton exerted over an area of one square meter (m
Root mean square (rms) is the quadratic mean sound pressure over the duration of an impulse. Rms is calculated by squaring all of the sound amplitudes, averaging the squares, and then taking the square root of the average (Urick 1983). Rms accounts for both positive and negative values; squaring the pressures makes all values positive so that they may be accounted for in the summation of pressure levels (Hastings and Popper 2005). This measurement is often used in the context of discussing behavioral effects, in part because behavioral effects, which often result from auditory cues, may be better expressed through averaged units than by peak pressures.
When underwater objects vibrate or activity occurs, sound-pressure waves are created. These waves alternately compress and decompress the water as the sound wave travels. Underwater sound waves radiate in all directions away from the source (similar to ripples on the surface of a pond), except in cases where the source is directional. The compressions and decompressions associated with sound waves are detected as changes in pressure by aquatic life and man-made sound receptors such as hydrophones.
Even in the absence of sound from the specified activity, the underwater environment is typically loud due to ambient sound. Ambient sound is defined as environmental background sound levels lacking a single source or point (Richardson
•
•
•
•
The sum of the various natural and anthropogenic sound sources at any given location and time—which comprise “ambient” or “background” sound—depends not only on the source levels (as determined by current weather conditions and levels of biological and shipping activity) but also on the ability of sound to propagate through the environment. In turn, sound propagation is dependent on the spatially and temporally varying properties of the water column and sea floor, and is frequency-dependent. As a result of the dependence on a large number of varying factors, ambient sound levels can be expected to vary widely over both coarse and fine spatial and temporal scales. Sound levels at a given frequency and location can vary by 10-20 dB from day to day (Richardson
In-water construction activities associated with the project would include impact pile driving, vibratory
Impulsive sound sources (
Non-impulsive sounds can be tonal, narrowband, or broadband, brief or prolonged, and may be either continuous or non-continuous (NIOSH 1998). Some of these non-impulsive sounds can be transient signals of short duration but without the essential properties of impulses (
Impact hammers operate by repeatedly dropping a heavy piston onto a pile to drive the pile into the substrate. Sound generated by impact hammers is characterized by rapid rise times and high peak levels, a potentially injurious combination (Hastings and Popper 2005). Vibratory hammers install piles by vibrating them and allowing the weight of the hammer to push them into the sediment. Vibratory hammers produce significantly less sound than impact hammers. Peak SPLs may be 180 dB or greater, but are generally 10 to 20 dB lower than SPLs generated during impact pile driving of the same-sized pile (Oestman
Anthropogenic sounds cover a broad range of frequencies and sound levels and can have a range of highly variable impacts on marine life, from none or minor to potentially severe responses, depending on received levels, duration of exposure, behavioral context, and various other factors. The potential effects of underwater sound from active acoustic sources can potentially result in one or more of the following direct impacts on marine mammals; temporary or permanent hearing impairment, non-auditory physical or physiological effects, behavioral disturbance, stress, and masking (Richardson
Richardson
We describe the more severe effects (
When PTS occurs, there is physical damage to the sound receptors in the ear (
Relationships between TTS and PTS thresholds have not been studied in marine mammals—PTS data exists only for a single harbor seal (Kastak
TTS is the mildest form of hearing impairment that can occur during exposure to sound (Kryter 1985). While experiencing TTS, the hearing threshold rises, and a sound must be at a higher
Marine mammal hearing plays a critical role in communication with conspecifics, and interpretation of environmental cues for purposes such as predator avoidance and prey capture. Depending on the degree (elevation of threshold in dB), duration (
Currently, TTS data only exist for four species of cetaceans (bottlenose dolphin (
In addition to PTS and TTS, there is a potential for non-auditory physiological effects or injuries that theoretically might occur in marine mammals exposed to high level underwater sound or as a secondary effect of extreme behavioral reactions (
When a live or dead marine mammal swims or floats onto shore and is incapable of returning to sea, the event is termed a “stranding” (16 U.S.C. 1421h(3)). Marine mammals are known to strand for a variety of reasons, such as infectious agents, biotoxicosis, starvation, fishery interaction, ship strike, unusual oceanographic or weather events, sound exposure, or combinations of these stressors sustained concurrently or in series (
Behavioral disturbance may include a variety of effects, including subtle changes in behavior (
Habituation can occur when an animal's response to a stimulus wanes with repeated exposure, usually in the absence of unpleasant associated events (Wartzok
Available studies show wide variation in response to underwater sound; therefore, it is difficult to predict specifically how any given sound in a particular instance might affect marine mammals perceiving the signal. If a marine mammal does react briefly to an underwater sound by changing its behavior or moving a small distance, the impacts of the change are unlikely to be significant to the individual, let alone the stock or population. However, if a sound source displaces marine mammals from an important feeding or breeding area for a prolonged period, impacts on individuals and populations could be significant (
Changes in dive behavior can vary widely, and may consist of increased or decreased dive times and surface intervals as well as changes in the rates of ascent and descent during a dive (
Disruption of feeding behavior can be difficult to correlate with anthropogenic sound exposure, so it is usually inferred by observed displacement from known foraging areas, the appearance of secondary indicators (
Variations in respiration naturally occur with different behaviors and alterations to breathing rate as a function of acoustic exposure can be expected to co-occur with other behavioral reactions, such as a flight response or an alteration in diving. However, respiration rates in and of themselves may be representative of annoyance or an acute stress response. Various studies have shown that respiration rates may either be unaffected or could increase, depending on the species and signal characteristics, again highlighting the importance in understanding species differences in the tolerance of underwater noise when determining the potential for impacts resulting from anthropogenic sound exposure (
Marine mammals vocalize for different purposes and across multiple modes, such as whistling, echolocation click production, calling, and singing. Changes in vocalization behavior in response to anthropogenic noise can occur for any of these modes and may result from a need to compete with an increase in background noise or may reflect increased vigilance or a startle response. For example, in the presence of potentially masking signals, humpback whales and killer whales have been observed to increase the length of their songs (Miller
Avoidance is the displacement of an individual from an area or migration path because of the presence of a sound or other stressors, and is one of the most obvious manifestations of disturbance in marine mammals (Richardson
A flight response is a dramatic change in normal movement to a directed and rapid movement away from the perceived location of a sound source. The flight response differs from other avoidance responses in the intensity of the response (
Behavioral disturbance can also impact marine mammals in more subtle ways. Increased vigilance may result in costs related to diversion of focus and attention (
Many animals perform vital functions, such as feeding, resting, traveling, and socializing, on a diel cycle (24-hour cycle). Disruption of such functions resulting from reactions to stressors such as sound exposure are more likely to be significant if they last more than one diel cycle or recur on subsequent days (Southall
In the absence of mitigation, impacts to marine species could be expected to include physiological and behavioral responses to the acoustic signature (Viada
The effects of sounds from pile driving, by impact or vibratory means, pile removal, and down the hole drilling might include one or more of the following: Temporary or permanent hearing impairment, non-auditory physical or physiological effects, behavioral disturbance, and masking (Richardson
Responses to continuous sound, such as vibratory pile installation or down the hole drilling, have not been documented as well as responses to impulsive sounds. With both types of pile driving, it is likely that the onset of pile driving could result in temporary, short-term changes in an animal's typical behavior and/or avoidance of the affected area. These behavioral changes may include, based on more general observations of behavioral responses to sound exposure (Richardson
Natural and artificial sounds can disrupt behavior by masking. The frequency range of the potentially masking sound is important in determining any potential behavioral impacts. Because sound generated from in-water pile driving and removal is mostly concentrated at low-frequency ranges, it may have less effect on high frequency echolocation sounds made by porpoises. The most intense underwater sounds in the Port's proposed action are those produced by impact pile driving. Given that the energy distribution of pile driving covers a broad frequency spectrum, sound from these sources would likely be within the audible range of marine mammals present in the project area. Impact pile driving activity is relatively short-term, with rapid impulsive sounds occurring for approximately 20 minutes per pile in this project. The probability for impact pile driving resulting from this proposed action masking acoustic signals important to the behavior and survival of marine mammal species is low and if it occurred, it would be for a short duration. Vibratory pile driving is also relatively short-term, with rapid oscillations occurring for approximately 20 minutes per pile in this project. It is possible that vibratory pile driving resulting from this proposed action may mask acoustic signals important to the behavior and survival of marine mammal species, but the short-term duration and limited affected area would result in insignificant impacts from masking.
Pinnipeds that occur near the project site could be exposed to airborne sounds associated with pile driving and removal that have the potential to cause behavioral harassment, depending on their distance from pile driving activities. Cetaceans are not expected to be exposed to airborne sounds that would result in harassment as defined under the MMPA.
Airborne noise will primarily be an issue for pinnipeds that are swimming or hauled out near the project site within the range of noise levels elevated above the acoustic criteria. We recognize that pinnipeds in the water could be exposed to airborne sound that may result in behavioral harassment when looking with their heads above water. Most likely, airborne sound would cause behavioral responses similar to those discussed above in relation to underwater sound. For instance, anthropogenic sound could cause hauled-out pinnipeds to exhibit changes in their normal behavior, such as reduction in vocalizations, or cause them to temporarily abandon the area and move further from the source. However, these animals would likely previously have been `taken' because of exposure to underwater sound above the behavioral harassment thresholds, which are in all cases larger than those associated with airborne sound. Thus, the behavioral harassment of these animals by airborne sound is already accounted for in the estimates of potential take from underwater exposure to pile driving sounds. Therefore, we do not believe that authorization of additional incidental take resulting from airborne sound for pinnipeds is warranted, and airborne sound is not discussed further here.
An animal's perception of a threat may be sufficient to trigger stress responses consisting of some combination of behavioral responses, autonomic nervous system responses, neuroendocrine responses, or immune responses (
Neuroendocrine stress responses often involve the hypothalamus-pituitary-adrenal system. Virtually all neuroendocrine functions that are affected by stress—including immune competence, reproduction, metabolism, and behavior—are regulated by pituitary hormones. Stress-induced changes in the secretion of pituitary hormones have been implicated in failed reproduction, altered metabolism, reduced immune competence, and behavioral disturbance (
The primary distinction between stress (which is adaptive and does not normally place an animal at risk) and “distress” is the cost of the response. During a stress response, an animal uses glycogen stores that can be quickly replenished once the stress is alleviated. In such circumstances, the cost of the stress response would not pose serious fitness consequences. However, when an animal does not have sufficient energy reserves to satisfy the energetic costs of a stress response, energy resources must be diverted from other functions. This state of distress will last until the animal replenishes its energetic reserves sufficient to restore normal function.
Relationships between these physiological mechanisms, animal behavior, and the costs of stress responses are well studied through controlled experiments and for both laboratory and free-ranging animals (
The proposed activities at the project area would not result in permanent negative impacts to habitats used directly by marine mammals, but may have potential short-term impacts to food sources such as forage fish and may affect acoustic habitat (see masking discussion above). There are no known foraging hotspots or other ocean bottom structure of significant biological importance to marine mammals present in the marine waters of the project area during the construction window. The project area is located in an industrial and commercial shipping port. Therefore, the main impact issue associated with the proposed activity would be temporarily elevated sound levels and the associated direct effects on marine mammals, as discussed previously in this document. The primary potential acoustic impacts to marine mammal habitat are associated with elevated sound levels produced by vibratory and impact pile driving, drilling, and sediment removal in the area. However, other potential impacts to the surrounding habitat from physical disturbance are also possible, although this will be minimal since construction is occurring in an already industrial and commercial shipping area.
Construction activities would produce continuous (
The most likely impact to fish from pile driving and pile removal activities at the Port's project area would be temporary behavioral avoidance of the area. The duration of fish avoidance of this area after pile driving stops is unknown, but a rapid return to normal recruitment, distribution and behavior is anticipated. In general, impacts to marine mammal prey species are expected to be minor and temporary due to the short timeframe (15 days) for the project.
The area likely impacted by the project is relatively small compared to the available habitat in the Mission Bay/Central Waterfront area of San Francisco Bay. Avoidance by potential prey (
The duration of the construction activities, including pile driving and dredging is relatively short, estimated at 55 days. The construction window for pile driving and drilling is a maximum of 15 days and each day, activities would only occur for a few hours during the day. Impacts to habitat and prey are expected to be minimal based on the short duration of activities.
In summary, given the short daily duration of sound associated with individual pile driving and removal events and the relatively small areas being affected, pile driving and pile removal activities associated with the proposed action are not likely to have a permanent, adverse effect on any fish habitat, or populations of fish species. Thus, any impacts to marine mammal habitat are not expected to cause significant or long-term consequences for individual marine mammals or their populations.
This section provides an estimate of the number of incidental takes proposed for authorization through this IHA, which will inform both NMFS' consideration of “small numbers” and the negligible impact determination.
Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to,
Authorized takes would be by Level B harassment only, in the form of disruption of behavioral patterns for individual marine mammals resulting from exposure to acoustic sources. Based on the nature of the activity and the anticipated effectiveness of the mitigation measures (
As described previously, no mortality is anticipated or proposed to be authorized for this activity. Below we describe how the take is estimated.
Generally speaking, we estimate take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) and the number of days of activities. We note that while these basic factors can contribute to a basic calculation to provide an initial prediction of takes, additional information that can qualitatively inform take estimates is also sometimes available (
Using the best available science, NMFS has developed acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).
Level B Harassment for non-explosive sources—Though significantly driven by received level, the onset of behavioral disturbance from anthropogenic noise exposure is also informed to varying degrees by other factors related to the source (
The Port of San Francisco's proposed activity includes the use of continuous (vibratory pile driving, down the hole drilling) and impulsive (impact pile driving) sources, and therefore the 120 and 160 dB re 1 μPa (rms) thresholds are applicable.
Level A harassment for non-explosive sources—NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Version 2.0) (NMFS, 2018) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). The Port of San Francisco's proposed activity includes the use of impulsive (impact pile driving) and non-impulsive (vibratory pile driving) sources.
These thresholds are provided in Table 3 below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS's 2018 Technical Guidance, which may be accessed at:
Here, we describe operational and environmental parameters of the activity that will feed into identifying the area ensonified above the acoustic thresholds, which include source levels and transmission loss coefficients.
Reference sound source levels used by the Port of San Francisco for all vibratory and impact piling/removal and drilling activities were derived from source level data from construction projects within Caltrans (2015) except for two cases noted below where Navy and Alaska Department of Transportation sources were used. To determine the ensonified areas for both the Level A and Level B harassment zones for vibratory piling of the 36-inch, 30-inch, and 16-inch steel piles and 14-inch steel H piles, the Port of San Francisco used SPLs of 170 dB re 1 μPa rms, 170 dB re 1 μPa rms, 158 dB re 1 μPa rms, and 158 dB re 1 μPa rms, respectively. These were derived from vibratory pile driving data of 36-inch (for 36-inch and 30-inch steel piles), 18-inch (for 16-inch steel piles) and 14-inch (for 14-inch steel H-pile) steel piles reported in the values listed in Table 1.2-2 and Table 1.2.3 of Caltrans (2015), and Table 6-1 of Navy (2017). For vibratory pile removal, the Port of San Francisco used an SPL of 155 dB re 1 μPa rms. This proxy source level was derived from vibratory pile driving data of 12-inch steel pipe piles in Caltrans (2015; Table 1.2-2). In addition, for down the hole drilling activities used to place 24-inch octagonal concrete piles, an SPL of 168 dB was used, corresponding to the mean SPL reported in Table 72 of the Alaska Department of Transportation (2016) hydroacoustic report.
For impact pile driving, the Port of San Francisco used both SPLs and Sound Exposure Levels (SEL) derived from summary source level values reported in Caltrans (2015). These source levels were then reduced by 7 dB due to the Port of San Francisco's use of a bubble curtain. NMFS used a reduction value of 7 dB as it was roughly the average sound reduction value derived from sound measurements of piles that used bubble curtains within Caltrans (2015). For piling of 36-inch steel piles, a source
The practical spreading model was used by the Port of San Francisco to generate the Level B harassment zones for all piling/removal activities. Practical spreading is described in full detail below.
Pile driving and drilling generates underwater noise that can potentially result in disturbance to marine mammals in the project area. Transmission loss (TL) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:
Utilizing the practical spreading loss model, the Port of San Francisco determined underwater noise will fall below the behavioral effects threshold of 120 dB rms for marine mammals at a maximum radial distance of 21,544 meters for vibratory piling and drilling (36 and 30-inch steel piles; drilling for 24-inch octagonal concrete pile). The maximum Level B harassment zone for this activity will therefore be set at 21,544 meters. However, previous sound monitoring for other projects in San Francisco Bay (
When the NMFS Technical Guidance (2016) was published, in recognition of the fact that the ensonified area could be more technically challenging to predict because of the duration component in the new thresholds, we developed a User Spreadsheet that includes tools to help predict a simple isopleth that can be used in conjunction with marine mammal density or occurrence to help predict takes. We note that because of some of the assumptions included in the methods used for these tools, we anticipate that isopleths produced are typically going to be overestimates of some degree, which will result in some overestimate of Level A harassment. However, these tools offer the best way to predict appropriate isopleths when more sophisticated 3D modeling methods are not available, and NMFS continues to develop ways to quantitatively refine these tools, and will qualitatively address the output where appropriate. For stationary sources (
In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations.
No systematic line transect surveys of marine mammals have been performed in San Francisco Bay. Therefore, the in-water densities of harbor seals, California sea lions, and harbor porpoises were calculated based on 17 years of observations during monitoring for the San Francisco Bay-Oakland Bay Bridge (SFOBB) construction and demolition project (Caltrans 2018). Care was taken to eliminate multiple observations of the same animal, although this can be difficult and is likely that the same individual may have been counted multiple times on the same day. The amount of monitoring performed per year varied, depending on the frequency and duration of construction activities with the potential to affect marine mammals. During the 257 days of monitoring from 2000 through 2017 (including 15 days of baseline monitoring in 2003), 1,029 harbor seals, 83 California sea lions, and 24 harbor porpoises were observed in waters in the project vicinity in total. In 2015, 2016, and 2017, the number of harbor seals in the project area increased significantly. In 2017, the number of harbor porpoise in the project area also increased significantly. Therefore, a harbor seal density estimate was calculated using the 2015-2017 data, and a harbor porpoise density estimate was calculated using the 2017 data, which may better reflect the current use of the project area by these animals. These observations included data from baseline, pre-, during, and post-pile driving, mechanical dismantling, on-shore blasting, and off-shore implosion activities.
Insufficient sighting data exist to estimate the density of bottlenose dolphins. However, a single bottlenose dolphin has been observed regularly near the project site. One individual was documented regularly, through photo ID, over several months off the coast of the former Alameda Air Station (Perlman 2017).
Insufficient sighting data exist to estimate elephant seal densities in the Bay. Generally, only juvenile elephant seals enter the Bay and do not remain long. The most recent sighting near the project area was in 2012, on the beach at Clipper Cove on Treasure Island, when a healthy yearling elephant seal hauled out for approximately 1 day. Approximately 100 juvenile northern elephant seals strand in or near the Bay each year, including individual strandings at YBI and Treasure Island (less than 10 strandings per year).
In addition, insufficient sighting data exist to estimate northern fur seal and gray whale densities in the Bay. Only two to four northern fur seals strand in the Bay each year, and they are unlikely to occur in the project area. Also, during the Caltrans Richmond-San Rafael Bridge project, monitors recorded 12 living and two dead gray whales in the surveys performed in 2012. All sightings were in either the Central or North Bay, and all but two sightings occurred during the months of April and May. One gray whale was sighted in June and one in October. The Oceanic Society has tracked gray whale sightings since they began returning to San Francisco Bay regularly in the late 1990s. Most sightings occurred just a mile or two inside of the Golden Gate, with some traveling into San Pablo Bay in the northern part of the San Francisco Bay (Self 2012). The Oceanic Society data show that all age classes of gray whales enter San Francisco Bay and they enter as singles or in groups of up to five individuals (Winning 2008). It is estimated that two to six gray whales enter San Francisco Bay in any given year.
Numbers used for density calculations are shown in Table 8. These numbers were calculated from observations in nearby waters of the San Francisco Bay during San Francisco-Oakland Bay Bridge construction conducted by Caltrans (Caltrans 2018). These observations occurred from 2000 to 2017 in a 2 km
For species without enough sightings to construct a density estimate, we used information based on group size and frequency of sightings from previous years of work to inform the number of animals estimated to be taken, which is detailed in the Take Estimation section below.
Here we describe how the information provided above is brought together to produce a quantitative take estimate.
When density data was available, Level B take for the project was calculated by multiplying the density times the largest Level B harassment zone (km
Gray whales occasionally enter San Francisco Bay during their northward migration period of February and March. Pile driving and drilling are not proposed to occur during this time and gray whales are not likely to be present at other times of the year. It is estimated that two to six gray whales enter the Bay in any given year, but they are unlikely to be present during the work period (June 1 through November 30). However, individual gray whales have occasionally been observed in San Francisco Bay during the work period, and therefore it is conservatively estimated that, at most, 3 gray whales, or one average sized group, may be exposed to Level B harassment during the 15 days of pile driving/drilling.
When bottlenose dolphins are present in San Francisco Bay, they are more typically found close to the Golden Gate. Recently, beginning in 2015, two individuals have been observed frequently in the vicinity of Oyster Point (GGCR 2016, 2017; Perlman 2017) and one individual has been observed near Alameda (GGCR 2016). Observations of bottlenose dolphins are primarily west of Treasure Island and concentrated along the nearshore areas of San Francisco south to Redwood City (Caltrans 2018). Bottlenose dolphins rarely occur in San Francisco Bay, but given the size of the Level B harassment zone NMFS is proposing to authorize take of 15 bottlenose dolphins by level B harassment.
Observations of northern fur seals are too few to establish a density for this species in San Francisco Bay. The Marine Mammal Center (TMMC) reported only two to four northern fur seal strandings in the Bay in 2015 and 2016 (in Marin, San Francisco, and Santa Clara counties) (TMMC 2017). To account for the possible rare presence of the species in the action area, NMFS proposes to authorize one level B take of northern fur seal.
Elephant seals breed between December and March and have been rarely cited in San Francisco Bay. It is anticipated that if an elephant seal is encountered at all during pile driving or drilling it would be a juvenile. To account for the possible rare presence of the species in the action area, NMFS proposed to authorize one level B take of elephant seal.
High frequency cetaceans (including harbor porpoise) have the largest Level A harassment zone resulting from this project as shown in Table 7. Estimated take by Level A harassment for harbor porpoise, based on density reported in Table 8 and the Level A harassment zone, is less than one individual (Density * Days * Ensonified Area). Given the required mitigation measures, including shutdown zones which exceed the Level A harassment zone, NMFS proposes no authorization of Level A harassment for harbor porpoise or any marine mammal.
In order to issue an IHA under Section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)).
In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, we carefully consider two primary factors:
(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if implemented as planned) the likelihood of effective implementation (probability implemented as planned); and
(2) The practicability of the measures for applicant implementation, which may consider such things as cost, impact on operations.
In addition to the specific measures described later in this section, the Port must conduct briefings for construction supervisors and crews, the monitoring team, and Port staff prior to the start of all pile driving activity, and when new personnel join the work, in order to explain responsibilities, communication procedures, the marine mammal monitoring protocol, and operational procedures.
All work will be conducted during daylight hours. If poor environmental conditions restrict full visibility of the shutdown zone, pile installation would be delayed.
Sound attenuation methods will be implemented for the duration of impact pile driving to install 36‐inch and 16‐inch steel and 20‐inch concrete piles (
• The bubble curtain must distribute air bubbles around 100 percent of the piling perimeter for the full depth of the water column.
• The lowest bubble ring shall be in contact with the mudline for the full circumference of the ring, and the weights attached to the bottom ring shall ensure 100 percent mudline contact. No parts of the ring or other objects shall prevent full mudline contact.
• The selected contractor will ensure that personnel are trained in the proper balancing of air flow to the bubblers and shall require that construction contractors submit an inspection/performance report for approval by the Port within 72 hours following the performance test. Corrections to the attenuation device to meet the performance standards shall occur prior to impact driving.
For in-water heavy machinery work (using,
For all pile driving/removal and drilling activities, The Port of San Francisco will establish a shutdown zone for a marine mammal species that is greater than its corresponding Level A harassment zone. The purpose of a shutdown zone is generally to define an area within which shutdown of the activity would occur upon sighting of a marine mammal (or in anticipation of an animal entering the defined area). The shutdown zones for each of the pile driving and drilling activities are listed below in Table 10.
The Port of San Francisco will establish and observe a monitoring zone. The monitoring zones for this project will differ based on activity. For vibratory pile driving and down the hole drilling, it may not be possible to observe the entire Level B harassment zones (areas where SPLs are equal to or exceed 120 dB rms) due to their size. The Port is expected to monitor and record observations in the largest reasonable portion of this Level B harassment zone based on the number of observers and visibility, but conditions may require efforts to be focused in a smaller monitoring zone. For impact pile driving, the monitoring zones are areas where SPLs are equal to or exceed 160 dB rms. For vibratory pile driving/drilling and impact pile driving the Level B Harassment zones are presented in Table 11 below. For the vibratory pile driving and drilling activities, it is noted that Level B harassment zone radius and area will not necessarily equal the monitoring zone. These zones provide utility for monitoring conducted for mitigation purposes (
If a species enters or approaches the Level B harassment zone and that species is either not authorized for take or its authorized takes are met, pile driving, pile removal, and drilling activities must shut down immediately using delay and shut-down procedures. Activities must not resume until the animal has been confirmed to have left the area or an observation time period of 15 minutes has elapsed.
The use of a soft-start procedure is believed to provide additional protection to marine mammals by providing warning and/or giving marine mammals a chance to leave the area prior to the impact hammer operating at full capacity. For impact pile driving, contractors will be required to provide an initial set of strikes from the hammer at 40 percent energy, each strike followed by no less than a 30-second waiting period. This procedure will be conducted a total of three times before impact pile driving begins. This soft start procedure must be implemented at the start of a day's impact pile driving and at any time following cessation of impact driving of 30 minutes or greater. Soft start is not required during vibratory pile driving/removal or drilling activities.
Prior to the start of daily in-water construction activity, or whenever a break in pile driving or drilling of 30 minutes or longer occurs, the observer will observe the shutdown and monitoring zones for a period of 30 minutes. The shutdown zone will be cleared when a marine mammal has not been observed within the zone for that 30-minute period. A determination that the shutdown zone is clear must be made during a period of good visibility (
Based on our evaluation of the applicant's proposed measures, as well as other measures considered by NMFS, NMFS has preliminarily determined that the proposed mitigation measures provide the means effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
In order to issue an IHA for an activity, Section 101(a)(5)(D) of the MMPA states that NMFS must set forth, requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.
Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:
• Occurrence of marine mammal species or stocks in the area in which take is anticipated (
• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (
• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;
• How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;
• Effects on marine mammal habitat (
• Mitigation and monitoring effectiveness.
The Port recognizes in their application the need to implement a sound monitoring plan (SMP) as required by the Regional NMFS and U.S. Army Corps of Engineers programmatic review for pile driving activities in San Francisco Bay. The Port indicates that this SMP will recommend sound monitoring stations at 10 m, 100 m, and 300 m to monitor ambient noise conditions in the area. NMFS feels that ambient noise measurements are highly specific to the time and place they were taken, and therefore might have limited
Monitoring would be conducted 30 minutes before, during, and 30 minutes after all pile driving/removal and drilling activities. In addition, observers shall record all incidents of marine mammal occurrence, regardless of distance from activity, and shall document any behavioral reactions in concert with distance from piles being driven, removed, or pile holes being drilled. Pile driving and drilling activities include the time to install, remove, or drill a hole for a single pile or series of piles, as long as the time elapsed between uses of the pile driving equipment is no more than thirty minutes.
Monitoring will be conducted by NMFS approved Protected Species Observers (PSOs). There will be at least two PSOs, but this number could be higher, depending on the type of pile driving/drilling and size of pile, which determines the size of the harassment zones. At least two land-based PSOs will monitor during all pile driving/removal and drilling activities.
PSOs shall scan the waters using binoculars, and/or spotting scopes, and shall use a handheld GPS or range-finder device to verify the distance to each sighting from the project site. All PSOs shall be trained in marine mammal identification and behaviors and are required to have no other project-related tasks while conducting monitoring. In addition, monitoring shall be conducted by qualified observers, who shall be placed at the best vantage point(s) practicable to monitor for marine mammals and implement shutdown/delay procedures when applicable by calling for the shutdown to the hammer operator. Qualified observers are trained and/or experienced professionals, with the following minimum qualifications:
i. At least one PSO must have prior experience working as a marine mammal observer during construction activities;
• Independent observers (
ii. Other PSOs may substitute education (degree in biological science or related field) or training for experience;
iii. Where a team of three or more PSOs are required, a lead observer or monitoring coordinator shall be designated. The lead observer must have prior experience working as a marine mammal observer during construction;
iv. The Port of San Francisco shall submit PSO CVs for approval by NMFS; The Port of San Francisco shall ensure that observers have the following additional qualifications:
• Visual acuity in both eyes (correction is permissible) sufficient for discernment of moving targets at the water's surface with ability to estimate target size and distance; use of binoculars may be necessary to correctly identify the target;
• Ability to conduct field observations and collect data according to assigned protocols;
• Experience or training in the field identification of marine mammals, including the identification of behaviors;
• Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates, times, and reason for implementation of mitigation (or why mitigation was not implemented when required); and marine mammal behavior;
• Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary; and
• Sufficient training, orientation, or experience with the construction operations to provide for personal safety during observations.
The Port of San Francisco shall submit a draft report to NMFS not later than 90 days following the end of construction activities. The Port of San Francisco shall provide a final report within 30 days following resolution of NMFS' comments on the draft report. Reports shall contain, at minimum, the following:
• Date and time that monitored activity begins and ends for each day conducted (monitoring period);
• Construction activities occurring during each daily observation period, including how many and what type of piles driven;
• Deviation from initial proposal in pile numbers, pile types, average driving times, etc.;
• Weather parameters in each monitoring period (
• Water conditions in each monitoring period (
• Extrapolated estimates of the total observed Level B harassment takes based on the percentage of the Level B harassment zone that was not visible or was not monitored
• For each marine mammal sighting:
○ Species, numbers, and, if possible, sex and age class of marine mammals;
○ Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving activity;
○ Location and distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;
○ Estimated amount of time that the animals remained in the Level B harassment zone;
○ Description of implementation of mitigation measures within each monitoring period (
○ Other human activity in the area within each monitoring period; and
○ A summary of the following:
Total number of individuals of each species detected within the monitoring zone, and estimated as taken if correction factor appropriate;
Total number of individuals of each species detected within the Level A harassment zone and the average amount of time that they remained in that zone; and
Daily average number of individuals of each species (differentiated by month as appropriate) detected within the monitoring zone, and estimated as taken, if appropriate.
NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
As stated in the mitigation section, bubble curtains will be used and shutdown zones that encompass the area in which Level A harassment might be expected to occur will be implemented. As a result, no Level A take is expected nor authorized for this activity. Exposures to elevated sound levels produced during pile driving activities may cause behavioral responses by an animal, but they are expected to be mild and temporary. Effects on individuals that are taken by Level B harassment, on the basis of reports in the literature as well as monitoring from other similar activities, will likely be limited to reactions such as increased swimming speeds, increased surfacing time, or decreased foraging (if such activity were occurring) (
During all impact driving, implementation of soft start procedures, the use of a bubble curtain, and monitoring of established shutdown zones will be required. Given sufficient notice through use of soft start (for impact driving), marine mammals are expected to move away from an irritating sound source prior to it becoming potentially injurious. In addition, PSOs will be stationed within the action area whenever pile driving/removal and drilling operations are underway. Depending on the activity, The Port of San Francisco will employ the use of at least two PSOs to ensure all monitoring and shutdown zones are properly observed.
Although the Mission Bay Ferry and Water Taxi Landing Project would have some permanent removal of habitat available to marine mammals, the area lost would negligible. Construction of the MBFL and WTL structures and dredging for the project will result in the disturbance of up to approximately 8.4 acres of predominantly fine‐grained sediment and the associated benthic infaunal community. Total habitat disturbed from the project activities is estimated at 0.000071 percent of the total South San Francisco Bay subtidal habitat available (NOAA 2007). This is a relatively small fraction of area relative to the total available habitat for foraging and transit for marine mammals. In addition, to minimize impacts, in‐water construction will be limited to locally established environmental work windows between June and November.
Overall, impacts to marine mammals and prey species due to the Mission Bay Ferry and Water Taxi Landing Project are expected to be minor and temporary. The area impacted by the project is very small compared to the available habitat around San Francisco Bay. The most likely impact to prey will be temporary behavioral avoidance of the immediate area. During pile driving and drilling, it is expected that fish and marine mammals would temporarily move to nearby locations and return to the area following cessation of in-water construction activities. Therefore, indirect effects on marine mammal prey during the construction are not expected to be substantial.
In summary and as described above, the following factors primarily support our determination that the impacts resulting from this activity are not expected to adversely affect the species or stock through effects on annual rates of recruitment or survival:
• Mortality is not anticipated or authorized;
• Minimal impacts to marine mammal habitat are expected;
• Bubble curtain and other sound attenuating devices are used during impact pile driving will lessen the amount of behavioral disturbance and contribute to the alleviation of the likelihood of injury;
• Impacts are not occurring in rookeries, or known areas or features of special significance for foraging or reproduction in the project area;
• Anticipated incidents of Level B harassment consist of, at worst, temporary modifications in behavior; and
• Required mitigation measures (
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the monitoring and mitigation measures, NMFS preliminarily finds that the total marine mammal take from the activity will have a negligible impact on all affected marine mammal species or stocks.
As noted above, only small numbers of incidental take may be authorized under Section 101(a)(5)(D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.
Take for all species authorized except harbor seal is less than five percent of their respective stock abundance. For harbor seal, the authorized take is less than 10 percent of the stock abundance. Based on this and the analysis contained herein of the proposed activity (including the proposed mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS preliminarily finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.
There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.
No incidental take of ESA-listed species is proposed for authorization or expected to result from this activity. Therefore, NMFS has determined that formal consultation under section 7 of the ESA is not required for this action.
As a result of these preliminary determinations, NMFS proposes to issue an IHA to the Port of San Francisco for conducting pile driving/removal and drilling in San Francisco Bay from June 1, 2019 to May 31, 2020, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. This section contains a draft of the IHA itself. The wording contained in this section is proposed for inclusion in the IHA (if issued).
1. This Incidental Harassment Authorization (IHA) is valid from June 1, 2019, to May 31, 2020.
2. This IHA is valid only for impact pile driving, vibratory pile driving, vibratory pile removal, and drilling activities associated with the construction of the Mission Bay Ferry and Water Taxi Landing Project in San Francisco Bay, California
3. General Conditions
(a) A copy of this IHA must be in the possession of the Port of San Francisco, its designees, and work crew personnel operating under the authority of this IHA;
(b) The species authorized for taking are gray whale (
(c) The taking, by Level B harassment only, is limited to the species listed in condition 3(b). See Table 9 for numbers of take authorized;
(d) The taking by serious injury or death of any of the species listed in condition 3(b) of the Authorization or any taking of any other species of marine mammal is prohibited and may result in the modification, suspension, or revocation of this IHA;
(e) The Port of San Francisco must conduct briefings between construction supervisors and crews and marine mammal monitoring team prior to the start of all pile driving, pile removal, and drilling, and when new personnel join the work, in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures; and
(f) Pile driving and drilling activities authorized under this IHA may only occur during daylight hours.
4. Mitigation Measures
The holder of this Authorization is required to implement the following mitigation measures:
(a) For all pile driving/removal, drilling, and in-water heavy machinery work, the Port of San Francisco must implement a shutdown zone around the pile or work zone. If a marine mammal comes within or approaches the shutdown zone, such operations must cease. See Table 10 for minimum radial distances required for shutdown zones;
(b) After a shutdown occurs, impact pile driving, vibratory piling driving/removal, and/or drilling can only begin after the animal is observed leaving the shutdown zone or has not been observed for 15 minutes;
(c) The Port of San Francisco must use sound attenuation devices (
(1) The bubble curtain must distribute air bubbles around 100 percent of the piling perimeter for the full depth of the water column;
(2) The lowest bubble ring must be in contact with the mudline for the full circumference of the ring, and the weights attached to the bottom ring must ensure 100 percent mudline contact. No parts of the ring or other objects shall prevent full mudline contact; and
(3) The selected contractor must ensure that personnel are trained in the proper balancing of air flow to the bubblers and must require that construction contractors submit an inspection/performance report for approval by the Port within 72 hours following the performance test. Corrections to the attenuation device to meet the performance standards must occur prior to impact driving;
(d) The Port of San Francisco must use a soft-start procedure for impact pile driving. During a soft start, The Port of San Francisco is required to provide an initial set of three strikes from the impact hammer at 40 percent energy, followed by a 30-second waiting period, then two subsequent 3-strike sets. This soft-start must be applied prior to beginning pile driving activities each day or when impact pile driving hammers have been idle for more than 30 minutes;
(e) If a species enters or approaches the Level B harassment zone and that species is either not authorized for take or its authorized takes are met, pile driving and removal activities must shut down immediately using delay and shut-down procedures; and
(f) The Port of San Francisco must establish monitoring locations as described below.
5. Monitoring
The holder of this Authorization is required to conduct marine mammal monitoring during all pile driving/removal and drilling activities. Monitoring and reporting must be conducted in accordance with the Monitoring Plan as described below.
(a) The Port of San Francisco must monitor the Level B harassment zones and shutdown zones shown in Tables 10 and 11 during all pile driving/removal and drilling activities. Monitoring efforts in the Level B harassment zone can be concentrated in a subset of the zone if it is not feasible to observe the entire zone.
(b) If waters exceed a sea-state which restricts the observers' ability to make observations within the marine mammal shutdown zone, pile installation/removal and drilling must cease. Pile driving and/or drilling must not be initiated or continue until the entire largest shutdown zone for the activity is visible.
(c) Prior to the start of daily in-water construction activity, or whenever a break in pile driving/removal and/or drilling of 30 minutes or longer occurs, the PSOs must observe the shutdown and monitoring zones for a period of 30 minutes before construction activities can begin.
(d) If the shutdown zones have been observed to be clear of marine mammals for 30 minutes, in-water construction can commence and work can continue even if visibility becomes impaired within the Level B harassment zone.
(e) Monitoring must be conducted by qualified PSOs, with minimum qualifications as described previously in the
(i) At least two PSOs must be on site to actively observe the shutdown and disturbance zones during all pile driving, removal, and drilling;
(ii) Observers must use their naked eye with the aid of binoculars, and/or a spotting scope during all pile driving and extraction activities;
(iii) All PSOs must be positioned in the best vantage point to have an unobstructed view of all water within the shutdown zone and as much of the Level B harassment zone as possible for pile driving/removal and/or drilling;
(iv) Observers must be independent (
(v) At least one PSO must have prior experience working as a marine mammal observer during construction activities;
(vi) (Other PSOs may substitute education (degree in biological science or related field) or training for experience;
(vii) Where a team of three or more PSOs are required, a lead observer or monitoring coordinator shall be designated. The lead observer must have prior experience working as a marine mammal observer during construction;
(viii) The Port of San Francisco shall submit PSO CVs for approval by NMFS;
(f) Marine mammal location must be determined using a rangefinder and a GPS or compass;
(g) Post-construction monitoring must be conducted for 30 minutes beyond the cessation of piling and drilling activities at end of day.
6. Reporting
The holder of this Authorization is required to:
(a) Submit a draft report on all monitoring conducted under the IHA within 90 calendar days of the completion of marine mammal monitoring. This report must detail the monitoring protocol, summarize the data recorded during monitoring, and estimate the number of marine mammals that may have been harassed, including the total number extrapolated from observed animals across the entirety of relevant monitoring zones. Given that the entire Level B harassment zone may not be readily observable, takes must be recorded and extrapolated based upon the amount of total observed takes and the percentage of the Level B harassment zone that was not visible.
A final report must be prepared and submitted within 30 days following resolution of comments on the draft report from NMFS. This report must contain the following:
(i) Date and time a monitored activity begins or ends;
(ii) Construction activities occurring during each observation period;
(iii) Record of implementation of shutdowns, including the distance of animals to the pile and description of specific actions that ensued and resulting behavior of the animal, if any;
(iv) An estimated total take extrapolated from the number of marine mammals observed during the course of construction activities, if necessary.
(v) Deviation from initial proposal in pile numbers, pile types, average driving times, etc.;
(vi) Weather parameters (
(vii) Water conditions (
(viii) Species, numbers, and, if possible, sex and age class of marine mammals;
(ix) Description of any observable marine mammal behavior patterns,
(x) Distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;
(x) Locations of all marine mammal observations; and
(xi) Other human activity in the area.
(b) Reporting injured or dead marine mammals:
(i) In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by this IHA, such as an injury (Level A harassment), serious injury, or mortality, The Port of San Francisco must immediately cease the specified activities and report the incident to the Office of Protected Resources, NMFS, and the West Coast Stranding Coordinator, NMFS. The report must include the following information:
1. Time and date of the incident;
2. Description of the incident;
3. Environmental conditions (
4. Description of all marine mammal observations and active sound source use in the 24 hours preceding the incident;
5. Species identification or description of the animal(s) involved;
6. Fate of the animal(s); and
7. Photographs or video footage of the animal(s).
Activities must not resume until NMFS is able to review the circumstances of the prohibited take. NMFS will work with the Port of San Francisco to determine what measures are necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. The Port of San Francisco may not resume their activities until notified by NMFS;
(i) In the event that the Port of San Francisco discovers an injured or dead marine mammal, and the lead observer determines that the cause of the injury or death is unknown and the death is relatively recent (
(ii) The report must include the same information identified in 6(b)(i) of this IHA. Activities may continue while NMFS reviews the circumstances of the incident. NMFS will work with the Port of San Francisco to determine whether additional mitigation measures or modifications to the activities are appropriate;
(iii) In the event that the Port of San Francisco discovers an injured or dead marine mammal, and the lead observer determines that the injury or death is not associated with or related to the activities authorized in the IHA (
7. This Authorization may be modified, suspended or withdrawn if the holder fails to abide by the conditions prescribed herein, or if NMFS determines the authorized taking is having more than a negligible impact on the species or stock of affected marine mammals.
We request comment on our analyses, the proposed authorization, the Port's potential sound source verification efforts, and any other aspect of this Notice of Proposed IHA for the proposed action. We also request comment on the potential for renewal of this proposed IHA as described in the paragraph below. Please include with your comments any supporting data or literature citations to help inform our final decision on the request for MMPA authorization.
On a case-by-case basis, NMFS may issue a second one-year IHA without additional notice when (1) another year of identical or nearly identical activities as described in the Specified Activities section is planned or (2) the activities would not be completed by the time the IHA expires and a second IHA would allow for completion of the activities beyond that described in the Dates and Duration section, provided all of the following conditions are met:
• A request for renewal is received no later than 60 days prior to expiration of the current IHA;
• The request for renewal must include the following:
(1) An explanation that the activities to be conducted beyond the initial dates either are identical to the previously analyzed activities or include changes so minor (
(2) A preliminary monitoring report showing the results of the required monitoring to date and an explanation showing that the monitoring results do not indicate impacts of a scale or nature not previously analyzed or authorized;
• Upon review of the request for renewal, the status of the affected species or stocks, and any other pertinent information, NMFS determines that there are no more than minor changes in the activities, the mitigation and monitoring measures remain the same and appropriate, and the original findings remain valid.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of telephonic meeting.
The North Pacific Fishery Management Council (Council) Observer Advisory Committee Subgroup will meet September 5, 2018.
The meeting will be held on Wednesday, September 5, 2018, from 1 p.m. to 2:30 p.m.
The meeting will be held telephonically. Teleconference line: (907) 271-2896.
Elizabeth Figus, Council staff; telephone: (907) 271-2809.
The agenda will include: A discussion of the Observer Program Fee Analysis developments since June 2018, including an outline, alternatives, monitoring objectives, and discussion of analysis methods.
Public comment letters will be accepted and should be submitted either electronically to Elizabeth Figus, Council staff:
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of agency decision.
NMFS announces approval of a marine conservation plan (MCP) for American Samoa.
This agency decision is effective from July 25, 2018, through July 24, 2021.
You may obtain a copy of the MCP, identified by NOAA-NMFS-2018-0014, from the Federal e-Rulemaking Portal,
Gabriel Forrester, Sustainable Fisheries, NMFS Pacific Island Regional Office, 808-725-5179.
Section 204(e) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) authorizes the Secretary of State, with the concurrence of the Secretary of Commerce (Secretary) and in consultation with the Council, to negotiate and enter into a Pacific Insular Area fishery agreement (PIAFA). A PIAFA would allow foreign fishing within the U.S. Exclusive Economic Zone (EEZ) adjacent to American Samoa, Guam, or the Northern Mariana Islands. The Governor of the Pacific Insular Area to which the PIAFA applies must request the PIAFA. The Secretary of State may negotiate and enter the PIAFA after consultation with, and concurrence of, the applicable Governor.
Before entering the PIAFA, the applicable Governor, with concurrence of the Council, must develop and submit to the Secretary a 3-year MCP providing details on uses for and funds collected by the Secretary for MCP review and approval. NMFS is the designee of the Secretary for MCP review and approval. The Magnuson-Stevens Act requires payments received under a PIAFA to be deposited into the United States Treasury and then conveyed to the Treasury of the Pacific Insular Area for which funds were collected.
In the case of violations by foreign fishing vessels in the EEZ around any Pacific Insular Area, amounts received by the Secretary attributable to fines and penalties imposed under the Magnuson-Stevens Act, including sums collected from the forfeiture and disposition or sale of property seized subject to its authority, shall be deposited into the Treasury of the Pacific Insular Area adjacent to the EEZ in which the violation occurred, after direct costs of the enforcement action are subtracted. The Pacific Insular Area government may use funds deposited into the treasury of the Pacific Insular Area for fisheries enforcement and for implementation of an MCP.
Federal regulations at 50 CFR 665.819 authorize NMFS to specify catch limits of longline-caught bigeye tuna for U.S. territories. NMFS may also authorize each territory to allocate a portion of that limit to U.S. longline fishing vessels that are permitted to fish under the Fishery Ecosystem Plan for Pelagic Fisheries of the Western Pacific (FEP). Payments collected under specified fishing agreements are deposited into the Western Pacific Sustainable Fisheries Fund, and any funds attributable to a particular Fisheries Fund, and any funds attributable to a particular territory may be used only for implementation of that territory's MCP.
An MCP must be consistent with the Council's fishery ecosystem plans, must identify conservation and management objectives (including criteria for determining when such objectives are met), and must prioritize planned marine conservation projects.
The Council reviewed and concurred with the American Samoa MCP in June 2018. On July 9, 2018, the Governor of American Samoa submitted the MCP to NMFS for review and approval. The following briefly describes the objectives of the MCP. Please refer to the MCP for planned projects and activities designed to meet each objective, the evaluative criteria, and priority ranking. The MCP contains six conservation and management objectives, listed below.
1. Maximize social and economic benefits through sustainable fisheries;
2. Support quality scientific research to assess and manage fisheries;
3. Promote an ecosystem approach in fisheries management;
4. Recognize the importance of island culture and traditional fishing in managing fishery resources and foster opportunities for participation;
5. Promote education and outreach activities and regional collaboration regarding fisheries conservation;
6. Encourage development of technologies and methods to achieve the most effective level of enforcement and to ensure safety at sea.
This notice announces that NMFS has reviewed the MCP, and has determined that it satisfies the requirements of the Magnuson-Stevens Act. Accordingly, NMFS has approved the MCP for the 3-year period from July 25, 2018, through July 24, 2021. This MCP supersedes the MCP previously approved for the period April 1, 2015, through March 31, 2018 (80 FR 18820, April 8, 2015).
Defense Acquisition Regulations System, Department of Defense (DoD).
Notice and request for comments regarding a proposed extension of an approved information collection requirement.
In compliance with the Paperwork Reduction Act of 1995, DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof.
DoD will consider all comments received by October 22, 2018.
You may submit comments, identified by OMB Control Number 0704-0231, using any of the following methods:
•
•
•
•
Comments received generally will be posted without change to
Mr. Carrie Moore, 571-372-6093.
The information collected under this clearance is used as follows:
a. The information collected pursuant to DFARS provision 252.237-7000(c) is used to verify that the offeror is properly licensed in the state or other political jurisdiction where the offeror operates its professional practice.
b. DFARS 252.237-7011, the DD Form 2062, Record of Preparation and Disposition of Remains (DoD Mortuary Facility), and the DD Form 2063, Record of Preparation and Disposition of Remains (Within CONUS), are used to verify that the deceased's remains have been properly cared by the mortuary contractor.
c. The written plan required by DFARS provision 252.237-7024, submitted by offerors concurrently with the proposal or offer, allows the contracting officer to assess the offeror's capability to continue providing contractually required services to support the DoD component's mission essential functions in an emergency.
d. The information collected pursuant to DFARS clause 252.237-7023 allows the contracting officer to provide approval of updates to the contractor's plan provided under DFARS clause 252.237-7024, to ensure that the contractor can continue to provide services in support of the DoD component's required mission essential functions in an emergency.
DFARS 237.270 prescribes the use of the provision at DFARS 252.237-7000,
DFARS 237.7003 prescribes the use of the clause at 252.237-7011, Preparation History, in all mortuary service solicitations and contracts. The information collected is used to verify that the remains have been properly cared for and the DD Forms 2062 and 2063 are generally used for this purpose.
DFARS 237.7603(b) prescribes the use of the provision at 252.237-7024, Notice of Continuation of Essential Contractor Services, in solicitations that require the acquisition of services to support a mission essential function. The provision requires the offeror to submit a written plan demonstrating its capability to continue to provide the contractually required services to support a DoD component's mission essential functions in an emergency.
DFARS 237.7603(a) prescribes the use of the clause at DFARS 252.237-7023, Continuation of Essential Contractor Services, in solicitations and contracts for services in support of mission essential functions. The clause requires the contractor to maintain and update its written plan as necessary to ensure that it can continue to provide services to support the DoD component's mission essential functions in an emergency.
Defense Acquisition Regulations System, Department of Defense (DoD).
Notice.
The Defense Acquisition Regulations System has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by September 21, 2018.
a.
b.
c.
d.
e.
Comments and recommendations on the proposed information collection should be sent to Ms. Jasmeet Seehra, DoD Desk Officer, at
You may also submit comments, identified by docket number and title, by the following method:
Written requests for copies of the information collection proposal should be sent to Mr. Licari at: WHS/ESD Directives Division, 4800 Mark Center Drive, 2nd Floor, East Tower, Suite 03F09, Alexandria, VA 22350-3100.
Institute of Education Sciences (IES), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new information collection.
Interested persons are invited to submit comments on or before October 22, 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 Felicia Sanders, 202-245-6264.
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.
IKAN provides information on students' number knowledge (that is, magnitude comparisons, knowledge of base 10 system and meaning of decimals and fractions), and the GloSS provides information on strategies students use when solving mathematical problems. When used together, the IKAN and GloSS assessments furnish teachers with information on how students solve mathematics problems and students' understanding of whole and rational number concepts. Teachers can then use the information from the assessments to tailor their instruction to students' levels of understanding and address problems that underlie lack of success with grade-level curriculum.
The Georgia Department of Education (GaDOE) has received positive feedback through testimonials from district-level personnel and math coaches supporting the use of IKAN/GloSS. Yet, very limited psychometric data exists to support the use of these measures. GaDOE has not conducted reliability or validity studies using its student population. While many studies have been conducted in New Zealand by the Ministry of Education, participating Georgia school districts and the GaDOE are interested in psychometric data using teachers and students in their state in the context of their state system of standards, assessments, and accountability. Thus, through the Improving Mathematics Research Alliance, the GaDOE requested REL Southeast conduct a study to determine the reliability and validity of the IKAN/GloSS diagnostic assessments.
The three research questions guiding the project relate to the inter-assessor reliability of the GloSS and IKAN assessments when administered by two assessors within a one-week period and the consequential validity of using IKAN and GloSS diagnostic assessments (that is, teachers' perception of their instructional utility for providing intervention).
Student data from the IKAN and GloSS assessments administered by teachers and mathematics coaches will be used to answer the two research questions related to the inter-assessor reliability studies.
Take notice that on August 13, 2018, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(2) (2017), Enterprise TE Products Pipeline Company LLC (Petitioner), filed a petition for a declaratory order seeking approval of general rate structure, terms of service, and prorationing methodology for an incremental expansion project, between an existing origin point at a tank farm and terminal facility near Indianapolis, and a currently idled destination point at a third party tank farm and terminal facility in Griffith, Indiana, all as more fully explained in the petition.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion
The Commission encourages electronic submission of protests and interventions in lieu of paper using the eFiling link at
This filing is accessible on-line at
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified date(s). Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
The licensee requests an extension of the license term so that it can complete, cooperatively with state and federal resource agencies and other entities, a feasibility assessment of options to provide multi-dam fish passage on the Kennebec River. The options would include, but not be limited to, alternative designs included in the approved Interim Species Protection Plan (Interim SPP) for the Shawmut Project, Weston Project (P-2325), and Lockwood Project (P-2574), as well as the approved Interim SPP for the Hydro-Kennebec Project (P-2611). These two Interim SPPs were developed for the projects to help ensure the protection of, and passage for, Atlantic salmon that use the Kennebec River and that are listed as endangered under the Endangered Species Act. The licensee proposes to develop, in consultation with the resource agencies, a single basin-wide Final SPP and draft Biological Assessment for the four projects together, which would be filed ahead of the December 31, 2019 expiration of the Interim SPPs, and concurrently with the Shawmut Project FLA. The licensee included with its request correspondence from the National Marine Fisheries Service, U.S. Fish and Wildlife Service, Maine Department of Marine Resources, and Maine Department of Inland Fisheries and Wildlife supporting the request.
k. This notice is available for review and reproduction at the Commission in the Public Reference Room, Room 2A, 888 First Street NE, Washington, DC 20426. The filing may also be viewed on the Commission's website at
l. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
m.
n.
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
On July 13, 2018, Contractor's Power Group, Inc. (transferor) and American Falls Reservoir District No. 2 (transferee) filed an application for the transfer of license of the Mile 28 Hydroelectric Project No. 10552. The project is located on the Bureau of Reclamation's Milner-Gooding Canal, in Jerome County, Idaho.
The applicants seek Commission approval to transfer the license for the Mile 28 Hydroelectric Project from the transferor to the transferee.
Environmental Protection Agency (EPA).
Notice of availability.
The Environmental Protection Agency (EPA) is conducting a periodic review of the air quality criteria and the secondary National Ambient Air Quality Standards (NAAQS) for oxides of nitrogen, oxides of sulfur, and particulate matter (PM). On or about August 6, 2018, the EPA will make available for public review the document titled
Comments should be received on or before October 22, 2018.
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2014-0128, to the Federal eRulemaking Portal:
Ginger Tennant, Office of Air Quality Planning and Standards (Mail Code C504-06), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711; telephone number: 919-541-4072; fax number: 919-541-0237; or email address:
1.
2.
• Identify the notice by docket number and other identifying information (subject heading,
• Follow directions. The agency may ask you to respond to specific questions or organize comments by referencing a CFR part or section number.
• Explain why you agree or disagree; suggest alternative and substitute language for your requested changes.
• Describe any assumption and provide any technical information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns and suggest alternatives.
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
• Make sure to submit your comments by the comment period deadline identified.
Two sections of the Clean Air Act (CAA) govern the establishment and revision of the NAAQS. Section 108 (42 U.S.C. 7408) directs the Administrator to identify and list certain air pollutants and then to issue air quality criteria for those pollutants. The Administrator is to list those air pollutants that in his “judgment, cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare;” “the presence of which in the ambient air results from numerous or diverse mobile or stationary sources;” and “for which . . . [the Administrator] plans to issue air quality criteria. . . . ” Air quality criteria are intended to “accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of [a] pollutant in the ambient air . . . ” 42 U.S.C. 7408(b). Under section 109 (42 U.S.C. 7409), the EPA establishes primary (health-based) and secondary (welfare-based) NAAQS for pollutants for which air quality criteria are issued. Section 109(d) requires periodic review and, if appropriate, revision of existing air quality criteria. The revised air quality criteria reflect advances in scientific knowledge on the effects of the pollutant on public health or welfare. The EPA is also required to periodically review and, if appropriate, revise the NAAQS based on the revised criteria. Section 109(d)(2) requires that an independent scientific review committee “shall complete a review of the criteria . . . and the national primary and secondary ambient air quality standards . . . and shall recommend to the Administrator any new . . . standards and revisions of existing criteria and standards as may be appropriate. . . .” Since the early
Presently, the EPA is reviewing the secondary NAAQS for oxides of nitrogen, oxides of sulfur, and PM.
The EPA's overall plan for this review is presented in the
The REA Planning Document will be discussed at a public meeting for review by CASAC and the public. A separate
Environmental Protection Agency (EPA).
Notice of intended transfer of confidential business information to contractor and its subcontractors and consultants.
The Environmental Protection Agency (EPA) intends to transfer confidential business information (CBI), collected from numerous industries, to ICF International (ICF) and its subcontractors and consultants, under an EPA contract newly awarded to ICF. Transfer of this information is necessary for ICF to assist the Office of Water in the preparation of economic analyses and environmental assessment activities conducted in support of Clean Water Act regulations and programs, such as effluent guidelines and associated planning and review activities, and water quality standards. Much of the information being transferred was or will be collected under the authority of section 308 of the Clean Water Act (CWA) to support effluent guidelines development in particular. Interested persons may submit comments on this intended transfer of information to the address noted below.
Comments on the transfer of data are due August 27, 2018.
Comments may be sent to M. Ahmar Siddiqui, Document Control Officer, Engineering and Analysis Division (4303T), U.S. EPA, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
M. Ahmar Siddiqui, Document Control Officer, at (202) 566-1044, or via email at
EPA has transferred CBI to its contractors and subcontractors as part of the effluent guidelines program under 40 CFR 2.302(h). EPA determined that this transfer was necessary to enable the contractors, subcontractors, and consultants to perform their work in supporting EPA in planning, developing, and reviewing effluent guidelines and standards for certain industries.
Pursuant to 40 CFR 2.302(h)(2), EPA is giving notice that it has entered into a new contract with ICF, contract number 68HE0C18D0001, located in Fairfax, Virginia. The purpose of this contract is to secure economic and environmental assessment support for EPA in its development, review, implementation, and defense of water-related initiatives for a variety of industries or states. To obtain assistance in responding to this contract, ICF has entered into contracts with the following subcontractors and consultants: The Cadmus Group, LLC (located in Waltham, Massachusetts), CognistX (located in Pittsburgh, Pennsylvania), Great Lakes Environmental Center, Inc. (located in Traverse City, Michigan), Horizon Systems Corporation (located in White Stone, Virginia), Innovate! Inc. (located in Alexandria, Virginia), LimnoTech Inc. (located in Ann Arbor, Michigan), Resources for the Future (located in Washington, DC), RTI International (located in Research Triangle Park, North Carolina), Wayne Gray (located in Worcester, Massachusetts), Robert Johnston (located in Millville, Massachusetts), Klaus Moeltner (located in Blacksburg, Virginia), Kerry Smith (located in Cave Creek, Arizona), and Raghavan Srinivasan (located in College Station, Texas).
All EPA contractor, subcontractor, and consultant personnel are bound by the requirements and sanctions contained in their contracts with EPA and in EPA's CBI regulations found at 40 CFR part 2, subpart B. ICF will adhere to an EPA-approved security plan which describes procedures to protect CBI. ICF will apply the procedures in this plan to CBI previously gathered by EPA and to CBI that may be gathered in the future. The security plan specifies that contractor personnel are required to sign non-disclosure agreements and are briefed
The information that will be transferred to ICF consists of information previously collected by EPA to support the development and review of effluent limitations guidelines and standards under the CWA. In particular, information, including CBI, collected for the planning, development, and review of effluent limitations guidelines and standards for the following industries may be transferred to ICF under the new contract: Airport deicing; aquaculture; centralized waste treatment; coal bed methane; concentrated animal feeding operations; coal mining; construction and development; drinking water treatment; industrial container and drum cleaning; industrial laundries; industrial waste combustors; iron and steel manufacturing; landfills; meat and poultry products; metal finishing; metal products and machinery; nonferrous metals manufacturing; oil and gas extraction (including coalbed methane); ore mining and dressing; organic chemicals, plastics, and synthetic fibers; pesticide chemicals; petroleum refining; pharmaceutical manufacturing; pulp, paper, and paperboard manufacturing; shale gas extraction; steam electric power generation; textile mills; timber products processing; tobacco; transportation equipment cleaning; and other industrial categories that EPA has reviewed as part of its CWA required annual review activities.
EPA also intends to transfer to ICF all information listed in this notice, of the type described above (including CBI) that may be collected in the future under the authority of section 308 of the CWA or voluntarily submitted (
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 by email at
Office of Acquisition Policy, General Services Administration (GSA).
Notice of request for comments regarding an extension of a previously existing OMB clearance.
Under the provisions of the Paperwork Reduction Act the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding identification of products with environmental attributes.
Submit comments on or before: September 21, 2018.
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:
•
•
Mr. Kevin Funk, Program Analyst, General Services Acquisition Policy Division, GSA, at telephone 202-357-5805 or via email to
The General Services Administration (GSA) requires contractors holding Multiple Award Schedule Contracts to identify in their GSA price lists those products that they market commercially that have environmental attributes in accordance with GSAR clause 552.238-72. The identification of these products will enable Federal agencies to maximize the use of these products and meet the responsibilities expressed in statutes and executive order.
Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate and based on valid assumptions and methodology; and ways to enhance the quality, utility, and clarity of the information to be collected. A 60-day notice was published in the
Office of Acquisition Policy, General Services Administration (GSA).
Notice of request for public comments regarding an extension to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding solicitation provisions and contract clauses, placement of orders clause, and ordering information clause.
Submit comments on or before: September 21, 2018.
Ms. Leah Price, Procurement Analyst, General Services Acquisition Policy Division, GSA, by phone at 202-714-9482 or by email at
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:
•
•
GSA has various mission responsibilities related to the acquisition and provision of the Federal Acquisition Service's (FAS's) Stock, Special Order, and Federal Supply Schedule (FSS) Programs. These mission responsibilities generate requirements that are realized through the solicitation and award of various types of FAS contracts. Individual solicitations and resulting contracts may impose unique information collection and reporting requirements on contractors, not required by regulation, but necessary to evaluate particular program accomplishments and measure success in meeting program objectives.
As such, the General Services Administration Acquisition Regulation (GSAR) 516.506, Solicitation provision and clauses, specifically directs contracting officers to insert 552.216-72, Placement of Orders, and 552.216-73, Ordering Information, when the contract authorizes FAS and other activities to issue delivery or task orders. These clauses include information reporting requirements for Offerors to receive electronic orders through computer-to-computer Electronic Data Interchange (EDI).
A notice was published in the
Office of Government-wide Policy (OGP), General Services Administration (GSA).
Notice of GSA Per Diem Bulletin FTR 19-01, Fiscal Year (FY) 2019 Continental United States (CONUS) per diem reimbursement rates.
The General Services Administration's (GSA) Fiscal Year (FY) 2019 per diem reimbursement rates review has resulted in lodging and meal allowance changes for certain locations within CONUS to provide for reimbursement of Federal employees' subsistence expenses while on official travel.
For clarification of content, contact Ms. Jill Denning, Program Analyst, Office of Government-wide Policy, Office of Asset and Transportation Management, at 202-208-7642, or by email at
For FY 2019, one new non-standard area (NSA) location was added for Cobb County, Georgia. Hancock and Knox Counties in Maine were combined into one NSA. The standard CONUS lodging allowance rate will increase from $93 to $94. The M&IE reimbursement rate tiers were revised for FY 2019; they were last revised in FY2016. The revised standard CONUS M&IE rate is now $55, and the M&IE NSA tiers are revised from $54-$74 to $56-$76.
GSA issues and publishes the CONUS per diem rates, formerly published in Appendix A to 41 CFR Chapter 301, solely on the internet at
Notices published periodically in the
Office of Acquisition Policy, General Services Administration (GSA).
Notice of request for comments regarding an extension to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, the General Services Administration will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding contract administration and quality assurance.
Submit comments on or before: September 21, 2018.
Mr. Kevin Funk, Program Analyst, General Services Acquisition Policy Division, at 202-357-5805 or via email to
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:
•
•
Under certain contracts, because of reliance on contractor inspection in lieu of Government inspection, GSA's Federal Acquisition Service requires documentation from its contractors to effectively monitor contractor performance and ensure that it will be able to take timely action should that performance be deficient.
A 60-day notice published in the
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Information Collection for Tuberculosis Data from Panel Physicians, which collects TB data gathered during overseas immigration medical exams.
CDC must receive written comments on or before October 22, 2018.
You may submit comments, identified by Docket No. CDC-2018-0049 by any of the following methods:
•
•
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffery M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
5. Assess information collection costs.
Information Collection for Tuberculosis Data from Panel Physicians—Revision—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
The Centers for Disease Control and Prevention's (CDC), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Global Migration and Quarantine (DGMQ), Immigrant, Refugee, and Migrant Health Branch (IRMH), requests approval for a revision of an existing information collection. This project pertains to collecting annual reports on certain tuberculosis data from U.S. panel physicians.
The respondents are panel physicians. More than 760 panel physicians from 336 panel sites perform overseas pre-departure medical examinations in accordance with requirements, referred to as technical instructions, provided by DGMQs Quality Assessment Program (QAP). The role of QAP is to assist and guide panel physicians in the implementation of the Technical Instructions; evaluate the quality of the overseas medical examination for U.S.-bound immigrants and refugees; assess potential panel physician sites; and provide recommendations to the U.S. Department of State in matters of immigrant medical screening.
To achieve DGMQ's mission, the Immigrant, Refugee and Migrant Health branch (IRMH) works with domestic and international programs to improve the health of U.S.-bound immigrants and refugees to protect the U.S. public by preventing the importation of infectious disease. These goals are accomplished through IRMH's oversight of medical exams required for all U.S.-bound immigrants and refugees who seek permanent residence in the U.S. IRMH is responsible for assisting and training the international panel physicians with the implementation of medical exam Technical Instructions (TI). Technical Instructions are detailed requirements and national policies regarding the medical screening and treatment of all U.S.-bound immigrants and refugees.
Screening for tuberculosis (TB) is a particularly important component of the immigration medical exam and allows panel physicians to diagnose active TB disease prior to arrival in the United States. As part of the Technical Instructions requirements, panel physicians perform chest x-rays and laboratory tests that aid in the identification of tuberculosis infection (Class B1 applicants) and diagnosis of active tuberculosis disease (Class A, inadmissible applicants). CDC uses these classifications to report new immigrant and refugee arrivals with a higher risk of developing TB disease to U.S. state and local health departments for further follow-up. Some information that panel physicians collect as part of the medical exam is not reported on the standard Department of State forms (DS-forms), thereby preventing CDC from evaluating TB trends in globally mobile populations and monitoring program effectiveness.
Currently, CDC is requesting this data be sent by panel physicians once per year. The consequences of reducing this frequency would be the loss of monitoring program impact and TB burdens in mobile populations and immigrants and refugees coming to the United States on an annual basis. The total hours requested is 1,008. There is no cost to the respondents other than their time.
Estimated annual burden is being reduced by 1,640 hours per year. The number of respondents is being reduced by 17. Reductions are due to revised estimates on burden time per response, and the removal of four variables from the data collection form and improved IT capacity at most panel sites.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS)
Notice with comment period
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed work and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a continuing information collection project titled Annual Submission of the Ingredients Added to, and the Quantity of Nicotine Contained in, Smokeless Tobacco Manufactured, Imported, or Packaged in the U.S.
CDC must receive written comments on or before October 22, 2018.
You may submit comments, identified by Docket No. CDC-2018-0076 by any of the following methods:
•
•
To request more information on the proposed project or to obtain a copy of the information collection plan and
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
5. Assess information collection costs.
Annual Submission of the Ingredients Added to, and the Quantity of Nicotine Contained in, Smokeless Tobacco Manufactured, Imported, or Packaged in the U. S.—Extension—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
Smokeless tobacco products (SLT) are associated with many health problems. Using smokeless tobacco: Can lead to nicotine addiction; causes cancer of the mouth, esophagus, and pancreas; is associated with diseases of the mouth; can increase risks for early delivery and stillbirth when used during pregnancy; can cause nicotine poisoning in children; and, may increase the risk for death from heart disease and stroke.
The CDC's Office on Smoking and Health (OSH) has the primary responsibility for the HHS smoking and health program. As required by the Comprehensive Smokeless Tobacco Health Education Act of 1986 (CSTHEA, 15 U.S.C. 4401
Ingredient reports for new SLT products are due at the time of first importation. Thereafter, ingredient reports are due annually on March 31. Information is submitted to CDC by mailing a written report on the respondent's letterhead, by CD, three-inch floppy disk, or thumb drive. Electronic mail submissions are not accepted. Annual submission reports are mailed to Attention: FCLAA Program Manager, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS S107-7, Atlanta, GA 30341-3717.
Upon receipt and verification of the annual nicotine and ingredient report, CDC issues a Certificate of Compliance to the respondent. As deemed appropriate by the Secretary of HHS, HHS is authorized to use the information to report to Congress the health effects of ingredients, research activities related to the health effects of ingredients, and other information that the Secretary determines to be of public interest. The estimated annual Burden Hours are
Administration for Children and Families, Department of Health and Human Services.
Notice of Tribal Consultation.
The Department of Health and Human Services, Administration for Children and Families (ACF) will host a Tribal Consultation to consult on ACF programs and tribal priorities.
September 13, 2018.
Capital Skyline Hotel, 10 “I” (eye) Street SW, Washington, DC 20024.
Jeannie Hovland, Commissioner, Administration for Native Americans and Deputy Assistant Secretary for Native American Affairs at 202-401-5156, by email at
In accordance with the ACF Tribal Consultation Policy, ACF announces tribal consultation with tribal leaders operating ACF programs.
The consultation will be conducted with elected or appointed leaders of tribal governments and their designated representatives. Designees must have a letter from the tribal government authorizing them to represent the tribe. Tribal governments must submit the designee letter at least 3 days in advance of the consultation session to the Administration for Native Americans at
ACF has identified the following topics for consultation:
TANF and Welfare reform
The ACF Tribal Consultation Session will begin at 9:00 a.m. on September 13 and continue throughout the day until all discussions have been completed. To help both you and the ACF Principals prepare for this consultation, planning teleconference calls will be held:
The purpose of the planning calls will be to identify individuals who will provide oral testimony to ACF, solicit for tribal moderators and identify specific topics of interest so we can ensure that all appropriate individuals are present.
For any tribe unable to attend in person, ACF will provide a webinar link, Please contact our 1-877-922-9ANA (1-877-922-9262) for the webinar information.
We have set up a registration for all participants whether attending in person or by webinar. The registration address is:
Unaccompanied Alien Children's (UAC) Program, Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S Department of Health and Human Services (HHS).
Notice of intent to issue one OPDIV-Initiated Supplement to BCFS Health and Human Services, San Antonio, TX under the UAC Program.
ACF, ORR, announces the intent to issue one OPDIV-Initiated Supplement to BCFS Health and Human Services, San Antonio, TX in the amount of $28,003,926. ORR has been identifying additional capacity to provide shelter for potential increases in apprehensions of Unaccompanied Children at the U.S. Southern Border. Planning for increased shelter capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter for Unaccompanied Alien Children referred to its care by the Department of Homeland Security (DHS). To ensure sufficient capacity to provide shelter to unaccompanied children referred to HHS, BCFS proposed to provide ORR with 850 beds in an expedited manner.
Supplemental award funds will support activities through September 13, 2018.
Jallyn Sualog, Director, Division of Children's Services, Office of Refugee Resettlement, 330 C Street SW, Washington, DC 20447. Phone: 202-401-4997. Email:
ORR is continuously monitoring its capacity to shelter the unaccompanied children referred to HHS, as well as the information received from interagency partners, to inform any future decisions or actions.
ORR has specific requirements for the provision of services. Award recipients must have the infrastructure, licensing, experience, and appropriate level of trained staff to meet those requirements. The expansion of the existing program and its services through this
(A) Section 462 of the Homeland Security Act of 2002, which in March 2003, transferred responsibility for the care and custody of Unaccompanied Alien Children from the Commissioner of the former Immigration and Naturalization Service (INS) to the Director of ORR of the Department of Health and Human Services (HHS).
(B) The Flores Settlement Agreement, Case No. CV85-4544RJK (C. D. Cal. 1996), as well as the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (Pub. L. 110-457), which authorizes post release services under certain conditions to eligible children. All programs must comply with the Flores Settlement Agreement, Case No. CV85-4544-RJK (C.D. Cal. 1996), pertinent regulations and ORR policies and procedures.
Food and Drug Administration, HHS.
Notice of public meeting.
The Food and Drug Administration (FDA or the Agency) is announcing the following public meeting entitled “Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC).” This public meeting is intended to provide members of the pharmaceutical industry and other interested stakeholders an opportunity to discuss with FDA, and provide input on, topics and issues related to standardized data for electronic submission of PQ/CMC data, as detailed in the 2017
The public meeting will be held on October 19, 2018, from 9 a.m. to 4 p.m. Submit either electronic or written comments on this public meeting by November 16, 2018.
The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, Section A), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to
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 November 16, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” 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
Bryan Spells, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002,
PQ/CMC is a term used to describe manufacturing and quality control information submitted to FDA in support of submissions. PQ/CMC plays an integral part in the regulatory review process and life cycle management of pharmaceutical products. This information is primarily submitted in Module 3 of the Electronic Common Technical Document. The standardization of PQ/CMC data elements and terminologies will facilitate the Agency's transition to a streamlined electronic review environment.
FDA intends to identify and standardize data elements and terminologies for information commonly used and submitted in support of drug product applications. The impetus for this standardization effort was the provisions from the Food and Drug Administration Safety and Innovation Act (21 U.S.C. 301 note) (Pub. L. 112-144), which authorized the Agency to require certain submissions to be submitted in a specified electronic format. The development of a structured format for PQ/CMC data will enable consistency in the content and format of PQ/CMC data submitted, thus providing a consistent look and feel for every application, and, in general, contributing to a more efficient and effective regulatory decision-making process by creating standardized data dictionaries.
As part of this effort, in 2017, FDA released a FRN presenting a “Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies” for public comment (
The purpose of the October 19, 2018, public meeting is to provide members of the pharmaceutical industry and other interested stakeholders an opportunity to discuss with FDA, and provide input on, topics and issues related to standardized data for electronic submission of PQ/CMC data, as detailed in the FRN, “Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies,” released in 2017 for public comment (
• Ongoing development of PQ/CMC data elements and terminologies, including revisions informed by public response to the “Draft Standardization” FRN, developing the technical specifications for PQ/CMC data submissions, and upcoming development and testing of PQ/CMC data exchange mechanisms.
• Ongoing efforts to maximize harmonization of PQ/CMC standardization with other national and international data standardization activities sharing the same domain space as PQ/CMC (
• An understanding of industry business practices regarding submission of PQ/CMC data which will help to inform development of PQ/CMC standardization.
FDA will consider all comments made at this meeting or received through the docket (see
Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public meeting must register by September 21, 2018, midnight Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted.
If you need special accommodations due to a disability, please contact Bryan Spells, 240-402-6511, email
Food and Drug Administration, HHS.
Notice of public meeting.
The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled “Expanding Access to Effective Treatment for Opioid Use Disorder: Provider Perspectives on Reducing Barriers to Evidence-Based Care.” Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, the public meeting is intended to generate a discussion with providers and health system stakeholders on the armamentarium of medications to treat opioid use disorder (OUD), current barriers to appropriate use of these medications, opportunities to further reduce stigma, and methods to expand access to effective pharmacotherapies as part of an evidence-based approach to OUD treatment.
The public meeting will be held on September 20, 2018, from 9 a.m. to 4 p.m. See the
The public meeting will be held at the National Press Club, 529 14th St. NW, Washington, DC 20045. For additional travel and hotel information, please refer to the following web page:
Mitra Ahadpour, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 4546, Silver Spring, MD 20993-0002, 301-796-8469,
The opioid epidemic remains a growing public health crisis. FDA efforts to address the opioid crisis have included, among other things, revision of the document entitled “FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain” (
Over 2.1 million persons aged 12 or older suffer from opioid use disorders related to prescription opioid analgesics or heroin (Ref. 2), and the majority of those suffering from OUD still lack access to evidence-based treatment. Although there is no one-size-fits-all approach to OUD treatment, there is strong evidence demonstrating the effectiveness of FDA-approved medications, combined with counseling and behavioral therapies, for these patients. Promoting the wider use of these safe and effective therapies is a key priority of FDA. However, substantial challenges remain in patient access and provider use of medications for OUD treatment.
This public meeting is intended to serve as a platform to engage in and generate an active discussion with provider communities and health system stakeholders on the armamentarium of medications to treat OUD, barriers to appropriate use of these medications, opportunities to further reduce stigma, and methods to expand access to effective OUD treatment.
During the public meeting, speakers and participants will cover issues related to expanding access to effective treatment for OUD, specifically in regard to provider perspectives on reducing barriers to evidence-based care. Topics will include, but are not limited to, the following:
• The role of FDA and the Department of Health and Human Services in confronting and combatting the opioid epidemic;
• The current state of knowledge on addiction, clinical approaches for identifying and assessing OUD, and use of medication-assisted treatment;
• Gaps in the pharmacological armamentarium for treating OUD, including shortfalls or unmet needs that should be considered in developing new therapies;
• Innovative and evidence-based approaches to OUD treatment delivery, lessons learned, and challenges to broader implementation;
• Legal, regulatory, and cultural barriers to access for treatment for OUD and potential opportunities to reduce stigma and expand access to effective OUD treatment;
• Care models and challenges for increasing access to OUD treatment for vulnerable and medically underserved populations; and
• Clinical, health system, and economic perspectives on defining successful outcomes for OUD treatment, including how establishing outcome measures may facilitate quality improvement, innovative payment approaches, and access to effective care.
During meeting sessions, audience and webcast participants will be invited to actively participate in the discussion regarding provider and clinical expert perspectives on treatment for OUD and barriers to care.
Registration is free and based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when the registration has been accepted. If time and space permit, onsite registration on the day of the public meeting will be provided beginning at 8 a.m. We will let registrants know if registration closes before the day of the public meeting.
If you need special accommodations due to a disability, please contact Sarah Supsiri at the Duke-Margolis Center for Health Policy (202-791-9561,
The following references are on display in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically 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 October 22, 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 October 22, 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
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
In the
In the
We determined that the third-party disclosure burden by manufacturers of OTC sunscreens covered by the 2011 sunscreen rule was based on: (1) An estimate of the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information; (2) the conduct of SPF testing based on the estimated number of existing formulations; (3) an estimate of the time to relabel currently marketed OTC sunscreens containing specified ingredients and marketed without approved applications; and (4) testing and labeling of new products introduced each year. The estimate for this burden in the 2011 60-day notice was a total of 30,066 hours in years 1 and 2, and a total of 966 in each subsequent year.
All currently marketed OTC sunscreen drug products are already required to comply with the SPF labeling requirements specified by the 2011 sunscreen final rule. However, our original estimate also included the burden of new products introduced each year. We estimated that as many as
We received only two comments on our estimated information collection burden (FDA-2011-N-0449-0002 and FDA-2011-N-0449-0003). These comments were already addressed in FDA's notice entitled “Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sun Protection Factor Labeling and Testing Requirements and Drug Facts Labeling for Over-the Counter Sunscreen Drug Products” published in the
In the
FDA estimates the burden of this collection of information as follows:
Because the 2011 sunscreen final rule also lifted the delay of implementing the Drug Facts regulations (§ 201.66) for OTC sunscreens, the rule also modified the information collection associated with § 201.66 (currently approved under OMB control number 0910-0340) and added a third-party disclosure burden resulting from requiring OTC sunscreen products to comply with Drug Facts regulations. In the 1999 Drug Facts labeling final rule, we amended our regulations governing requirements for human drug products to establish standardized format and content requirements for the labeling of all marketed OTC drug products, codified in § 201.66. This section establishes requirements for the Drug Facts portion of labels on OTC drug products requiring such labeling, to include uniform headings and subheadings, presented in a standardized order with minimum standards for type size and other graphical features. Therefore, OTC sunscreen products already on the market at that time incurred a one-time burden to comply with the requirements in § 201.66(c) and (d). In the 60-day notice, the burden was estimated as 43,200 hours for existing sunscreen SKUs and 720 hours for new sunscreen SKUs.
The compliance dates for the 2011 sunscreen final rule that lifted the delay of the § 201.66 labeling implementation data for OTC sunscreen products were December 17, 2012, for sunscreen products with annual sales of $25,000 or more and December 17, 2013, for sunscreen products with annual sales of less than $25,000, respectively, when we published the 2012 extension date notice. All currently marketed sunscreen products are, therefore, already required to comply with the Drug Facts labeling requirements in § 201.66 and will incur no further burden in the 1999 Drug Facts labeling final rule. However, new OTC sunscreen drug products will be subject to a one-time burden to comply with Drug Facts labeling requirements in § 201.66. In the 2011 60-day notice, we estimated that as many as 60 new product SKUs marketed each year must comply with Drug Facts regulations. We estimated that these 60 SKUs would be marketed by 30 manufacturers, which will spend approximately 12 hours on each label based on the most recent estimate used for other OTC drug products to comply with the 1999 Drug Facts labeling final rule, including public comments received on this estimate in 2010 that addressed sunscreens. This is equal to 720 hours annually (60 SKUs, 12 hours per SKU). We stated that we do not expect any OTC sunscreens to apply for exemptions or deferrals of the Drug Facts regulations in § 201.66(e). However, we considered this in 2013 and estimated the burden for an exemption or deferral by considering the number of exemptions or deferrals we have received since publication of the 1999 Drug Facts labeling final rule (one response) and estimating that a request for deferral or exemption would require 24 hours to complete. Multiplying the annual frequency of response (0.125) by the number of hours per response (24) gives a total response time for requesting an exemption or deferral equal to 3 hours.
FDA estimates the burden of this collection of information as follows:
We note that these estimates may be adjusted in the future development of an upcoming rulemaking on over-the-counter sunscreen products (RIN 0910-AA01). FDA intends to amend this information collection and/or seek approval of additional information collections, as appropriate, concurrent with this rulemaking.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) has determined that DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 15 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 15 mg, if all other legal and regulatory requirements are met.
Glen Cheng, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6210, Silver Spring, MD 20993-0002, 301-796-1494.
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 5 mg, 10 mg, and 15 mg, are the subject of NDA 020897, held by Janssen Pharmaceuticals Inc., and initially approved on December 16, 1998. DITROPAN XL is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, and for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (
In a letter dated December 14, 2017, Janssen Pharmaceuticals Inc. notified FDA that DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 15 mg, were being discontinued, and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book. Although DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 5 mg and 10 mg, were also previously listed in the “Discontinued Drug Product List” section of the Orange Book, they are now listed in the “Prescription Drug Product List” section of the Orange Book.
Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated March 30, 2018 (Docket No. FDA-2018-P-1335), and Ajanta Pharma Limited submitted a citizen petition dated April 2, 2018 (Docket No. FDA-2018-P-1361), under 21 CFR 10.30, requesting that the Agency determine whether DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 5 mg, 10 mg, and 15 mg, were withdrawn from sale for reasons of safety or effectiveness.
As noted, DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 5 mg and 10 mg, are no longer listed in the “Discontinued Drug Product List” section of the Orange Book, and therefore we need not determine whether they were withdrawn from sale for reasons of safety or effectiveness.
With regard to DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 15 mg, after considering the citizen petition and reviewing Agency records, and based on the information we have at this time, FDA has determined under § 314.161 that DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. The petitioners have identified no data or other information suggesting that this drug
Accordingly, the Agency will continue to list DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 15 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 15 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice; extension of the comment period.
The Food and Drug Administration (FDA or we) is extending the comment period for the notice of a public meeting and request for comments, published in the
FDA is extending the comment period on the notice and its request for comment, published in the
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 October 11, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Claudine Kavanaugh, Food and Drug Administration, Office of Foods and Veterinary Medicine, 10903 New Hampshire Ave., Bldg. 1, Rm. 3218, Silver Spring, MD 20993, 301-796-4647.
In the
• Considering using a standard icon to denote the claim “healthy” on food labels.
• Creating a more efficient review strategy for evaluating qualified health claims on food labels.
• Discussing new or enhanced labeling statements or claims that could facilitate innovation to produce more healthful foods and more healthful consumer food choices.
• Modernizing the standards of identity to provide more flexibility for the development of healthier products, while making sure consumers have accurate information about these food products.
• Providing opportunities to make ingredient information more helpful to consumers.
• FDA's educational campaign for consumers about the updated Nutrition Facts label.
See 83 FR 30180 at 30181 to 30182.
The notice invited interested parties to provide information on these and other topics related to FDA's Nutrition Innovation Strategy. We asked that comments be submitted on or before August 27, 2018.
After the public meeting, we received several requests to extend the comment period. The requesters asserted that the time period of 32 days was insufficient to respond fully to FDA's specific request for comments and to ensure comprehensive public input and allow potential respondents to thoroughly evaluate and address pertinent issues.
We have considered the requests and are extending the comment period for another 45 days, until October 11, 2018. We believe that a 45-day extension allows adequate time for interested persons to submit comments while ensuring the continued forward progress of FDA's Nutrition Innovation Strategy.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) has determined that DANOCRINE (danazol) Capsules, 50 milligrams (mg), 100 mg, and 200 mg, were not withdrawn from sale for reasons of safety or effectiveness, except with respect to the indication of fibrocystic breast disease that was withdrawn for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to suspend approval of abbreviated new drug applications (ANDAs) that refer to this drug product and have removed the indication for fibrocystic breast disease. This determination also will allow FDA to continue to approve ANDAs that refer to this drug as long as they meet relevant legal and regulatory requirements. However, the Agency will not accept or approve ANDAs for DANOCRINE (danazol) Capsules, 50 mg, 100 mg, and 200 mg that include fibrocystic breast disease as an indication.
Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363.
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
Under § 314.161(a)(2), the Agency must also determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness if ANDAs that referred to the listed drug have already been approved prior to its market withdrawal. If the Agency determines that a listed drug was withdrawn from sale for reasons of safety or effectiveness, and there are approved ANDAs that reference that listed drug, FDA will initiate a proceeding to determine whether the suspension of the ANDAs is also required (§ 314.161(d)).
DANOCRINE (danazol) Capsules, 50 mg, 100 mg, and 200 mg, is the subject of NDA 017557 held by Sanofi-Aventis, and initially approved on June 21, 1976. DANOCRINE is indicated for the treatment of endometriosis amenable to hormonal management, prevention of attacks of angioedema of all types (cutaneous, abdominal, and laryngeal) in males and females, and fibrocystic breast disease. Specifically, with respect to fibrocystic breast disease, the labeling states “Most cases of fibrocystic breast disease may be treated by simple
DANOCRINE (danazol) Capsules, 50 mg, 100 mg, and 200 mg, were discontinued from sale in December 2004. FDA moved the product to the “Discontinued Drug Product List” section of the Orange Book at that time. In a letter dated October 17, 2011, Sanofi-Aventis requested the withdrawal of the DANOCRINE application. On July 19, 2013, the Agency issued a
After reviewing our records and based on the information we have at this time, FDA has determined that under § 314.161 DANOCRINE (danazol) Capsules, 50 mg, 100 mg, and 200 mg, were not withdrawn from sale for reasons of safety or effectiveness, except with respect to the indication for fibrocystic breast disease. Fibrocystic breast disease refers to mastalgia or breast pain caused by benign proliferative breast tissue. The term fibrocystic breast disease is no longer used, in part because it is not accurate to describe the condition as a disease when it is in fact the result of normal physiologic changes.
DANOCRINE (danazol) has been associated with two serious adverse reactions: hepatocellular injury (
The Agency conducted a review of the benefit-risk profile for each indication of DANOCRINE (danazol). For the treatment of fibrocystic breast disease, the Agency concluded that the benefit-risk profile of the product is unfavorable given the risk of potentially serious adverse reactions and that the condition is a benign, non-disease state. In addition, many other treatment options exist for this condition, including dietary measures, use of supportive undergarments and pain relievers such as acetaminophen or non-steroidal anti-inflammatory drug products. Many of these treatment options present a very low risk of adverse reactions. For the indications of treatment of endometriosis amenable to hormone management and prevention of attacks of angioedema of all types (cutaneous, abdominal, and laryngeal) in males and females, the Agency has determined that DANOCRINE (danazol) continues to have a favorable benefit-risk profile.
Accordingly, the Agency will continue to list DANOCRINE (danazol) Capsules, 50 mg, 100 mg, and 200 mg, in the “Discontinued Drug Product List” section of the Orange Book. All approved ANDAs have removed the fibrocystic breast disease indication from their labeling. In addition, FDA will continue to approve ANDAs that refer to DANOCRINE (danazol) Capsules as long as they meet relevant legal and regulatory requirements, but FDA will not accept or approve ANDAs that refer to this drug product and propose to include the fibrocystic breast disease indication.
Health Resources and Service Administration (HRSA), Department of Health and Human Services (HHS).
Notice of meeting.
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD) will hold a public meeting. Information about ACTPCMD and the agenda for this meeting can be found on the ACTPCMD website at:
September 10, 2018, 9:00 a.m.-5:00 p.m. ET, and September 11, 2018, 8:30 a.m.-2:30 p.m. ET.
This meeting will be held in person and offer virtual access through teleconference and webinar. The address for the meeting is 5600 Fishers Lane, Rockville, Maryland 20857.
•
•
Dr. Kennita Carter, Designated Federal Official (DFO), Division of Medicine and Dentistry, Bureau of Health Workforce, HRSA, 5600 Fishers Lane, 15N-116, Rockville, Maryland 20857; 301-945-3505; or
ACTPCMD provides advice and recommendations to the Secretary of HHS (Secretary) on policy, program development, and other matters of significance concerning the activities under section 747 of Title VII of the Public Health Service (PHS) Act, as it existed upon the enactment of Section 749 of the PHS Act in 1998. ACTPCMD prepares an annual report describing the activities of the Committee, including findings and recommendations made by the Committee concerning the activities under section 747, as well as training programs in oral health and dentistry. The annual report is submitted to the Secretary and Chairman and ranking members of the Senate Committee on Health, Education, Labor and Pensions, and the House of Representatives Committee on Energy and Commerce. The Committee also develops, publishes, and implements performance measures and guidelines for longitudinal evaluations of programs authorized under Title VII, Part C, of the PHS Act, and recommends appropriation levels for programs under this Part.
During the September 10-11, 2018, meeting, ACTPCMD will have follow-up discussions on PHS Act section 747 and oral health training programs, and finalize its recommendations on funding and appropriation levels to be included in its 16th report. In addition, the Committee will complete the 16th report and a pending report on promoting clinical trainee and faculty well-being and mitigating burnout. Agenda items are subject to change as priorities dictate.
Members of the public will have the opportunity to provide comments. Public participants may submit written statements in advance of the scheduled meeting. Oral comments will be honored in the order they are requested
Individuals who plan to attend and need special assistance or another reasonable accommodation should notify Dr. Kennita R. Carter at the address and phone number listed above at least 10 business days prior to the meeting. Since this meeting occurs in a federal government building, attendees must go through a security check to enter the building. Non-U.S. Citizen attendees must notify HRSA of their planned attendance at least 10 business days prior to the meeting in order to facilitate their entry into the building. All attendees are required to present government-issued identification prior to entry.
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Notice.
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
For information about requirements for filing petitions, and the Program in general, contact Lisa L. Reyes, Clerk of Court, United States Court of Federal Claims, 717 Madison Place NW, Washington, DC 20005, (202) 357-6400. For information on HRSA's role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 08N146B, Rockville, MD 20857; (301) 443-6593, or visit our website at:
The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10
A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that “[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the
Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:
1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and
2. Any allegation in a petition that the petitioner either:
a. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by” one of the vaccines referred to in the Table, or
b. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table.
In accordance with Section 2112(b)(2), all interested persons may submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading
Health Resources and Service Administration (HRSA), Department of Health and Human Services (HHS).
Notice of meeting.
The Advisory Commission on Childhood Vaccines (ACCV) has scheduled a public meeting. Information about ACCV and the agenda for this meeting can be found on the ACCV website at
September 6, 2018, from 11:00 a.m. ET to 3:00 p.m. ET.
This meeting will be held in-person, by teleconference, and via webinar. The address for the meeting is 5600 Fishers Lane, Rockville, Maryland, 20857 in conference room 5W07. The public can join the meeting by:
1. (In Person) Persons interested in attending the meeting in person are encouraged to submit a written notification to: Annie Herzog, Division of Injury Compensation Programs (DICP), Healthcare Systems Bureau (HSB), HRSA, Room 08N146B, 5600 Fishers Lane, Rockville, Maryland 20857 or email:
2. (Audio Portion) Calling the conference phone number 800-988-0218 and providing the following information:
3. (Visual Portion) Connecting to the ACCV Adobe Connect Meeting using the following URL:
Annie Herzog, Program Analyst at DICP, HRSA, 5600 Fishers Lane, 08N146B, Rockville, Maryland 20857; 301-443-6593; or
The ACCV was established by section 2119 of the Public Health Service Act (the Act) (42 U.S.C. 300aa-19), as enacted by Public Law (Pub. L.) 99-660, and as subsequently amended, and advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP).
During the September 6, 2018, meeting, the ACCV will discuss updates from DICP, Department of Justice (DOJ), National Vaccine Program Office (NVPO), Immunization Safety Office (Centers for Disease Control and Prevention), National Institute of Allergy and Infectious Diseases (National Institutes of Health) and Center for Biologics, Evaluation and Research (Food and Drug Administration). Agenda items are subject to change as priorities dictate.
Members of the public will have the opportunity to provide comments. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to make oral comments or provide written statements to the ACCV should be sent to Annie Herzog, using the contact information above by Thursday, August 30, 2018.
Individuals who plan to attend and need special assistance or another reasonable accommodation should notify Annie Herzog at the address and phone number listed above at least 10 days prior to the meeting.
Office of the Secretary, HHS.
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Comments on the ICR must be received on or before October 22, 2018.
Submit your comments to
When submitting comments or requesting information, please include the document identifier 0990-0313 and project title for reference, to
Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
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 (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel.
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 a meeting of the National Advisory Environmental Health Sciences Council.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the provisions set forth in 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.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
U.S. Coast Guard, Department of Homeland Security.
Notice of Federal Advisory Committee meeting.
The National Offshore Safety Advisory will meet in Houston, Texas to discuss committee matters relating to the safety of operations and other matters affecting the offshore oil and gas industry. All meetings will be open to the public.
All meetings will be held at United States Coast Guard Sector Houston-Galveston, 13411 Hillard Street, Houston, Texas 77034.
For information on facilities or services for individuals with disabilities or to request special assistance at the meetings, contact the individuals listed in the
Written comments must be submitted using the Federal eRulemaking Portal at
Lieutenant Commander William Nabach, Alternate Designated Federal Officer of the National Offshore Safety Advisory Committee, Commandant (CG-OES-2), U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE, Stop 7509, Washington, DC 20593-7509; telephone (202) 372-1410, fax (202) 372-8382 or email
Notice of this meeting is in compliance with the Federal Advisory Committee Act, (Title 5 U.S.C. Appendix). The National Offshore Safety Advisory Committee provides advice and recommendations to the Department of Homeland Security on matters relating to activities directly involved with, or in support of, the exploration of offshore mineral and energy resources insofar as they relate to matters within Coast Guard jurisdiction.
The National Offshore Safety Advisory Committee's subcommittees on Regulatory Review will meet on September 10, 2018 from 1:00 p.m. to 2:00 p.m. (Central Time) to review, discuss and formulate addendums to the recommendations presented to the full Committee during the March 27, 2018 public meeting. This will be followed by a meeting of the Lessons Learned Subcommittee from 2:00 p.m. to 4:00 p.m. (Central Time) where they will review, discuss and formulate recommendations for presentation to the Committee on September 11, 2018.
The National Offshore Safety Advisory Committee will hold a public meeting on September 11, 2018 from 8 a.m. to 6 p.m. (Central Time) to review and discuss the progress of, and any reports and recommendations received from the above listed subcommittees from their deliberations. The Committee will then use this information and consider public comments in discussing and formulating recommendations to the United States Coast Guard. Public comments or questions will be taken at
A complete agenda for the September 11, 2018 full Committee meeting is as follows:
(1) Welcoming remarks.
(2) General Administration and acceptance of minutes from March 28, 2018 National Offshore Safety Advisory Committee public meeting.
(3) Current Business—Presentation and discussion of progress from the Regulatory Review Subcommittee and from the Lessons Learned Subcommittee.
(4) New Business—
(a) Panel on Recognized Organizations.
(b) Panel discussion on Ballast Water Management and issues relating to Mobile Offshore Drilling Units.
(c) Bureau of Safety and Environmental Enforcement Operational Update.
(d) Maritime Administration Update.
(e) International Association of Drilling Contractors Presentation
(f) Introduction of new task statements:
(i) Use of Offshore Supply Vessels and other non-purpose built vessels for Restoration/Recovery Activities.
(ii) Standards for Letters of Non-Availability.
(5) Public comment period.
A copy of all meeting documentation will be available at
Public comments or questions will be taken throughout the meeting as the committee discusses the issues and prior to deliberations and voting. There will also be a public comment period at the end of the meeting. Speakers are requested to limit their comments to 3 minutes. Please note that the public comment period may end before the period allotted, following the last call for comments. Contact the individuals listed in the
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0015, Bridge Permit Application Guide, without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Comments must reach the Coast Guard on or before October 22, 2018.
You may submit comments identified by Coast Guard docket number [USCG-2018-0497] to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the internet at
Contact Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period.
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2018-0497], and must be received by October 22, 2018.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of Saybolt LP (Linden, NJ), as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that Saybolt LP (Linden, NJ), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of February 6, 2018.
Saybolt LP (Linden, NJ) was approved and accredited as a commercial gauger and laboratory as of February 6, 2018. The next triennial inspection date will be scheduled for February 2021.
Christopher J. Mocella, Laboratories and Scientific Services, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW, Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that Saybolt LP, 1026 E Elizabeth Ave., #10, Linden, NJ 07036, has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13.
Saybolt LP (Linden, NJ) is approved for the following gauging procedures for petroleum and certain petroleum products from the American Petroleum Institute (API):
Saybolt LP (Linden, NJ) is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of AmSpec LLC (Mobile, AL), as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that AmSpec LLC (Mobile, AL), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of April 4, 2018.
AmSpec LLC (Mobile, AL) was approved and accredited as a commercial gauger and laboratory as of April 4, 2018. The next triennial inspection date will be scheduled for April 2021.
Christopher J. Mocella, Laboratories and Scientific Services, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW, Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that AmSpec LLC, 5237 Halls Mill Rd., Building U, Mobile, AL 36619, has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13.
AmSpec LLC (Mobile, AL) is approved for the following gauging procedures for petroleum and certain petroleum products from the American Petroleum Institute (API):
AmSpec LLC (Mobile, AL) is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
Fish and Wildlife Service, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Fish and Wildlife Service (Service), are proposing to renew an information collection.
Interested persons are invited to submit comments on or before October 22, 2018.
Send your comments on the information collection request (ICR) by mail to the Service Information Collection Clearance Officer, U.S. Fish and Wildlife Service, MS: BPHC, 5275 Leesburg Pike, Falls Church, VA 22041-3803; or by email to
Madonna L. Baucum, Service Information Collection Clearance Officer, by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the Service; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. 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.
With this renewal request, the Service plans to consolidate two forms previously approved by OMB into a single form. FWS Forms 3-154a (Part I-Certification) and 3-154b (Part II-Summary of Hunting and Sport Fishing Licenses Issued), will be combined into a single Form 3-154, Certification and Summary of Hunting and Sport Fishing Licenses Issued. We made no substantive changes to the questions on the final consolidated form. This change will streamline the submission process on the public.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
U.S. Geological Survey, Interior.
Notice of public meeting.
In accordance with the Federal Advisory Committee Act of 1972, the U.S. Geological Survey (USGS) is publishing this notice to announce that a Federal Advisory Committee meeting of the National Geospatial Advisory Committee (NGAC) will take place.
The meeting will be held on Wednesday, September 5, 2018, from 8:30 a.m. to 5 p.m., and on Thursday, September 6, 2018, from 8:30 a.m. to 4 p.m. (Eastern Standard Time).
The meeting will be held at the National Conservation Training Center, 698 Conservation Way, Shepherdstown, WV 25443. Send your comments to the Group Federal Officer by email to
Mr. John Mahoney, Federal Geographic Data Committee (FGDC), U.S. Geological Survey (USGS), 909 First Avenue, Suite 800, Seattle, WA 98104; by email at
This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552B, as amended), and 41 CFR 102-3.140 and 102-3.150.
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 may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Bureau of Ocean Energy Management (BOEM), Interior; and Bureau of Safety and Environmental Enforcement (BSEE), Interior.
Notice of Availability
The Bureau of Ocean Energy Management (BOEM) and Bureau of Safety and Environmental Enforcement (BSEE) have prepared a Draft Programmatic Environmental Assessment (PEA) to evaluate the potential environmental effects of reviewing and approving new applications for well drilling, conductor installation, temporary well abandonment, and other permitted downhole activities at platforms on existing leases on the Pacific OCS.
Comments on this Draft PEA will be accepted until September 21, 2018.
For more information on the Draft PEA, you may contact Mr. Rick Yarde, Regional Supervisor, Office of Environment Pacific Region, BOEM, (805) 384-6379 or Mr. David Fish, Chief Environmental Compliance Division, BSEE, (703) 787-1567.
This Notice of Availability is published pursuant to the regulations (40 CFR part 1503) implementing the provisions of the National Environmental Policy Act (NEPA) of 1969, as amended, (42 U.S.C. 4321
1. You may download or view the Draft PEA on the following website:
2. Hard copies of the Draft PEA may be obtained by contacting either Mr. Rick Yarde or Mr. David Fish.
COMMENTS: Government agencies and other interested parties are requested to send their written comments on the Draft PEA in one of the following ways:
1. Preferred: Submit your comment on the project's public review website at:
2. In an envelope labeled “Comments on the Draft PEA for BSEE Permitted Activities in the Southern California Planning Area” and mailed (or hand carried) to Mr. Rick Yarde, Regional Supervisor, Office of Environment Pacific Region, Bureau of Ocean Energy Management, 760 Paseo Camarillo, Suite 102 (CM102), Camarillo, CA 93010; or Mr. David Fish, Chief Environmental Compliance Division, Bureau of Safety and Environmental Enforcement, 45600 Woodland Road, VAE-ECD, Sterling, VA 20166.
Comments must be submitted by September 21, 2018.
Before including your address, phone number, email address or other personal identifying information in your comment, be advised 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 from public review your personal identifying information, we cannot guarantee that we will be able to do so. The Bureaus will not consider anonymous comments, and the Bureaus will make available for inspection, in their entirety, all comments submitted by organizations or businesses or by individuals identifying themselves as representatives of organizations or businesses.
9:30 a.m., Tuesday, September 11, 2018.
NTSB Conference Center, 429 L'Enfant Plaza SW, Washington, DC 20594.
The one item is open to the public.
Telephone: (202) 314-6100.
The press and public may enter the NTSB Conference Center one hour prior to the meeting for set up and seating.
Individuals requesting specific accommodations should contact Rochelle 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
Christopher O'Neil at (202) 314-6100 or by email at
Nuclear Regulatory Commission.
License renewal application; notice of opportunity to request a hearing and to petition for leave to intervene; order imposing procedures.
The U.S. Nuclear Regulatory Commission (NRC) is considering an application for the renewal of Special Nuclear Materials (SNM) License No. SNM-2510, which currently authorizes Sacramento Municipal Utility District (SMUD) to receive, possess, transfer, and store spent fuel from Rancho Seco Nuclear Generating Station in the Rancho Seco Independent Spent Fuel Storage Installation (ISFSI). The renewed license would authorize SMUD to continue to store spent fuel in the Rancho Seco ISFSI for an additional 40 years beyond the current license expiration date of June 30, 2020. For this license renewal application, the NRC proposes to determine that it involves no significant hazards consideration. Because this license renewal application contains sensitive unclassified non-safeguards information (SUNSI), an order imposes procedures to obtain access to SUNSI for contention preparation.
Requests for a hearing or petition for leave to intervene must be filed by October 22, 2018. Any potential party as defined in section 2.4 of title 10 of the
Please refer to Docket ID NRC-2018-0147 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
•
Wendy Reed, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-7213; email:
The NRC has received, by letter dated March 19, 2018 (ADAMS Accession No. ML18101A020), an application from SMUD for renewal of SNM License No. SNM-2510 for the Rancho Seco ISFSI for an additional 40 years (ADAMS Accession No. ML18221A281), supplemented June 25, 2018 (ADAMS Accession No. ML18221A295). The license authorizes SMUD to receive, possess, transfer, and store spent fuel from Rancho Seco Nuclear Generating Station. This license renewal, if approved, would authorize SMUD to continue to store spent fuel at the Rancho Seco ISFSI, under the provisions of 10 CFR part 72, “Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater Than Class C Waste.”
Following an NRC administrative completeness review, documented in a letter to SMUD dated July 20, 2018 (ADAMS Accession No. ML18201A455), the NRC staff has determined that the renewal application contains sufficient information for the NRC staff to begin its technical review and is acceptable for docketing. The application has been docketed in Docket No. 72-11, the existing docket for SNM License No. SNM-2510. If the NRC approves the renewal application, the approval will be documented in the renewal of SNM License No. SNM-2510. The NRC will approve the license renewal application if it determines that the application meets the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the NRC's regulations. These findings will be documented in a safety evaluation report. The NRC will complete an environmental evaluation, in accordance with 10 CFR part 51, to determine if the preparation of an environmental impact statement is warranted or if an environmental assessment and finding of no significant impact are appropriate. This action will be the subject of a subsequent notice in the
Within 60 days after the date of publication of this notice, any persons (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. Petitions shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309. The NRC's regulations are accessible electronically from the NRC Library on the NRC's website at
As required by 10 CFR 2.309(d) the petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements for standing: (1) The name, address, and telephone number of the petitioner; (2) the nature of the petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the petitioner's interest.
In accordance with 10 CFR 2.309(f), the petition must also set forth the specific contentions which the petitioner seeks to have litigated in the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner must provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene. Parties have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that party's admitted contentions, including the opportunity to present evidence, consistent with the NRC's regulations, policies, and procedures.
Petitions must be filed no later than 60 days from the date of publication of this notice. Petitions and motions for leave to file new or amended contentions that are filed after the deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii). The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document.
A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission no later than 60 days from the date of publication of this notice. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions set forth in this section. Alternatively, a State, local governmental body, Federally-recognized Indian Tribe, or agency thereof may participate as a non-party under 10 CFR 2.315(c).
If a hearing is granted, any person who is not a party to the proceeding and is not affiliated with or represented by a party may, at the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of his or her position on the issues but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Details regarding the opportunity to make a limited appearance will be provided by the presiding officer if such sessions are scheduled.
All documents filed in NRC adjudicatory proceedings, including a request for hearing and petition for leave to intervene (petition), any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities that request to participate under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 FR 46562; August 3, 2012). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Detailed guidance on making electronic submissions may be found in the Guidance for Electronic Submissions to the NRC and on the NRC website at
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public website at
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC's Electronic Filing Help Desk through the “Contact Us” link located on the NRC's public website at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing stating why there is good cause for not filing electronically and requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at
A. This Order contains instructions regarding how potential parties to this proceeding may request access to documents containing Sensitive Unclassified Non-Safeguards Information (SUNSI).
B. Within 10 days after publication of this notice of hearing and opportunity to petition for leave to intervene, any potential party who believes access to SUNSI is necessary to respond to this notice may request access to SUNSI. A “potential party” is any person who intends to participate as a party by demonstrating standing and filing an admissible contention under 10 CFR 2.309. Requests for access to SUNSI submitted later than 10 days after publication of this notice will not be considered absent a showing of good cause for the late filing, addressing why the request could not have been filed earlier.
C. The requester shall submit a letter requesting permission to access SUNSI to the Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff, and provide a copy to the Associate General Counsel for Hearings, Enforcement and Administration, Office of the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The expedited delivery or courier mail address for both offices is: U.S. Nuclear Regulatory Commission, 11555 Rockville Pike, Rockville, Maryland 20852. The email address for the Office of the Secretary and the Office of the General Counsel are
(1) A description of the licensing action with a citation to this
(2) The name and address of the potential party and a description of the potential party's particularized interest that could be harmed by the action identified in C.(1); and
(3) The identity of the individual or entity requesting access to SUNSI and the requester's basis for the need for the information in order to meaningfully participate in this adjudicatory proceeding. In particular, the request must explain why publicly available versions of the information requested would not be sufficient to provide the basis and specificity for a proffered contention.
D. Based on an evaluation of the information submitted under paragraph C.(3) the NRC staff will determine within 10 days of receipt of the request whether:
(1) There is a reasonable basis to believe the petitioner is likely to establish standing to participate in this NRC proceeding; and
(2) The requestor has established a legitimate need for access to SUNSI.
E. If the NRC staff determines that the requestor satisfies both D.(1) and D.(2) above, the NRC staff will notify the requestor in writing that access to SUNSI has been granted. The written notification will contain instructions on how the requestor may obtain copies of the requested documents, and any other conditions that may apply to access to those documents. These conditions may include, but are not limited to, the signing of a Non-Disclosure Agreement or Affidavit, or Protective Order
F. Filing of Contentions. Any contentions in these proceedings that are based upon the information received as a result of the request made for SUNSI must be filed by the requestor no later than 25 days after receipt of (or access to) that information. However, if more than 25 days remain between the petitioner's receipt of (or access to) the information and the deadline for filing all other contentions (as established in the notice of hearing or opportunity for hearing), the petitioner may file its SUNSI contentions by that later deadline.
G. Review of Denials of Access.
(1) If the request for access to SUNSI is denied by the NRC staff after a determination on standing and requisite need, the NRC staff shall immediately notify the requestor in writing, briefly stating the reason or reasons for the denial.
(2) The requester may challenge the NRC staff's adverse determination by filing a challenge within 5 days of receipt of that determination with: (a) The presiding officer designated in this proceeding; (b) if no presiding officer has been appointed, the Chief Administrative Judge, or if he or she is unavailable, another administrative judge, or an Administrative Law Judge with jurisdiction pursuant to 10 CFR 2.318(a); or (c) if another officer has been designated to rule on information access issues, with that officer.
(3) Further appeals of decisions under this paragraph must be made pursuant to 10 CFR 2.311.
H. Review of Grants of Access. A party other than the requester may challenge an NRC staff determination granting access to SUNSI whose release would harm that party's interest independent of the proceeding. Such a challenge must be filed within 5 days of the notification by the NRC staff of its grant of access and must be filed with: (a) The presiding officer designated in this proceeding; (b) if no presiding officer has been appointed, the Chief Administrative Judge, or if he or she is unavailable, another administrative judge, or an Administrative Law Judge with jurisdiction pursuant to 10 CFR 2.318(a); or (c) if another officer has been designated to rule on information access issues, with that officer.
If challenges to the NRC staff determinations are filed, these procedures give way to the normal process for litigating disputes concerning access to information. The availability of interlocutory review by the Commission of orders ruling on such NRC staff determinations (whether granting or denying access) is governed by 10 CFR 2.311.
(4) The Commission expects that the NRC staff and presiding officers (and any other reviewing officers) will consider and resolve requests for access to SUNSI, and motions for protective orders, in a timely fashion in order to minimize any unnecessary delays in identifying those petitioners who have standing and who have propounded contentions meeting the specificity and basis requirements in 10 CFR part 2. The attachment to this Order summarizes the general target schedule for processing and resolving requests under these procedures.
For the Nuclear Regulatory Commission.
The ACRS Subcommittee on NuScale will hold a meeting on August 23, 2018, at 11545 Rockville Pike, Room T-2B1, Rockville, Maryland 20852.
The meeting will be open to public attendance with the exception of portions that may be closed to protect information that is proprietary pursuant to 5 U.S.C. 552b(c)(4). The agenda for the subject meeting shall be as follows:
The Subcommittee will review the NuScale Design Control Document and the NRC staff Safety Evaluation Report with No Open Items, Chapter 7, “Digital Instrumentation and Control.” The Subcommittee will hear presentations by and hold discussions with the NRC staff, NuScale, and other interested persons regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Christina Antonescu (Telephone 301-415-6792 or Email:
Detailed meeting agendas and meeting transcripts are available on the NRC website at
If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, Maryland 20852. After registering with Security, please contact Mr. Theron Brown (Telephone 301-415-6702) to be escorted to the meeting room.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
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 website (
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.
1.
2.
3.
6.
This Notice will be published in the
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to remove text currently contained in Rule 1080(a) and relocate and add text into that section (a) to codify the definitions of the protocols that members can use to enter quotes and orders on the Exchange.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to: (i) Retitle Rule 1080; (ii) remove the current rule text located at Phlx Rule 1080(a); and (iii) relocate the definition of the Specialized Quote Feed (“SQF”) from Commentary .01(a) of Rule 1080 to proposed 1080(a)(i)(b) and relocate the definition of the Options Floor Based Management System (“FBMS”) from Commentary .06 of Rule 1080 to proposed 1080(a)(i)(c) and codify the Financial Information eXchange (“FIX”) within Rule 1080(a)(i)(a).
Rule 1080 is currently titled “Phlx.” The Exchange proposes to retitle Rule 1080 as “Electronic Acceptance of Quotes and Orders.”
The Exchange proposes to delete paragraph (a), “General,” which defines the Exchange's System using a prior system's names AUTOM and AUTO-X, which terms are obsolete, as are references to and the functions of each.
The Exchange also proposes to delete cross-references to Rules 1014(b) and 1017, which are unnecessary. Rule 1014, entitled, “Obligations and Restrictions Applicable to Specialists and Registered Options Traders,” contains various definitions, including a Registered Options Trader at Rule 1014(b). The Exchange believes it is unnecessary to cite the specific rule. Further, Rule 1017 entitled “Openings in Options” does not require a specific citation.
The Exchange believes that codifying definitions of these protocols in its rules will increase transparency around its operations.
The Exchange proposes to add a new section (a) entitled “Entry and Display of Orders and Quotes.” The Exchange proposes to state in proposed Rule 1080(a) “Members may enter orders and quotes into the System as specified below.” The Exchange proposes to add a section 1080(a)(i) which provides, “The Exchange offers members the following protocols for entering orders and quotes respectively.”
Although the Exchange is changing how it categorizes various features included on FIX and SQF as part of its harmonization effort, the list of features included in the proposed definitions are intended to be exhaustive with respect to the buckets of information provided on each protocol. Overall, the Exchange believes that the proposed changes will allow members to more easily understand what information is available on which protocol.
This protocol is not memorialized within the Exchange's Rulebook, however rule changes describing FIX have been filed.
SQF is currently defined at Commentary .01(a) to Rule 1080 as “A specialist, RSQT or SQT may establish an option pricing model via a specialized connection, which is known as a specialized quote feed (“SQF”).” The Exchange proposes to remove this description from Commentary .01(a) to Rule 1080 and relocate the definition to proposed Rule 1080(a)(i)(B) and instead a more descriptive definition of this protocol. The Exchange proposes the following:
SQF is an interface that allows Specialists, Streaming Quote Traders (“SQTs”) and Remote Streaming Quote Traders (“RSQTs”) to connect, send, and receive messages related to quotes, Immediate-or-Cancel Orders, and auction responses into and from the Exchange. Features include the following: (1) Options symbol directory messages (
The Exchange also proposes to remove the remainder of Commentary .01(a) to Rule 1080, which provides, “Specialists, SQTs and RSQTs individually determine which model to select per option and may change models during the trading day. Each pricing model requires the specialist, SQTs and RSQTs to input various parameters, such as interest rates, volatilities (delta, vega, theta, gamma, etc.) and dividends.” The Exchange is no longer involved in the pricing models that its users choose. This rule text is obsolete. Specialists, SQTs, and RSQTs provide their quotations to the Exchange using their own proprietary models; the Exchange does not offer any pricing models to its members. The Exchange proposes to reserve this section.
The Exchange proposes to relocate the Options Floor Based Management System currently defined in Commentary .06 of Rule 1080 to proposed Rule 1080(a)(i)(C). No substantive changes are being made to the description. The Exchange proposes to delete .06 and also to delete .07 and .08 of the Commentary, which are currently reserved.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange believes that renaming Phlx Rule 1080 will better describe the information contained in the rule. Also, removing obsolete rule text from Phlx Rule 1080(a) and Commentary .01(a) to Rule 1080 will remove confusion as to the System and its offerings. The rule text being removed is obsolete.
The Exchange believes that the proposed rule change is consistent with the protection of investors and the public interest as it codifies the protocols used to connect to the Exchange's System. While no functional changes to the protocols are proposed in this filing, the Exchange believes that including a description of the protocols in its rulebook will benefit members by increasing transparency around the operation of the Exchange. Furthermore, the proposed definitions being included in the rulebook will more clearly and accurately reflect the information included on the protocols, and will be harmonized with language to be included in the rules of its affiliated exchanges to the extent that the protocols operate in the same manner. The protocols described in this filing provide a range of important features to members, including the ability to submit quotes and orders, and perform other functions necessary to manage trading on the Exchange. The Exchange believes codifying the quote and order entry protocols will increase transparency to the members that use these protocols to connect to the Exchange.
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 explained above, the Exchange is codifying the quote and order entry protocols that members use to connect to the Exchange's System. The obsolete rule text does not currently apply to any member on Phlx and therefore removing the inapplicable language will not impact any member on Phlx.
The Exchange does not believe that codifying the order entry protocols in the rulebook will have any competitive impact. Locating all the descriptions within a single rule and adding context around each order entry protocol will increase transparency around the operation of the Exchange without having any impact on inter-market or intra-market competition. All market participants have the ability to subscribe to the protocols for order entry. The quoting protocols are limited to the market participants who are permitted by rule to quote on Phlx, but the function is uniformly available to these eligible participants.
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
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.
On June 15, 2018, New York Stock Exchange LLC (“Exchange”) 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”)
FINRA is proposing to amend FINRA Rule 1220(a)(4) (Financial and Operations Principal and Introducing Broker-Dealer Financial and Operations Principal) to: (1) Reflect that certain firms remain exempt from the requirement to designate an individual as a Financial and Operations Principal (“FINOP”) or an Introducing Broker-Dealer Financial and Operations Principal (“Introducing FINOP”); and (2) provide that the individual designated as Principal Financial Officer and Principal Operations Officer of these exempt firms is not required to be qualified and registered as a FINOP or an Introducing FINOP.
The text of the proposed rule change is available on FINRA's website at
In its filing with the Commission, FINRA 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. FINRA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
In July 2017, the SEC approved a proposed rule change to,
Subparagraph (A) of FINRA Rule 1220(a)(4) requires that each firm designate an individual as a FINOP or an Introducing FINOP to carry out specified financial and operational responsibilities,
Certain members, hereinafter referred to as exempt firms, are exempt from the requirement in current NASD Rules 1022(b) and 1022(c) to designate an individual as a FINOP or an Introducing FINOP to carry out specified financial and operational responsibilities, including from the requirement that such an individual pass the Series 27 or Series 28 examination (or obtain a waiver of the examination) and register in the CRD system with the designation FN or FI.
Subparagraph (B) of FINRA Rule 1220(a)(4) requires each firm to designate an individual as Principal Financial Officer with primary responsibility over the firm's financial filings and the related books and records and an individual as Principal Operations Officer with primary responsibility over the firm's day-to-day operations. Such individuals must also pass the Series 27 or Series 28 examination, as applicable, or obtain a waiver of the examination. Further, they must register in the CRD system with the designation FN or FI. The responsibilities of a designated Principal Financial Officer and Principal Operations Officer intersect with the responsibilities of a designated FINOP or Introducing FINOP. However,
As stated in
Exempt firms have noted that the responsibilities of a Principal Financial Officer and a Principal Operations Officer are functional equivalents to the responsibilities that a designated FINOP or Introducing FINOP would carry out at their firms. Exempt firms have also noted that, given their exempt status, they do not have an individual designated as a FINOP or an Introducing FINOP to whom to assign the responsibilities of a Principal Financial Officer and Principal Operations Officer. Similarly, they do not have any other associated persons who are qualified and registered as a FINOP or an Introducing FINOP (
Therefore, exempt firms have stated that FINRA Rule 1220(a)(4)(B) would have the indirect impact of eliminating their FINOP and Introducing FINOP exemptions by requiring them to designate an individual who is qualified and registered as a FINOP or an Introducing FINOP to carry out responsibilities that are functionally equivalent to those responsibilities that would otherwise be carried out by a designated FINOP or Introducing FINOP.
FINRA recognizes that the rule change would have the impact of eliminating longstanding exemptions that were granted to members, which was not the intended purpose of the rule change. The purpose of the rule change is to ensure that each member has designated individual(s) with primary responsibility for specified financial and operational functions carried out by the firm.
Accordingly, FINRA is proposing to amend FINRA Rule 1220(a)(4)(A) to reflect that exempt firms remain exempt from the requirements of FINRA Rule 1220(a)(4)(A). FINRA is also proposing to amend FINRA Rule 1220(a)(4)(B) to provide that individuals designated as Principal Financial Officers and Principal Operations Officers of exempt firms are not required to be qualified and registered as FINOPs or Introducing FINOPs. FINRA Rule 1220(a)(4)(B) would continue to require exempt firms to designate an individual as a Principal Financial Officer and Principal Operations Officer to carry out specified financial and operational responsibilities, but such individual would not be required to be qualified and registered as a FINOP or an Introducing FINOP.
Finally, as indicated in
FINRA is filing the proposed rule change for immediate effectiveness. The implementation date will be October 1, 2018, to coincide with the implementation date of the consolidated registration rules.
FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act,
FINRA 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.
FINRA has undertaken an economic impact assessment, as set forth below, to further analyze the regulatory need for the proposed rule change, the economic baseline of analysis, the economic impact and the alternatives considered.
Exempt firms are not required to designate an individual as a FINOP or an Introducing FINOP to carry out specified financial and operational responsibilities. The requirements under FINRA Rule 1220(a)(4)(B), which become operative on October 1, 2018, would effectively and unintentionally undo these exemptions. FINRA is therefore preserving these exemptions, while ensuring that each FINRA member, including exempt firms, has a designated Principal Financial Officer and Principal Operations Officer to carry out specified financial and operational responsibilities.
The economic baseline for the proposed rule change relates to the activities and costs associated with financial and operational controls conducted by exempt firms. There are approximately 140 current exempt firms.
For purposes of this discussion, FINRA has identified the potentially material impacts of the proposed rule change.
The proposed rule change would preserve the ability of exempt firms to maintain financial and operational controls without the addition of a designated individual as FINOP or Introducing FINOP. Relative to current practices, the proposed rule change would not impose material costs on members or associated persons. However, the proposed rule change would eliminate, or significantly reduce, the operational, administrative and cost burden on exempt firms once FINRA Rule 1220(a)(4)(B) becomes effective.
Among other benefits, exempt firms would not be required to employ, or otherwise associate with, an individual who is currently qualified and registered as a FINOP or an Introducing FINOP by October 1, 2018 to carry out the responsibilities of Principal Financial Officer and Principal Operations Officer. Alternatively, exempt firms would not be required to ensure that a current associated person is qualified and registered as a FINOP or an Introducing FINOP by October 1, 2018 to carry out the responsibilities of Principal Financial Officer and Principal Operations Officer. The proposed rule change would also reduce the costs and burdens on current associated persons of exempt firms who will be designated as Principal Financial Officers and Principal Operations Officers because such individuals would not be required to qualify and register as FINOPs or Introducing FINOPs.
The proposed rule change would not alter the obligations of members that are currently required to have a designated individual as FINOP or Introducing FINOP. As noted above, a firm's designated FINOP or Introducing FINOP is eligible to perform the responsibilities of a Principal Financial Officer and a Principal Operations Officer.
The proposed rule change is not expected to materially alter the protections that customers of exempt firms currently receive.
FINRA considered whether alternative qualifications and registrations would be appropriate for Principal Financial Officers and Principal Operations Officers, other than qualification and registration as a FINOP or an Introducing FINOP. However, FINRA determined not to adopt an alternative qualification and registration requirement pending its evaluation of the structure of its principal-level examinations.
Written comments were neither solicited nor 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) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to 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 website 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 [sic] may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The purpose of this proposed rule change is to amend the definition of the Cross Price Constraint utilized in the opening process for non-IEX-listed securities pursuant to Rule 11.231. On July 24, 2017, the Commission approved a proposed rule change filed by the Exchange to amend IEX Rule 11.231 to modify the manner in which the Exchange opens trading for non-IEX-listed securities beginning at the start of Regular Market Hours (the “Opening Process”).
Pursuant to Rule 11.231, the Exchange attempts to perform the Opening Process in each non-IEX-listed security, in which all eligible interest resting on the Order Book in the Pre-Market Session available for continuous trading (
Cross Eligible Orders resting on the Continuous Book are ranked by the price at which they are resting on the Continuous Book and Cross Eligible Orders resting on the Cross Book are ranked by the limit price defined by the User, if any, except in the case of pegged orders, which are ranked by their current book price (in each case, the order's “resting price”).
Rule 11.190(f)(1) sets forth the operation of the IEX Order Collar. Except for orders that are eligible for the Cross Book, the IEX Order Collar prevents any incoming order (including those marked ISO), or order resting on the Order Book, from executing at prices outside of the Order Collar price range.
• The consolidated last sale price disseminated during the Regular Market Session on the current trade date;
• Last trade price disseminated outside of the Regular Market Session (Form T, as communicated by the relevant SIP) on trade date which other than for the Form T designation would have been considered a valid last sale price; or
• If neither of the prices above are available, the prior days Official Closing Price from the listing exchange, adjusted to account for corporate actions, news events, etc.
The Exchange recently identified a minor omission in the Cross Price Constraint rule provisions with respect to manner in which the IEX Order Collar price range applies. Specifically, as described above, the Exchange does not apply the IEX Order Collar to orders eligible for the Cross Book so that it does not impact their relative priority of execution.
Based on the foregoing, the Exchange believes the existing Cross Price Constraint definition should explicitly account for the IEX Order Collar price range. Accordingly, the Exchange is proposing to amend rule 11.231(c)(1)(iii) to explicitly state that the Cross Price Constraint is adjusted by the IEX Order Collar price range, as described below:
• The upper threshold price of the Cross Price Constraint is equal to the lesser of the price of the Away Protected NBO or the upper threshold of the Order Collar price range for the Regular Market Session, calculated pursuant to Rule 11.190(f)(1)(C), except in the event that an Away Protected Bid is crossing an Away Protected Offer, the upper threshold price is equal to the greater of five cents ($0.05) or one half of a percent (0.5%) higher than the lowest Away Protected Offer; and
• The lower threshold price of the Cross Price Constraint is equal to the greater of the price of the Away Protected NBB or the lower threshold of the Order Collar price range for the Regular Market Session, calculated pursuant to Rule 11.190(f)(1)(C), except in the event that an Away Protected Bid is crossing an Away Protected Offer, the lower threshold price is equal to the greater of five cents ($0.05) or one half of a percent (0.5%) lower than the highest Away Protected Bid.
IEX believes that the proposed rule change is consistent with the provisions of Section 6(b)
The Exchange believes it is consistent with the protection of investors and the public interest to constrain the Opening Process match by the IEX Order Collar price range because executions outside of the Order Collar price range are significantly dislocated from recent trading activity (as measured by the Order Collar Reference Price), and often are the result of erroneous system processing or manual trading errors. The Exchange also notes that executions outside of the IEX Order Collar price range often meet the clearly erroneous criteria and are therefore eligible to be reviewed for cancellation pursuant to Rule 11.270. Thus, the Exchange believes that applying the IEX Order Collar to the cross price in connection with the Opening Match is consistent with the protection of investors and the public interest because it is designed to prevent executions at dislocated prices that are significantly dislocated from recent trading activity and may be canceled pursuant to Rule 11.270.
Furthermore, the Exchange believes that the proposed rule change does not materially alter the Opening Process, because the Opening Process match is already subject to the Cross Price Constraint. Instead, the Exchange believes the proposed changes are designed to make the Cross Price Constraint definition more robust by accounting for the rare scenarios where the Away Protected NBB is below the lower threshold of the IEX Order Collar price range, or the Away Protected NBO is above the upper threshold of the IEX Order Collar price range (
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. The Exchange believes that the proposed changes do not impact competition in any respect since it is designed to avoid any potential confusion regarding the Opening Process functionality, and to make the Exchange's rules more accurate, complete, and descriptive of the System's functionality without materially changing the Opening Process. In addition, the Exchange believes there will be no impact on intra-market competition, as the proposed changes will apply equally to all Members and therefore no new burdens are being proposed. Furthermore, the Exchange believes there will be no impact on intra-market competition because as discussed above, the proposed changes to the Cross Price Constraint do not impact the relative execution priority of orders eligible for the Cross Book, as the constraint is not applied at the order level but instead to the cross price in connection with the Opening Match.
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
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B) 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 June 13, 2018, ICE Clear Credit LLC (“ICC”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act (“Act”)
Section 19(b)(2) of the Act
The Commission is extending the 45-day time period for Commission action on the proposed rule change. ICC proposes to revise the ICC Rulebook to provide for the clearance of an additional Standard Emerging Market Sovereign CDS contract. The Commission finds it appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider ICC's proposed rule change.
Accordingly, the Commission, pursuant to Section 19(b)(2)
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 adopt initial and continued listing standards for subscription receipts and fees for their listing.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to adopt initial and continued listing standards for the listing of Subscription Receipts on the Nasdaq Capital Market and fees for their listing.
Subscription Receipts are a financing technique that has been used for many years by Canadian public companies. Typically, Canadian companies use Subscription Receipts as a means of providing cash consideration in merger or acquisition transactions. Subscription Receipts are sold in a public offering that occurs after the execution of an acquisition agreement. The proceeds of the Subscription Receipt offering are held in a custody account and, if the related acquisition closes, the Subscription Receipt holders receive a specified number of shares of the issuer. If the acquisition does not close, then the Subscription Receipts are redeemed for their original purchase price plus any interest accrued on the custody account. The benefit of Subscription Receipts to the issuer is that they provide a contingent form of financing that only becomes permanent if the acquisition is completed. By contrast, a company financing the cash consideration for an acquisition by means of a traditional equity or debt offering is at risk of having incurred unnecessary dilution of its shareholders or indebtedness if the related acquisition fails to close. Subscription Receipts provide investors with flexibility to elect to invest in the post merger company and not in the company in its pre-merger form.
Nasdaq has received inquiries from market participants about the possibility of the use of Subscription Receipts as a fundraising alternative for listed companies. As a result of this interest, the Exchange is now proposing to adopt listing standards for Subscription Receipts. Under the proposed rule, Nasdaq will initially list Subscription Receipts on the Capital Market pursuant to proposed Rule 5520 if they meet the following requirements:
(a) The security that the Subscription Receipts are exchangeable for must be listed on the Nasdaq Global Select, Global or Capital Market.
(b) The issuer of the Subscription Receipts must not have received a Staff Delisting Determination with respect to the security the Subscription Receipts are exchangeable for and must not have been notified about a deficiency in any continued listing standard with respect to the issuer of the Subscription Receipts or the security the Subscription Receipts are exchangeable for, except with respect to a corporate governance requirement where the issuer has received a grace period under Rule 5810(c)(3)(E).
(c) The proceeds of the Subscription Receipts offering must be designated solely for use in connection with the consummation of a specified acquisition that is the subject of a binding acquisition agreement (the “Specified Acquisition”).
(d) The proceeds of the Subscription Receipts offering must be held in an interest-bearing custody account by an independent custodian.
(e) The Subscription Receipts will promptly be redeemed for cash (i) at any
(f) If the Specified Acquisition is consummated, the holders of the Subscription Receipts will receive the shares of common stock for which their Subscription Receipts are exchangeable.
(g) At the time of initial listing, the Subscription Receipts must have a price per Subscription Receipt of at least $4.00, a minimum Market Value of Publicly Held Shares of $100 million, 1,100,000 Publicly Held Shares
(h) The sale of the Subscription Receipts and the issuance of the common stock of the issuer in exchange for the Subscription Receipts must both be registered under the Securities Act.
Listed Subscription Receipts will be convertible into the primary listed class of common stock of the listed company issuing the Subscription Receipts and will thereafter be subject to all of the continued listing requirements applicable to a primary class of common stock listed on the Nasdaq.
Nasdaq proposes to adopt Rule 5565 to include continued listing standards applicable to Subscription Receipts. The Exchange will immediately initiate suspension and delisting procedures under the Rule 5800 Series when (i) the number of publicly held shares is less than 100,000, (ii) the number of public holders is less than 100, (iii) the total market value of the listed Subscription Receipts is below $15 million over 30 consecutive trading days, (iv) the related common equity security ceases to be listed or receives a delisting determination from Nasdaq staff, or (v) the issuer announces that the Specified Acquisition has been terminated.
Because the issuer of the Subscription Receipt is already listing its primary common stock on Nasdaq, it must comply with the continued listing standards for common stock as well as the corporate governance requirements applicable to listed companies. In addition to the foregoing, Subscription Receipts will be subject to potential delisting for all of the reasons generally applicable to operating companies under the Rule 5800 Series. The Exchange notes that an issuer of Subscription Receipts may be subject to delisting at the time of closing of the related acquisition pursuant to Rule 5110(a), which requires a company to meet the initial listing standards following a business combination with a non-Nasdaq entity resulting in a change of control of the listed company and potentially allowing the non-Nasdaq entity to obtain a Nasdaq listing.
Nasdaq proposes to amend Rule 4120(a) and IM-5250-1 to provide that whenever it halts trading in a security of a listed company pending dissemination of material news or implements any other required regulatory trading halt, the Exchange will also halt trading in any listed Subscription Receipt that is exchangeable by its terms into the common stock of such company. The Exchange will monitor activity in Subscription Receipts to identify and deter any potential improper trading activity in such securities and will adopt surveillance procedures, and make any enhancements necessary, to enable it to monitor Subscription Receipts alongside the common equity securities into which they are convertible. Additionally, the Exchange will rely on its existing trading surveillances, administered by the Exchange, or the Financial Industry Regulatory Authority (“FINRA”) on behalf of the Exchange,
Finally, Nasdaq proposes to adopt fees for Subscription Receipts in proposed Rule 5920. Specifically, Nasdaq proposes to charge a $25,000 entry fee, which would include a $5,000 application fee, for the listing of a class of Subscription Receipts on the Nasdaq Capital Market. Given their short-term nature, Nasdaq does not propose to charge a separate annual fee to list Subscription Receipts and Subscription Receipts would not be included in the shares considered when calculating Nasdaq's All-inclusive Annual Listing Fee.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange believes that the proposed listing standard is consistent with Section 6(b)(5) of the Act in that it contains requirements in relation to the listing of Subscription Receipts that provide adequate protections for investors and the public interest. In particular, the Exchange believes that the quantitative requirements, which require that Subscription Receipts must have a price per share of at least $4.00, a minimum total market value of publicly held shares of $100 million, 1,100,000 publicly held shares, and 400 holders of round lots (collectively, the “Distribution Criteria”), are designed to protect investors in that they are identical to the requirements the Commission recently approved for NYSE to list Subscription Receipts.
Similarly, the Exchange believes that the proposed continued listing standards for Subscription Receipts are consistent with the requirements of the Act and the protection of investors. Under the proposal, the Exchange will immediately initiate suspension and delisting procedures when (i) the number of publicly held shares is less than 100,000, (ii) the number of public holders is less than 100, (iii) the total market value of listed Subscription Receipts is below $15 million over 30 consecutive trading days, (iv) the related common equity security ceases to be listed or receives a delisting determination from Nasdaq staff, or (v) the issuer announces that the Specified Acquisition has been terminated. In addition, Subscription Receipts will be subject to potential delisting for all of the reasons generally applicable to operating companies, including those outlined in the Rule 5800 Series of Nasdaq's rules, and may also be subject to delisting at the time of closing of the related acquisition pursuant to Rule 5110(a), which requires a company to meet the initial listing standards following a business combination with a non-Nasdaq entity resulting in a change of control of the listed company and potentially allowing the non-Nasdaq entity to obtain a Nasdaq listing. The Exchange believes the application of Rule 5110(a), which requires a company to meet the initial listing standards following a business combination with a non-Nasdaq entity resulting in a change of control of the listed company and potentially allowing the non-Nasdaq entity to obtain a Nasdaq listing, will help to ensure that companies that would not otherwise qualify for original listing on the Exchange could not list, for example, by merging with a listed company. Taken as a whole, Nasdaq believes that these standards should help ensure that a sufficient market, with adequate depth and liquidity, exists for the continued listing of Subscription Receipts and are similar to the continued listing standards for other securities that have similar characteristics.
Nasdaq also notes that once the Specified Acquisition has occurred and a Subscription Receipt is converted to common stock, that common stock is subject to the continued listing requirements for such common stock under Rules 5450 or 5550, as applicable. In addition to the quantitative listing requirements proposed for Subscription Receipts, the proposed initial and continued listing standards also include additional protections for Subscription Receipt holders. For example, the issuer of Subscription Receipts must be a Nasdaq-listed company that is not currently non-compliant with any applicable continued listing standard and must continue to be listed on the Exchange throughout the time the Subscription Receipts are traded on the Exchange. The proposed rules also provide that whenever Nasdaq halts trading in a security of a listed company pending dissemination of material news or implements any other required regulatory trading halt, Nasdaq will also halt trading in any listed Subscription Receipt that is exchangeable by its terms into the common stock of such company.
Nasdaq believes that these additional requirements should protect investors and the public interest, consistent with Section 6(b)(5) of the Act, by assuring that information with respect to the listed company issuing the Subscription Receipts is publicly available and that the issuing company is meeting all continued listing standards, including corporate governance requirements, of the Exchange. In addition, these requirements should help assure that the Exchange has a listing relationship with, and direct access to information from, the issuer of the Subscription Receipts. Among other things, this direct relationship the Exchange has with the listed company issuing the Subscription Receipts will help to ensure that the Exchange will receive information in a timely manner to halt trading in the Subscription Receipts when there is a material news, or other regulatory, trading halt imposed on the common stock, and other securities, of the listed company.
There are additional protections for investors in the proposed standards. These include that all the proceeds of the Subscription Receipts offering must be designated solely for use in connection with the consummation of a Specified Acquisition pursuant to a definitive acquisition agreement, the material terms of which would be subject to disclosure. Additionally, the proceeds of the Subscription Receipts offering must also be held in an interest-bearing custody account by an independent custodian and holders will promptly redeem the Subscription Receipts for cash, equal to the holder's proportionate share of the funds in the custody account plus any interest earned, at any time the Specified Acquisition is terminated or if the Specified Acquisition does not close within twelve months from the date of issuance of the Subscription Receipts (or such earlier time as specified in the operative agreements). If the Specified Acquisition is consummated, the holders of the Subscription Receipts will receive the shares of common stock for which their Subscription Receipts are exchangeable. Finally, the listing standards specifically state and remind issuers that the sale of Subscription Receipts and the issuance of the common stock of the issuer in exchange for the Subscription Receipts must both be registered under the Securities Act of 1933. This is important because shareholders, at the time they purchase a Subscription Receipt, are making an investment decision to also purchase the common stock of the merged listed company should the Specified Acquisition be consummated within twelve months or such shorter specified time period. Therefore, it is important to have registration and disclosure under the Securities Act of both the Subscription Receipt and the related common stock. Based on the above, Nasdaq believes that specifically setting forth the Securities Act registration requirements in its rules for listing Subscription Receipts is consistent with the requirements of Section 6(b)(5) of the Act to further investor protection and the public interest.
The Exchange will also monitor activity in Subscription Receipts to identify and deter any potential improper trading activity in such securities and will adopt surveillance procedures, and make any enhancements necessary, to enable it to monitor Subscription Receipts alongside the common equity securities into which they are convertible. Since the Subscription Receipts are related to, and represent an interest in, the common stock of the post-acquisition listed company, this surveillance should help to monitor the trading activity in both the issuer's listed common stock and the Subscription Receipts. Nasdaq believes that these safeguards and standards should help to ensure that the listing, and continued listing, of any Subscription Receipts will be consistent with investor protection, the public
For the above reasons, Nasdaq believes that the proposed initial and continued listing standards are consistent with the Act.
Nasdaq also believes that the proposed fee set forth in Rule 5920 is consistent with Section 6(b)(4) and 6(b)(5) of the Act in that it is designed to provide for the equitable allocation of reasonable dues, fees, and other charges and is not designed to permit unfair discrimination among its members and issuers and other persons using its facilities. Subscription Receipts are designed to be used for the limited purpose of raising capital for an announced merger transaction and by their terms must be redeemed within 12 months if the transaction does not close. While other securities listed on Nasdaq can have short terms, no other security that can be listed on Nasdaq is required, as a condition for listing, to have a term of twelve months from issuance or less. As such, Nasdaq believes it is not unfairly discriminatory under Section 6(b)(5) of the Act as between issuers listing other types of securities, to charge a fee that differs from its fee for other equity securities, which generally have longer terms or no fixed term, and that it is equitable and reasonable under Section 6(b)(4) of the Act to charge a single $25,000 fee, which includes a $5,000 application fee, for the listing of these securities during their lifetime. This fee is also not unfairly discriminatory because the same fee will apply to all issuers seeking to list Subscription Receipts. Further, Nasdaq operates in a competitive environment and its fees are constrained by competition in the marketplace. Other venues currently list Subscription Receipts and if a company believes that Nasdaq's fee is unreasonable it can decide either not to list the Subscription Receipts or to list them on an alternative venue.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The purpose of the proposed rule is to enhance competition by providing issuers and investors with an additional type of listed security that is not currently available on Nasdaq, but that is available on another domestic listing exchange. As such, the Exchange does not believe the proposed rule change imposes any burden on competition but instead will enhance competition.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On January 30, 2018, The Nasdaq Stock Market LLC (“Nasdaq” or the “Exchange”) 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 it appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change so that it has sufficient time to consider the proposed rule change and the comment letters. 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”)
FINRA is proposing to amend FINRA Rule 7620A to modify certain fees applicable to members that use the FINRA/Nasdaq Trade Reporting Facility Carteret (the “FINRA/Nasdaq TRF Carteret”) and the FINRA/Nasdaq Trade Reporting Facility Chicago (the “FINRA/Nasdaq TRF Chicago”) (collectively, the “FINRA/Nasdaq TRFs”).
The text of the proposed rule change is available on FINRA's website at
In its filing with the Commission, FINRA 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. FINRA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The FINRA/Nasdaq TRFs are facilities of FINRA that are operated by Nasdaq, Inc. (“Nasdaq”) and utilize Automated Confirmation Transaction Service technology. In connection with the establishment of the FINRA/Nasdaq TRFs, FINRA and Nasdaq entered into a limited liability company agreement (the “LLC Agreement”). Under the LLC Agreement, FINRA, the “SRO Member,” has sole regulatory responsibility for the FINRA/Nasdaq TRFs. Nasdaq, the “Business Member,” is primarily responsible for the management of the FINRA/Nasdaq TRFs' business affairs, including establishing pricing for use of the FINRA/Nasdaq TRFs, to the extent those affairs are not inconsistent with the regulatory and oversight functions of FINRA. Additionally, the Business Member is obligated to pay the cost of regulation and is entitled to the profits and losses, if any, derived from the operation of the FINRA/Nasdaq TRFs.
Pursuant to the FINRA Rule 7600A Series, participants in the FINRA/Nasdaq TRFs are charged fees and may qualify for fee caps (Rule 7620A) and also may qualify for revenue sharing payments for trade reporting to the FINRA/Nasdaq TRFs (Rule 7610A). These rules are administered by Nasdaq, in its capacity as the Business Member and operator of the FINRA/Nasdaq TRFs on behalf of FINRA,
Pursuant to FINRA Rule 7620A, participants in the FINRA/Nasdaq TRFs are subject to four categories of fees, each of which is applicable to transactions on the three Tapes:
Pursuant to the Rule's Supplementary Material, the “Executing Party (EP)” is defined as the member with the trade reporting obligation under FINRA rules, and the “Contra (CP)” is defined as the member on the contra side of a trade report.
Nasdaq, as the Business Member, has determined to make several adjustments to the schedule of fees and caps that applies to participants in the FINRA/Nasdaq TRFs. As discussed below, the overall aims of the proposed adjustments are to: (1) Align the activity-based fees and cap levels with the rising costs of operating, maintaining, and improving the FINRA/Nasdaq TRF Carteret and, going forward, the FINRA/Nasdaq TRF Chicago; (2) re-calibrate the fee structure so that it provides for a more equitable allocation of fees among Executing Parties and Contra Parties; (3) ensure that all FINRA/Nasdaq TRF participants, regardless of the level of their reporting or contra activity, bear at least some baseline responsibility for the costs of their participation; and (4) clarify the fee structure. Nasdaq also intends for the proposed adjustments to generate profits for itself as the Business Member. FINRA is proposing to amend Rule 7620A accordingly.
Specifically, the proposed rule change would: (1) Raise the threshold daily average number of Media/Executing Party trades that are necessary for a participant to qualify for a fee cap program during a month; (2) lower uncapped monthly charges for reporting Media/Executing Party and Non-Media/Executing Party trades and raise the caps on such fees, if applicable; (3) raise the caps on Media/Contra Party and Non-Media/Contra Party fees, if applicable; (4) raise the level of the cap that applies to ATS market makers; (5) establish a new fee cap program known as the “ATS Market Maker Combined Activity Cap”; (6) establish a new fixed monthly fee known as the “Participation Fee”; and (7) establish a special pricing tier for participants whose trade reporting activity to the FINRA/Nasdaq TRF consists of substantially all retail orders (“Retail Participants”). The proposed rule change also would re-organize the fee schedule and make other clarifying changes to Rule 7620A. Each of these proposals is described in detail below.
The proposed rule change would raise the level of “Cap Qualifying Activity”—
The levels of Cap Qualifying Activity have not increased since they were introduced in 2010,
The proposed rule change would amend the schedule of fees and associated caps for both Media/
Nasdaq has advised that the proposed changes are aimed at rationalizing Media (Non-Media)/Executing Party fee caps with the 47 percent increase in reporting activity to the FINRA/Nasdaq TRFs [sic] and the 16 percent increase in costs associated with the operation of the TRF that have occurred over the past six years. However, Nasdaq also proposes downward adjustments to the uncapped rates for reporting Media/Executing Party trades to dampen the financial impact of the increase in the cap upon participants that will no longer qualify for it under the proposed rule change.
The proposed rule change would raise the caps for both Media/Contra Party and Non-Media/Contra Party trades while keeping the uncapped monthly charge of $0.013 per side the same. For both types of trades, Nasdaq, as the Business Member, has determined to modify the cap formulas so that, instead of being $0.013 × 2,500 × (the number of trading days during the month), the formulas will be $0.013 × 5,000 × (the number of trading days during the month). The rationale for this increase is the same as is described above.
FINRA Rule 7620A provides for a monthly “Media/Contra” fee cap of $5,000 per Tape (A, B or C) that applies to all trades (
Nasdaq, as the Business Member, has determined to modify the Media/Contra Party fee cap program by increasing the maximum monthly per Tape charge applicable to qualifying participants. Specifically, the maximum monthly charge will increase from $5,000 per Tape per month to $10,000 per Tape per month. Nasdaq, as the Business Member, has determined that the existing cap level, which has not changed since it was introduced in 2015, no longer bears a reasonable relationship to the volume of qualifying participant reporting activity that occurs on the FINRA/Nasdaq TRFs [sic]. The volume of market maker Media/Contra Party reports to the FINRA/Nasdaq TRFs [sic] is growing rapidly. From January 2016 through June 2017, the firms that presently qualify for the cap increased their activity on the FINRA/Nasdaq TRF Carteret by 60%. Their activity presently exceeds the minimum qualifying threshold for the cap by more than fourfold.
In addition, the proposed rule change would change the name of this cap to the “ATS Market Maker Media/Contra Party Cap” to more accurately describe the program, add clarity to the fee schedule and avoid potential confusion with the other Media/Contra cap.
Nasdaq, as the Business Member, has determined to establish a new fee cap program, entitled the “ATS Market Maker Combined Media Activity Cap.” The purpose of the proposed cap is to foster new reportable business activities among FINRA members that do not qualify for the existing FINRA/Nasdaq TRFs [sic] fee cap program.
For example, a participant may be a new FINRA member or it may engage in new off-exchange business activities, such as the establishment of a single-dealer platform or an ATS. In the initial stages of these business activities, the participant may not qualify for the existing fee cap programs because the participant may not achieve the requisite daily average number of Media/Executing Party trades during a month or because it may not reliably maintain the requisite volume of Media/Contra Party activity to qualify for the Media/Contra Party cap (which, as noted above, would cap both its Executing Party and Contra Party fees).
The proposed ATS Market Maker Combined Media Activity Cap will provide assistance to such a participant by capping the combined FINRA/Nasdaq TRFs fees (
To qualify for the proposed ATS Market Maker Combined Media Activity Cap, a participant must: (1) Qualify as a market maker on an ATS (as defined below); (2) engage in both Executing Party and Contra Party activities; and (3) average at least 2,500 Media/Executing Party trades in a given Tape per day during a month. If the participant meets this threshold, then the participant will pay for that month, on a per Tape basis, the lesser of $7,500 or the sum of all the participant's combined monthly Executing Party and Contra Party fees for that Tape during the month (as calculated using the regular uncapped Media/Executing Party, Non-Media/Executing Party, Media/Contra Party, and Non-Media/Contra Party rates). If the participant's average daily Media/Executing Party trade reports reach at least 5,000 in a given Tape in a given month, then the participant will no longer qualify for the proposed ATS Market Maker Combined Media Activity
As with the ATS Market Maker Media/Contra Party Cap, a participant qualifies as a market maker on an ATS by maintaining a two-sided quote for each security that the FINRA member maintains interest in within each ATS and by displaying a quotation size of at least one normal unit of trading (specific for each security). Additionally, as with the existing ATS Market Maker Media/Contra Party cap, the participant must attest to its market maker qualifications in writing and must re-certify its qualifications every six months.
Nasdaq, as the Business Member, has determined to assess a new fixed monthly Participation Fee of $350 that will apply to each participant in the FINRA/Nasdaq TRFs.
Nasdaq, as the Business Member, has determined to establish a new pricing program for participants that qualify as “Retail Participants” due to the fact that substantially all of their trade reporting activity to the FINRA/Nasdaq TRFs constitutes “Retail Orders.”
The purpose of this retail pricing program is to help Retail Participants to control their costs associated with reporting trades to the FINRA/Nasdaq TRFs and, in doing so, to limit or reduce any such costs that Retail Participants pass on to their retail customers. Such retail customers generally include individuals who trade less frequently and have fewer trades reported to the FINRA/Nasdaq TRFs than do other categories of customers; therefore, it is fair and reasonable to charge Retail Participants and their customers less than these other categories of participants and customers.
A Retail Participant will be subject to the following fee schedule when it reports trades to the FINRA/Nasdaq TRF. For Media/Executing Party (Non-Media/Executing Party) fees, the monthly charge for a Retail Participant will be $0.018 multiplied by the number of Media/Executing Party (Non-Media/Executing Party) trades that the Retail Participant reports to the FINRA/Nasdaq TRFs during that month. Such fees will be capped for a given month once the Retail Participant reports to the FINRA/Nasdaq TRFs, on average, at least 2,500 Media/Executing Party trades per day in Tapes A, B, or C during that month. If capped for trades in a particular Tape, Media/Executing Party (Non-Media/Executing Party) fees for a Retail participant will equal $0.018 multiplied by 2,500 multiplied by the number of trading days during that month. Additionally, Retail Participants will be exempt from paying the $350 per month Participant Fee.
The foregoing preserves for Retail Participants the existing Media/Executing Party (Non-Media/Executing Party) fee schedules, cap thresholds, and cap formulas. It excludes Retail Participants from the adjustments that Nasdaq, as the Business Member, is otherwise proposing to make to the fee schedules and caps and the addition of the Participant Fee. In other words, the average daily trade threshold for Retail Participants to qualify for the Media/Executing Party (Non-Media/Executing Party) cap will remain at 2,500 Media/Executing Party trade reports and will not rise to 5,000, as it will for other participants. However, Retail Participants also will not be subject to proposed decreases in the $0.018 per trade report fee that other participants will experience.
As to Media/Contra Party (Non-Media/Contra Party) fees, the monthly charge for a Retail Participant will be the same as that which applies to all other participants: $0.013 multiplied by the number of Media/Contra Party (Non-Media/Contra Party) trades that the participant reports to the FINRA/Nasdaq TRFs during the month. However, the threshold for Retail Participants to
To qualify as a Retail Participant and receive pricing under the Retail Participant fee schedule, a participant must complete and submit to Nasdaq, as the Business Member, an application. The application form will require the participant to attest to its qualifications as a Retail Participant on the FINRA/Nasdaq TRFs in which it is a participant and for which it seeks Retail Participant pricing.
Finally, the proposed rule change would clarify and simplify Rule 7620A. Presently, the Rule is complex and potentially confusing as to the requirements for and interaction among the various cap programs. The proposed rule change would add prefatory language to the Rule to explain more clearly how the fees and cap programs work. As discussed above, the proposed rule change would add a title to the schedule of the daily average Media/Executing Party trade reporting activity needed to qualify for a cap—“Cap Qualifying Activity.” In addition, the amended Rule would be reorganized so that its provisions are listed in a more logical order and would segregate Comparison/Accept fees from the other “Standard Fees” (renamed as “Other Fees”). Lastly, as discussed above, the proposed rule change would rename the special Media/Contra cap program that applies only to ATS market makers so that it is more clearly differentiated from the regular Media/Contra Party cap.
FINRA has filed the proposed rule changes for immediate effectiveness. The operative date will be September 1, 2018.
FINRA believes that the proposed rule changes [sic] are consistent with the provisions of Section 15A(b)(5) of the Act,
The proposed rule change is reasonable to: (1) Raise from 2,500 to 5,000 the Cap Qualifying Activity that a participant needs to achieve to qualify for a Media (Non-Media)/Executing Party cap or a Media (Non-Media)/Contra Party cap under Rule 7620A; (2) raise the overall
These proposed increases are also reasonable because they will also help to allocate responsibility for the upkeep of the FINRA/Nasdaq TRFs more equitably among Executing Parties and Contra Parties. Over time, the fee burden associated with the FINRA/Nasdaq TRF Carteret has shifted disproportionately to Contra Parties; the proposed re-allocation will help ensure that Executing Parties pay their fair share of fees.
Nasdaq advises that it expects to earn a profit from the proposed changes, but it believes that such profit represents a reasonable return on its work in support of and investments in the FINRA/Nasdaq TRFs, and that the extent of such profit will be subject to and constrained by competitive pressures. As the Commission has recognized, “[i]f competitive forces are operative, the self-interest of the exchanges themselves will work powerfully to constrain unreasonable or unfair behavior,”
Finally, and except as described below, these proposals to adjust fee levels and fee caps are equitable and not unfairly discriminatory because they will apply to all similarly situated participants.
The establishment of a special schedule of fees and fee caps for “Retail Participants,” for whom the existing system of trade reporting fees, cap thresholds, and cap formulas will continue to apply, is reasonable, equitable, and not unfairly discriminatory. Although the proposed rule change would make a distinction in pricing in favor of Retail Participants and retail investors, the Act only prohibits unfair discrimination. In this instance, FINRA believes that the establishment of a distinct category of Retail Participant pricing is fair because
The proposal to establish a new ATS Market Maker Combined Media Activity Cap is reasonable as a means of fostering the establishment and growth among FINRA members of new businesses that involve reportable activity, such as single-dealer platforms and ATSs. In the early stages of these businesses, participants many not yet qualify for the existing fee cap programs because they may not yet conduct enough business as Executing Parties to qualify for the Media/Executing Party cap or otherwise meet the qualifications for the Media/Contra Party cap. The proposed cap will help these participants to establish and grow their businesses by limiting the fees that they will otherwise incur as they grow.
Furthermore, the proposed ATS Market Maker Combined Media Activity Cap is available to all FINRA members that use the FINRA/Nasdaq TRFs and meet the threshold requirements to qualify for the terms of the fee cap. While only some participants will qualify for the proposed cap and thus see a reduction in their FINRA/Nasdaq TRF trade reporting fees, Nasdaq, as the Business Member, has advised FINRA that the proposed cap is not unfairly discriminatory because the proposed fee cap is targeted to benefit those participants that have a small but growing volume of Executing Party activity on the FINRA/Nasdaq TRFs. Nasdaq advises FINRA that it is not unfairly discriminatory to limit participation to market makers with a daily average number of Media/Executing Party trades of less than 5,000 because participants with at least 5,000 Media/Executing Party trades will be eligible to graduate to the Media/Executing Party Cap.
The proposed establishment of a fixed monthly Participation Fee is a reasonable means of ensuring that all participants in the FINRA/Nasdaq TRFs (other than Retail Participants, as discussed above) bear a share of financial responsibility for funding their use of the Facility, even if the extent of their use is minimal. Indeed, the FINRA/Nasdaq TRFs incur (or, in the case of the FINRA/Nasdaq TRF Chicago, will incur) costs associated with the mere addition and maintenance of participants' accounts that are independent of the participants' usage of those accounts to report trades. FINRA believes that it is equitable and non-discriminatory to assess a Participation Fee to help the FINRA/Nasdaq TRFs to recover these costs from all participants.
Finally, FINRA believes that it is reasonable to reorganize and clarify Rule 7620A so that it is easier to comprehend and presented in a more logical order. The proposal to reorganize and restate the Rule is also equitable and not unfairly discriminatory in that the proposal will apply to all similarly situated participants in the FINRA/Nasdaq TRFs.
FINRA does not believe that the proposed rule changes will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
Nasdaq, as the Business Member and operator of the FINRA/Nasdaq TRFs, collects all fees on behalf of the FINRA/Nasdaq TRFs. As discussed above, Nasdaq has observed an increase in off exchange volumes and the associated cost of operating and improving the FINRA/Nasdaq TRFs, and thus determined to make several adjustments to the schedule of fees and caps to align those with the costs.
As discussed above, pursuant to FINRA Rule 7620A, participants in the FINRA/Nasdaq TRFs [sic] are currently subject to four categories of fees, each of which is applicable to transactions on the three Tapes: (1) Media/Executing Party; (2) Non-Media/Executing Party; (3) Media/Contra Party; (4) and Non-Media/Contra Party. The Rule also provides fee caps for participants for a particular Tape during a given month, separately for Media/Executing Party trades and Media/Contra Party trades.
The proposed rule change entails several changes to the fee and cap structure. The potential marginal impact of each proposed change is discussed below.
Nasdaq has determined to raise the threshold for the “Cap Qualifying Activity”—
Under the proposed calculation for the Media/Executing Party and Non-Media/Executing fee, the cap would effectively increase by approximately 44%, from $990 ($0.018 × 2,500 × 22) to $1,430 ($0.013 × 5,000 × 22), assuming 22 trading days in a month. Based on the reporting activity from the fourth quarter of 2017 and assuming that reporting activity would remain similar, under the proposed increase in fees and the cap, 27 participants would potentially be impacted from such increase in the cap and thus would pay more in reporting fees under the proposed change. Similarly, under the proposed calculation for the Media/Contra Party and Non-Media/Contra Party fee, the cap would increase 100%, from $715 ($0.013 × 2,500 × 22) to $1,430 ($0.013 × 5,000 × 22), again assuming 22 trading days in a month.
An analysis of the participants show [sic] that the firms impacted by the cap qualifier for Media/Executing Party and Non-Media/Executing activity are the same firms who would potentially incur the 100% increase on the Contra Party fees. Under the combined capped activity, the cost increase would be 68%, on average, for the participants who report both Executing Party and Contra Party trades. The proposed increase in the maximum monthly “Media/Contra” fee from $5,000 per Tape per month to $10,000 per Tape per month would potentially impact a few number [sic] of qualifying participants, but could provide savings in the future if they qualify for the ATS Market
The ATS Market Maker Combined Media Activity Cap would initially benefit only a small number of ATSs due to their reporting activity. The reporting fees would potentially decrease by 25%, from $30,000 to $22,500 under the ATS Market Maker Combined Media Activity Cap. However, the fees could potentially decrease by approximately 43% if reporting activity increases.
The proposed participant fee would be assessed on all participants equally and would raise the overall reporting fees by $350 per month regardless of the reporting activity. Retail Participants would be exempt from paying this fee.
The proposed rule change establishes a “Retail Participant Pricing Program” for participants whose trade reporting activity to the FINRA/Nasdaq TRFs constitutes “Retail Orders.” Under the proposed program, reporting activity to be eligible for the cap would be lower compared to that for non-retail participants. Retail Participants would potentially benefit from the proposed program, and incur relatively lower costs, consistent with relatively fewer trades that are considered retail.
FINRA analyzed data provided by Nasdaq that contain fees incurred by 545 participants in the final quarter of 2017, and projected fees that were estimated under the proposed fee and cap schedule assuming that the reporting behavior would be the same under the current and the proposed schedule. On a net basis,
The potential net impact of the proposed rule change depends on whether participants alter their reporting activity across TRFs to be eligible for the fee caps. To the extent that the proposed increases impose a burden on participants, they may choose to shift their reporting to other TRFs. The net impact would also depend on whether the proposed fee caps create an optimal reporting strategy to be eligible for a specific cap to maximize the overall savings for all trade types reported to the FINRA/Nasdaq TRFs.
Investors may also potentially incur costs to the extent that participants choose to pass some or all of the fee increase to their customers.
Finally, FINRA notes that the proposed fee and fee cap changes occur within the context of a competitive environment in which the various trade reporting facilities vie for market share. If any existing or prospective participant in either FINRA/Nasdaq TRF determines that the new fees or fee cap thresholds are too high or are unfavorable relative to fees and fee cap programs applicable to the FINRA/NYSE TRF, such participants may choose to report to the FINRA/NYSE TRF in lieu of the FINRA/Nasdaq TRFs, in which case the FINRA/Nasdaq TRFs will lose market share. Likewise, the FINRA/NYSE TRF is free to adjust its fees and fee cap programs, or to modify its functionality, in response to the changes proposed herein to render them more attractive relative to the FINRA/Nasdaq TRFs. FINRA notes, however, that in certain instances, differences in the relative functionalities among the FINRA/Nasdaq and FINRA/NYSE TRFs may impact participants' decisions to report to the FINRA/NYSE TRF, even if the participants find the FINRA/NYSE TRF fees and fee cap programs to be preferable.
No other alternatives were considered for the proposed rule change.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) 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.
Securities and Exchange Commission.
Notice of meeting of Securities and Exchange Commission Dodd-Frank Investor Advisory Committee.
The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, is providing notice that it will hold a public meeting. The public is invited to submit written statements to the Committee.
The meeting will be held on Thursday, September 13, 2018 from 9:00 a.m. until 3:30 p.m. (ET). Written statements should be received on or before September 13, 2018.
The meeting will be held in Multi-Purpose Room LL-006 at the Commission's headquarters, 100 F Street NE, Washington, DC 20549. The meeting will be webcast on the Commission's website at
Use the Commission's internet submission form (
Send an email message to
Send paper statements to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
Statements also will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Room 1503, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. All statements received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly.
Marc Oorloff Sharma, Chief Counsel, Office of the Investor Advocate, at (202) 551-3302, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
The meeting will be open to the public, except during that portion of the meeting reserved for an administrative work session during lunch. Persons needing special accommodations to take part because of a disability should notify the contact person listed in the section above entitled
The agenda for the meeting includes: remarks from Commissioners; a discussion regarding the U.S. proxy voting infrastructure; a discussion regarding the Commission's Proposed Transaction Fee Pilot in NMS stocks (which may include a recommendation of the Market Structure Subcommittee); a discussion regarding the implications of passive investing; subcommittee reports; and a nonpublic administrative work session during lunch.
Pursuant to the authority vested in the Secretary of State, including under section 7045(b)(6) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2018 (Div. K, Pub. L. 115-141) and Senate Report 115-152, I hereby certify and report that:
(1) the Peace Tribunal and other judicial bodies within the special jurisdiction for peace are independent and have authority to document “truth declarations” from perpetrators of gross violations of human rights and to sentence such perpetrators to meaningful sanctions, including guarantee of non-repetition and deprivation of liberty;
(2) the Government of Colombia is continuing to dismantle illegal armed groups, taking effective steps to protect the rights of human rights defenders, journalists, trade unionists, and other civil society activists, and protecting the rights and territory of indigenous and Afro-Colombian communities; and
(3) military personnel responsible for ordering, committing, or covering up cases of false positives are being prosecuted and appropriately punished, including removal from positions of command.
This Certification shall be published in the
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
The Federal Motor Carrier Safety Administration (FMCSA) announces its decision to grant Traditional Trucking Corporation's (TTC) application for a limited 5-year exemption on behalf of motor carriers operating commercial motor vehicles (CMVs) to allow a Global Positioning System (GPS) device to be mounted on the interior of the windshield of a CMV within the areas allowed for “vehicle safety technology” devices. The Agency has determined that the placement of the GPS device in the windshield area would not have an adverse impact on safety, and that adherence to the terms and conditions of the exemption would achieve a level of safety equivalent to or greater than the level of safety provided by the regulation.
This exemption is effective August 22, 2018 and ending August 22, 2023.
Mr. Luke Loy, Vehicle and Roadside Operations Division, Office of Carrier, Driver, and Vehicle Safety, MC-PSV, (202) 366-0676, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain parts of the Federal Motor Carrier Safety Regulations. FMCSA must publish a notice of each exemption request in the
The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the
TTC applied for an exemption from 49 CFR 393.60(e)(1)(i) to allow a GPS device to be mounted on the interior of the windshield of a CMV within the areas allowed for devices with “vehicle safety technology” as defined in the FMCSRs. A copy of the application in included in the docket referenced at the beginning of this notice.
Section 393.60(e)(1)(i) of the FMCSRs prohibits the obstruction of the driver's field of view by devices mounted on the interior of the windshield. Antennas and similar devices must not be mounted more than 152 mm (6 inches) below the upper edge of the windshield, and outside the driver's sight lines to the road and highway signs and signals. Section 393.60(e)(1)(i) does not apply to vehicle safety technologies, as defined in 49 CFR 390.5, including a “a fleet-related incident management system, performance or behavior management system, speed management system, lane departure warning system, forward collision warning or mitigation system, active cruise control system, and transponder.” Section 393.60(e)(1)(ii) requires devices with vehicle safety technologies to be mounted (1) not more than 100 mm (4 inches) below the upper edge of the area swept by the windshield wipers, or (2) not more than 175 mm (7 inches) above the lower edge of the area swept by the windshield wipers, and outside the driver's sight lines to the road and highway signs and signals. GPS is not a “vehicle safety technology” under the definition in the regulation, and, as such, GPS devices are not permitted to be mounted on the interior of the windshield and within the area swept by the windshield wipers TTC's application stated:
The exemption is necessary because the dash is not suitable for mounting the fixture to hold the GPS unit, and the location of the GPS unit (if mounted on the top of the dash) is in the same location as currently allowed for “vehicle safety technologies” mounted on the windshield. The GPS fixture cannot be mounted to the “face” of the control panel as that area is covered with controls and displays necessary for the operation of the commercial vehicle . . .
We do not believe that there will be any potential impacts to safety due to the requested temporary exemption. The size of GPS units is approximately the same size as the currently allowed “vehicle safety technologies” and the current location is much lower within the CMV which takes the driver's eyes farther from the road to determine his/her vehicle's correct lane, bridge height, speed, etc. The current allowed location is a more unsafe operating condition.
The exemption would be for any carrier who wishes to mount a GPS device on the windshield within the area defined for “vehicle safety technology”—not more than 4 inches below the upper edge of the windshield wipers, and not more than 7 inches above the lower edge of the area swept by the windshield wipers and outside the driver's sight lines to the road and highway signs and signals. This would yield an equivalent level of safety for GPS devices as compared to those “vehicle safety technologies,” and it would be a potentially safer location than lower in the CMV where the driver must take his/her eyes off the road to look at the location of his CMV on the GPS device. Back in August of 2016, in the BASIC SMS, our Unsafe-driving category was in the cautionary status. Only one of the violations was not due to speeding; all of those with violations said it was due to a speed limit change and they were keeping with what they thought was the speed limit. GPS systems display the posted speed limit and flash in red when they are traveling above the posted speed limit.
The exemption would apply to all CMV operators driving vehicles with GPS devices. TTC believes that the exemption will maintain a level of safety that is equivalent to, or greater than, the level of safety achieved without the exemption because the GPS device is approximately the same size as vehicle safety technology devices, and the current compliant mounting location is much lower in the vehicle which causes the driver to look away from the road to view the GPS device.
FMCSA published a notice of the application in the
The FMCSA has evaluated the TTC exemption application, and the comments received. The Agency believes that granting the temporary exemption to allow the placement of GPS devices in the same location permitted for vehicle safety technologies as identified in Section 393.60(e)(1)(ii), “mounted (1) not more than 100 mm (4 inches) below the upper edge of the area swept by the windshield wipers; or (2)
This action is consistent with previous Agency action permitting the placement of vehicle safety technologies on CMVs outside the driver's sight lines to the road and highway signs and signals. FMCSA is not aware of any evidence showing that the installation of other vehicle safety technologies mounted on the interior of the windshield has resulted in any degradation in safety.
Section 392.80 of the FMCSRs prohibits (a) drivers from engaging in texting while driving, and (b) motor carriers from allowing or requiring its drivers to engage in texting while driving. The term “texting” is defined in section 390.5 of the FMCSRs as “manually entering alphanumeric text into, or reading text from an electronic device,” and includes, but is not limited to, “short message service, emailing, instant messaging, a command or request to access a World Wide web page, pressing more than a single button to initiate or terminate a voice communication using a mobile telephone, or engaging in any other form of electronic text retrieval or entry, for present or future communication.” While the definition of “texting” in section 390.5 of the FMCSRs expressly excludes “Inputting, selecting, or reading information on a global positioning system or navigation system,” FMCSA strongly encourages CMV drivers utilizing GPS devices under this temporary exemption to minimize/avoid possible distraction associated with using these devices by (1) programming the device before starting to drive, (2) stopping to reprogram the device if necessary, and (3) enabling the voice command on the device (instead of muting it) to help avoid glancing at the device display.
The Agency hereby grants the exemption for a 5-year period, beginning August 22, 2018 and ending August 22, 2023. During the temporary exemption period, motor carriers will be allowed to operate CMVs equipped with GPS devices mounted (1) not more than 100 mm (4 inches) below the upper edge of the area swept by the windshield wipers; or (2) not more than 175 mm (7 inches) above the lower edge of the area swept by the windshield wipers; and (3) outside the driver's sight lines to the road and highway signs and signals.
The exemption will be valid for 5 years unless rescinded earlier by FMCSA. The exemption will be rescinded if: (1) Motor carriers and/or commercial motor vehicles fail to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b).
Interested parties possessing information that would demonstrate that motor carriers operating GPS devices mounted on the windshield in the same location as vehicle safety technologies are not achieving the requisite statutory level of safety should immediately notify FMCSA. The Agency will evaluate any such information and, if safety is being compromised or if the continuation of the exemption is not consistent with 49 U.S.C. 31136(e) and 31315(b), will take immediate steps to revoke the exemption.
In accordance with 49 U.S.C. 31313(d), as implemented by 49 CFR 381.600, during the period this exemption is in effect, no State shall enforce any law or regulation applicable to interstate commerce that conflicts with or is inconsistent with this exemption with respect to a firm or person operating under the exemption. States may, but are not required to, adopt the same exemption with respect to operations in intrastate commerce.
National Highway Traffic Safety Administration (NHTSA), U.S. Department of Transportation (DOT).
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Request (ICR) below is being forwarded to the Office of Management and Budget (OMB) for review and comments. A
Comments must be submitted on or before September 21, 2018.
Send comments regarding the burden estimate, including suggestions for reducing the burden, to the Office of Management and Budget, Attention: Desk Officer for the Office of the Secretary of Transportation, 725 17th Street NW, Washington, DC 20503.
Mr. Robert Mazurowski, Office of Crashworthiness Standards, NRM-130, 202-366-1012, National Highway Traffic Safety Administration, Room W43-445, Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590. Please identify the relevant collection of information by referring to its OMB Control Number.
Before a Federal agency can collect certain information from the public, it must receive approval from the OMB. In compliance with those requirements, this notice announces that the following information collection request has been forwarded to OMB.
Federal Motor Vehicle Safety Standard (FMVSS) No. 218, “Motorcycle helmets,” requires that each helmet shall be labeled permanently and legibly in a manner such that the label(s) can be read easily without removing padding or any other permanent part. This collection pertains to the labeling requirements in FMVSS No. 218.
NHTSA published a
The Governors Highway Safety Association (GHSA) expressed its support for strong motorcycle helmet labeling requirements, and submitted information about motorcycle safety. GHSA commented that this information collection was “atypical” in their view. GHSA explained that typically ICRs involved the collection or submission of information directly to the agency and that while NHTSA spot checks the performance of motorcycle helmets through a compliance program, the content of the label is more for the benefit of consumers and law enforcement.
GHSA is correct that a common type of information collection under the Paperwork Reduction Act (PRA) occurs when an agency directly collects information from the public. However, a collection of information, as defined by the PRA, means “the obtaining, causing to be obtained, soliciting, or requiring the disclosure to third parties or the public, of facts or opinions by or for an agency, regardless of form or format . . .”
The following describes the collection of information for which NHTSA intends to seek OMB approval. It is titled “Motorcycle Helmets (Labeling),” OMB Control Number: 2127-0518. NHTSA's existing collection for FMVSS No. 218 expired during the 60 day notice comment period, therefore the agency has amended the type of request to be a reinstatement of a previously approved collection.
Using this authority, the agency issued the initial FMVSS No. 218 in 1974. Motorcycle helmets are devices used to protect motorcyclists from head injury in motor vehicle crashes. FMVSS No. 218 S5.6 requires that each helmet shall be labeled permanently and legibly in a manner such that the label(s) can be read easily without removing padding or any other permanent part.
The 45 respondents (helmet manufacturers) produce a total of 3,250,000 annual responses. A manufacturer spends approximately 0.0028 hours per response. The estimated annual number of burden hours for helmet manufacturers is 9,100 burden hours per year (3,250,000 × 0.028 hours). Using a total labeling cost of $0.40, the estimated total annual burden cost is $1,300,000 (3,250,000 × $0.40).
Financial Crimes Enforcement Network (“FinCEN”), U.S. Department of the Treasury.
Notice and request for comments.
FinCEN invites comment on the renewal of information collections in existing regulations requiring records concerning owners of foreign banks and agents of foreign banks for service of legal process.
Written comments are welcome and must be received on or before October 22, 2018.
Comments may be submitted by any of the following methods:
•
•
Please submit comments by one method only. Comments will also be incorporated to FinCEN's retrospective regulatory review process, as mandated by E.O. 12866 and 13563. All comments submitted in response to this notice will become a matter of public record. Therefore, you should submit only information that you wish to make publicly available.
The FinCEN Resource Center at 800-767-2825 or electronically at
The Bank Secrecy Act (“BSA”), Titles I and II of Public Law 91-508, as amended, codified at 12 U.S.C. 1829(b), 12 U.S.C. 1951-1959, and 31 U.S.C.
Regulations implementing Title II of the BSA appear at 31 CFR Chapter X. The authority of the Secretary of the Treasury to administer Title II of the BSA has been delegated to the Director of FinCEN. The information collected and retained under the regulation addressed in this notice assists Federal, state, and local law enforcement as well as regulatory authorities in the identification, investigation and prosecution of money laundering and other matters.
This request for comments is being made pursuant to the Paperwork Reduction Act (“PRA”) of 1995, Public Law 104-13, 44 U.S.C. 3506(c)(2)(A). In accordance with the requirements of the PRA and its implementing regulations, the following information is presented concerning the information collection below.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Records required to be retained under the BSA must be retained for five years. Generally, information collected pursuant to the BSA is confidential, but may be shared as provided by law with regulatory and law enforcement authorities.
Financial Crimes Enforcement Network (“FinCEN”), U.S. Department of the Treasury.
Notice and request for comments.
FinCEN invites comment on the renewal of an information collection requirement for the recordkeeping and reporting of suspicious activities by brokers or dealers in securities and futures commission merchants and introducing brokers in commodities.
Written comments are welcome and must be received on or before October 22, 2018.
Comments may be submitted by any of the following methods:
•
•
Please submit comments by one method only. Comments will also be incorporated to FinCEN's retrospective regulatory review process, as mandated by E.O. 12866 and 13563. All comments submitted in response to this notice will become a matter of public record. Therefore, you should submit only information that you wish to make publicly available.
The FinCEN Resource Center at 800-767-2825 or electronically at
The Bank Secrecy Act (“BSA”), Titles I and II of Public Law 91-508, as amended, codified at 12 U.S.C. 1829(b), 12 U.S.C. 1951-1959, and 31 U.S.C.
Regulations implementing Title II of the BSA appear at 31 CFR Chapter X. The authority of the Secretary of the Treasury to administer Title II of the BSA has been delegated to the Director of FinCEN. The information collected and retained under the regulation addressed in this notice assist Federal, state, and local law enforcement as well as regulatory authorities in the identification, investigation and prosecution of money laundering and other matters.
The Bank Secrecy Act Suspicious Activity Report, (“BSAR”) is used by these entities to report suspicious activity to FinCEN. This request for comments also covers 31 CFR 1023.320 and 31 CFR 1026.320, and is being made pursuant to the Paperwork Reduction Act (“PRA”) of 1995.
In accordance with the requirements of the PRA and its implementing regulations, the following information is presented concerning the information collection below.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Records required to be retained under the BSA must be retained for five years. Generally, information collected pursuant to the BSA is confidential, but may be shared as provided by law with regulatory and law enforcement authorities.
Financial Crimes Enforcement Network (“FinCEN”), U.S. Department of the Treasury.
Notice and request for comments.
FinCEN invites comment on the renewal of information collections in existing regulations requiring money services businesses (“MSBs”), mutual funds, and operators of credit card systems to develop and implement written anti-money laundering programs reasonably designed to prevent those financial institutions from being used to facilitate money laundering and the financing of terrorist activities. This request for comments is being made pursuant to the Paperwork Reduction Act (“PRA”) of 1995, Public Law 104-13, 44 U.S.C. 3506(c)(2)(A).
Written comments are welcome and must be received on or before October 22, 2018.
Comments may be submitted by any of the following methods:
•
•
Please submit comments by one method only. Comments will also be incorporated to FinCEN's retrospective regulatory review process, as mandated by E.O. 12866 and 13563. All comments submitted in response to this notice will become a matter of public record. Therefore, you should submit only information that you wish to make publicly available.
The FinCEN Resource Center at 800-767-2825 or electronically at
The Bank Secrecy Act (“BSA”), Titles I and II of Public Law 91-508, as amended, codified at 12 U.S.C. 1829(b), 12 U.S.C. 1951-1959, and 31 U.S.C.
Regulations implementing Title II of the BSA appear at 31 CFR Chapter X. The authority of the Secretary of the Treasury to administer Title II of the BSA has been delegated to the Director of FinCEN. The information collected and retained under the regulation addressed in this notice assist federal, state, and local law enforcement as well as regulatory authorities in the identification, investigation and prosecution of money laundering and other matters.
In accordance with the requirements of the PRA and its implementing regulations, the following information is presented concerning the information collection below.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Records required to be retained under
Internal Revenue Service (IRS), Treasury.
Notice of meeting; correction.
In the
The meeting will be held Wednesday, September 19, 2018.
Matthew O'Sullivan at 1-888-912-1227 or (510) 907-5274.
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that a meeting of the Taxpayer Advocacy Panel Special Projects Committee will be held Wednesday, September 19, 2018, at 2:00 p.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Matthew O'Sullivan. For more information please contact Matthew O'Sullivan at 1-888-912-1227 or (510) 907-5274, or write TAP Office, 1301 Clay Street, Oakland, CA 94612-5217 or contact us at the website:
The agenda will include a discussion on various special topics with IRS processes.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and continuing information collections, as required by the Paperwork Reduction Act of 1995 (PRA). This notice requests comments on all forms used by tax-exempt organizations:
• 990, 990(BR), 990 EZ SCH B (BR), 990-EZ SCH L (LP), 990-EZ, 990-PF, 990-SCH B, 990-C, 990-EZ, 990-EZ (BR), 990-N, OR 990-EZ (SCH A), 990-EZ (SCH C), 990-EZ (SCH E), 990-EZ (SCH G), 990-EZ (SCH L), 990-EZ (SCH N), 990-EZ (SCH N-1), 990-EZ (SCH O), 990-EZ(SCH O)(BR), 990-PF. 990-PF (BR), 990-SCH A (BR), 990-SCH D, 990-SCH D (BR), 990-SCH F, 990-SCH F-1, 990-SCH H, 990-SCH I, 990-SCH I (BR), 990-SCH I-1, 990-SCH J, 990-SCH J (BR), 990-SCH J-1, 990-SCH J-2, 990-SCH K, 990-SCH M, 990-SCH R, 990-SCH R (BR), 990-SCH R-1, 990-T, 990-T SCH M, 990-T (BR), 990-W, 1023, 990-(BR), 990-I, 1024, 1028, 1028-BR, 5578, 5884 C, 8038, 8038 B, 8038 CP, 8030 G, 8038 GC, 8038 R, 8038 T, 8038 TC, 8282, 8328, 8453-E.O., 8453-X, 8718, 8868, 8868-(BR), 8870, 8871, 8872, 8879-E.O., 8886-T, 8899 and all attachments to these forms (see the Appendix A to this notice). With this notice, the IRS is also announcing significant changes to (1) the manner in which tax forms used by tax-exempt organizations will be approved under the PRA and (2) its method of estimating the paperwork burden imposed on all tax-exempt organizations.
Written comments should be received on or before October 22, 2018 to be assured of consideration.
Direct all written comments to Laurie Brimmer, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Elaine Christophe, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet, at
Under the PRA, OMB assigns a control number to each “collection of information” that it reviews and approves for use by an agency. A single information collection may consist of one or more forms, recordkeeping requirements, and/or third-party disclosure requirements. Under the PRA and OMB regulations, agencies have the discretion to seek separate OMB approvals for forms, recordkeeping requirements, and third-party reporting requirements or to combine any number of forms, recordkeeping requirements, and/or third-party disclosure requirements (usually related in subject matter) under one OMB Control Number. Agency decisions on whether to group individual requirements under a single OMB Control Number or to disaggregate them and request separate OMB Control Numbers are based largely on considerations of administrative practicality.
The PRA also requires agencies to estimate the burden for each collection of information. Accordingly, each OMB Control Number has an associated burden estimate. The burden estimates for each control number are displayed in (1) the PRA notices that accompany collections of information, (2)
As described below under the heading “Taxpayer Burden Model,” the IRS's Taxpayer Burden Model (TBM) estimates of taxpayer burden are based on taxpayer characteristics and activities, taking into account, among other things, the forms and schedules used by these taxpayers and the recordkeeping and other activities needed to complete those forms. The expansion of the TBM to calculate the burden estimate for tax-exempt organizations represents the third phase of a long-term effort to improve the ability of IRS to measure the burden imposed on all groups of taxpayers by the federal tax system. While the TBM methodology provides a more accurate and comprehensive estimate of tax-exempt organization burden, it will not provide burden estimates on a form-by-form basis, as has been done under the previous methodology. When the prior model was developed in the mid-1980s, almost all tax returns were prepared manually, either by the taxpayer or a paid provider. In this context, it was determined that estimating burden on a form-by-form basis was an appropriate methodology. Today, over 90 percent of all tax-exempt organization tax returns are prepared using software or with preparer assistance. In this environment, a taxpayer-centric view of the tax compliance burden is more relevant.
Currently, there are 58 forms used primarily by tax-exempt organizations. These include Forms 990, 990(BR), 990 EZ SCH B (BR), 990-EZ SCH L (LP), 990-EZ, 990-PF, 990-SCH B, 990-C, 990-EZ, 990-EZ (BR), 990-N, OR 990-EZ (SCH A), 990-EZ (SCH C), 990-EZ (SCH E), 990-EZ (SCH G), 990-EZ (SCH L), 990-EZ (SCH N), 990-EZ (SCH N-1), 990-EZ (SCH O), 990-EZ(SCH O)(BR), 990-PF. 990-PF (BR), 990-SCH A (BR), 990-SCH D, 990-SCH D (BR), 990-SCH F, 990-SCH F-1, 990-SCH H, 990-SCH I, 990-SCH I (BR), 990-SCH I-1, 990-SCH J, 990-SCH J (BR), 990-SCH J-1, 990-SCH J-2, 990-SCH K, 990-SCH M, 990-SCH R, 990-SCH R (BR), 990-SCH R-1, 990-T, 990-T SCH M 990-T (BR), 990-W, 1023, 990- (BR), 990-I, 1024, 1028, 1028-BR, 5578, 5884 C, 8038, 8038 B, 8038 CP, 8030 G, 8038 GC, 8038 R, 8038 T 8038 TC, 8328 8718 8282 8453-E.O., 8453-X, 8868, 8868-(BR), 8870 8871, 8872, 8879-E.O., 8886-T, 8899 and their schedules and all the forms tax-exempt organizations attach to their tax returns (see the Appendix A to this notice). For most of these forms, IRS has in the past obtained separate OMB approvals under unique OMB Control Numbers and separate burden estimates.
The TBM estimates the aggregate burden imposed on tax-exempt organizations based upon their tax-related characteristics and activities. IRS therefore will seek OMB approval of all 58-tax-exempt organization-related tax forms as a single “collection of information.” The aggregate burden of these tax forms will be accounted for under OMB Control Number 1545-0047, which is currently assigned to Form 990 and its schedules. OMB Control Number 1545-0047 will be displayed on all tax-exempt organization tax forms and other information collections. As a result of this change, burden estimates for tax-exempt organizations will now be displayed differently in PRA Notices on tax forms and other information collections, and in
That Taxpayer Burden Model method of burden estimation replaces the Arthur D. Little (ADL) legacy burden model developed in the mid-1980s. Since the 1980s, improved technology and modeling sophistication have enabled the IRS to improve the burden estimates. The TBM provides taxpayers and the IRS with a more comprehensive understanding of the current levels of taxpayer burden. It reflects major changes over the past three decades in the way taxpayers prepare and file their returns. The TBM also represents a substantial step forward in the IRS's ability to assess likely impacts of administrative and legislative changes on tax compliance burden.
The TBM's approach to estimating tax compliance burden focuses on the characteristics and activities of taxpayers. Key determinants of tax compliance burden in the model are the type of entity, total assets, total receipts, and activities reported on the tax return (income, deductions, credits, etc.). In contrast, the previous estimates primarily focused on the length and complexity of each tax form. The changes between the ADL model estimates and the TBM estimates are due to the improved ability of the TBM to estimate burden and the expanded scope of what is included in the TBM. The transition to the TBM burden estimation methodology will create a one-time change in the estimate of burden levels that reflects the improved estimation methodology of the TBM. The differences in estimates between the models do not reflect any change in the actual burden experienced by taxpayers. Comparisons should not be made between these and the earlier published estimates, because the models measure burden in different ways.
Burden is defined as the time and out-of-pocket costs incurred by taxpayers to comply with the federal tax system. As has been done for individual taxpayer burden since 2005 and business entities since 2015, both the time expended and
For more information about tax compliance burden and the TBM, go to the article “Tax Compliance Burden” posted on the IRS website at
The estimates are subject to change as new forms and data become available.
Amounts below are for FY2018. Reported time and cost burdens are national averages and do not necessarily reflect a “typical” case. Most taxpayers experience lower than average burden, with taxpayer burden varying considerably by taxpayer type. Detail may not add due to rounding.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB Control Number.
Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Summary presentation of final rules.
This document summarizes the Federal Acquisition Regulation (FAR) rules agreed to by the Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) in this Federal Acquisition Circular (FAC) 2005-100. A companion document, the
For effective dates see the separate documents, which follow.
The analyst whose name appears in the table below in relation to the FAR case. Please cite FAC 2005-100 and the specific FAR case number. For information pertaining to status or publication schedules, contact the Regulatory Secretariat Division at 202-501-4755.
Summaries for each FAR rule follow. For the actual revisions and/or amendments made by these rules, refer to the specific item numbers and subjects set forth in the documents following these item summaries. FAC 2005-100 amends the FAR as follows:
DoD, GSA, and NASA are converting to a final rule, without change, an interim rule that amended the Federal Acquisition Regulation (FAR) to implement Executive Order (E.O.) 13706 and a Department of Labor final rule issued on September 30, 2016, both entitled Establishing Paid Sick Leave for Federal Contractors. The rule requires contractors to allow all employees performing work on or in connection with a contract covered by the E.O. to accrue and use paid sick leave in accordance with E.O. 13706 and 29 CFR part 13. Contracting officers will include a clause in covered contracts. This FAR rule neither increases nor decreases the cost of the interim rule (81 FR 91627), which has been in effect since January 1, 2017.
DoD, GSA, and NASA are converting to a final rule, without change, an interim rule that amended the Federal Acquisition Regulation (FAR) to implement Executive Order (E.O.) 13665, Non-Retaliation for Disclosure of Compensation Information. E.O. 13665, signed April 8, 2014, amended E.O. 11246, Equal Opportunity in Federal Employment. The interim FAR rule also implemented a final rule issued by the Office of Federal Contract Compliance Programs (OFCCP) of the Department of Labor, entitled Government Contractors, Prohibitions Against Pay Secrecy Policies and Actions, which was published on September 11, 2015.
E.O. 11246, originally issued September 24, 1965, establishes nondiscrimination and affirmative action obligations in employment for Federal contractors and subcontractors. It prohibits employment discrimination because of race, color, religion, sex, sexual orientation, gender identity, and national origin. E.O. 13665 amends E.O. 11246 and its Equal Opportunity Clause by incorporating, as a covered prohibition, discriminating against employees and job applicants who inquire about, discuss, or disclose the compensation of the employee or applicant or another employee or applicant. Federal contractors and subcontractors must disseminate this nondiscrimination provision, using language prescribed by the Director of OFCCP, including incorporating the provision into existing employee manuals or handbooks and posting it. There is no significant impact on small entities imposed by the FAR rule.
Editorial changes and updates to web links are made at FAR 2.101, 4.1603, 4.1702, 5.102, 5.201, 5.207, 5.704, 5.705, 6.305, 7.103, 7.105, 7.107-4, 8.405-6, 8.501, 8.602, 9.406-3, 9.407-3, 14.201-2, 16.505, 17.502-1, 18.205, 19.704, 19.1503, 22.001, 22.404-3, 22.1001, 22.1021, 22.1022, 22.1304, 23.202, 23.203, 23.205, 23.401, 23.405, 23.802, 25.003, 25.703-2, 28.106-1, 28.106-3, 28.203-3, 28.204-3, 31.205-6, 36.104, 36.700, 41.301, 49.602, 52.208-8, 52.212-1, 52.212-3, 52.212-5, 52.213-4, 52.219-9, 52.222-6, 52.222-8, 52.222-30, 52.222-31, 52.222-32, 52.222-41, 52.222-43, 52.223-17, 52.225-5, 52.225-18, 52.225-25, 52.228-11, 52.243-1, 52.244-6, 53.000, 53.102, 53.209-1, 53.228, 53.249 and subpart 53.3.
Federal Acquisition Circular (FAC) 2005-100 is issued under the authority of the Secretary of Defense, the Administrator of General Services, and the Administrator for the National Aeronautics and Space Administration.
Unless otherwise specified, all Federal Acquisition Regulation (FAR) and other directive material contained in FAC 2005-100 is effective August 22, 2018.
Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Final rule.
DoD, GSA, and NASA are adopting as final, without change, an interim rule amending the Federal Acquisition Regulation (FAR) to implement the Executive Order (E.O.), Establishing Paid Sick Leave for Federal Contractors. The interim rule also implemented a final rule issued by the Department of Labor.
Ms. Zenaida Delgado, Procurement Analyst, at 202-969-7207 for clarification of content. For information pertaining to status or publication schedules, contact the Regulatory Secretariat Division at 202-501-4755. Please cite FAC 2005-100, FAR Case 2017-001.
DoD, GSA, and NASA published an interim rule in the
The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (the Councils) reviewed the comments in the development of the final rule. A discussion of the comments is provided as follows:
There are no changes to the interim rule.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563, Improving Regulation and Regulatory Review, emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
This rule is not subject to E.O. 13771, Reducing Regulation and Controlling Regulatory Costs, because this rule is not a significant regulatory action under E.O. 12866.
DoD, GSA, and NASA have prepared a Final Regulatory Flexibility Analysis (FRFA) consistent with the Regulatory Flexibility Act, 5 U.S.C. 601
DoD, GSA, and NASA are converting to a final rule, without change, an interim rule that amended the Federal Acquisition Regulation (FAR) to implement Executive Order (E.O.) 13706, Establishing Paid Sick Leave for Federal Contractors, dated September 7, 2015, and associated Department of Labor (DOL) regulatory requirements at 29 CFR part 13. DOL published a final regulatory flexibility analysis in their final rule (81 FR 67598 at 67703).
The FAR rule established requirements for contractors under contracts containing the clauses at FAR 52.222-6, Construction Wage Rate Requirements, or FAR 52.222-41, Service Contract Labor Standards,
No public comments were received in response to the initial regulatory flexibility analysis.
This rule applies to contracts and subcontracts at all tiers covered by the Service Contract Labor Standards statute, or the Wage Rate Requirements (Construction) statute, which require performance in whole or in part within the United States. For procurement contracts where employees' wages are governed by the Fair Labor
The DOL final rule identifies records to be kept by all firms, including small entities (29 CFR 13.25). Some records are already required under the Fair Labor Standards Act, Service Contract Labor Standards statute, the Wage Rate Requirements (Construction) statute, and their governing regulations. DOL noted in their final rule (81 FR 67598 at 67669) that OMB assigned control number 1235-0029 for the recordkeeping requirements related to paid sick leave. The information collection requirement under 1235-0029 includes recordkeeping and regulatory familiarization.
Regarding initial implementation, DOL assumed firms that need to create a sick leave policy will each spend 10 hours of time developing this policy, regardless of the number of employees, and firms with a program in place will spend one hour, regardless of the number of employees. DOL also stated in its final rule that “Transfers from small contractors and costs to small contractors in Year 1 are less than 0.02 percent of revenues on average and are no more than 0.17 percent in any industry”. Therefore, according to DOL its final rule would not have a significant impact on small businesses. This FAR rule finalizes the interim rule without change and neither increases nor decreases the cost of the interim rule (81 FR 91627), which has been in effect since January 1, 2017.
There are no known significant alternatives to the rule that would accomplish the stated objectives of the E.O. and DOL regulation. In its final rule, DOL introduced several changes and clarifications that may ease the compliance burden. For instance, DOL provided greater detail and clarity about how companies with paid time off policies can use those policies to satisfy their obligations under the E.O. In addition, if a collective bargaining agreement (CBA) ratified before September 30, 2016, applies to an employee's work performed on or in connection with a covered contract and provides at least 56 hours of paid sick time each year, the employee will be exempted from the requirements of the E.O. and 29 CFR part 13 until CBA termination or January 1, 2020, whichever is earlier.
The rule was also modified to allow employers to meet the requirements of this rule through multiemployer plans or other funds, plans, or programs. This may ease the burden for those employers in industries with transitory or mobile workforces.
Interested parties may obtain a copy of the FRFA from the Regulatory Secretariat Division. The Regulatory Secretariat Division has submitted a copy of the FRFA to the Chief Counsel for Advocacy of the Small Business Administration.
The Paperwork Reduction Act (44 U.S.C. Chapter 35) applies. However, the information collection requirements to the paperwork burden were previously approved for the DOL regulations under OMB Control Numbers 1235-0018, Records to be kept by Employers—Fair Labor Standards Act, 1235-0021, Employment Information Form, and 1235-0029, Government Contractor Paid Sick Leave.
Government procurement.
Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Final rule.
DoD, GSA, and NASA adopted as final, without change, an interim rule amending the Federal Acquisition Regulation (FAR) to implement Executive Order (E.O.), Non-Retaliation for Disclosure of Compensation Information. The interim rule also implemented a final rule issued by the Department of Labor.
Ms. Zenaida Delgado, Procurement Analyst, at 202-969-7207 for clarification of content. For information pertaining to status or publication schedules, contact the Regulatory Secretariat Division at 202-501-4755. Please cite FAC 2005-100, FAR Case 2016-007.
DoD, GSA, and NASA published an interim rule in the
The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (the Councils) reviewed the public comments in the development of the final rule. A discussion of the comments is provided as follows:
There are no changes to the interim rule.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563, Improving Regulation and Regulatory Review, emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
This rule is not subject to E.O. 13771, Reducing Regulation and Controlling Regulatory Costs, because this rule is not a significant regulatory action under E.O. 12866.
DoD, GSA, and NASA have prepared a Final Regulatory Flexibility Analysis (FRFA) consistent with the Regulatory Flexibility Act, 5 U.S.C. 601
DoD, GSA, and NASA are converting to a final rule, without change, an interim rule that amended the Federal Acquisition Regulation (FAR) to implement Executive Order (E.O.) 13665, Non-Retaliation for Disclosure of Compensation Information. E.O. 13665 amended E.O. 11246, Equal Opportunity in Federal Employment. The interim rule also implemented a final rule issued by the Department of Labor (DOL) at 41 CFR part 60-1, published in the
The objective of this rule is to provide for a uniform policy for the Federal Government to prohibit Federal contractors from discriminating against employees and job applicants who inquire about, discuss, or disclose their own compensation or the compensation of other employees or applicants.
No public comments were received in response to the initial regulatory flexibility analysis.
The rule will apply to all entities, both small and other than small. Based on the most current System for Award Management data available, defining small as fewer than 500 employees, then there are 328,552 small contractor firms. Defining small as firms with less than $35.5 million in revenue, then there are 315,902 small contractor firms. Thus, the total number of small contractor firms that may be impacted by the rule range from 315,902 to 328,552.
Recordkeeping and reporting requirements of the interim rule involved regulatory familiarization and administrative costs associated with incorporating revised language into policies, instructions, notices to employees, and subcontracts. In implementing the additional prohibition, the interim rule required that contractors and subcontractors disseminate the nondiscrimination provision, using language prescribed by the Director of the Office of Federal Contract Compliance Programs (OFCCP), including incorporating the nondiscrimination provision into existing employee manuals and handbooks and posting it electronically or in conspicuous places available to employees and applicants. An analysis of estimated costs of the regulatory changes was performed in the DOL final rule published in the
DoD, GSA, and NASA are not aware of any significant alternatives to the rule that would accomplish the stated objectives of the E.O. and the DOL implementing regulations.
It is necessary for the rule to apply to small entities, because E.O. 11246, as amended, applies to all contracts above $10,000 that are not completely exempted. Every effort has been made to minimize the burdens imposed.
Interested parties may obtain a copy of the FRFA from the Regulatory Secretariat Division. The Regulatory Secretariat Division has submitted a copy of the FRFA to the Chief Counsel for Advocacy of the Small Business Administration.
The Paperwork Reduction Act (44 U.S.C. chapter 35) does apply; however, the information collection authorization is under the DOL final rule issued by the OFCCP of the DOL, which was published in the
Government procurement.
Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Final rule.
This document makes amendments to the Federal Acquisition Regulation (FAR) in order to make editorial changes and to update web links.
Ms. Lois Mandell, Regulatory Secretariat Division (MVCB), 1800 F Street NW, 2nd Floor, Washington, DC 20405, 202-501-4755. Please cite FAC 2005-100, Technical Amendments.
In order to update certain elements in 48 CFR parts 2, 4, 5, 6, 7, 8, 9, 14, 16, 17, 18, 19, 22, 23, 25, 28, 31, 36, 41, 49, 52, and 53 this document makes editorial changes to the FAR.
Government procurement.
Therefore, DoD, GSA, and NASA amend 48 CFR parts 2, 4, 5, 6, 7, 8, 9, 14, 16, 17, 18, 19, 22, 23, 25, 28, 31, 36, 41, 49, 52, and 53 as set forth below:
40 U.S.C. 121(c); 10 U.S.C. chapter 137; and 51 U.S.C. 20113.
(b)
(1)
(2)
(d) For more information see
(h) A copy of the Uniform Customs and Practice (UCP) for Documentary Credits, 2007 Edition, International Chamber of Commerce Publication No. 600, is available from: ICC Books USA, 1212 Avenue of the Americas, 21st Floor, New York, NY 10036; Phone: 212-703-5078; Fax: 212-391-6568; Email:
* * * A listing of the Standard forms is located in subpart 53.3.
* * * A listing of the Standard forms is located in subpart 53.3.
The revision reads as follows:
(b) * * *
(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;
The revision reads as follows:
The revisions and addition read as follows:
(b) * * *
___(17)(i) 52.219-9, Small Business Subcontracting Plan (AUG 2018) (15 U.S.C. 637(d)(4)).
__(v) Alternate IV ([AUG 2018]) of 52.219-9.
___(28)(i) 52.222-26, Equal Opportunity (SEPT 2016) (E.O. 11246).
___(ii) Alternate I (Feb 1999) of 52.222-26.
___(29)(i) 52.222-35, Equal Opportunity for Veterans (OCT 2015)(38 U.S.C. 4212).
___(ii) Alternate I (July 2014) of 52.222-35.
___(30)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793).
___(ii) Alternate I (July 2014) of 52.222-36.
___(48) 52.225-5, Trade Agreements (AUG 2018) 19 U.S.C. 2501,
___(49) 52.225-13, Restrictions on Certain Foreign Purchases (JUNE 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).
___(58) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).
___(60)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).
___(ii) Alternate I (Apr 2003) of 52.247-64.
___(iii) Alternate II (Feb 2006) of 52.247-64.
(c) * * *
___(2) 52.222-41, Service Contract Labor Standards (AUG 2018)(41 U.S.C. chapter 67).
___(4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price
(e)(1) * * *
(xii) 52.222-41, Service Contract Labor Standards (AUG 2018)(41 U.S.C. chapter 67).
(e)(1) * * *
(ii) * * *
(J) 52.222-41, Service Contract Labor Standards (AUG 2018)(41 U.S.C. chapter 67).
(P) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017)(E.O. 13706).
(Q)(
(
(R) 52.225-26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
(a) * * *
(2) * * *
(viii) 52.244-6, Subcontracts for Commercial Items (AUG 2018).
(b) * * *
(1) * * *
(vii) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67) (Applies to service contracts over $2,500 that are subject to the Service Contract Labor Standards statute and will be performed in the United States, District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, Johnston Island, Wake Island, or the outer Continental Shelf).
The revision reads as follows:
The revisions read as follows:
Alternate IV (AUG 2018) * * *.
The revision reads as follows:
The revision reads as follows:
The revision reads as follows:
The revision reads as follows:
The revision reads as follows:
The revision reads as follows:
The revision reads as follows:
The revision reads as follows:
The revision reads as follows:
The revision reads as follows:
The revision reads as follows:
As prescribed in 43.205(a)(1), insert the following clause. The 30-day period may be varied according to agency procedures.
(c) * * *
(1) * * *
(iv) 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (JUN 2016), other than subcontracts for commercially available off-the-shelf items, if flow down is required in accordance with paragraph (c) of FAR clause 52.204-21.
(v) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (JUL 2018) (Section 1634 of Pub. L. 115-91).
(vi) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)), if the subcontract offers further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.
(xv) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706), if flow down is required in accordance with paragraph (m) of FAR clause 52.222-62.
(xvi)(A) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a) if flow down is required in accordance with 52.224-3(f).
(B) Alternate I (JAN 2017) of 52.224-3, if flow down is required in accordance with 52.224-3(f) and the agency specifies that only its agency-provided training is acceptable).
The form prescriptions in subpart 53.2 and the FAR forms located at
The following forms are prescribed for use in conducting preaward surveys of prospective contractors, as specified in 9.106-1, 9.106-2, and 9.106-4. These forms are authorized for local reproduction and can be found at the GSA Forms Library at
(a) SF 1403 (Rev. 01/2014), Preaward Survey of Prospective Contractor (General).
(b) SF 1404 (Rev. 01/2014), Preaward Survey of Prospective Contractor—Technical.
(c) SF 1405 (Rev. 01/2014), Preaward Survey of Prospective Contractor—Production.
(d) SF 1406 (Rev. 01/2014), Preaward Survey of Prospective Contractor—Quality Assurance.
(e) SF 1407 (Rev. 01/2014), Preaward Survey of Prospective Contractor—Financial Capability.
(f) SF 1408 (Rev. 01/2014), Preaward Survey of Prospective Contractor—Accounting System.
The following standard forms are prescribed for use for bond and
(a) SF 24 (Rev. 8/2016) Bid Bond. (See 28.106-1.)
(b) SF 25 (Rev. 8/2016) Performance Bond. (See 28.106-1(b).)
(c) SF 25A (Rev. 8/2016) Payment Bond. (See 28.106-1(c).)
(d) SF 25B (For Standard Forms 24, 25, and 25A) (Rev. 10/1983) Continuation Sheet for Standard Forms 24, 25 and 25A. (See 28.106-1(c).)
(e) SF 28 (Rev. 6/2003) Affidavit of Individual Surety. (See 28.106-1(e) and 28.203(b).)
(f) SF 34 (Rev 8/2016) Annual Bid Bond. (See 28.106-1(f).)
(g) SF 35 (Rev. 8/2016) Annual Performance Bond. (See 28.106-1.)
(h) SF 273 (Rev. 4/2013) Reinsurance Agreement for a Bonds statute Performance Bond. (See 28.106-1(h) and 28.202-1(a)(4).)
(i) SF 274 (Rev. 4/2013) Reinsurance Agreement for a Bonds statute Payment Bond. (See 28.106-1(i) and 28.202-1(a)(4).)
(j) SF 275 (Rev. 10/1998) Reinsurance Agreement in Favor of the United States. (See 28.106-1(j) and 28.202-1(a)(4).)
(k) SF 1414 (Rev. 05/1997), Consent of Surety.
(l) SF 1415 (Rev. 7/1993), Consent of Surety and Increase of Penalty. (See 28.108-1(l).)
(m) SF 1416 (Rev. 10/1998) Payment Bond for Other than Construction Contracts. (See 28.106-1(m).)
(n) SF 1418 (Rev. 2/1999) Performance Bond For Other Than Construction Contracts. (See 28.106-1(n).)
(o) OF 90 (Rev. 1/1990), Release of Lien on Real Property. (See 28.106-1(o) and 28.203-5(a).)
(p) OF 91 (Rev. 1/1990), Release of Personal Property from Escrow. (See 28.106-1(p) and 28.203-5(a).)
(a) The following forms are prescribed for use in connection with the termination of contracts, as specified in subpart 49.6. These forms are available at the GSA Forms Library at
(1) SF 1034 (GAO), Public Voucher for Purchases and Services Other Than Personal. (See 49.302(a).)
(2) SF 1435 (Rev. 03/2016), Settlement Proposal (Inventory Basis). (See 49.602-1(a).)
(3) SF 1436 (Rev. 5/2004), Settlement Proposal (Total Cost Basis). (See 49.602-1(b).)
(4) SF 1437 (Rev. 9/1997), Settlement Proposal for Cost-Reimbursement Type Contracts. (See 49.602-1(c) and 49.302.)
(5) SF 1438 (Rev. 5/2004), Settlement Proposal (Short Form). (See 49.602-1(d).)
(6) SF 1439 (Rev. 7/1989), Schedule of Accounting Information. (See 49.602-3.)
(7) SF 1440 (Rev. 01/1995), Application for Partial Payment. (See 49.602-4.)
(b) SF 1428 (Rev. 6/2007), Inventory Disposal Schedule, and Standard Form 1429 (Rev. 1/2016), Inventory Disposal Schedule—Continuation Sheet, shall be used to support termination settlement proposals listed in paragraph (a) of this section, as specified in 49.602-2. These forms are available at the GSA Forms Library at
This subpart identifies, in numerical sequence, Standard Forms (SF), Optional Forms (OF) and agency forms that are specified by the FAR for use in acquisitions.
(a) You can access the forms in Table 53-1 at the GSA Forms Library at
(b) You can access the forms in Table 53-2 at the websites listed in the table.
Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Small Entity Compliance Guide.
This document is issued under the joint authority of DoD, GSA, and NASA. This
August 22, 2018.
For clarification of content, contact the analyst whose name appears in the table below. Please cite FAC 2005-100 and the FAR case number. For information pertaining to status or publication schedules, contact the Regulatory Secretariat Division at 202-501-4755.
Summaries for each FAR rule follow. For the actual revisions and/or amendments made by these rules, refer to the specific item numbers and subjects set forth in the documents following these item summaries. FAC 2005-100 amends the FAR as follows:
DoD, GSA, and NASA are converting to a final rule, without change, an interim rule that amended the Federal Acquisition Regulation (FAR) to implement Executive Order (E.O.) 13706 and a Department of Labor final rule issued on September 30, 2016, both entitled Establishing Paid Sick Leave for Federal Contractors. The rule requires contractors to allow all employees performing work on or in connection with a contract covered by the E.O. to accrue and use paid sick leave in accordance with E.O. 13706 and 29 CFR part 13. Contracting officers will include a clause in covered contracts. This FAR rule neither increases nor decreases the cost of the interim rule (81 FR 91627), which has been in effect since January 1, 2017.
DoD, GSA, and NASA are converting to a final rule, without change, an interim rule that amended the Federal Acquisition Regulation (FAR) to implement Executive Order (E.O.) 13665, Non-Retaliation for Disclosure of Compensation Information. E.O. 13665, signed April 8, 2014, amended E.O. 11246, Equal Opportunity in Federal Employment. The interim FAR rule also implemented a final rule issued by the Office of Federal Contract Compliance Programs (OFCCP) of the Department of Labor, entitled Government Contractors, Prohibitions Against Pay Secrecy Policies and Actions, which was published on September 11, 2015.
E.O. 11246, originally issued September 24, 1965, establishes nondiscrimination and affirmative action obligations in employment for Federal contractors and subcontractors. It prohibits employment discrimination because of race, color, religion, sex, sexual orientation, gender identity, and national origin. E.O. 13665 amends E.O. 11246 and its Equal Opportunity Clause by incorporating, as a covered prohibition, discriminating against employees and job applicants who inquire about, discuss, or disclose the compensation of the employee or applicant or another employee or applicant. Federal contractors and subcontractors must disseminate this nondiscrimination provision, using language prescribed by the Director of OFCCP, including incorporating the provision into existing employee manuals or handbooks and posting it. There is no significant impact on small entities imposed by the FAR rule.
Editorial changes and updates to web links are made at FAR 2.101, 4.1603, 4.1702, 5.102, 5.201, 5.207, 5.704, 5.705, 6.305, 7.103, 7.105, 7.107-4, 8.405-6, 8.501, 8.602, 9.406-3, 9.407-3, 14.201-2, 16.505, 17.502-1, 18.205, 19.704, 19.1503, 22.001, 22.404-3, 22.1001, 22.1021, 22.1022, 22.1304, 23.202, 23.203, 23.205, 23.401, 23.405, 23.802, 25.003, 25.703-2, 28.106-1, 28.106-3, 28.203-3, 28.204-3, 31.205-6, 36.104, 36.700, 41.301, 49.602, 52.208-8, 52.212-1, 52.212-3, 52.212-5, 52.213-4, 52.219-9, 52.222-6, 52.222-8, 52.222-30, 52.222-31, 52.222-32, 52.222-41, 52.222-43, 52.223-17, 52.225-5, 52.225-18, 52.225-25, 52.228-11, 52.243-1, 52.244-6, 53.000, 53.102, 53.209-1, 53.228, 53.249 and subpart 53.3.
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration |