Federal Register Vol. 81, No.14,
Federal Register Volume 81, Issue 14 (January 22, 2016)
Federal Register Volume 81, Issue 14 (January 22, 2016)
| Page Range | 3699-3937 | |
| FR Document |
Document Created: 2015-12-31 23:05:37
Document Modified: 2015-12-31 23:05:37
| Page and Subject | |
|---|---|
| 81 FR 3723 - Approval and Promulgation of Implementation Plans; Arkansas; Crittenden County Base Year Emission Inventory | |
| 81 FR 3775 - Fisheries of the Exclusive Economic Zone Off of Alaska; Observer Coverage Requirements for Small Catcher/Processors in the Gulf of Alaska and Bering Sea and Aleutian Islands Groundfish Fisheries | |
| 81 FR 3935 - Continuation of the National Emergency With Respect to Terrorists Who Threaten To Disrupt the Middle East Peace Process | |
| 81 FR 3856 - Culturally Significant Objects Imported for Exhibition Determinations: “Cave Temples of Dunhuang: Buddhist Art on China's Silk Road” Exhibition | |
| 81 FR 3838 - Sunshine Act; Notice of a Matter To Be Added to the Agenda for Consideration at an Agency Meeting | |
| 81 FR 3801 - Sunshine Act Meeting; Notice of a Matter To Be Added to the Agenda for Consideration at an Agency Meeting | |
| 81 FR 3780 - Sunshine Act Meeting | |
| 81 FR 3837 - Sunshine Act Meetings | |
| 81 FR 3784 - Sunshine Act Meetings Notice | |
| 81 FR 3792 - Product Cancellation Order for Certain Pesticide Registrations | |
| 81 FR 3727 - Medicare Program; Explanation of FY 2004 Outlier Fixed-Loss Threshold as Required by Court Rulings | |
| 81 FR 3786 - Notice of Intent To Audit | |
| 81 FR 3784 - Notice of Intent To Audit | |
| 81 FR 3785 - Notice of Intent To Audit | |
| 81 FR 3818 - Public Land Order No. 7848; Extension of Public Land Order No. 7179, California | |
| 81 FR 3781 - Notification of Proposed Production Activity; GE Generators (Pensacola) L.L.C.; Subzone 249A (Wind Turbine Nacelles and Hubs); Pensacola, Florida | |
| 81 FR 3787 - Notice of Public Workshop To Provide Comments on Field Testing and Verification for Project DE-EE0006789, “Assimilation of Wave Imaging Radar Observations for Real-Time Wave-by-Wave Forecasting” | |
| 81 FR 3791 - Receipt of Test Data Under the Toxic Substances Control Act | |
| 81 FR 3716 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Technical Amendment | |
| 81 FR 3830 - MET Laboratories, Inc.: Application for Expansion of Recognition and Modification to the List of Appropriate NRTL Program Test Standards | |
| 81 FR 3833 - TUV SUD America, Inc.: Application for Expansion of Recognition | |
| 81 FR 3799 - Environmental Impact Statements; Notice of Availability | |
| 81 FR 3825 - New Jersey State Plan for State and Local Government Employees; Approval of Plan Supplements and Certification of Completion of Developmental Steps | |
| 81 FR 3823 - SGS North America, Inc.: Grant of Expansion of Recognition and Modification to the List of Appropriate NRTL Program Test Standards | |
| 81 FR 3832 - QPS Evaluation Services Inc.: Application for Expansion of Recognition | |
| 81 FR 3800 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority | |
| 81 FR 3835 - National Advisory Committee on Occupational Safety and Health (NACOSH); Request for Nominations | |
| 81 FR 3841 - New Postal Product | |
| 81 FR 3783 - Procurement List; Addition and Deletions | |
| 81 FR 3855 - Culturally Significant Objects Imported for Exhibition Determinations: “Picasso: The Great War, Experimentation and Change” Exhibition | |
| 81 FR 3810 - Mississippi; Amendment No. 1 to Notice of a Major Disaster Declaration | |
| 81 FR 3855 - Notice of Public Meeting | |
| 81 FR 3856 - Notice of Public Meeting | |
| 81 FR 3856 - Notice of a Public Meeting | |
| 81 FR 3839 - Proposal Review Panel for Ocean Sciences; Notice of Meeting | |
| 81 FR 3859 - Notice of Receipt of Petition for Decision That Nonconforming Model Year 2008-2010 Alfa Romeo 8C Spider Passenger Cars Are Eligible for Importation | |
| 81 FR 3837 - Records Schedules; Availability and Request for Comments | |
| 81 FR 3819 - Generalized System of Preferences: Possible Modifications, 2015 Review | |
| 81 FR 3820 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Consortium Management Group, Inc. on Behalf of Medical Countermeasure Systems Consortium | |
| 81 FR 3821 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-American Gap Association | |
| 81 FR 3779 - Submission for OMB Review; Comment Request | |
| 81 FR 3823 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Advanced Media Workflow Association, Inc. | |
| 81 FR 3810 - Missouri; Amendment No. 2 to Notice of an Emergency Declaration | |
| 81 FR 3822 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-National Cyberspace Consortium | |
| 81 FR 3731 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Fishery and Golden Crab Fishery of the South Atlantic, and Dolphin and Wahoo Fishery of the Atlantic | |
| 81 FR 3821 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Allseen Alliance, Inc. | |
| 81 FR 3776 - Submission for OMB Review; Comment Request | |
| 81 FR 3822 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Opendaylight Project, Inc. | |
| 81 FR 3821 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Network Centric Operations Industry Consortium, Inc. | |
| 81 FR 3701 - Black Stem Rust; Additions of Rust-Resistant Species and Varieties | |
| 81 FR 3820 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-IMS Global Learning Consortium, Inc. | |
| 81 FR 3801 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 81 FR 3802 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 81 FR 3805 - Arthritis Advisory Committee; Notice of Meeting; Correction | |
| 81 FR 3810 - National Advisory Council; Meeting | |
| 81 FR 3927 - Notice Seeking Public Comment on the Evolution of the Treasury Market Structure | |
| 81 FR 3778 - Southern Montana Resource Advisory Committee | |
| 81 FR 3777 - Gallatin County Resource Advisory Committee | |
| 81 FR 3777 - El Dorado County Resource Advisory Committee | |
| 81 FR 3781 - Endangered and Threatened Species; Notice of Initiation of a 5-Year Review and Notice of Intent To Update the Recovery Plan for the U.S. Distinct Population Segment of Smalltooth Sawfish (Pristis pectinata) | |
| 81 FR 3838 - Federal Council on the Arts and the Humanities Arts and Artifacts Indemnity Panel Advisory Committee | |
| 81 FR 3750 - Standards for Business Practices of Interstate Natural Gas Pipelines | |
| 81 FR 3791 - Public Utility District No. 2 of Grant County; Notice of Application and Soliciting Comments, Motions To Intervene, and Protests | |
| 81 FR 3788 - Consolidated Water Power Company; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests | |
| 81 FR 3789 - Texas Gas Transmission, LLC; Revised Notice of Schedule for Environmental Review of the Northern Supply Access Project | |
| 81 FR 3790 - Florida Gas Transmission Company, LLC: Notice of Availability of the Environmental Assessment for the Proposed Jacksonville Expansion Project | |
| 81 FR 3789 - Combined Notice of Filings #2 | |
| 81 FR 3788 - Combined Notice of Filings #1 | |
| 81 FR 3847 - The Guardian Insurance & Annuity Company, Inc., et al; Notice of Application | |
| 81 FR 3718 - Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972 | |
| 81 FR 3817 - Draft Environmental Assessment; Dallas Zoo Management; Dallas, Texas | |
| 81 FR 3730 - General Services Administration Acquisition Regulation (GSAR); Technical Amendments; Corrections | |
| 81 FR 3862 - Privacy Act of 1974; System of Records | |
| 81 FR 3802 - Subcommittee for Dose Reconstruction Reviews (SDRR), Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH) | |
| 81 FR 3859 - Prevention of Alcohol Misuse and Prohibited Drug Use in Transit Operations | |
| 81 FR 3836 - Assessing the Goals in the Strategic Plan 2012-2016; Request for Comments | |
| 81 FR 3778 - Forest Resource Coordinating Committee | |
| 81 FR 3839 - New Postal Product | |
| 81 FR 3783 - Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting | |
| 81 FR 3720 - Stewardship End Result Contracting Projects | |
| 81 FR 3787 - Privacy Act of 1974; System of Records | |
| 81 FR 3806 - Request for Public Comment: 60 Day Information Collection: Indian Health Service Forms To Implement the Privacy Rule | |
| 81 FR 3853 - Leaning Pine II, L.L.C.; Notice of Application | |
| 81 FR 3841 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fees Schedule | |
| 81 FR 3850 - Self-Regulatory Organizations; OneChicago, LLC; Notice of Filing of Proposed Rule Change Relating to the Summary Imposition of Fines | |
| 81 FR 3809 - National Institute of Mental Health; Notice of Closed Meeting | |
| 81 FR 3809 - National Institute of Mental Health; Notice of Closed Meetings | |
| 81 FR 3807 - Center for Scientific Review; Notice of Closed Meetings | |
| 81 FR 3782 - Proposed Information Collection; Comment Request; Economic Impacts of Diving and Snorkeling Expenditures in Southern Florida | |
| 81 FR 3802 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 81 FR 3768 - Fisheries of the Northeastern United States; Atlantic Mackerel, Squid, and Butterfish Fisheries; Specifications and Management Measures | |
| 81 FR 3729 - Updating Competitive Bidding Rules | |
| 81 FR 3800 - Information Collections Being Submitted for Review and Approval to the Office of Management and Budget | |
| 81 FR 3799 - Information Collection Being Reviewed by the Federal Communications Commission | |
| 81 FR 3805 - Advisory Committee; Pharmaceutical Science and Clinical Pharmacology Advisory Committee (Formerly Known as the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology), Renewal | |
| 81 FR 3840 - New Postal Product | |
| 81 FR 3751 - Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods; Reopening of the Comment Period | |
| 81 FR 3751 - Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression | |
| 81 FR 3803 - Postmarket Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | |
| 81 FR 3816 - 30-Day Notice of Proposed Information Collection: Request for Acceptance of Changes in Approved Drawings and Specifications | |
| 81 FR 3816 - 30-Day Notice of Proposed Information Collection: Renewable Energy Commitment Form | |
| 81 FR 3748 - Privacy Act of 1974: Implementation of Exemptions; Department of Homeland Security/ALL-030 Use of the Terrorist Screening Database System of Records | |
| 81 FR 3861 - Van Hool N.V., Receipt of Petition for Decision of Inconsequential Noncompliance | |
| 81 FR 3811 - Privacy Act of 1974; Department of Homeland Security/ALL-030 Use of the Terrorist Screening Database System of Records | |
| 81 FR 3815 - 30-Day Notice of Proposed Information Collection: Notice of Application for Designation as a Single Family Foreclosure Commissioner | |
| 81 FR 3723 - Propanoic acid, 2-methyl-, monoester With 2,2,4-trimethyl-1,3-pentanediol; Exemption From the Requirement of a Tolerance | |
| 81 FR 3767 - Endangered and Threatened Wildlife and Plants; Endangered Status for 49 Species From the Hawaiian Islands | |
| 81 FR 3865 - Endangered and Threatened Wildlife and Plants; Designation of Critical Habitat for Consolea corallicola (Florida Semaphore Cactus) and Harrisia aboriginum (Aboriginal Prickly-Apple) | |
| 81 FR 3714 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Technical Amendment | |
| 81 FR 3816 - Federal Property Suitable as Facilities To Assist the Homeless | |
| 81 FR 3699 - Implementation of OMB Guidance on Drug-Free Workplace Requirements | |
| 81 FR 3762 - Semipostal Stamp Program | |
| 81 FR 3763 - Federal Acquisition Regulation: Contractor Employee Internal Confidentiality Agreements | |
| 81 FR 3857 - Notice of Final Federal Agency Actions on Proposed Highway in Utah | |
| 81 FR 3858 - Notice of Final Federal Agency Actions on Proposed Transportation Project in and Between the States of New York and New Jersey: Cross Harbor Freight Program, Tier 1 Final Environmental Impact Statement | |
| 81 FR 3703 - Discrimination on the Basis of Disability in Federally Assisted and Federally Conducted Programs and Activities |
Issue
Animal and Plant Health Inspection Service
Farm Service Agency
Food and Nutrition Service
Forest Service
National Institute of Food and Agriculture
Foreign-Trade Zones Board
National Oceanic and Atmospheric Administration
Air Force Department
Navy Department
Energy Efficiency and Renewable Energy Office
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
Indian Health Service
National Institutes of Health
Federal Emergency Management Agency
Fish and Wildlife Service
Land Management Bureau
Antitrust Division
Occupational Safety and Health Administration
National Endowment for the Humanities
Federal Highway Administration
Federal Transit Administration
National Highway Traffic Safety Administration
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
U.S. Department of Commerce.
Final rule.
The U.S. Department of Commerce (Commerce) is removing its regulation implementing the prior government-wide common rule on drug-free workplace requirements for financial assistance, and issuing a new regulation to adopt updated Office of Management and Budget (OMB) guidance on the topic. This action implements OMB's initiative to streamline and consolidate into one title of the Code of Federal Regulations (CFR) all Federal regulations on drug-free workplace requirements for financial assistance. These changes constitute an administrative simplification that would make no substantive change in Commerce's policy or procedures for drug-free workplace.
This rule will be effective on February 22, 2016.
Gary Johnson,
The Drug-Free Workplace Act of 1988, Public Law 100-690, Title V, Subtitle D; 41 U.S.C. 701,
In 2004, OMB established Title 2 of the CFR as the new central location for OMB guidance and agency-implementing regulations concerning grants and agreements (69 FR 26276, May 11, 2004). In conjunction with that action, OMB announced its intention to replace common rules with OMB guidance that agencies could adopt in brief regulations. OMB began that process by proposing (70 FR 51863, August 31, 2005) and finalizing (71 FR 66431, November 15, 2006) government-wide guidance on nonprocurement suspension and debarment in 2 CFR part 180.
As the next step in that process, OMB finalized (74 FR 28149, June 15, 2009) government-wide guidance for policies and procedures to implement drug-free workplace requirements for financial assistance. The guidance requires each agency to replace the common rule on drug-free workplace requirements that the agency previously issued in its own CFR title with a brief regulation in 2 CFR adopting the government-wide policies and procedures.
On May 25, 2010, Commerce proposed new regulations to implement OMB's guidelines on drug-free workplace requirements (75 FR 29215). Specifically, Commerce proposed to take two regulatory actions: (1) Removing its drug-free workplace common rule from 15 CFR part 29; and (2) replacing the common rule with a regulation at 2 CFR part 1329 adopting OMB's government-wide policies and procedures for a drug-free workplace. Commerce proposed, and this final rule enacts, no substantive change to either the Department's or the Government's policies on a drug-free workplace, but instead merely moves the location of the policy in the Code of Federal Regulations from one part to another.
Commerce received no comments on this proposed rulemaking, and now is making that proposed action final. There are no changes from the proposed rule, which is adopted in final form as it was proposed.
OMB has determined this rule to be not significant for purposes of E.O. 12866.
Pursuant to section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 605(b)), at the proposed rule stage, the Chief Counsel for Regulation certified to the Chief Counsel for Advocacy at the Small Business Administration that this rule will not have a significant economic impact on a substantial number of small entities. No comments were received in response to the proposed rule. Accordingly, no regulatory flexibility analysis was required, and none was prepared.
This regulatory action does not contain a Federal mandate that will result in the expenditure by State, local, and tribal governments, in aggregate, or by the private sector of $100 million or more in any one year.
This regulatory action does not impose any additional reporting or recordkeeping requirements under the Paperwork Reduction Act.
This regulatory action does not have Federalism implications, as set forth in Executive Order 13132. It does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
Administrative practice and procedure, Drug abuse, Grant programs, Reporting and recordkeeping requirements.
Administrative practice and procedure, Drug abuse, Grant programs,
Accordingly, for the reasons set forth in the preamble, and under the authority of 5 U.S.C. 301 and 41 U.S.C.701
5 U.S.C. 301; 41 U.S.C. 701-707.
This part requires that the award and administration of Department of Commerce grants and cooperative agreements comply with Office of Management and Budget (OMB) guidance implementing the portion of the Drug-Free Workplace Act of 1988 (41 U.S.C. 701-707, as amended, hereafter referred to as “the Act”) that applies to grants. It thereby—
(a) Gives regulatory effect to the OMB guidance (subparts A through F of 2 CFR part 182) for the Department of Commerce's grants and cooperative agreements; and
(b) Establishes Department of Commerce policies and procedures for compliance with the Act that are the same as those of other Federal agencies, in conformance with the requirement in 41 U.S.C. 705 for Governmentwide implementing regulations.
This part and, through this part, pertinent portions of the OMB guidance in subparts A through F of 2 CFR part 182 (see table at 2 CFR 182.115(b)) apply to you if you are a—
(a) Recipient of a Department of Commerce grant or cooperative agreement; or
(b) Department of Commerce awarding official.
(a)
(b)
(c)
[Reserved]
A recipient other than an individual that is required under 2 CFR 182.225(a) to notify Federal agencies about an employee's conviction for a criminal drug offense must notify each Department of Commerce office from which it currently has an award.
A recipient who is an individual and is required under 2 CFR 182.300(b) to notify Federal agencies about a conviction for a criminal drug offense must notify each Department of Commerce office from which it currently has an award.
To obtain a recipient's agreement to comply with applicable requirements in the OMB guidance at 2 CFR part 182, you must include the following term or condition in the award: Drug-free workplace. You as the recipient must comply with drug-free workplace requirements in Subpart B (or Subpart C, if the recipient is an individual) of 2 CFR part 1329, which adopts the Govemmentwide implementation (2 CFR part 182) of sec. 5152-5158 of the Drug-Free Workplace Act of 1988 (Pub. L. 100-690, Title V, Subtitle D; 41 U.S.C. 701-707).
The Secretary of Commerce or designee determines that a recipient other than an individual violated the requirements of this part.
The Secretary of Commerce or designee determines that a recipient who is an individual violated the requirements of this part.
Animal and Plant Health Inspection Service, USDA.
Direct final rule.
We are amending the black stem rust quarantine and regulations by adding nine varieties to the list of rust-resistant
This rule will be effective on March 22, 2016, unless we receive written adverse comments or written notice of intent to submit adverse comments on or before February 22, 2016. If we receive written adverse comments or written notice of intent to submit adverse comments, we will publish a document in the
You may submit comments or written notice of intent to submit adverse comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
Mr. Randolph Cadet, National Policy Manager, Black Stem Rust, Pest Management, PHP, PPQ, APHIS, 4700 River Road, Unit 26, Riverdale, MD 20737-1231; (301) 851-2094.
Black stem rust is one of the most destructive plant diseases of small grains that is known to exist in the United States. The disease is caused by a fungus (
The black stem rust quarantine and regulations, which are contained in 7 CFR 301.38 through 301.38-8 (referred to below as the regulations), quarantine the conterminous 48 States and the District of Columbia and govern the interstate movement of certain plants of the genera
•
•
•
•
•
•
•
•
•
The addition of these species is based on recent testing to determine rust resistance conducted by the Agricultural Research Service of the United States Department of Agriculture (USDA) at its Cereal Disease Laboratory in St. Paul, MN. The testing is performed in the following manner: In a greenhouse, the suspect plant or test subject is placed under a screen with a control plant—a known rust-susceptible species of
We are publishing this rule without a prior proposal because we view this action as noncontroversial and anticipate no adverse public comment. This rule will be effective, as published in this document, on March 22, 2016, unless we receive written adverse comments or written notice of intent to submit adverse comments on or before February 22, 2016.
Adverse comments are comments that suggest the rule should not be adopted or that suggest the rule should be changed.
If we receive written adverse comments or written notice of intent to submit adverse comments, we will publish a document in the
As discussed above, if we receive no written adverse comments or written notice of intent to submit adverse comments within 30 days of publication of this direct final rule, this direct final rule will become effective 60 days following its publication. We will publish a document in the
This rule is subject to Executive Order 12866. However, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.
This analysis provides the basis, as required by the Regulatory Flexibility Act, for certification by the APHIS Administrator that the rule will not have a significant economic impact on a substantial number of small entities.
This direct final rule will amend 7 CFR 301.38-2 by adding nine varieties to the list of rust-resistant
The introduction and spread of plant pests can result in damage to crops and losses to the U.S. agricultural sector. For the purpose of this analysis and following the Small Business Administration (SBA) guidelines, we note that a major segment of entities potentially affected by this rule are classified within the following industries: Nursery and Tree Production (NAICS 111421), and Floriculture Production (NAICS 111422). According to the Census of Agriculture, these two categories, along with Greenhouse production, which makes up the rest of NAICS 1114, included 52,777 farms in 2012, and represented 2.5 percent of all farms in the United States. These entities are considered small by SBA standards if their annual sales are $750,000 or less. Over 87 percent of the farms in these industries had annual sales of less than $500,000.
Barberry plants are not one of the crops tracked by the Census of Agriculture and therefore data on production and number of producers are not available. Nurseries producing barberry plant species and varieties will not be negatively affected. In fact, they will benefit from being able to market the nine varieties interstate. In addition, the rule does not require any additional reporting, recordkeeping, or other compliance measures beyond what is already in place.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.
This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.
This rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Agricultural commodities, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Transportation.
Accordingly, 7 CFR part 301 is amended as follows:
7 U.S.C. 7701-7772 and 7781-7786; 7 CFR 2.22, 2.80, and 371.3.
Section 301.75-15 issued under Sec. 204, Title II, Public Law 106-113, 113 Stat. 1501A-293; sections 301.75-15 and 301.75-16 issued under Sec. 203, Title II, Public Law 106-224, 114 Stat. 400 (7 U.S.C. 1421 note).
(a) * * *
(1) * * *
National Aeronautics and Space Administration.
Final rule.
This rule revises the National Aeronautics and Space Administration (NASA) regulations implementing section 504 of the Rehabilitation Act of 1973 (section 504), which prohibits discrimination on the basis of disability in programs, services, and activities by recipients of Federal financial assistance from NASA as well as those programs, services, and activities conducted by NASA. The revisions to this rule are part of NASA's retrospective plan under Executive Order 13563 completed in August 2011. NASA's full plan can be accessed at:
Robert Cosgrove, Equal Opportunity Specialist, (202) 358-0446.
NASA implements the requirements of Section 504 of the Rehabilitation Act of 1973 (section 504), which prohibits discrimination on the basis of disability in federally conducted and federally assisted programs or activities, through its regulations in Part 1251.
On November 13, 2014 NASA published a Notice of Proposed Rulemaking (NPRM) in the
NASA also proposed amending its section 504 regulations to incorporate changes required by the Rehabilitation Act Amendments of 1992 (1992 Amendments) by revising subpart 1251.2—Employment Practices (federally assisted programs) and § 1251.540—Employment (federally conducted programs) and instead referencing the U.S. Equal Employment Opportunity Commission's (EEOC's) Americans with Disabilities Act of 1990 (ADA) title I regulation. NASA also proposed updating outdated terminology and references that currently exist in Part 1251 including changing the word “handicapped” and similar variations of that word that appear throughout part 1251, and replacing it with “people first” language (
This final rule has been reviewed and approved by the U.S. Department of Justice (DOJ) in the exercise of its section 504 coordination authority under Executive Order 12250.
NASA received only one comment from a member of the public in response to its NPRM. This individual raised three concerns which are discussed below.
The commenter suggested that NASA simplify its language by replacing the phrase “nonhandicapped persons” wherever it is used in the regulations with the phrase “persons without a disability” rather than the phrase proposed by NASA, “persons who do not have a disability” NASA agrees and is making this change, except that instead of the phrase “persons without a disability,” NASA will use the phrase “individuals without disabilities.”
The commenter also objected to NASA's inclusion of the activity of “speaking” in the list of major life activities in proposed § 1251.102(h)(2)(ii)(A). In the commenter's view, because the list already provided “communicating” as an example, including “speaking” was redundant and unnecessary. NASA disagrees with the commenter. The ADA Amendments Act specifically references both “speaking” and “communicating” in its list of examples of major life activities. See 42 U.S.C. 12102(2)(A). NASA's final rule no longer spells out a list of examples of major life activities, however, because the rule now incorporates by reference the definition of disability contained in DOJ's ADA title II regulation at 29 CFR part 35.
The commenter also suggested that NASA revise the definition of disability in § 1251.102(h)(2)(iii)(A)(
Since the publication of the NPRM, NASA has added definitions of “drug abuse” and “illegal use of drugs,” and a provision specifically addressing the application of section 504 to persons who use illegal drugs. These provisions were added to conform the regulations to the express requirements of the Rehabilitation Act of 1973.
Finally, NASA has made a number of nonsubstantive clarifying edits and corrections to the regulatory text.
NASA's section 504 federally assisted regulation at § 1251.1 applies to recipients to whom the Agency extends Federal financial assistance, such as research, education, and training grants, and cooperative agreements, as well as programs, services, and activities conducted by NASA. NASA's section 504 federally assisted regulation at § 1251.103 prohibits denial of the benefits of, exclusion from participation in, or other discrimination against qualified individuals with disabilities in programs or activities because a recipient's facilities are inaccessible to or unusable by persons with disabilities. Many of the entities that receive financial assistance from NASA are also covered by Title II of the ADA (title II), which prohibits discrimination on the basis of disability by public entities (
The ADA Amendments Act was signed into law in September 2008 and became effective on January 1, 2009. Congress enacted the ADA Amendments Act in order to ensure that the definition of disability is broadly construed and applied without extensive analysis, in response to Supreme Court decisions that had too narrowly interpreted the ADA's definition of a disability. The ADA Amendments Act not only amended the meaning and interpretation of the definition of disability applicable to the ADA, it also amended the Rehabilitation Act of 1973 to require similar changes to the meaning and interpretation of the definition of disability at 29 U.S.C. 705(20)(B) applicable to section 504. In the NPRM, NASA proposed to amend its section 504 regulations to include specific provisions implementing these revised requirements.
Although NASA's original section 504 federally assisted and federally conducted regulations referenced the provision of auxiliary aids,
NASA's rule also revises subpart 1251.2—Employment Practices (federally assisted programs) and § 1251.540—Employment (federally conducted programs) to conform to the 1992 Amendments (Pub. L. 102-569, sec. 506), which amended title V of the Rehabilitation Act to make the same employment standards set forth in title I of the ADA apply to employment discrimination under section 504. As such, the proposed rule deletes the existing requirements related to discriminatory employment practices and references the standards applied under Title I of the ADA (42 U.S.C. 12111
In this final rule, NASA is clarifying its role in the processing and coordination of complaints alleging employment discrimination by its recipients. Title I of the ADA (title I) prohibits discrimination against individuals with disabilities employed in a business that has fifteen or more employees. Title I is enforced by the EEOC, which is the designated Federal agency for the processing and adjudication of all complaints filed under title I. Many of the Agency's recipients may fall under both the jurisdiction of title I and section 504. NASA has authority to receive complaints of employment discrimination by recipients under section 504 and has developed
In the final rule, NASA also clarifies its role in the processing and adjudication of section 504 complaints in its federally conducted programs.
NASA's original section 504 federally assisted regulation at § 1251.103(b)(3) provides that “[r]ecipients shall take appropriate steps to ensure that no handicapped individual is denied the benefits of, excluded from participation in, or otherwise subjected to discrimination in any program or activity receiving Federal financial assistance because of the absence of auxiliary aids for individuals with impaired sensory, manual, or speaking skills.”
The final rule clarifies this existing obligation to provide auxiliary aids and services by using affirmative language explaining this obligation. Similar language is already included in NASA's federally conducted regulation at § 1251.560 (Communications).
NASA's existing section 504 regulation at § 1251.107(a) requires a recipient that employs 15 or more persons to take appropriate initial and continuing steps to notify participants, beneficiaries, applicants, and employees, including those with hearing and vision disabilities, and unions or professional organizations holding collective bargaining or professional agreements with the recipient that it does not discriminate on the basis of disability in violation of section 504 and this part. The notification shall state, where appropriate, that the recipient does not discriminate in admission, access to, treatment, or employment in, its programs or activities. The notification shall also include an identification of the responsible employee designated to coordinate the recipient's efforts to comply with section 504 pursuant to § 1251.106(a). The regulation requires a recipient to make the initial notification required by this paragraph within 90 days of the effective date of this part. This regulation also delineates a choice of methods of initial and continuing notification “that may include the posting of notices, publication in newspapers and magazines, placement of notices in recipient's publication, and distribution of memoranda or other written communications.” NASA recognizes that the methods by which a recipient communicates with interested persons have changed significantly since this regulation was promulgated and this regulation, as currently written, does not reflect the current and future state of information dissemination. With the advent of the broad application of the Internet and the World Wide Web, as well as electronic publishing, electronic mail (email), text messaging, and social media platforms, NASA has determined that the regulation does not adequately include electronic methods of communication. Furthermore, NASA's grant recipients currently rely on their Web sites, email, text messaging, and social media to communicate with and provide information to the beneficiaries of their programs, services, and activities. Many of the publications that previously were available in print, such as pamphlets, brochures, maps, course catalogs, policies, and procedures, are now posted on recipients' Web sites and can be printed or downloaded by an interested person viewing the Web site. In revising the regulation to include electronic communications, NASA is also providing its grant recipients the ability to provide this information in a more cost-effective and expeditious manner than by relying on printed media. Information or programs provided to the public on recipients' Web sites should be provided in accessible formats in order to ensure equal access by individuals with communication disabilities to the recipients' programs, services, and activities.
NASA's existing section 504 regulation at § 1251.302(c) requires that, if construction of a recipient's facility commenced after the effective date of the regulation (January 18, 1991), the facility must be designed and constructed so that it is readily accessible to and usable by persons with disabilities. This regulatory provision also requires that facility alterations commenced after January 18, 1991, that affect or may affect the facility's usability, must be accomplished so that, to the maximum extent feasible, the altered portion of the facility is readily accessible and usable by persons with disabilities.
For facilities subject to the new construction and alterations requirements, the NASA regulation at § 1251.302(c) has always incorporated by reference an accessibility design standard, such that construction or alterations in conformance with that standard would be deemed in compliance with NASA's section 504 regulation. Under the original regulation, new construction or alterations made in conformance with the Uniform Federal Accessibility Standards (UFAS) are deemed to be in compliance with NASA's section 504 regulation, although a recipient may depart from UFAS when other methods provide equivalent or greater access to and usability of the facility.
The adoption of UFAS as an accessibility design standard in NASA's section 504 regulation occurred in 1991 as part of a joint rulemaking with other Federal agencies, led by DOJ pursuant to its coordinating authority for section 504 under Executive Order 12250.
DOJ's 1991 title II ADA regulation incorporated by reference two sets of standards for new construction and alterations: UFAS and the 1991 ADA Standards for Accessible Design (1991 Standards), except that the elevator exemption contained at sections 4.1.3(5) and 4.1.6(1)(k) of the 1991 Standards did not apply. The 1991 title II ADA regulation also permitted departures from the particular requirements of either standard by the use of other methods when it was clearly evident that equivalent access to the facility or part of the facility was thereby provided. UFAS was included as an option for title II entities because it was deemed the accessibility standard under existing section 504 accessibility regulations. However, UFAS was not an accessibility option under the ADA for title III entities, even if they were also
On September 15, 2010, DOJ published revised title II and title III ADA regulations that included the adoption of revised accessibility standards, the 2010 ADA Standards for Accessible Design (2010 Standards).
In the preamble to the final title II regulation, DOJ stated that Federal agencies that extend Federal financial assistance should revise their section 504 regulations to adopt the 2010 Standards as section 504 standards for new construction and alterations
As proposed in the NPRM, in coordination with DOJ, NASA is adopting the 2010 Standards as set forth in 28 CFR part 35, in lieu of UFAS, for new construction and alterations commencing on or after one year from the publication date of the final rule in the
Under NASA's current section 504 federally assisted regulation, the same title II accessibility standards for new construction and alterations are applied to all recipients regardless of whether they are public or private entities with an obligation to comply with title II or title III of the ADA, respectively. That is, both private and public recipients are subject to the same requirements for the purposes of compliance with NASA's section 504 federally assisted regulation. The 2010 Standards impose several different requirements for buildings and facilities covered by title II as compared to buildings and facilities covered by title III. For example, Exception 1 of section 206.2.3 of the 2010 Standards exempts certain multistory buildings owned by private entities from the requirement to provide an elevator. This exemption does not apply to buildings owned by public entities. Similarly, the 2010 Standards specify TTY requirements for public buildings that are different than those required for private buildings. In order to maintain consistency in the requirements applicable to all its recipients, regardless of whether they are public or private entities, NASA is requiring all buildings and facilities covered by its section 504 federally assisted rule to comply with the scoping and technical requirements for a “public building or facility,” which are the requirements for buildings subject to title II of the ADA.
Compliance with the 2010 Standards is required one year from the publication date of the final rule in the
Under § 1251.301(b) of NASA's original section 504 federally assisted regulation, recipients that choose to make structural changes to their facilities in order to comply with the section 504 program accessibility requirements, must make those changes in compliance with the requirements of § 1251.302(c), which deems UFAS as the relevant accessibility standard. NASA's revision of § 1251.302 to adopt the 2010 Standards, raises the question of whether recipients will have to update elements in UFAS-compliant buildings or facilities that are not otherwise being altered, in order to comply with the 2010 Standards. When DOJ revised its title II ADA regulation to adopt the 2010 Standards, it included a “safe harbor” provision in the regulation that provided that elements in existing buildings that complied with the requirements in UFAS or the 1991 Standards did not have to be modified to comply with corresponding requirements in the 2010 Standards. In order to ensure consistency between the requirements for existing facilities in title II of the ADA and the corresponding program accessibility requirements in section 504, NASA has added a similar “safe harbor” provision in the final rule. This provision, which is directly modeled after the title II “safe harbor,” clarifies that for the purposes of complying with NASA's program accessibility requirements for existing facilities, elements that have not been altered in existing buildings or facilities on or after the date that is one year after the date of publication of this Final Rule in the
The current NASA section 504 regulation at § 1251.301(e) requires recipients to adopt and implement procedures to ensure that interested individuals, including individuals with vision or hearing disabilities, can obtain information as to the existence and location of services, activities, and facilities that are accessible to and usable by individuals with disabilities. Since the publication of the NPRM, NASA has determined that the current NASA section 504 federally assisted regulation does not include a provision that is contained in the section 504 regulations of other Federal agencies that requires recipients to provide signs at a primary entrance to each of its inaccessible facilities directing users to an accessible facility or to a location at which they can obtain information about accessible facilities. This provision also requires that the international symbol for accessibility be used at each accessible entrance to a facility. NASA is adding this provision to § 1251.301(e) in order to conform to section 504 regulatory standards across the Government.
Triggering event: The rule also adopts the approaches used in both title II at 28 CFR 35.151(c) and title III at 28 CFR 36.406(a) to determine the “triggering event” for applying the standards to new construction and alterations under section 504. For NASA recipients that are public entities who would otherwise comply with title II (
In
Subsequently, in
In keeping with these Supreme Court decisions, over the past decades Federal courts and Federal agencies have regularly acknowledged Federal agencies' affirmative obligation to provide qualified individuals with disabilities reasonable accommodations in programs, services, and activities. However, their section 504 regulations have lacked a specific provision implementing this requirement.
When the ADA was enacted, Congress stated the obligation to make reasonable changes in policies, practices, or procedures when necessary to avoid discrimination on the basis of disability as a positive requirement.
NASA notes that title I of the ADA also uses the term “reasonable accommodation” to apply to changes in policies, practices and procedures with respect to employment, but the specific ADA title I regulatory requirements related to this term should not be applied to non-employment related requests for reasonable accommodations under section 504.
NASA has revised § 1251.102, which adds paragraph (n) defining “qualified individual with a disability.” The definition for “qualified individual with a disability” in this final rule is also revised in order to update the references to employment to cite to the EEOC's
In
Federal agencies have the responsibility to ensure that their recipients comply with civil rights regulations that prohibit discrimination in programs, services, and activities that receive Federal financial assistance and generally have provisions in their regulations that provide the authority for agencies to ensure compliance and conduct enforcement activities. NASA's original section 504 regulation at § 1251.400 incorporates by reference several provisions in NASA's regulation implementing Title VI of the Civil Rights Act of 1964, at 14 CFR part 1250 that authorize NASA to conduct compliance activities to ensure that recipients do not discriminate on the basis of disability in their programs, services, and activities. These provisions require NASA to: Conduct periodic compliance reviews of recipient programs; receive, investigate and resolve complaints of discrimination on the basis of disability alleged by recipient beneficiaries;
NASA has amended its section 504 federally assisted regulation at § 1251.400 to incorporate by reference those title VI regulatory provisions, originally omitted from the existing regulation. Accordingly, NASA incorporated by reference into § 1251.400, NASA's title VI regulation at § 1250.105 (Compliance information), which: Requires NASA to seek the cooperation of recipients in obtaining compliance with this part; requires recipients and subrecipients to keep records and provide reports to NASA upon request to determine compliance with this part; requires recipients to permit NASA to have access to records and sources of information to determine compliance with this part; and requires recipients to make available information regarding provisions of this part and their applicability to the program for which the recipient receives Federal financial assistance in a manner deemed appropriate by NASA to apprise interested persons of the rights and protections afforded to them by this part. NASA also incorporated by reference into § 1251.400, NASA's title VI regulation at § 1250.107 (Procedures for effecting compliance), which delineates the process by which NASA will effectuate compliance with this part through the termination, suspension, or refusal to grant or continue Federal financial assistance if a recipient's noncompliance with this part cannot be remedied through informal means. Lastly, NASA incorporated by reference into § 1251.400, NASA's title VI regulation at § 1250.109 (Decisions and notices) which delineates the process for rendering decisions and issuing findings in accordance with § 1250.107.
In addition to its revisions to its section 504 federally assisted regulation at part 1251, NASA also revised its section 504 regulation at § 1251.5 that prohibits discrimination on the basis of disability in programs, services, and activities conducted by NASA. In 1978, Congress extended application of section 504 to programs and activities conducted by Federal Executive agencies and the United States Postal Service. Pursuant to Executive Order 12250, the Department of Justice developed a prototype regulation to implement the 1978 amendment for federally conducted programs and activities. More than 80 Federal agencies, including NASA, issued regulations previously based on that prototype, prohibiting discrimination based on disability in the programs and activities they conduct. Despite the large number of regulations implementing section 504 for federally assisted and federally conducted programs and activities, there is very little variation in their substantive requirements, or even in their language. The regulatory revisions in this rulemaking impose similar requirements for NASA's federally conducted and NASA's federally assisted regulations, with the exception of the applicable accessibility standards for new and altered facilities.
Consistent with its revision to the definition of disability in § 1251.102(g), NASA has revised the definition of “disability” at § 1251.503(e) to incorporate by reference the definition of disability in the Department of Justice's title II ADA regulation at 28 CFR part 35. NASA also revised the definition of “direct threat” and added definitions of “drug abuse” and “illegal use of drugs” to § 1251.503 to conform
Executive Orders 13563 and 12866 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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This Final Rule has been designated a “significant regulatory action,” although not an economically significant one, under section 3(f) of Executive Order 12866. Accordingly, this rule has been reviewed by the Office of Management and Budget.
NASA certifies that this rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities.
This rule does not contain an information collection requirement subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Section 4(2) of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1503(2), excludes from coverage under that Act any proposed or final Federal regulation that “establishes or enforces any statutory rights that prohibit discrimination on the basis of race, color, religion, sex, national origin, age, handicap, or disability.” Accordingly, NASA's rulemaking is not subject to the provisions of the Unfunded Mandates Reform Act.
This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996 (as amended), 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.
Administrative practice and procedure, Civil rights, Equal employment opportunity, Federal buildings and facilities, and Individuals with disabilities.
For the reasons stated in the preamble, the National Aeronautics and Space Administration amends 14 CFR part 1251 as follows:
Sec. 504 (29 U.S.C. 794)
(a)
(b)
As used in this part, the term:
(a)
(b)
(c)
(d)
(e)
(1) Qualified interpreters onsite or through video remote interpreting (VRI) services; notetakers; real-time computer-aided transcription services; written materials; exchange of written notes; telephone handset amplifiers; assistive listening devices; assistive listening systems; telephones compatible with hearing aids; closed caption decoders; open and closed captioning, including real-time captioning; voice, text, and video-based telecommunications products and systems, including text telephones (TTYs), videophones, and captioned telephones, or equally effective telecommunications devices; videotext displays; accessible electronic and information technology; or other effective methods of making aurally delivered information available to individuals who are deaf or hard of hearing;
(2) Qualified readers; taped texts; audio recordings; Brailled materials and displays; screen reader software; magnification software; optical readers; secondary auditory programs (SAP); large print materials; accessible electronic and information technology; or other effective methods of making visually delivered materials available to individuals who are blind or have low vision;
(3) Acquisition or modification of equipment or devices; and
(4) Other similar services and actions.
(f)
(g)
(h)
(i)
(j)
(1) Funds;
(2) Services of Federal personnel; or
(3) Real and personal property or any interest in or use of such property, including:
(i) Transfers or leases of such property for less than fair market value or for reduced consideration; and
(ii) Proceeds from a subsequent transfer or lease of such property if the Federal share of its fair market value is not returned to the Federal Government.
(k)
(l)
(m)
(1)(i) A department, agency, special purpose district, or other instrumentality of a State or of a local government; or
(ii) The entity of such State or local government that distributes such assistance and each such department or agency (and each other State or local government entity) to which the assistance is extended, in the case of assistance to a State or local government;
(2)(i) A college, university, or other postsecondary institution, or a public system of higher education; or
(ii) A local educational agency (as defined in 20 U.S.C. 7801), system of vocational education, or other school system;
(3)(i) An entire corporation, partnership, or other private organization, or an entire sole proprietorship—
(A) If assistance is extended to such corporation, partnership, private organization, or sole proprietorship as a whole; or
(B) Which is principally engaged in the business of providing education, health care, housing, social services, or parks and recreation; or
(ii) The entire plant or other comparable, geographically separate facility to which Federal financial assistance is extended, in the case of any other corporation, partnership, private organization, or sole proprietorship; or
(4) Any other entity which is established by two or more of the entities described in paragraph (m)(1), (2), or (3) of this section.
(n)
(1) With respect to any aid, benefit, or service, provided under a program or activity subject to this part, an individual with a disability who, with or without reasonable accommodations in rules policies, or procedures, the removal of architectural, communication, or transportation barriers, or the provision auxiliary aids or services, meets the essential eligibility requirements for participation in, or receipt from, that aid, benefit, or service, and
(2) With respect to employment, the definition given that term in the Equal Employment Opportunity Commission's regulation at 29 CFR part 1630, implementing Title I of the Americans with Disabilities Act of 1990, which regulation is made applicable to this part by § 1251.2.
(o)
(p)
(q)
(a) A recipient that employs 15 or more persons shall take appropriate initial and continuing steps to notify participants, beneficiaries, applicants, and employees, including those with vision or hearing disabilities, and unions or professional organizations holding collective bargaining or professional agreements with the recipient that it does not discriminate on the basis of disability in violation of section 504 and this part. The notification shall state, where appropriate, that the recipient does not discriminate in admission or access to, or treatment or employment in, its programs or activities. The notification shall also include an identification of the responsible employee designated pursuant to § 1251.106(a). A recipient shall make the initial notification required by this paragraph within 90 days of the effective date of this part. Methods of initial and continuing notification may include the posting of notices, transmission via electronic mail or text message, publication on the recipient's internet Web site, or in newspapers and magazines, placement of notices in recipient's publication, and distribution of memoranda or other written communications.
(a) This part does not require a recipient to permit an individual to participate in or benefit from the services, programs, or activities of that recipient when that individual poses a direct threat to the health or safety of others.
(b) In determining whether an individual poses a direct threat to the health or safety of others, a recipient must make an individualized assessment, based on reasonable judgment that relies on current medical knowledge or on the best available objective evidence, to ascertain: The nature, duration, and severity of the risk; the probability that the potential injury will actually occur; and whether reasonable accommodations in policies, practices, or procedures or the provision of auxiliary aids or services will mitigate the risk.
A recipient shall make reasonable accommodations in policies, practices, or procedures when such accommodations are necessary to avoid discrimination on the basis of disability, unless the recipient can demonstrate that making the accommodations would fundamentally alter the nature of the service, program, or activity or result in an undue financial and administrative burden.
(a) A recipient shall take appropriate steps to ensure that communications with applicants, participants, beneficiaries, members of the public, and companions with disabilities, are as effective as communications with others.
(b)(1) A recipient shall furnish appropriate auxiliary aids or services where necessary to afford qualified individuals with disabilities, including applicants, participants, beneficiaries, and members of the public, an equal opportunity to participate in, and enjoy the benefits of, a program or activity of the recipient.
(i) In determining what type of auxiliary aid or service is necessary, the recipient shall give primary consideration to the requests of the individual with a disability.
(ii) The recipient need not provide individually prescribed devices, readers for personal use or study, or other devices of a personal nature.
(2) Where the recipient communicates with applicants and beneficiaries by telephone, telecommunication devices for deaf persons (TTY's) or equally effective telecommunication systems shall be used to communicate with persons who are deaf or hard of hearing or have speech impairments.
(c) This section does not require the recipient to take any action that it can demonstrate would result in a fundamental alteration in the nature of a program or activity or in undue financial and administrative burdens. In those circumstances where the recipient believes that the proposed action would fundamentally alter the program or activity or would result in undue financial and administrative burdens, the recipient has the burden of proving that compliance with § 1251.112 would result in such alteration or burdens. The decision that compliance would result in such alteration or burdens must be made by the chief executive officer of the recipient or his or her designee after considering all of the recipient's resources available for use in the funding and operation of the conducted program or activity and must be accompanied by a written statement of the reasons for reaching that conclusion. If an action required to comply with this section would result in such an alteration or such burdens, the recipient shall take any other action that would not result in such an alteration or such burdens but would nevertheless ensure that, to the maximum extent possible, individuals with disabilities receive the benefits and services of the program or activity.
(a)
(2) A recipient shall not discriminate on the basis of illegal use of drugs against an individual who is not engaging in current illegal use of drugs and who—
(i) Has successfully completed a supervised drug rehabilitation program or has otherwise been rehabilitated successfully;
(ii) Is participating in a supervised rehabilitation program; or
(iii) Is erroneously regarded as engaging in such use.
(b)
(2) A drug rehabilitation or treatment program may deny participation to individuals who engage in illegal use of drugs while they are in the program.
(c)
(2) Nothing in this paragraph (c) shall be construed to encourage, prohibit, restrict, or authorize the conduct of testing for the illegal use of drugs.
(a)
(b)
(e)
(f)
(2)
The revisions and additions read as follows:
(a)
(c)
(ii) New construction and alterations on or after the compliance dates specified in paragraph (c)(2) of this section must comply with the 2010 Standards.
(iii) New construction and alterations of buildings or facilities undertaken in compliance with the 2010 Standards shall comply with the requirements for a “public building or facility” as defined in the 2010 Standards regardless of whether the recipient is a public or private entity.
(iv) Departures from particular requirements of either standard by the use of other methods shall be permitted when it is clearly evident that equivalent access to the facility or part of the facility is thereby provided.
(2)
(B) New construction and alterations in which the last application for a building permit or permit extension for such construction or alterations is certified to be complete by a state, county, or local government (or, in those jurisdictions where the government does not certify completion of applications, if the date when the last application for a building permit or permit extension is received by the state, county, or local government) is on or after January 23, 2017, or if no permit is required, if the start of physical construction or alterations occurs on or after January 23, 2017, then such new construction and alterations shall comply with the 2010 Standards.
(ii) New construction and alterations by recipients that are public entities. (A) If physical construction or alterations commence prior to January 23, 2017, then such new construction and alterations must comply with either UFAS or the 2010 Standards.
(C) If physical construction or alterations commence on or after January 23, 2017, then such new construction and alterations shall comply with the 2010 Standards.
(3) For the purposes of this section, ceremonial groundbreaking or razing of structures prior to site preparation will not be considered to commence or start physical construction or alterations.
(a) The investigative, compliance, and enforcement procedural provisions of Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d) are hereby adopted and apply to this section 504 regulation. These procedures are found at §§ 1250.105 through 1250.110 of this chapter.
(b) The Agency shall ensure that complaints alleging violations of section 504 with respect to employment are processed according to the procedures established by the EEOC in 29 CFR part 1640 and the United States DOJ at 28 CFR part 37.
As used in this part, the term:
(a)
(b)
(1) Qualified interpreters onsite or through Video Remote Interpreting (VRI) services; notetakers; real-time computer-aided transcription services; written materials; exchange of written notes; telephone handset amplifiers; assistive listening devices; assistive listening systems; telephones compatible with hearing aids; closed caption decoders; open and closed captioning, including real-time captioning; voice, text, and video-based telecommunications products and systems, including text telephones (TTYs), videophones, and captioned telephones, or equally effective telecommunications devices; videotext displays; accessible electronic and information technology; or other effective methods of making aurally delivered information available to individuals who are deaf or hard of hearing;
(2) Qualified readers; taped texts; audio recordings; Brailled materials and displays; screen reader software; magnification software; optical readers; secondary auditory programs (SAP); large print materials; accessible electronic and information technology; or other effective methods of making visually delivered materials available to individuals who are blind or have low vision;
(3) Acquisition or modification of equipment or devices; and
(4) Other similar services and actions.
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(a)
(b)
(a) * * *
(2) In the case of historic preservation programs, require the Agency to take any action that would threaten or destroy the historic significance of historic properties.
Each building or part of a building that is constructed or altered by, on behalf of, or for the use of the agency shall be designed, constructed, or altered so as to be readily accessible to and usable by individuals with disabilities. The definitions, requirements, and standards of the Architectural Barriers Act (42 U.S.C. 4151-4157), as established in 41 CFR part 102-76, subpart C, apply to buildings covered by this section.
(b) The Agency shall process complaints alleging violations of section 504 of the Rehabilitation Act with respect to employment according to the procedures established by the Equal Employment Opportunity Commission in 29 CFR part 1640 pursuant to section 501 of the Rehabilitation Act of 1973 (29 U.S.C. 791).
(c) The Associate Administrator for Diversity and Equal Opportunity shall be responsible for coordinating implementation of this section. Complaints may be sent to the Office of Diversity and Equal Opportunity, NASA Headquarters, 300 E Street SW., Washington, DC 20546.
(a) This part does not require the Agency to permit an individual to participate in or benefit from the services, programs, or activities of that recipient when that individual poses a direct threat to the health or safety of others.
(b) In determining whether an individual poses a direct threat to the health or safety of others, the Agency must make an individualized assessment, based on reasonable judgment that relies on current medical knowledge or on the best available objective evidence, to ascertain: The nature, duration, and severity of the risk; the probability that the potential injury will actually occur; and whether reasonable accommodations in policies, practices, or procedures or the provision of auxiliary aids or services will mitigate the risk.
The Agency shall make reasonable accommodations in policies, practices, or procedures when such accommodations are necessary to avoid discrimination on the basis of disability, unless the Agency can demonstrate that making the accommodations would fundamentally alter the nature of the service, program, or activity or result in an undue financial and administrative burden.
(a)
(2) The Agency shall not discriminate on the basis of illegal use of drugs against an individual who is not engaging in current illegal use of drugs and who—
(i) Has successfully completed a supervised drug rehabilitation program or has otherwise been rehabilitated successfully;
(ii) Is participating in a supervised rehabilitation program; or
(iii) Is erroneously regarded as engaging in such use.
(b)
(2) A drug rehabilitation or treatment program may deny participation to individuals who engage in illegal use of drugs while they are in the program.
(c)
(2) Nothing in this paragraph (c) shall be construed to encourage, prohibit, restrict, or authorize the conducting of testing for the illegal use of drugs.
Food and Drug Administration, HHS.
Final rule; technical amendment.
The Food and Drug Administration (FDA or we) is amending a final rule that published in the
Effective January 22, 2016.
Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2166.
In the
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, Reporting and recordkeeping requirements.
Food packaging, Foods.
15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.
21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.
(b) The operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is required to comply with, and is not in compliance with, section 418 of the Federal Food, Drug, and Cosmetic Act or subpart C, D, E, F, or G of this part is a prohibited act under section 301(uu) of the Federal Food, Drug, and Cosmetic Act.
The revisions read as follows:
(1) Is located:
(a) Except as provided by subpart E of this part, subparts C and G of this part do not apply to a qualified facility. * * *
(h) * * *
(3) * * *
(v) Extracting (including by pressing, by distilling, and by solvent extraction) dried/dehydrated herb and spice products (
(a) * * *
(2) You rely on your customer who is subject to the requirements for hazard analysis and risk-based preventive controls in this subpart to ensure that the identified hazard will be significantly minimized or prevented and you:
(5) You have established, documented, and implemented a system that ensures control, at a subsequent distribution step, of the hazards in the food you distribute and you document the implementation of that system.
(b) * * *
(5) Your system, in accordance with paragraph (a)(5) of this section, that ensures control, at a subsequent distribution step, of the hazards in the food you distribute.
(a)
(b) * * *
(2) * * *
(i) * * *
(B) Write to the U.S. Food and Drug Administration (HFS-681), 5100 Paint Branch Pkwy., College Park, MD 20740; or
(ii) Send a paper Form FDA 3942a to the U.S. Food and Drug Administration (HFS-681), 5100 Paint Branch Pkwy., College Park, MD 20740. We recommend that you submit a paper copy only if your facility does not have reasonable access to the Internet.
(e) A statement that a facility may request that FDA reinstate an exemption that was withdrawn by following the procedures in § 117.287;
(a) * * *
(1) Submit the appeal in writing to the FDA District Director in whose district the facility is located (or, in the case of a foreign facility, the Director of the Office of Compliance in the Center for Food Safety and Applied Nutrition), at the mailing address, email address, or facsimile number identified in the order within 15 calendar days of the date of receipt of confirmation of the order; and
Food and Drug Administration, HHS.
Final rule, technical amendment.
The Food and Drug Administration (FDA or we) is amending a final rule that published in the
Effective January 22, 2016.
Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246, email:
In the
Animal foods, Labeling, Packaging and containers, Reporting and recordkeeping requirements.
Accordingly, FDA is amending 21 CFR part 507 with the following technical amendments:
21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.
(e) * * *
(5) Molasses (
(b) * * *
(2) * * *
(i) * * *
(B) Write to the U.S. Food and Drug Administration (HFS-681), 5100 Paint Branch Pkwy., College Park, MD 20740; or
(ii) Send a paper Form FDA 3942b to the U.S. Food and Drug Administration (HFS-681), 5100 Paint Branch Pkwy., College Park, MD 20740. We recommend that you submit a paper copy only if your facility does not have reasonable access to the Internet.
(b) * * *
(2) In wet processing of animal food, when cleaning and sanitizing are necessary to protect against the introduction of undesirable microorganisms into animal food, all animal food-contact surfaces must be cleaned and sanitized before use and after any interruption during which the animal food-contact surfaces may have become contaminated.
(b) The labeling for the animal food ready for distribution must contain, when applicable, information and instructions for safely using the animal food for the intended animal species.
(c)(1) The hazard analysis must include an evaluation of the hazards identified in paragraph (b) of this section to assess the severity of the illness or injury to humans or animals if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls.
(a) * * *
(2) You rely on your customer who is subject to the requirements for hazard analysis and risk-based preventive controls in this subpart to ensure that the identified hazard will be significantly minimized or prevented; and you:
(3) You rely on your customer who is not subject to the requirements for hazard analysis and risk-based preventive controls in this subpart to provide assurance it is manufacturing, processing, or preparing the animal food in accordance with applicable animal food safety requirements and you:
(5) You have established, documented, and implemented a system that ensures control, at a subsequent distribution step, of the hazards in the animal food you distribute and you document the implementation of that system.
(b) * * *
(5) Your system, in accordance with paragraph (a)(5) of this section, that ensures control, at a subsequent
(b) * * *
(1) * * *
(i)(A) Prior to implementation of the food safety plan; or
(B) * * *
(
(c) * * *
(1) Before any change in activities (including any change in preventive control) at the facility is operative; or
(a) * * *
(4) * * *
(iii) Reviewing records of monitoring and corrective actions taken to correct a problem with the control of temperature within 7-working days after the records are created or within a reasonable timeframe, provided that the preventive controls qualified individual prepares (or oversees the preparation of) a written justification for a timeframe that exceeds 7-working days; and
(e) A statement that a facility may request that FDA reinstate an exemption that was withdrawn by following the procedures in § 507.85;
(a) * * *
(1) Submit the appeal in writing to the FDA District Director in whose district the facility is located (or, in the case of a foreign facility, the Director of the Division of Compliance in the Center for Veterinary Medicine), at the mailing address, email address, or facsimile number identified in the order within 15 calendar days of the date of receipt of confirmation of the order; and
Department of the Navy, DoD.
Final rule.
The Department of the Navy (DoN) is amending its certifications and exemptions under the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), to reflect that the Deputy Assistant Judge Advocate General (DAJAG) (Admiralty and Maritime Law) has determined that USS
This rule is effective January 22, 2016 and is applicable beginning December 15, 2015.
Commander Theron R. Korsak, JAGC, U.S. Navy, Admiralty Attorney, (Admiralty and Maritime Law), Office of the Judge Advocate General, Department of the Navy, 1322 Patterson Ave. SE., Suite 3000, Washington Navy Yard, DC 20374-5066, telephone number: 202-685-5040.
Pursuant to the authority granted in 33 U.S.C. 1605, the DoN amends 32 CFR part 706.
This amendment provides notice that the DAJAG (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS
Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.
Marine safety, Navigation (water), and Vessels.
For the reasons set forth in the preamble, the DoN amends part 706 of title 32 of the Code of Federal Regulations as follows:
33 U.S.C. 1605.
15. * * *
16. * * *
Forest Service, USDA.
Final rule.
The United States Department of Agriculture (Department) is issuing this rule to carry out Stewardship End Result Contracting Projects. This authority originated on a limited pilot basis and then was expanded through a succession of subsequent amendments and continued into Fiscal Year 2014. The enactment of section 8205 of the Agricultural Act of 2014 (2014 Act) establishes permanent authority to conduct Stewardship End Result Contracting projects by adding a new section 604 to the Healthy Forests Restoration Act of 2003 (HFRA). Accordingly, this final rule sets forth the regulations implementing this permanent authority. These regulations generally follow the Forest Service policy and processes that have been in place for some time. The regulations revise existing Forest Service policy to provide greater uniformity in the administration of the various mechanisms used by the Forest Service to implement stewardship projects.
This rule is effective January 22, 2016.
David Lawrence, at 202-205-1269 or
Individuals who use telecommunication devices for the deaf may call the Federal Information Relay Service at 800-877-8339 between 8 a.m. and 8 p.m. Eastern Standard Time, Monday through Friday.
Beginning in 1998 with the enactment of section 347 of the Omnibus Consolidated Appropriations Act, 1999 (Pub. L. 105-277), the Forest Service has been authorized to enter into stewardship projects since 1999 (16 U.S.C. 2104 note); however, this authority was not permanent. The 2014 Act makes the authority permanent through an amendment to HFRA. With limited exceptions, the permanent authority is identical to the temporary authority. Section 604(b) of HFRA provides that the Forest Service, “via agreement or contract as appropriate, may enter into stewardship contracting projects with private persons or other public or private entities to perform services to achieve land management goals for the national forests and the public lands that meet local and rural community needs.” Section 604(d)(1) provides that a source for performance of a stewardship agreement or contract must be selected on a best value basis. Section 604(d)(4) further provides that the Forest Service can apply the value of timber or other forest products removed under the project as an offset against the value of the services received by the Forest Service. In accordance with section 604(e), the Forest Service can collect funds received under a stewardship project if doing so is a secondary objective of the project.
Pursuant to section 604 of HFRA, the land management goals of a stewardship project may include any of the following:
1. Road and trail maintenance or obliteration to restore or maintain water quality;
2. Soil productivity, habitat for wildlife and fisheries, or other resource values;
3. Setting of prescribed fires to improve the composition, structure, condition, and health of stands or to improve wildlife habitat;
4. Removing vegetation or other activities to promote healthy forest stands, reduce fire hazards, or achieve other land management objectives;
5. Watershed restoration and maintenance;
6. Restoration and maintenance of wildlife and fish; and
7. Control of noxious and exotic weeds and reestablishing native plant species.
The Forest Service has utilized several types of contracts to implement the stewardship end result contracting authority. Generally, a contract that resulted in the Forest Service's receipt of service work in an amount greater than the value of the timber or forest product removed by a contractor utilized a contract that resembled a procurement of service contract. A contract that resulted in the Forest Service's receipt of service work in an amount less than the value of the timber or forest product removed by a contractor utilized a contract that resembled a timber sale contract.
Recognizing the unique nature of the use of timber and forest products as consideration for the services received under stewardship contracts and agreements, section 604(d)(2) provides that the Secretary may consider a stewardship contract to be a contract for the sale of property under terms prescribed by the Secretary without regard to any other provision of law. Accordingly, section 223.301 of this rule continues the use of the different types of contracts based on the value of the products removed and services received. In order to ensure consistency in the operation of these projects to the extent that is practicable, sections 223.303 and 223.304 provide for the use of existing regulatory provisions. Section 223.303 sets forth the rules for contracts that are principally the acquisition of a service and rely upon the Federal Acquisition Regulations (FAR) set forth in Title 48 of the Code of Federal Regulations. Section 223.304 sets forth the rules for contracts that are principally sales of property contracts and generally rely upon existing Forest Service Timber Sale regulations set forth in 36 CFR part 223, subparts A & B, except as provided in section 223.304(a).
The regulations in 2 CFR 200, as adopted and supplemented by the USDA in 2 CFR 400, 416 and 422 set forth the general rules that are applicable to all grants and cooperative agreements made by the Department of Agriculture. Because the Forest Service's use of agreements entered into under this part are not financial assistance for the benefit of the recipient but instead are entered into for the benefit of the Forest Service, the assistance regulations in 2 CFR 200, as adopted and supplemented by the USDA in 2 CFR 400, are not applicable to such agreements.
While this final rule generally sets forth the manner in which the Forest Service has implemented stewardship projects since 1999, this final rule also sets forth with greater clarity the process for selecting the appropriate mechanism to implement a stewardship end result project. Section 604(d) of HFRA requires that a source for performance of a stewardship agreement or contract be selected on a best-value basis. A stewardship agreement or contract may also be entered into notwithstanding subsections (d) and (g) of section 14 of the National Forest Management Act of
With the enactment of section 8205 of the 2014 Act, and the corresponding HFRA amendments, the Forest Service's authority to enter into Stewardship End Result Contracting Projects is now permanently authorized. Since the primary purpose of this rule is to set forth contracting procedures that were used to implement the prior statutory provisions that were not of a permanent nature, it has been determined that this rule should become effective upon publication.
This final rule would revise Part 223 to set forth the regulations used in the conduct of Stewardship End Result Contracting Projects. The Forest Service has determined that this final rule falls within this category of actions and that no extraordinary circumstances exist which would require preparation of an environmental assessment or environmental impact statement.
We are issuing this final rule without prior notice and opportunity for comment. The Administrative Procedures Act (APA) exempts rules “relating to agency management or personnel or to public property, loans, grants, benefits, or contracts” from the statutory requirement for prior notice and opportunity for comment, as well as the statutory requirement for 30 days to pass before the action can be effective.
This final rule has been reviewed under USDA procedures and Executive Order 12866 on Regulatory Planning and Review. The Office of Management and Budget (OMB) has determined that this is not a significant rule. This rule would not have an annual effect of $100 million or more on the economy, nor would it adversely affect productivity, competition, jobs, the environment, public health and safety, or State or local governments. This final rule would not interfere with an action taken or planned by another agency, nor raise new legal or policy issues. Finally, this final rule would not alter the budgetary impact of entitlement, grant, user fee, or loan programs or the rights and obligations of beneficiaries of such programs. Accordingly, this final rule is not subject to Office of Management and Budget (OMB) review under Executive Order (E.O.) 12866.
The Forest Service has considered this final rule in light of the Regulatory Flexibility Act (5 U.S.C. 602
The Forest Service has analyzed this final rule in accordance with the principles and criteria contained in E.O. 12630 and determined that the rule would not pose the risk of taking private property.
The Forest Service has reviewed this final rule under E.O. 12988, Civil Justice Reform. Under this rule, (1) all State and local laws and regulations that conflict with this rule or that impede its full implementation would be preempted; (2) no retroactive effect would be given to this final rule; and (3) it would require administrative proceedings before parties may file suit in court challenging its provisions.
The Forest Service has considered this final rule under the requirements of E.O. 13132 on federalism and has determined that this rule conforms with the federalism principles in the E.O.; would not impose any compliance costs on the States; and would not have any substantial direct effects on the States, the relationship between the Federal Government and the States, or the distribution of power and responsibilities among the various levels of government. Moreover, this final rule does not have tribal implications as defined by E.O. 13175, Consultation and Coordination with Indian Tribal Governments, and therefore advance consultation with tribes is not required.
The Forest Service has reviewed this final rule under E.O. 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use”, and has determined that this rule would not constitute a significant energy action as defined in the E.O.
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the Forest Service has assessed the effects of this final rule on State, local, and tribal governments and the private sector. This rule would not compel the expenditure of $100 million or more by any State, local, or tribal government or anyone in the private sector. Therefore, a statement under section 202 of the Act is not required.
This final rule does not contain any record-keeping or reporting requirements or other information collection requirements as defined in 5 CFR 1320 that are not already required by law or not already approved for use. Accordingly, the review provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Administrative practice and procedure, Exports, Forests and forest products, Government contracts, National forests, Reporting and recordkeeping requirements.
Therefore, for the reasons stated in the preamble, the Forest Service amends 36 CFR part 223 as follows:
16 U.S.C. 618, 620-620j, 472a, and 6591c.
(a) This part sets forth the regulations applicable to the implementation of section 604 of the Healthy Forest Restoration Act of 2003, “Stewardship End Result Contracting Projects” 16 U.S.C. 6591c. This section provides for the use of contracts and agreements to achieve land management goals for the national forests and the public lands that meet local and rural community needs. In the fulfillment of these activities, the Forest Service may apply the value of timber or other forest products removed from the project site as an offset against the cost of services received under such contracts or agreements.
(b)(1)
(2)
(3)
(4)
(c)
(a)
(b)
(1)
(2)
(c)
(1) It is in the best interest of the government that a sale of property contract is more suitable for a contract that would otherwise be subject to paragraph (b)(1) of this section; or
(2) It is in the best interest of the government that a procurement of service contract is more suitable for a contract that would otherwise be subject to paragraph (b)(2) of this section.
Section 604(d) of HFRA requires that a source for performance of a stewardship agreement or contract be selected on a best-value basis. A stewardship agreement or contract may also be entered into notwithstanding subsections (d) and (g) of section 14 of the National Forest Management Act of 1976 (16 U.S.C. 472a).
All contracts determined under § 223.301(b)(1) to be a contract for receipt of a service shall:
(a) Be administered under the Federal Acquisition Regulations, Title 48 of the Code of Federal Regulations including the regulations issued by the Department of Agriculture set forth in Chapter 4 of Title 48; and
(b) Provide for a fire liability provision. All contracts under this section shall contain a fire liability provision that is in substantially the same form as the fire liability provision contained in integrated resource timber contracts, as described in Forest Service contract numbered 2400-13, part H, section 4.
(c) Utilize the following provisions of subparts A and B of this part:
(1) Section 223.1 Authority to sell timber.
(2) Section 223.3 Sale of seized material.
(3) Section 223.14 Where timber may be cut.
(4) Section 223.30 Consistency with plans, environmental standards, and other management requirements.
(5) Section 223.34 Advance payment.
(6) Section 223.36 Volume determination.
(7) Section 223.37 Revegetation of temporary roads.
(8) Section 223.38 Standards for road design and construction.
(9) Section 223.40 Cancellation for environmental protection or inconsistency with plans.
(10) Section 223.48 Restrictions on export and substitution of unprocessed timber.
(11) Section 223.60 Determining fair market value.
(12) Section 223.61 Establishing minimum stumpage rates.
(13) Section 223.87 Requirements of bidders concerning exports.
(14) Section 223.113 Modification of contracts to prevent environmental damage or to conform to forest plans.
(d) Products may be valued on a per acre basis.
(e) Such other provisions as are necessary to carry out the provisions of section 604 of the Healthy Forest Restoration Act of 2003 (16 U.S.C. 6591c).
All contracts determined under § 223.301(b) to be a contract for a sale of property shall:
(a) Utilize the provisions of subparts A and B of this part, except that the following provisions will not be applicable:
(1) Section 223.4 Exchange of trees or portions of trees.
(2) Section 223.31 Duration of contracts.
(3) Section 223.42 Transfer of effective purchaser credits.
(4) Section 223.43 Limit on amounts of transferred purchaser credits.
(5) Section 223.44 Collection rights on contracts involved in transfer of purchaser credit.
(6) Section 223.44 Collection rights on contracts involved in transfer of purchaser credit.
(7) Section 223.45 Definitions applicable to transfer of purchaser credit.
(8) Section 223.49 Downpayments. Paragraph (d).
(9) Section 223.62 Timber purchaser road construction credit.
(10) Section 223.65 Appraisal of timber for land exchange; right-of-way, or other authorized use.
(11) Section 223.80 When advertisement is required.
(12) Section 223.82 Contents of advertisement.
(13) Section 223.83 Contents of prospectus.
(14) Section 223.84 Small business bid form provisions on sales with specified road construction.
(15) Section 223.88 Bidding methods.
(16) Section 223.100 Award to highest bidder.
(17) Section 223.102 Procedure when sale is not awarded to highest bidder.
(18) Section 223.103 Award of small business set aside sales.
(19) Section 223.118 Appeal process for small business timber sale set-aside program share recomputation decisions.
(b) Include the following additional provisions:
(1) If determined by the Forest Service to be necessary to protect the interests of the United States, a performance and payment bond, as described on February 7, 2014, in section 28-103-2 and 28-103-3 of Part 48 of the Code of Federal Regulations, in an amount sufficient to protect the investment in receipts by the United States generated by the contractor from the estimated value of the forest products to be removed under the contract;
(2) Provide for a fire liability provision.
(3) Redetermination of stumpage rates and deposits: The cost of service work included in stewardship contracts will be evaluated along with stumpage values at the time of a rate determination in accordance with normal rate determination procedures.
(4) Products may be valued on a per acre basis.
(5) Such other provisions as are necessary to carry out the provisions of section 604 of the Healthy Forest Restoration Act of 2003 (16 U.S.C. 6591c).
The Forest Service may enter into an agreement under this subpart in lieu of a contract.
(a) The regulations governing Federal financial assistance relationships are not applicable to such agreements.
(b) All agreements under this section shall contain a fire liability provision that is in substantially the same form as the fire liability provision contained in integrated resource timber contracts, as described in Forest Service contract numbered 2400-13, part H, section 4.
In rule document 2016-00559 beginning on page 1884 in the issue of Thursday, January 14, 2016, make the following correction:
On page 1885, in the first column, in the 14th line, “March 14, 2016” should read “February 16, 2016”.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol when used as an inert ingredient (solvent, co-solvent) in pesticide formulations applied to growing crops or raw agricultural commodities under the EPA's regulations. Dow AgroSciences submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol.
This regulation is effective January 22, 2016. Objections and requests for hearings must be received on or before March 22, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0373, is available at
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0373 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before March 22, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0373, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol follows.
EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.
Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol has low acute toxicity with oral lethal dose (LD)
No chronic toxicity studies were available; however, the lack of systemic toxicity in two shorter repeat dose studies at the limit dose of 1,000 mg/kg bw/day indicates that chronic toxicity is not a concern.
Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol was negative genotoxicity in the Ames assay and in vivo micronucleus assay.
No cancer study is available for propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol, however based on the lack of genotoxicity, no adverse effects seen in subchronic toxicity studies, and structure-activity relationship models (QSAR) modeling that did not indicate any triggers for carcinogenicity, propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol is not expected to be carcinogenic.
Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol is a mixture of the 1-substituted (−65%) and the 3-substituted (−35%) monoisobutyrate isomers of 2,2,4-trimethyl-l,3-pentanediol. The half-life of the 1-substituted isomer in human and rat blood is between 15 to 22 minutes. No specific information is available on toxicity of propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol metabolites. However, propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol is rapidly metabolized in rat blood, and toxicity of parent propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol in rats was not observed at doses up to 1,000 mg/kg/day, so metabolite toxicity is anticipated to be low.
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
Since there is no indication of toxicity at the limit dose, a toxicological endpoint of concern for risk assessment purposes was not identified. Since no endpoint of concern was identified for the acute and chronic dietary exposure assessment and short and intermediate dermal and inhalation exposure, a quantitative risk assessment for propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol is not necessary.
1.
Dietary exposure can occur from eating foods containing residues of propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol. Because no hazard endpoint of concern was identified for the acute and chronic dietary assessment (food and drinking water), a quantitative dietary exposure risk assessment was not conducted.
2.
3.
Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol is used as an inert ingredient in pesticide products that could result in short- and intermediate-term residential exposure. However, based on the lack of toxicity, a quantitative exposure assessment from residential exposures was not performed.
4.
EPA has not found propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol to share a common mechanism of toxicity with any other substances, and propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at
Based on an assessment of propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children, and has determined that a qualitative assessment is appropriate. As part of its qualitative assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
Based on the lack of any toxicological endpoints of concern, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol residues.
An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol (CAS Reg. No. 25265-77-4) when used as an inert ingredient (solvent or co-solvent) in pesticide formulations applied to growing crops or raw agricultural commodities after harvest.
This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
Centers for Medicare & Medicaid Services (CMS), HHS.
Clarification.
In accordance with court rulings in cases that challenge the federal fiscal year (FY) 2004 outlier fixed-loss threshold rulemaking, this document provides further explanation of certain methodological choices made in the FY 2004 fixed-loss threshold determination.
January 22, 2016.
Ing-Jye Cheng, 410-786-2260 or Don Thompson, 410-786-6504.
On May 19, 2015, the Court of Appeals for the District of Columbia (DC) Circuit issued a decision in
On remand, the Secretary should explain why she corrected for only 50 turbo-charging hospitals in the 2004 rulemaking rather than for the 123 she had identified in the NPRM. She should also explain what additional measures (if any) were taken to account for the distorting effect that turbo-charging hospitals had on the dataset for the 2004 rulemaking. And if she decides that it is appropriate to recalculate the 2004 outlier threshold, she should also decide what effect (if any) the recalculation has on the 2005 and 2006 outlier and fixed loss thresholds.
On September 2, 2015, the District Court for the District of Columbia issued an opinion and order in a separate case,
The Medicare statute requires that outlier payments be calculated based on charges, adjusted to cost (see 42 U.S.C. 1395ww(d)(5)(A)(ii)). To compute an outlier payment, we use hospital-specific cost-to-charge ratios (CCRs), calculated from historical cost and charge data, to reduce the charge on the claim to a cost estimate. The estimated costs of the case are then compared to the Diagnosis Related Group (DRG) payment plus the fixed loss outlier threshold to determine if an outlier payment is appropriate and, if so, the amount of any such payment. Thus, CCRs play a significant role in determining the outlier payment for a case.
In the March 5, 2003,
In the outlier proposed rule, we proposed multiple policy changes that affected outlier payments. These policies were finalized in the outlier final rule. The changes were intended to respond to turbocharging, a practice in which hospitals would repeatedly increase their charges at rates exceeding the rates of increase in their costs. Turbocharging would lead to outlier payments greater than warranted by a hospital's actual costs because the historical CCR used to generate cost estimates would not capture the true present relationship between the hospital's costs and its charges.
Three specific changes made in the outlier final rule are relevant to our present discussion. The first important change made in the outlier final rule was to alter our policy regarding when to apply statewide average CCRs. Prior to the outlier final rule, when a hospital's CCR dipped below a pre-determined CCR floor (set in the annual IPPS final rule), it would be assigned a statewide average CCR in place of the hospital's computed CCR. We noted that if a hospital repeatedly increased its charges at a faster rate than its costs increased, its CCR could fall below the floor, which would lead to the application of a higher statewide average CCR, and would significantly increase outlier payments. Therefore, in order to mitigate gaming of the application of the statewide average CCR, we finalized a policy that would no longer substitute statewide average CCRs if a hospital's actual CCR dipped below the floor. Hospitals would be assigned their actual CCRs no matter how low their CCR dipped.
The second key change to the outlier policy was to require use of CCRs from tentative settled Medicare cost reports when available. Previously, a hospital's outlier payments would be calculated based on a CCR drawn from its most recent final settled cost report, that is, its most recent cost report that had undergone complete review. We observed that if a hospital had significantly increased its charges since the period covered by its most recent final settled cost report, the hospital could receive inordinately high outlier payments because the CCR used to calculate its payments would not reflect its recent charge increases. Therefore, we modified the outlier policy to require use of more up-to-date CCR data drawn from a tentative settled cost report, when available. The tentative settlement is a cursory review of the cost report that takes place within 60 days of the acceptance of a cost report by CMS. We explained that we expected use of this more up-to-date data would reduce the time lag between a hospital's CCR and its current billed charges by a year or more. In our discussion of this policy change in the March 2003 outlier
The third key change made in the outlier final rule was to make outlier payments subject to adjustments when hospitals' cost reports are settled. We explained that outlier payments would be processed throughout the year using operating and capital CCRs based on the best information available at that time, but at the time a cost report was settled, outlier payments could be reconciled using updated CCRs that are computed from more recent cost report and charge data. We instructed our contractors to put a hospital through outlier reconciliation if it: 1) has a 10-percentage point change in its CCR from the time the claim was paid compared to the CCR at final cost report settlement; and 2) receives total outlier payments exceeding $500,000 during the cost reporting period.
Some of the provisions of the outlier final rule became effective for discharges occurring on or after August 8, 2003. The remaining provisions became effective for discharges occurring on or after October 1, 2003.
After these changes were finalized in the June 2003 outlier final rule, we then set the fixed loss outlier threshold for FY 2004 in the FY 2004 IPPS final rule (68 FR 45476 through 45478). When we calculated the fixed-loss threshold for FY 2004, we simulated payments by applying FY 2004 rates and policies to cases from the FY 2002 MedPAR file. The FY 2004 policies applied in the payment simulations included the policy changes that had been finalized in the June 2003 outlier final rule: 1) we attempted to approximate the use of tentative settled cost report data by calculating updated cost-to-charge ratios for each hospital from recent cost reporting data; and 2) we used a hospital's computed CCR even if it was very low, rather than substituting a statewide average CCR. We noted that it was difficult to project which hospitals would be subject to reconciliation of their outlier payments using then-available data. Nevertheless, we stated that our analysis at that time had identified approximately 50 hospitals that we thought would be subject to reconciliation. For those approximately 50 hospitals, we employed cost-to-charge ratios estimated from recent data using the hospital's rate of increase in charges per case based on FY 2002 charges, compared to costs (inflated to FY 2004 using actual market basket increases).
The court rulings discussed previously stated that we should explain why, in simulating FY 2004 payments to calculate the FY 2004 fixed loss outlier threshold, we made additional adjustments to the cost-to-charge ratios for approximately 50 hospitals, given that the March 2003 outlier proposed rule had discussed 123 hospitals that appeared to have benefited from vulnerabilities in the outlier payment rules. The reason is that the adjustments made to approximately 50 hospitals were intended to account for changes that might be made to hospitals' cost-to-charge ratios through reconciliation when their cost reports were settled. Those particular adjustments were not intended to account for possible disparities between hospitals' historical cost-to-charge ratios and the ratios that would be used to calculate FY 2004 outlier payments at the time the hospitals' claims were processed. We had separately accounted for disparities of that kind by computing new cost-to-charge ratios for all hospitals, including the 123 hospitals previously identified as possible turbochargers.
As discussed previously, our June 2003 outlier final rule was motivated by our observation that, because of turbocharging, the cost-to-charge ratios used to calculate a hospital's outlier payments sometimes failed to reflect the actual relationship between the hospital's costs and its charges at the time the hospital submitted a claim for payment. The June 2003 outlier final rule included separate measures that were each designed to address a different component of this problem. We adopted the use of more up to date cost-to-charge ratio data from tentative settled cost reports to ensure that the cost-to-charge ratio used to make a hospital's payments would come as close as possible to reflecting the present relationship between the hospital's costs and its charges. However, we recognized that while using data from tentative settled cost reports would reduce the time lag between cost-to-charge ratio data and outlier payment claims, it would not eliminate the time lag altogether. Data from a tentative settled cost report still would not reflect recent charge increases that had occurred since the submission of the cost report. Therefore, we separately provided for reconciliation of outlier payments at the time a cost report was settled. Thus, if a hospital received unduly high outlier payments because it had significantly increased its charges since the time of its most recent tentative settled cost report, there would be some opportunity to readjust those payments at a later date based on even newer data.
To simulate FY 2004 payments for purposes of calibrating the FY 2004 fixed loss outlier threshold, we needed to apply the rules that would be in place in FY 2004, and so we needed to simulate application of the new rules that had been adopted as part of the June 2003 outlier final rule. To approximate the use of more recent data from tentative settled cost reports, we calculated cost-to-charge ratios from more recent data for all hospitals, including the 123 hospitals discussed in the March 2003 proposed rule. Our most immediate purpose in this measure was to ensure that our simulated FY 2004 payments would match up as closely as possible with how FY 2004 claims would actually be paid. But this measure also had the additional benefit of reducing any reason for concern that cost-to-charge ratios drawn from older historical data for the 123 hospitals would not reliably approximate the cost-to-charge ratios that would be used to pay FY 2004 claims for those 123 hospitals. The payment simulations employed cost-to-charge ratios calculated from very recent data for all hospitals, including the 123 hospitals, and did not employ cost-to-charge ratios drawn from older historical data.
The additional adjustments made to approximately 50 hospitals were intended to simulate the operation of the newly adopted rule permitting some outlier payments to be adjusted through reconciliation after they were paid. Reconciliation of outlier payments is a burdensome process, and we had indicated that reconciliation would not be performed for all hospitals, or even all hospitals suspected of turbocharging in the past. Rather, reconciliation generally would be performed only if a hospital met the criteria we had specified for reconciliation: A 10-percentage point change in the hospital's CCR from the time the claim was paid compared to the CCR at cost
The court rulings also called for an explanation of other steps taken to account for any “distorting effect” associated with the 123 hospitals discussed in the March 2003 proposed rule. As we explained previously, our payment simulations employed cost-to-charge ratios calculated from recent data for all hospitals, including the 123 hospitals, and did not employ cost-to-charge ratios drawn from older historical data. That reduced any reason for concern that cost-to-charge ratios drawn from older historical data for the 123 hospitals would not reliably approximate the cost-to-charge ratios that would be used to pay FY 2004 claims for those 123 hospitals. We also anticipated that implementation of the June 2003 outlier final rule would curb the turbocharging practices that had caused rapid increases in charges in previous years; and therefore, we saw no reason to further adjust our payment simulations to account for future turbocharging by the 123 hospitals. Therefore, we did not apply any additional adjustments focused on the 123 hospitals that had been discussed in the March 2003 proposed rule, beyond the adjustments we have already discussed.
The court rulings also stated that we should explain further why we did not exclude the 123 identified turbo charging hospitals from the charge inflation calculation for FY 2004. We simply did not have strong reason to believe that excluding the 123 hospitals from the charge inflation calculation, or from other parts of the fixed loss outlier threshold calculation, would improve our projections.
When we simulate payments for purposes of calculating the fixed loss outlier threshold, we use MedPAR data from an earlier period to produce a simulated set of claims for the period for which we are calculating the fixed loss outlier threshold. For the FY 2004 final rule, we used cases from the FY 2002 MedPAR file to simulate FY 2004 cases. We applied a charge inflation factor to account for growth in hospital charges between the period covered by the MedPAR data and the period for which we are calculating the fixed loss outlier threshold. In this instance, the charge inflation factor was intended to account for growth in hospital charges over the 2-year period between FY 2002 and FY 2004. We estimated charge growth over this period based on actual charge growth over an earlier 2-year period, FY 2000 to FY 2002. More specifically, our estimate of charge inflation was based on the 2-year average annual rate of change in charges per case from FY 2000 to FY 2001 and from FY 2001 to FY 2002 (12.5978 percent annually, or 26.8 percent over 2 years).
Although we expected the June 2003 outlier final rule to curb turbocharging, which would affect the rate of charge growth after the rule became effective, we believed that past charge growth would still be a satisfactory basis for estimating more recent charge growth, for the 123 hospitals as well as for other hospitals. The outlier final rule was in effect for only part of the interval that our charge inflation estimate was intended to reflect. The outlier final rule went into effect only in part for the last 2 months of FY 2003, and went into effect in full only at the beginning of FY 2004.
We had no strong reason to expect that excluding the 123 hospitals from our charge inflation calculations, or from other parts of our simulations, would improve our simulations in a way that would bring outlier payments closer to our target of 5.1 percent of operating DRG payments. The 123 hospitals were not excluded from claiming outlier payments in FY 2004, so excluding them from our simulations would have introduced a different form of distortion into our simulations, by causing the simulations to disregard the impact of those hospitals. While excluding the 123 hospitals might produce a lower estimate of charge inflation, a lower estimate is not necessarily a better estimate. A charge inflation estimate that is too low could lead to a fixed loss outlier threshold that produces outlier payments farther from, instead of closer to, the target of 5.1 percent of operating DRG payments.
Finally, the court rulings state that if we decide to recalculate the FY 2004 fixed loss outlier threshold, we should also address any effect that recalculation has on the FY 2005 and FY 2006 outlier and fixed-loss thresholds. We are not recalculating the FY 2004 fixed-loss threshold. We also note that the fixed loss outlier thresholds are set based on new calculations each year without reference to the previous year's threshold; even if the FY 2004 threshold had been reset, there would be no reason to revisit the FY 2005 or FY 2006 calculation.
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Federal Communications Commission.
Final rule; announcement of effective date.
In this document, the Commission announces that the Office of Management and Budget (OMB) approved, on an emergency basis, a revision to an approved information collection to implement modified and new collection requirements on FCC Form 175, Application to Participate in an FCC Auction, contained in the
47 CFR 1.2105(a)(2), 1.2105(a)(2)(iii)-(vi), (a)(2)(viii)-(x), (a)(2)(xii), 1.2105(c)(3), and 1.2112(b)(1)(iii)-(vi), published at 80 FR 56764 on September 18, 2015, and
Contact Cathy Williams,
This document announces that, on January 14, 2016, OMB approved, on an emergency basis, a revision to an approved information collection to implement modified and new collection requirements on FCC Form 175, Application to Participate in an FCC Auction, and under 47 CFR 1.2105(a)(2), 1.2105(a)(2)(iii)-(vi), (a)(2)(viii)-(x), (a)(2)(xii), 1.2105(a)(3), 1.2105(c)(3), 1.2110(b)(1), 1.2112(b), and 1.2112(b)(1)(iii)-(vi), published at 80 FR 56764 on September 18, 2015. The OMB Control Number is 3060-0600. The Commission publishes this document as an announcement of the effective date of the rules and requirements. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 1-C823, 445 12th Street SW., Washington, DC 20554. Please include the OMB Control Number, 3060-0600, in your correspondence. The Commission will also accept your comments via the Internet if you send them to
To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to
As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the Commission is notifying the public that it received emergency approval from OMB on January 14, 2016 for the revised information collection requirements contained in the information collection 3060-0600, Application to Participate in an FCC Auction.
Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.
No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-0600. The foregoing document is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.
The total annual reporting burdens and costs for the respondents are as follows:
Office of Acquisition Policy, General Services Administration (GSA).
Correcting amendments.
GSA published a technical amendment document, GSAR-TA-01, which was published in the
Ms. Leah Price, Procurement Analyst, by phone at 703-605-2558, or email at
In order to update certain elements in 48 CFR parts 504 and 552, this document makes an editorial change to the GSAR.
Government procurement.
Therefore, GSA amends 48 CFR parts 504 and 552 as set forth below:
40 U.S.C. 121(c).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
NMFS issues this final rule to implement management measures described in Amendment 34 to the Fishery Management Plan (FMP) for the Snapper-Grouper Fishery of the South Atlantic Region, Amendment 9 to the FMP for the Golden Crab Fishery of the South Atlantic Region, and Amendment 8 to the FMP for the Dolphin and Wahoo Fishery of the Atlantic; collectively referred to as the Generic Accountability Measures (AM) and Dolphin Allocation Amendment (Generic AM Amendment), as prepared and submitted by the South Atlantic Fishery Management Council (Council). This final rule revises the commercial and recreational AMs for numerous snapper-grouper species and golden crab. This final rule also revises commercial and recreational sector allocations for dolphin in the Atlantic. The actions are intended to make the AMs consistent for snapper-grouper species addressed in the final rule and for golden crab, and revise the allocations between the commercial and recreational sectors for dolphin.
This final rule is effective February 22, 2016.
Electronic copies of the Generic AM Amendment, which includes an environmental assessment, a Regulatory Flexibility Act (RFA) analysis, and a regulatory impact review, may be obtained from the Southeast Regional Office Web site at
Mary Janine Vara, NMFS Southeast Regional Office, telephone: 727-824-5305, or email:
The snapper-grouper fishery in the South Atlantic is managed under the FMP for the Snapper-Grouper Fishery of the South Atlantic Region (Snapper-Grouper FMP). The golden crab fishery in the South Atlantic is managed under the FMP for the Golden Crab Fishery of the South Atlantic Region (Golden Crab FMP). The dolphin and wahoo fishery in the Atlantic is managed under the FMP for the Dolphin and Wahoo Fishery of the Atlantic (Dolphin Wahoo FMP). The FMPs were prepared by the Council and implemented by NMFS through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).
On July 15, 2015, NMFS published a notice of availability for the Generic AM Amendment in the
This final rule revises the AMs for golden tilefish, snowy grouper, gag grouper (gag), red grouper, black grouper, scamp, the other shallow-water grouper complex (SASWG: Red hind, rock hind, yellowmouth grouper, yellowfin grouper, coney, and graysby), greater amberjack, the other jacks complex (lesser amberjack, almaco jack, and banded rudderfish), bar jack, yellowtail snapper, mutton snapper, the other snappers complex (cubera snapper, gray snapper, lane snapper, dog snapper, and mahogany snapper), gray triggerfish, wreckfish (recreational sector), Atlantic spadefish, hogfish, red porgy, the other porgies complex (jolthead porgy, knobbed porgy, whitebone porgy, scup, and saucereye porgy), and golden crab (commercial sector).
This final rule modifies the AMs for these species, including those identified in the species complexes, to make them consistent with the majority of the AMs already in place for other snapper-grouper species. Specifically, the final rule updates the recreational AMs to allow NMFS to close the applicable recreational sector when the recreational annual catch limit (ACL) is met or projected to be met, unless NMFS determines that no closure is necessary based on the best scientific information available. This final rule also modifies the AMs to trigger post-season ACL reductions in the commercial and recreational sectors in the year following any ACL overage under certain situations.
If the recreational sector exceeds its ACL, NMFS will monitor the recreational sector for a persistence in increased landings during the following fishing year. In the following fishing year, if the best scientific information available determines it necessary, NMFS will publish a notice in the
If the commercial sector exceeds its ACL, NMFS will publish a notice in the
Modifying the AMs in this manner creates regulatory consistency among the majority of federally managed snapper-grouper species and golden crab in the South Atlantic region.
This final rule revises the commercial sector allocation to be 10 percent of the dolphin stock ACL with the ACL set at 1,534,485 lb (696,031 kg), round weight, and the recreational sector allocation for dolphin to be 90 percent of the stock ACL with the ACL set at 13,810,361 lb (6,264,274 kg), round weight. This change in sector allocations constitutes an equivalent ACL increase for the commercial sector and an ACL decrease for the recreational sector of 377,484 lb (171,224 kg), round weight.
In addition to the measures described in the Generic AM Amendment, this final rule clarifies the AM provisions in § 622.193 (the ACLs/AMs section of the regulations for South Atlantic snapper-grouper species) that will reduce a season length in the following recreational fishing year. These clarifications will aid law enforcement efforts. For those snapper-grouper species that have a post-season AM if a recreational ACL is exceeded, under certain conditions NMFS will reduce the season length (
In addition, this final rule removes and consolidates language in § 622.190(a)(6) for the red porgy commercial quota from past fishing years that is no longer applicable.
Finally, this final rule fixes an error in § 622.280 for Atlantic dolphin and wahoo. Atlantic dolphin and wahoo are managed off the Atlantic states (Maine through the east coast of Florida) via the Dolphin Wahoo FMP; however, in the AMs section of the codified text, the closure provisions currently apply in the South Atlantic EEZ only. This inadvertent error was implemented in the rulemaking for the Comprehensive ACL Amendment (77 FR 15916, March 16, 2011). This final rule changes “South Atlantic EEZ” to “Atlantic EEZ” in the AMs for dolphin and wahoo in paragraphs (a)(1)(i) and (b)(1)(i) of § 622.280, which is consistent with the FMP for management of these species from Maine through the east coast of Florida.
NMFS received comments from individuals, fishing associations, a marine resource conservation group, a seafood dealer, and a municipal chamber of commerce on the notice of availability and the proposed rule for the Generic AM Amendment, along with other issues. NMFS received comments that were beyond the scope of the notice of availability and proposed rule, and therefore, they have not been addressed in this final rule. The 19 unique comments that relate to one or more of the management actions in the Generic AM Amendment and the proposed rule are summarized and responded to below.
Fishermen with Federal commercial vessel permits for dolphin and wahoo may not retain HMS species without the relevant Federal HMS permit. Fishing for dolphin with J-hooks is allowed under the Dolphin Wahoo FMP, and the use of circle hooks was not considered in the Generic AM Amendment, although the Council could consider measures in a future amendment to require the use of circle hooks. At this time, fishermen with Federal commercial vessel permits for dolphin and wahoo are not required to carry observers under the Dolphin Wahoo FMP, but they are required to complete logbooks for retained and discarded catch and report that information to NMFS. Additionally, at this time, the Council has not chosen to further restrict the number of commercial vessel permit holders who may fish for dolphin using pelagic longline gear.
Studies that consider the economic efficiency of allocating dolphin between the commercial and recreational sectors are not currently available. The absence of such studies precludes the determination of the economic efficiency gains and losses to the commercial or recreational sector, and net gains or losses to the public as a whole, from each of the allocation alternatives within the Generic AM Amendment. The economic analysis notes that, with the recreational sector's harvest being well below its allocation, decreasing the recreational allocation by 2.46 percentage points (with an equivalent increase to the commercial allocation) would have no adverse economic impacts on the recreational sector.
Because the commercial ACL is increasing, there is a chance the small portion of the fishery that uses longlines may increase or those that already use that gear type may increase their fishing effort. Since longline gear have the potential to catch a large number of dolphin at one time, an increase in longline effort could result in temporary localized depletion. However, NMFS does not expect localized depletion of dolphin since only a small subset of Federal dolphin wahoo commercial permit holders (11 vessels) use pelagic longlines to harvest dolphin and, given the small increase in the commercial allocation being implemented in this amendment, it is unlikely that longlining effort for dolphin would
Both the commercial and recreational sectors for dolphin are limited to their respective ACLs and the AMs that are in place. The current system of AMs is designed to prevent the ACLs from being exceeded, and to correct for any ACL overages if they occur.
The Regional Administrator, Southeast Region, NMFS has determined that this final rule is consistent with the Generic AM Amendment, the FMPs, the Magnuson-Stevens Act, and other applicable laws.
This final rule has been determined to be not significant for purposes of Executive Order 12866.
The Magnuson-Stevens Act provides the statutory basis for this rule.
In compliance with section 604 of the RFA, NMFS prepared a Final Regulatory Flexibility Analysis (FRFA) for this final rule. The FRFA incorporates the Initial Regulatory Flexibility Analysis (IRFA), a summary of the significant economic issues raised by public comment, NMFS' responses to those comments, and a summary of the analyses completed to support the action. The FRFA follows.
NMFS also expects this final rule to directly affect federally permitted commercial fishermen harvesting dolphin in the South Atlantic and off states north of North Carolina (northeastern states).
Charter vessels and headboats (for-hire vessels) sell fishing services, which include the harvest of any species considered in this final rule, to recreational anglers. These vessels provide a platform for the opportunity to fish and not a guarantee to catch or harvest any species, though expectations of successful fishing, however defined, likely factor into the decision to purchase these services. Any change in demand for these fishing services and associated economic affects as a result of regulatory changes will be a consequence of behavioral change by anglers, secondary to any direct effect on anglers and, therefore, an indirect effect of the regulatory action. Because the effects on for-hire vessels will be indirect, they fall outside the scope of the RFA. Recreational anglers, who may be directly affected by the changes in this final rule, are not small entities under the RFA.
To serve as a benchmark for determining whether a business entity is a small entity, the Small Business Administration (SBA) established size criteria for all major industry sectors in the U.S., including fish harvesters and for-hire operations. A business involved in fish harvesting is classified as a small business if independently owned and operated, is not dominant in its field of operation (including its affiliates), and its combined annual receipts are not in excess of $20.5 million (NAICS code 114111, finfish fishing) for all of its affiliated operations worldwide.
The snapper-grouper fishery is a multi-species fishery and vessels generally land many species on the same trips. Vessels in the dolphin fishery also catch other species jointly with dolphin. The golden crab fishery is more specialized than either the snapper-grouper or dolphin fishery, and there is a comparatively lower proportion of bycatch; as a result, the target species, golden crab, dominates the total catch during a trip.
Because of the possibility that some vessels land only species not affected by this final rule, the following provides a description of vessels and their revenues by focusing on the key species (black grouper, mutton snapper, yellowtail snapper, greater amberjack, red porgy, gag, golden tilefish, red grouper, snowy grouper, wreckfish, golden crab, and dolphin) addressed in this final rule. These species provide higher landings and revenues than the other affected species, such that focusing on them should provide enough information to determine if certain small entities (
Approximately 188 vessels landing at least 1 lb (0.45 kg) of black grouper generated approximately $54,000 in revenues from black grouper and other species; 266 vessels landing at least 1 lb (0.45 kg) of mutton snapper had revenues of approximately $51,000 from mutton snapper and other species; 252 vessels landing at least 1 lb (0.45 kg) yellowtail snapper had revenues of approximately $38,000 from yellowtail snapper and other species; 295 vessels landing at least 1 lb (0.45 kg) of greater amberjack had revenues of approximately $53,000 from greater amberjack and other species; 191 vessels landing at least 1 lb (0.45 kg) of red porgy had revenues of approximately $60,000 from red porgy and other species; 273 vessels landing at least 1 lb (0.45 kg) of gag had revenues of approximately $49,000 from gag and other species; 63 vessels landing at least 1 lb (0.45 kg) of golden tilefish had revenues of approximately $68,000 from golden tilefish and other species; 278 vessels landing at least 1 lb (0.45 kg) of red grouper had revenues of approximately $50,000 from red grouper and other species; 138 vessels landing at least 1 lb (0.45 kg) of snowy grouper had revenues of approximately $78,000 from snowy grouper and other species; and 488 vessels landing at least 1 lb (0.45 kg) of dolphin had revenues of approximately $64,000 from dolphin and other species. Revenues for vessels landing at least 1 lb (0.45 kg) of wreckfish or golden crab can be approximated based on total revenues from landings of those species and the number of permits. As of August 6, 2015, there were 5 Federal wreckfish commercial permits and 11 Federal golden crab commercial permits. For fishing years 2009/2010 through 2013/2014, annual revenues from wreckfish landings averaged $752,881, implying average annual revenue per wreckfish
Some vessels, other than those in the golden crab fishery, may have caught and landed a combination of the 12 key species, hogfish, and unassessed snapper-grouper species, and revenues therefrom are included in the foregoing estimates.
Vessels that caught and landed any of the species addressed in this final rule may also operate in other fisheries, the revenues of which are not known due to lack of information and are not reflected in these totals.
Based on the revenue information provided above, all commercial vessels expected to be affected by this final rule are assumed to be small entities.
Because all entities expected to be affected by this final rule are assumed to be small entities, NMFS has determined that this rule will affect a substantial number of small entities. However, the issue of disproportionate effects on small versus large entities does not arise in the present case.
Designating a species to be overfished presupposes a stock assessment has been completed, implying that the ACL payback action,
Based on landings history, it is likely that the payback action for snowy grouper in this final rule will adversely affect the profits of commercial vessels. The amount of payback for any ACL overages and resulting profit loss to the commercial vessels cannot be estimated due to lack of information. However, current Federal regulations enable NMFS to implement a snowy grouper in-season closure for the commercial sector and in-season monitoring and possible closure for the recreational sector if the respective sector's ACL is reached or projected to be reached. In addition, this final rule will implement an in-season closure for the snowy grouper recreational sector once the recreational ACL is reached or is projected to be reached.
These current measures and this final rule are expected to limit the amount of any ACL overage, meaning that the resulting loss in profits to commercial vessels due to the ACL payback provision should be small.
The commercial and recreational sector re-allocation of the ACL for dolphin will increase the ACL share of the commercial sector at the expense of the recreational sector. In theory, this would tend to increase the revenues or profits of commercial vessels and potentially reduce the revenues or profits of for-hire vessels. In practice, commercial vessels are not expected to experience any profit changes in the near-term based on historical landings for the sector from 2009 through 2013. Relative to the new sector allocations, based on applying the new allocation ratios to the current total ACL, commercial landings of dolphin (based on 2009-2013 commercial landings) are projected to range from 33 percent to 80 percent of the commercial ACL. In the years 2009 through 2013, the highest commercial landings occurred in 2009 and the lowest in 2013. However, commercial fishing for dolphin closed this fishing year on June 30, 2015, when the commercial sector reached its ACL. If future commercial landings of dolphin were equal to or greater than they were in 2015, the new allocation ratio may be expected to increase the revenues, and possibly profits, of commercial vessels. As noted earlier, for-hire vessels will only be affected indirectly by this final rule.
Because the commercial and recreational sector re-allocation of the ACL for dolphin is not expected to result in any negative effects on any directly affected entities, the issue of significant alternatives to reduce any significant negative effects is not relevant.
Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as small entity compliance guides. As part of the rulemaking process, NMFS prepared a fishery bulletin, which also serves as a small entity compliance guide. The fishery bulletin will be sent to all interested parties.
Accountability measure, Annual catch limit, Dolphin, Fisheries, Fishing, Golden crab, Snapper-grouper, South Atlantic.
For the reasons set out in the preamble, 50 CFR part 622 is amended as follows:
16 U.S.C. 1801
(a) * * *
(6)
(a)
(ii)
(iii) If commercial landings for golden tilefish, as estimated by the SRD, exceed the commercial ACL (including both the hook-and-line and longline component ACLs) specified in § 622.190(a)(2)(i), and the combined commercial and recreational ACL of 558,036 lb (253,121 kg), gutted weight, 625,000 lb (283,495 kg), round weight, is exceeded during the same fishing year, and golden tilefish are overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for golden tilefish, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if the species is overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 558,036 lb (253,121 kg), gutted weight, 625,000 lb (285,495 kg), round weight, is exceeded during the same fishing year. The AA will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for golden tilefish in or from the South Atlantic EEZ are zero.
(b)
(ii) If commercial landings for snowy grouper, as estimated by the SRD, exceed the commercial ACL, and the combined commercial and recreational ACL specified in § 622.193(b)(1)(iii) is exceeded, and snowy grouper are overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(iii) The combined commercial and recreational ACL for snowy grouper is 139,098 lb (63,094 kg), gutted weight, 164,136 lb (74,451 kg), round weight, for 2015; 151,518 lb (68,727 kg), gutted weight, 178,791 lb (81,098 kg), round weight, for 2016; 163,109 lb (73,985 kg), gutted weight, 192,469 lb (87,302 kg), round weight, for 2017; 173,873 lb (78,867 kg), gutted weight, 205,170 lb (93,064 kg), round weight, for 2018; 185,464 lb (84,125 kg), gutted weight, 218,848 lb (99,268 kg), round weight, for 2019 and subsequent years.
(2)
(ii) If recreational landings for snowy grouper, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if snowy grouper are overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL specified in § 622.193(b)(1)(iii) is exceeded during the same fishing year. NMFS will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for snowy grouper in or from the South Atlantic EEZ are zero.
(c)
(ii) If the commercial landings for gag, as estimated by the SRD, exceed the commercial ACL specified in § 622.193(c)(1)(iii), and the combined commercial and recreational ACL specified in § 622.193(c)(1)(iv), is exceeded during the same fishing year, and gag are overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(iii) The commercial ACL for gag is 322,677 lb (146,364 kg), gutted weight, 380,759 lb (172,709 kg), round weight, for 2015; 325,100 lb (147,463 kg), gutted weight, 383,618 lb (174,006 kg), round weight, for 2016; 345,449 lb (197,516 kg), gutted weight, 407,630 lb (184,898 kg), round weight, for 2017; 362,406 lb (164,385 kg), gutted weight, 427,639 lb (193,974 kg), round weight, for 2018; and 374,519 lb (169,879 kg), gutted weight, 441,932 lb (200,457 kg), round weight, for 2019 and subsequent fishing years.
(iv) The combined commercial and recreational ACL for gag is 632,700 lb (286,988 kg), gutted weight, 746,586 lb (338,646 kg), round weight, for 2015; 637,451 lb (289,143 kg), gutted weight, 752,192 lb (341,189 kg), round weight, for 2016; 677,351 lb (307,241 kg), gutted weight, 799,274 lb (362,545 kg), round weight, for 2017; 710,600 lb (322,323 kg), gutted weight, 838,508 lb (380,341 kg), round weight, for 2018; and 734,351 lb (333,096 kg), gutted weight, 866,534 lb (393,053 kg), round weight, for 2019 and subsequent fishing years.
(2)
(ii) If recreational landings for gag, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if the species is overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL specified in § 622.193(c)(1)(iv) is exceeded during the same fishing year. NMFS will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for gag in or from the South Atlantic EEZ are zero.
(d)
(ii) If the commercial landings for red grouper, as estimated by the SRD, exceed the commercial ACL, and the combined commercial and recreational ACL of 780,000 lb (353,802 kg), round weight, is exceeded during the same fishing year, and the species is overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL in the following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for red grouper, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if the species is overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 780,000 lb (353,802 kg), round weight, is exceeded during the same fishing year. The AA will use the best scientific information available to determine if reducing the length of the recreational season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for red grouper in or from the South Atlantic EEZ are zero.
(g)
(ii) If commercial landings for black grouper, as estimated by the SRD, exceed the commercial ACL, and the combined commercial and recreational ACL of 262,594 lb (119,111 kg), round weight, is exceeded during the same fishing year, and the species is overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for black grouper, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if black grouper are overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 262,594 lb (119,111 kg), round weight, is exceeded during the same fishing year. NMFS will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for black grouper in or from the South Atlantic EEZ are zero.
(i)
(ii) If commercial landings for scamp, as estimated by the SRD, exceed the commercial ACL, and the combined commercial and recreational ACL of 335,744 lb (152,291 kg), round weight, is exceeded, and scamp are overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for scamp, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if scamp are overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 335,744 lb (152,291 kg), round weight, is exceeded during the same fishing year. NMFS will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for scamp in or from the South Atlantic EEZ are zero.
(j)
(ii) If commercial landings for other SASWG combined, as estimated by the SRD, exceed the commercial ACL, and the combined commercial and recreational ACL of 104,190 lb (47,260 kg), round weight, is exceeded, and at least one of the species in other SASWG combined is overfished based on the most recent status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for other SASWG combined, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if at least one of the species in other SASWG combined is overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 104,190 lb (47,260 kg) is exceeded during the same fishing year. NMFS will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for any species in the other SASWG combined in or from the South Atlantic EEZ are zero.
(k)
(ii) If commercial landings for greater amberjack, as estimated by the SRD, exceed the commercial ACL, and the combined commercial and recreational ACL of 1,968,001 lb (892,670 kg), round weight, is exceeded during the same fishing year, and the species is overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL in the following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for greater amberjack, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and recreational ACL by the amount of the recreational ACL overage, if the species is overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 1,968,001 lb (892,670 kg), round weight, is exceeded during the same fishing year. The AA will use the best scientific information available to determine if reducing the length of the recreational season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for greater amberjack in or from the South Atlantic EEZ are zero.
(l)
(ii) If commercial landings for the other jacks complex, as estimated by the SRD, exceed the commercial ACL, and the combined commercial and recreational ACL of 457,221 lb (207,392 kg), round weight, is exceeded, and at least one of the species in the other jacks complex is overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for the other jacks complex, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if at least one of the species in the other jacks complex is overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 457,221 lb (207,392 kg), round weight, is exceeded during the same fishing year. NMFS will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for any species in the other jacks complex in or from the South Atlantic EEZ are zero.
(m)
(ii) If commercial landings for bar jack, as estimated by the SRD, exceed the commercial ACL, and the combined commercial and recreational ACL of 62,249 lb (28,236 kg), round weight, is exceeded, and bar jack are overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for bar jack, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if bar jack are overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 62,249 lb (28,236 kg), round weight, is exceeded during the same fishing year. NMFS will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for bar jack in or from the South Atlantic EEZ are zero.
(n)
(ii) If commercial landings for yellowtail snapper, as estimated by the SRD, exceed the commercial ACL, and the combined commercial and recreational ACL of 3,037,500 lb (1,377,787 kg), round weight, is exceeded during the same fishing year, and yellowtail snapper are overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for yellowtail snapper, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if the species is overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 3,037,500 lb (1,377,787 kg), round weight, is exceeded during the same fishing year. The AA will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for yellowtail snapper in or from the South Atlantic EEZ are zero.
(o)
(ii) If commercial landings for mutton snapper, as estimated by the SRD, exceed the commercial ACL, and the combined commercial and recreational ACL of 926,600 lb (420,299 kg), round weight, is exceeded during the same fishing year, and the species is overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL in the following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for mutton snapper, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if the species is overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 926,600 lb (420,299 kg), round weight, is exceeded during the same fishing year. NMFS will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for mutton snapper in or from the South Atlantic EEZ are zero.
(p)
(ii) If commercial landings for the other snappers complex, as estimated by the SRD, exceed the commercial ACL, and the combined commercial and recreational ACL of 1,517,716 lb (688,424 kg), round weight, is exceeded, and at least one of the species in the other snappers complex is overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for the other snappers complex, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if at least one of the species in the other snappers complex is overfished based on the most recent Status of U.S. Fisheries Report to Congress, and the combined commercial and recreational ACL of 1,517,716 lb (688,424 kg), round weight, is exceeded during the same fishing year. NMFS will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for any species in the other snappers complex in or from the South Atlantic EEZ are zero.
(q)
(ii) If commercial landings for gray triggerfish, as estimated by the SRD, exceed the commercial ACL, and the combined commercial and recreational ACL of 716,999 lb (325,225 kg), round weight, is exceeded, and gray triggerfish are overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for gray triggerfish, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if gray triggerfish are overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 716,999 lb (325,225 kg), round weight, is exceeded during the same fishing year. NMFS will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for gray triggerfish in or from the South Atlantic EEZ are zero.
(r)
(ii) The combined commercial and recreational ACL for wreckfish is 433,000 lb (196,405 kg), round weight, for 2015; 423,700 lb (192,187 kg), round weight, for 2016; 414,200 lb (187,878 kg), round weight, for 2017; 406,300 lb (184,295 kg), round weight, for 2018; 396,800 lb (179,985 kg), round weight, for 2019; and 389,100 lb (176,493 kg), round weight, for 2020 and subsequent fishing years.
(2)
(ii) If recreational landings for wreckfish, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if the species is overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL specified in § 622.193(r)(1)(ii) is exceeded during the same fishing year. The AA will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for wreckfish in or from the South Atlantic EEZ are zero.
(iii) The recreational ACL for wreckfish is 21,650 lb (9,820 kg), round weight, for 2015; 21,185 lb (9,609 kg), round weight, for 2016; 20,710 lb (9,394 kg), round weight, for 2017; 20,315 lb (9,215 kg), round weight, for 2018; 19,840 lb (8,999 kg), round weight, for 2019; and 19,455 lb (8,825 kg), round weight, for 2020 and subsequent fishing years.
(t)
(ii) If commercial landings for Atlantic spadefish, as estimated by the SRD, exceed the ACL, and the combined commercial and recreational ACL of 812,478 lb (368,534 kg), round weight, is exceeded, and Atlantic spadefish are overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for Atlantic spadefish, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if Atlantic spadefish are overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 812,478 lb (368,534 kg), round weight, is exceeded during the same fishing year. NMFS will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for Atlantic spadefish in or from the South Atlantic EEZ are zero.
(u)
(ii) If commercial landings for hogfish, as estimated by the SRD, exceed the commercial ACL, and the combined commercial and recreational ACL of 134,824 lb (61,155 kg), round weight, is exceeded, and hogfish are overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for hogfish, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if hogfish are overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 134,824 lb (61,155 kg), round weight, is exceeded during the same fishing year. NMFS will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for hogfish in or from the South Atlantic EEZ are zero.
(v)
(ii) If commercial landings for red porgy, as estimated by the SRD, exceed the commercial ACL, and the combined commercial and recreational ACL of 315,384 lb (143,056 kg), gutted weight, 328,000 lb (148,778 kg), round weight, is exceeded during the same fishing year, and red porgy are overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL in the following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for red porgy, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if the species is overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 315,384 lb (143,056 kg), gutted weight, 328,000 lb (148,778 kg), round weight, is exceeded during the same fishing year. The AA will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for red porgy in or from the South Atlantic EEZ are zero.
(w)
(ii) If commercial landings for the other porgies complex, as estimated by the SRD, exceed the commercial ACL, and the combined commercial and recreational ACL of 143,262 lb (64,983 kg), round weight, is exceeded, and at least one of the species in the complex is overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for the other porgies complex, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if one of the species in the complex is overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 143,262 lb (64,983 kg), round weight, is exceeded during the same fishing year. NMFS will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for any species in the other porgies complex in or from the South Atlantic EEZ are zero.
(x)
(ii) If commercial landings for the grunts complex, as estimated by the SRD, exceed the commercial ACL, and the combined commercial and recreational ACL of 836,025 lb (379,215 kg), round weight, and at least one of the species in the complex is overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register, at or near the beginning of the following fishing year to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.
(2)
(ii) If recreational landings for the grunts complex, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if at least one of the species in the grunts complex is overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 836,025 lb (379,215 kg), round weight, is exceeded during the same fishing year. NMFS will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for any species in the grunts complex in or from the South Atlantic EEZ are zero.
(a)
(2) If commercial landings for golden crab, as estimated by the SRD, exceed the ACL, and the species is overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the ACL in the following fishing year by the amount of the ACL overage in the prior fishing year.
(a) * * *
(1) * * *
(i) If commercial landings for Atlantic dolphin, as estimated by the SRD, reach or are projected to reach the commercial ACL of 1,534,485 lb (696,031 kg), round weight, the AA will file a notification with the Office of the Federal Register to close the commercial sector for the remainder of the fishing year. On and after the effective date of such a notification, all sale or purchase of Atlantic dolphin is prohibited and harvest or possession of Atlantic dolphin in or from the Atlantic EEZ is limited to the bag and possession limits. These bag and possession limits apply in the Atlantic on board a vessel for which a valid Federal commercial or charter vessel/headboat permit for Atlantic dolphin and wahoo has been issued, without regard to where such species were harvested,
(2) * * *
(i) If recreational landings for Atlantic dolphin, as estimated by the SRD, exceed the recreational ACL of 13,810,361 lb (6,264,274 kg), round weight, then during the following fishing year recreational landings will be monitored for a persistence in increased landings.
(b) * * *
(1) * * *
(i) * * * On and after the effective date of such a notification, all sale or purchase of Atlantic wahoo is prohibited and harvest or possession of Atlantic wahoo in or from the Atlantic EEZ is limited to the bag and possession limits. These bag and possession limits apply in the Atlantic on board a vessel for which a valid Federal commercial or charter vessel/headboat permit for Atlantic dolphin and wahoo has been issued, without regard to where such species were harvested,
Privacy Office, Department of Homeland Security.
Notice of proposed rulemaking.
The Department of Homeland Security is giving concurrent notice of an updated and reissued system of records pursuant to the Privacy Act of 1974 for the “Department of Homeland Security/ALL-030 Use of the Terrorist Screening Database System of Records” and this proposed rulemaking. In this proposed rulemaking, the Department proposes to exempt portions of the system of records from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements.
Comments must be received on or before February 22, 2016.
You may submit comments, identified by docket number DHS-2016-0001 by one of the following methods:
•
•
•
For general questions or privacy issues please contact: Karen L. Neuman, (202-343-1717), Chief Privacy Officer, Privacy Office, Department of Homeland Security, Washington, DC 20528.
In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the Department of Homeland Security (DHS) is giving notice of a proposed rule to accompany an updated system of records notice titled, “DHS/ALL-030 Use of the Terrorist Screening Database (TSDB) System of Records.”
DHS maintains a synchronized copy of the Department of Justice (DOJ)/Federal Bureau of Investigation (FBI)-019 Terrorist Screening Records System of Records (August 22, 2007, 72 FR 47073) via a technological mechanism called DHS Watchlist Service (WLS) that disseminates the feed to authorized DHS components. The WLS supports an automated and centralized data transmission of TSDB data to DHS. The WLS replaced multiple data feeds from the FBI/TSC to DHS and its components, as documented by information sharing agreements. The WLS is a system to system secure connection with no direct user interface.
DHS is publishing this notice of proposed rulemaking to account for the expansion of the current system of records notice to clarify one category of individuals and add two new categories of individuals whose information is currently included in, or is contemplated for inclusion in, the TSDB. These categories of information have been included in the TSDB to in support of the White House's “Strategy to Combat Transnational Organized Crime” (July 19, 2011), and National Security Presidential Directive-59/Homeland Security Presidential Directive-24, “Biometrics for Identification and Screening to Enhance National Security” (June 5, 2008). These executive strategies are relevant to DHS's vetting and screening operations.
DHS is clarifying the category of individuals to explicitly include relatives, associates, or others closely connected with a known or suspected terrorist who are excludable from the United States based on these relationships by virtue of sec. 212(a)(3)(B) of the Immigration and Nationality Act, as amended, and do not otherwise satisfy the requirements for inclusion in the TSDB.
DHS is adding two new categories of individuals to include: (1) Individuals who were officially detained during military operations, but not as enemy prisoners of war, and who have been identified as possibly posing a threat to national security, and who do not otherwise satisfy the requirements for inclusion in the TSDB (“military detainees”), consistent with E.O. 12333 (or successor order) and the DOJ/FBI-019; and (2) individuals who may pose a threat to national security because they are (a) known or suspected to be or have been engaged in conduct constituting, in aid of, or related to transnational organized crime, thereby posing a possible threat to national security, and (b) do not otherwise satisfy the requirements for inclusion in the TSDB (“transnational organized crime actors”), consistent with E.O. 12333 (or successor order) (“national security threats”) and in support of the White House's “Strategy to Combat Transnational Organized Crime” (July 19, 2011), and National Security Presidential Directive-59/Homeland Security Presidential Directive-24, “Biometrics for Identification and Screening to Enhance National Security” (June 5, 2008).
DHS is also publishing this notice of proposed rulemaking to account for the expansion of the current system of records to clarify and expand the categories of records maintained by the Department. These categories of records are types of data elements included in the TSDB and are shared with DHS and have been deemed relevant to supporting DHS's vetting and screening operations.
1. Identifying biographic information, such as name, date of birth, place of birth, passport or driver's license information, and any other available identifying particulars used to compare the identity of an individual being screened with a subject in the TSDB;
2. Biometric information, such as photographs, fingerprints, or iris images, and associated biographic and contextual information;
3. References to, or information from, other government law enforcement and intelligence databases, or other relevant
4. Information collected and compiled to maintain an audit trail of the activity of authorized users of WLS information systems; and
5. System-generated information, including metadata, archived records and record histories from WLS.
DHS is planning future enhancements to the WLS that will provide for a central mechanism to receive information from DHS components when they encounter a potential match to the TSDB and send this information to the FBI/TSC. DHS will update this SORN to reflect such enhancements to the WLS once that capability is implemented. All encounter-related information sharing from DHS to the FBI/TSC will be conducted pursuant to the programmatic system of records notices outlined above.
DHS previously published a Final Rule in the
The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which Federal Government agencies collect, maintain, use, and disseminate personally identifiable information. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. As a matter of policy, DHS extends administrative Privacy Act protections to all individuals where systems of records maintain information on U.S. citizens, lawful permanent residents, and visitors.
The Privacy Act allows government agencies to exempt certain records from the access and amendment provisions. If an agency claims an exemption, however, it must issue a Notice of Proposed Rulemaking to make clear to the public the reasons why a particular exemption is claimed.
DHS is claiming exemptions from certain requirements of the Privacy Act for DHS/ALL-030 Use of the Terrorist Screening Database System of Records. Some information in DHS/ALL-030 Use of the Terrorist Screening Database System of Records relates to official DHS national security and law enforcement activities. These exemptions are needed to protect information relating to DHS activities from disclosure to subjects or others related to these activities. Specifically, the exemptions are required to preclude subjects of these activities from frustrating these processes. Disclosure of information to the subject of the inquiry could also permit the subject to avoid detection or apprehension. In appropriate circumstances, when compliance would not appear to interfere with or adversely affect the law enforcement purposes of this system and the overall law enforcement process, the applicable exemptions may be waived on a case-by-case basis.
A notice of system of records for DHS/ALL-030 Use of the Terrorist Screening Database System of Records is also published elsewhere in this issue of the
Freedom of information; Privacy.
For the reasons stated in the preamble, DHS proposes to amend Chapter I of Title 6, Code of Federal Regulations, as follows:
6 U.S.C. 101
66. The DHS/ALL-030 Use of the Terrorist Screening Database System of Records consists of electronic and paper records and will be used by DHS and its components. The DHS/ALL-030 Use of the Terrorist Screening Database System of Records is a repository of information held by DHS in connection with its several and varied missions and functions, including, the enforcement of civil and criminal laws; investigations, inquiries, and proceedings there under; and national security and intelligence activities. The DHS/ALL-030 Use of the Terrorist Screening Database System of Records contains information that is collected by, on behalf of, in support of, or in cooperation with DHS and its components and may contain personally identifiable information collected by other Federal, State, local, tribal, foreign, or international government agencies. The Secretary of Homeland Security, pursuant to 5 U.S.C. 552a(j)(2), has exempted this system from the following provisions of the Privacy Act: 5 U.S.C. 552a(c)(3), (c)(4), (d), (e)(1), (e)(2), (e)(3), (e)(4)(G), (e)(4)(H), (e)(4)(I), (e)(5), (e)(8), (f), and (g). Additionally, the Secretary of Homeland Security, pursuant to 5 U.S.C. 552a(k)(1) and (k)(2), has exempted this system from the following provisions of the Privacy Act: 5 U.S.C. 552a(c)(3), (d), (e)(1), (e)(4)(G), (e)(4)(H), (e)(4)(I), and (f). When a record received from another system has been exempted in that source system under 5 U.S.C. 552a(j)(2), DHS will claim the same exemptions for those records that are claimed for the original primary systems of records from which they originated and claims any additional exemptions set forth here. Exemptions from these particular subsections are justified, on a case-by-case basis to be determined at the time a request is made, for the following reasons:
(a) From subsection (c)(3) and (4) (Accounting for Disclosures) because release of the accounting of disclosures could alert the subject of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of that investigation and reveal investigative interest on the part of DHS as well as the recipient agency. Disclosure of the accounting would therefore present a serious impediment to law enforcement efforts and/or efforts to preserve national security. Disclosure of the accounting would also permit the individual who is the subject of a record to impede the investigation, to tamper with witnesses or evidence, and to avoid detection or apprehension, which would undermine the entire investigative process.
(b) From subsection (d) (Access to Records) because access to the records contained in this system of records could inform the subject of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of that investigation and reveal investigative interest on the part of DHS or another agency. Access to the records could permit the individual who is the subject of a record to impede the investigation, to tamper with witnesses or evidence, and to avoid detection or apprehension. Amendment of the records could interfere with ongoing investigations and law enforcement activities and would impose an unreasonable administrative burden by requiring investigations to be continually reinvestigated. In addition, permitting access and amendment to such information could disclose security-sensitive information that could be detrimental to homeland security.
(c) From subsection (e)(1) (Relevancy and Necessity of Information) because in the course of investigations into potential violations of Federal law, the accuracy of information obtained or introduced
(d) From subsection (e)(2) (Collection of Information from Individuals) because requiring that information be collected from the subject of an investigation would alert the subject to the nature or existence of the investigation, thereby interfering with that investigation and related law enforcement activities.
(e) From subsection (e)(3) (Notice to Subjects) because providing such detailed information could impede law enforcement by compromising the existence of a confidential investigation or reveal the identity of witnesses or confidential informants.
(f) From subsections (e)(4)(G), (e)(4)(H), and (e)(4)(I) (Agency Requirements) and (f) (Agency Rules), because portions of this system are exempt from the individual access provisions of subsection (d) for the reasons noted above, and therefore DHS is not required to establish requirements, rules, or procedures with respect to such access. Providing notice to individuals with respect to existence of records pertaining to them in the system of records or otherwise setting up procedures pursuant to which individuals may access and view records pertaining to themselves in the system would undermine investigative efforts and reveal the identities of witnesses, and potential witnesses, and confidential informants.
(g) From subsection (e)(5) (Collection of Information) because with the collection of information for law enforcement purposes, it is impossible to determine in advance what information is accurate, relevant, timely, and complete. Compliance with subsection (e)(5) would preclude DHS agents from using their investigative training and exercise of good judgment to both conduct and report on investigations.
(h) From subsection (e)(8) (Notice on Individuals) because compliance would interfere with DHS's ability to obtain, serve, and issue subpoenas, warrants, and other law enforcement mechanisms that may be filed under seal and could result in disclosure of investigative techniques, procedures, and evidence.
(i) From subsection (g) (Civil Remedies) to the extent that the system is exempt from other specific subsections of the Privacy Act.
Federal Energy Regulatory Commission. DOE.
Proposed rule; request for comment on filing.
Take notice that on January 11, 2016, the North American Energy Standards Board (NAESB) filed a report with the Commission stating it had approved a minor correction to Standard No. 1.3.22 (ii) of Version 3.0 of the NAESB Wholesale Gas Quadrant standards, which were incorporated by reference in the Commission's regulations by order issued by the Commission on October 16, 2015. Comments are invited on whether to incorporate this minor correction by reference in the Commission's regulations.
Comments are due on or before February 10, 2016.
Comments, identified by docket number, may be filed in the following ways:
•
•
Gary D. Cohen (legal issues), Office of the General Counsel, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, Telephone: (202) 502-8321, Email:
Comments are requested on whether to incorporate by reference the following NAESB Wholesale Gas Quadrant Standard into § 284.12 of the Commission's regulations: Nominations Related Standards (Version 3.0, November 14, 2014, with minor corrections applied through June 29, 2015 and MC15021 effective November 25, 2015).
Office of Management and Budget Circular A-119 (section 11) (February 10, 1998) provides that federal agencies should publish a request for comment in a Notice of Proposed Rulemaking when the agency is seeking to issue or revise a regulation proposing to adopt a voluntary consensus standard or a government-unique standard. Standard 1.3.22 would be incorporated by reference.
The Office of the Federal Register requires agencies incorporating material by reference in final rules to discuss, in the preamble of the final rule, the ways that the materials it incorporates by reference are reasonably available to interested parties and how interested parties can obtain the materials.
The procedures used by NAESB make its standards reasonably available to those affected by the Commission regulations, which is comprised of entities that have the means to acquire the information they need to effectively participate in Commission proceedings. Participants can join NAESB, for an annual membership cost of only $7,000, which entitles them to full participation in NAESB and enables them to obtain these standards at no additional cost.
Food and Drug Administration, HHS.
Proposed rule; reopening of the comment period.
In the
Submit either electronic or written comments on information collection issues under the PRA by February 22, 2016.
Submit comments on information collection issues to the Office of Management and Budget in the following ways:
• Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
On November 18, 2015 (80 FR 71990), the Food and Drug Administration (FDA) published a proposed rule entitled, “Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods.” In the
Food and Drug Administration, HHS.
Proposed order.
The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the cranial electrotherapy stimulator (CES) devices intended to treat insomnia and/or anxiety, a preamendments class III device, into class II (special controls) and subject to premarket notification, and to require the filing of a premarket approval application (PMA) for CES devices intended to treat depression. FDA is proposing the reclassification of CES devices intended to treat insomnia and/or anxiety under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) based on new information pertaining to the device. This proposed action would implement certain statutory requirements. FDA is also clarifying the identification for CES devices in this proposed order by identifying CES as a prescription device that applies electrical current that is not intended to induce a seizure to a patient's head to treat psychiatric conditions. This clarification distinguishes CES from electroconvulsive therapy (ECT).
Submit either electronic or written comments on this proposed order by April 21, 2016. See sections IX and XVII of this document for, respectively, the proposed dates when the new requirements apply and the proposed effective date of a final order based on this proposed order.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• 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
Michael Ryan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993, 301-796-6283,
The FD&C Act, as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629), Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), among other amendments, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).
Under section 513(d) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976 (generally referred to as preamendments devices), are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.
Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification (510(k)) procedures to such a preamendments device or to a device within that type (both the preamendments and substantially equivalent devices are referred to as preamendments class III devices) may be marketed without submission of a PMA until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval.
Although under the FD&C Act the manufacturer of a preamendments class III device may respond to the call for PMAs by filing a PMA or a notice of completion of a product development protocol (PDP), in practice the option of filing a notice of completion of a PDP has not been used. For simplicity, although corresponding requirements for PDPs remain available to manufacturers in response to a final order under section 515(b) of the FD&C Act, this document will refer only to the requirement for the filing and receiving approval of a PMA.
On July 9, 2012, FDASIA was enacted. Sections 608(a) and (b) of FDASIA (126 Stat. 1056) amended sections 513(e) and 515(b) of the FD&C Act, changing the mechanism for, respectively, reclassifying a device and requiring premarket approval for a preamendments class III device from rulemaking to an administrative order.
FDA is publishing this document to propose the reclassification of CES devices to treat insomnia and/or anxiety from class III to class II.
Section 513(e) of the FD&C Act provides that FDA may, by administrative order, reclassify a device based upon “new information.” FDA can initiate a reclassification under section 513(e) of the FD&C Act or an interested person may petition FDA to reclassify a preamendments device. The term “new information,” as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See,
Reevaluation of the data previously before the Agency is an appropriate basis for subsequent regulatory action where the reevaluation is made in light of newly available regulatory authority (see
FDA relies upon “valid scientific evidence” in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information,
Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final order for reclassifying a device. Specifically, prior to the issuance of a final order reclassifying a device, the following must occur: (1) Publication of a proposed order in the
FDAMA added section 510(m) to the FD&C Act. Section 510(m) of the FD&C Act provides that a class II device may be exempted from the premarket notification requirements under section 510(k) of the FD&C Act if the Agency determines that premarket notification is not necessary to provide reasonable assurance of safety and effectiveness of the device. FDA has determined that premarket notification is necessary to provide reasonable assurance of safety and effectiveness of CES devices intended for treating insomnia and/or anxiety and, therefore, this device type is not exempt from premarket notification requirements.
FDA is proposing to require PMAs for CES devices intended to treat depression. Section 515(b)(1) of the FD&C Act sets forth the process for issuing a final order requiring PMAs. Specifically, prior to the issuance of a final order requiring premarket approval for a preamendments class III device, the following must occur: (1) Publication of a proposed order in the
Section 515(b)(2) of the FD&C Act provides that a proposed order to require premarket approval shall contain: (1) The proposed order, (2) proposed findings with respect to the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to have an approved PMA or a declared completed PDP and the benefit to the public from the use of the device, (3) an opportunity for the submission of comments on the proposed order and the proposed findings, and (4) an opportunity to request a change in the classification of the device based on new information relevant to the classification of the device.
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification panel described in section 513(b) of the FD&C Act, issue a final order to require premarket approval or publish a document terminating the proceeding together with the reasons for such termination. If FDA terminates the proceeding, FDA is required to initiate reclassification of the device under section 513(e) of the FD&C Act, unless the reason for termination is that the device is a banned device under section 516 of the FD&C Act (21 U.S.C. 360f).
Under section 501(f) of the FD&C Act (21 U.S.C. 351(f)), a preamendments class III device may be commercially distributed without a PMA until 90 days after FDA issues a final order (or a final rule issued under section 515(b) of the FD&C Act prior to the enactment of FDASIA) requiring premarket approval for the device, or 30 months after final classification of the device under section 513 of the FD&C Act, whichever is later. For CES devices, the preamendments class III devices that are the subject of this proposal, the later of these two time periods is the 90-day period. Since these devices were classified in 1979, the 30-month period has expired (44 FR 51770, September, 4, 1979). Therefore, if the proposal to require premarket approval for CES devices to treat depression is finalized, section 501(f)(2)(B) of the FD&C Act requires that a PMA for such device be filed within 90 days of the effective date of the final order. However, FDA does not intend to enforce compliance with the 90-day deadline for PMA submissions for currently legally marketed CES devices to treat depression. See further discussion in section IX “Dates New Requirements Apply” for proposed compliance dates.
Also, a preamendments device subject to the order process under section 515(b) of the FD&C Act is not required to have an approved investigational device exemption (IDE) (see part 812 (21 CFR part 812)) contemporaneous with its interstate distribution until the date identified by FDA in the final order requiring the filing of a PMA for the device. At that time, an IDE is required only if a PMA has not been filed. If the sponsor, manufacturer, or importer of the device submits an IDE application and FDA approves it, the device may be distributed for investigational use. If a PMA is not filed by the later of the two dates (
In accordance with section 515(b)(2)(D) of the FD&C Act, interested persons are being offered the opportunity to request reclassification of CES devices to treat depression.
In 1978, the Neurological Devices Panel (the 1978 Panel) discussed the original classification for the CES device at two separate meetings (43 FR 55716, November 28, 1978). The 1978 Panel ultimately recommended that the device be classified into class III because the safety and effectiveness of the device had not been demonstrated. The 1978 Panel considered, among other data, information from the National Research Council, which reviewed 88 published studies on CES and concluded that the device had not been shown to be effective in treating any of the conditions for which it was prescribed. In addition, the 1978 Panel indicated that there was insufficient information to establish an adequate performance standard for CES because the characteristics of the electrical current necessary for potential effectiveness were not known. The 1978 Panel believed that general controls would not provide sufficient control over these characteristics, and that the device presented a potential unreasonable risk of illness or injury to the patient if the practitioner relied on the device instead of more conventional treatment, and the device was ineffective in treating any of the conditions for which it was prescribed. FDA agreed with the 1978 Panel's recommendation, and the CES device was classified into class III in 1979 (44 FR 51770, September 4, 1979).
In support of a subsequent proposed rule in 1993 to require PMAs for CES devices (58 FR 45865, August 31, 1993), FDA performed a literature review and identified additional studies that had been conducted on the use of CES. After a review of the scientific literature, FDA concluded that the effectiveness of CES had still not been established by adequate valid scientific evidence. On August 24, 1995, FDA issued a final rule requiring PMAs (60 FR 43967), but later proposed to revoke the call for PMAs because the Agency had received new information and wanted to reconsider the classification of CES and put out a call for information (62 FR 4023, January 28, 1997) under section 515(i) of the FD&C Act. The Agency subsequently revoked the call for PMAs (62 FR 30456, June 4, 1997).
On April 9, 2009, FDA published a notice for the submission of safety and effectiveness information on CES devices (74 FR 16214). In response to that order, FDA received information in support of reclassification from five device manufacturers that all recommended CES devices be reclassified to class II. The manufacturers stated that safety and effectiveness of these devices may be assured by limited postmarket surveillance; adequate instructions for use, including warnings about the possibility of unsafe use; availability only upon the order of a health care professional licensed to diagnose and differentiate the primary indications of CES for anxiety, insomnia, and depression from other disorders (
On August 8, 2011, FDA published a proposed rule under section 515(b) of the FD&C Act proposing to require PMAs for CES devices (76 FR 48062). In developing the proposed rule, FDA considered literature on CES devices published since the previous 1993 proposed rule and the information provided in response to the 2009 notice. FDA concluded from the review of the scientific literature that the effectiveness of CES had not been established by adequate valid scientific evidence and the 1978 Panel's original class III recommendation remained appropriate. The August 8, 2011, proposed rule also provided an opportunity for interested persons to submit comments on the proposed rule and the Agency's findings. Under section 515(b)(2) of the FD&C Act, FDA also provided an opportunity for interested persons to request a change in the classification of the devices based on new information relevant to its classification. Any petition requesting a change in classification of the CES device was required to be submitted by August 23, 2011. The comment period for the proposed rule closed on November 7, 2011.
FDA received three petitions conforming to the requirements of § 860.123 (21 CFR 860.123) requesting a change in the classification of CES devices. Of these petitions, one requested the Agency to reclassify CES devices from class III to class II for the treatment of “insomnia, depression, or anxiety.” The second reclassification petition presented a more focused indication, requesting the Agency to reclassify CES devices from class III to class II for the “treatment of depression, anxiety, and insomnia in adult substance abuse patients who have failed to achieve satisfactory improvement from one prior antidepressant or sleep medication at or above the minimal effective dose and duration in the current episode, or are unable to tolerate such medication.” The third reclassification petition requested the Agency to reclassify CES devices from class III to class II for the “general treatment of anxiety, depression, and insomnia as part of an approved program of medical care when conventional approaches have failed or are deemed inappropriate” and “for the treatment of the primary symptoms of substance abuse: Anxiety, depression, and insomnia when conventional approaches have failed or are deemed inappropriate.”
Consistent with the FD&C Act as it existed at the time, on February 10, 2012, FDA referred the reclassification petitions to the Neurological Devices Panel (the 2012 Panel) for its recommendation on the requested change in classification. FDA provided the 2012 Panel members with the three reclassification petitions and FDA's executive summary, which included an updated review of the available scientific literature on the CES device (Ref. 1). Based on its review of the data as well as information presented during an open meeting (Ref. 2), the majority of the 2012 Panel did not think there was valid scientific evidence supporting effectiveness for treatment of insomnia, depression, or anxiety. However, three 2012 Panel members, including the industry and patient representatives, did believe there was valid scientific evidence of effectiveness, and a fourth member believed effectiveness had been demonstrated for treatment of anxiety but not for insomnia or depression. The 2012 Panel also pointed out that there was a lack of device risk, meaning that a benefit/risk analysis might be favorable with any demonstrated effectiveness. The majority of the 2012 Panel, however, recommended that CES should be kept in class III. The class III recommendation from the 2012 Panel also applied to the more focused indication of the two petitioners that requested class II for use in the substance abuse population, which is an indication outside the scope of the current classification effort as CES devices have not been cleared for use in this patient population. The 2012 Panel did not consider, however, the possibility of splitting different indications into different classifications (though one 2012 Panel member did state that there seemed to be effectiveness for treatment of anxiety), or whether there is sufficient evidence to establish clinical performance testing as a special control. The Agency has since considered these possibilities, as discussed in this document.
FDA later issued a proposed administrative order to comply with the new procedural requirement created by FDASIA when requiring PMAs for a preamendments class III device (78 FR 20268, April 4, 2013). The proposed order provided for a comment period that was open until May 6, 2013. FDA received approximately 100 comments related to the CES device, most suggesting that the device should be reclassified from class III to class II considering the limited safety risks associated with the device and the ability to establish special controls to mitigate the risks to health. FDA also received one additional reclassification petition requesting that the device be reclassified from class III to class II.
On June 12, 2014, FDA withdrew the proposed rule and proposed order calling for PMAs for CES, stating in the
A CES device is currently defined as a device that applies electrical current to a patient's head to treat insomnia, depression, or anxiety. FDA is proposing in this order to modify the identification language from how it is presently written in § 882.5800(a) (21 CFR 882.5800(a)) for additional clarification. FDA is clarifying in the identification that these are prescription devices and that the electrical current should not be intended to induce a seizure in patients. Clarifying that the stimulation is specifically not intended to induce a seizure makes a more definitive distinction between CES and ECT devices. However, FDA does not intend to otherwise describe the stimulation or electrode placement in the definition. Existing CES technology encompasses a range of stimulation settings and electrode placements, and with supportive clinical data, FDA believes that it is not necessary to establish limitations on the technical characteristics of CES devices within the definition.
FDA is proposing that CES devices intended to treat insomnia and/or anxiety be reclassified from class III to class II. In order to reclassify these devices, the Agency must determine that there is sufficient information to establish special controls that, combined with the general controls, will provide a reasonable assurance of device safety and effectiveness. FDA has reconsidered the information before the Agency, including the deliberations of the 2012 Panel meeting and the reclassification petitions submitted for these devices, and has determined that there is sufficient information to establish special controls to effectively mitigate the risks to health identified in section V, and that these special controls, together with general controls, will provide a reasonable assurance of safety and effectiveness when applied to CES devices intended to treat insomnia and/or anxiety, including those existing legally marketed devices that have been previously cleared by FDA in 510(k)s.
Therefore, in accordance with sections 513(e) and 515(i) of the FD&C Act and § 860.130 (21 CFR 860.130), based on new information with respect to the devices and taking into account the public health benefit of the use of the device and the nature and known incidence of the risk of the device, FDA, on its own initiative, is proposing to reclassify this preamendments class III device into class II when the device is intended to treat insomnia and/or anxiety. FDA believes that this new information is sufficient to demonstrate that the proposed special controls can mitigate the risks to health identified in the next section, and that these special controls, together with general controls, will provide a reasonable assurance of safety and effectiveness for CES devices intended for treating insomnia and/or anxiety.
In this proposed order, the Agency has identified special controls under section 513(a)(1)(B) of the FD&C Act that, together with general controls (including prescription-use restrictions) applicable to the devices, are necessary to provide reasonable assurance of their safety and effectiveness.
Section 510(m) to the FD&C Act authorizes the Agency to exempt class II devices from premarket notification (510(k)) requirements. FDA has considered CES devices intended for treating insomnia and/or anxiety and decided that the device does require premarket notification. Therefore, the Agency does not intend to exempt this proposed class II device from premarket notification (510(k)) submission.
After considering available information for the classification of CES devices intended to treat insomnia and/or anxiety, FDA has determined that the following risks to health are associated with use of the CES devices:
•
•
•
•
•
FDA believes that CES devices intended to treat insomnia and/or anxiety should be reclassified from class III to class II because, in light of new information about the effectiveness of these devices, special controls, in addition to general controls, can be established to provide reasonable assurance of safety and effectiveness of the device, and because general controls themselves are insufficient to provide reasonable assurance of its safety and effectiveness. FDA believes that the risks of the CES devices intended to treat insomnia and/or anxiety can be mitigated with special controls and that these mitigations will provide a reasonable assurance of safety for these devices. Based on a reconsideration of the available information and data, FDA believes that there is valid scientific evidence of effectiveness for CES devices in the treatment of insomnia and/or anxiety. However, because the information available to the Agency includes evaluations of different CES devices and the methodology of CES delivery (
FDA believes that the identified special controls, in addition to general controls (including prescription use restrictions and 510(k) notification requirements for devices that have not been legally marketed prior to the effective date of the final order, or devices that have been legally marketed but are required to submit a new 510(k) under § 807.81(a)(3) (21 CFR 807.81(a)(3)) because the device is about to be significantly changed or modified), will provide a reasonable assurance of safety and effectiveness of CES devices intended to treat insomnia and/or anxiety. Therefore, in accordance with sections 513(e) and 515(i) of the FD&C Act and § 860.130, based on new information with respect to the device and taking into account the public health benefit(s) of the use of the device and the nature and known incidence of the risk(s) of the device, FDA is proposing to reclassify these devices from class III to class II. The Agency has identified special controls that, when combined with general controls, are necessary to provide reasonable assurance of their safety and effectiveness.
There is a reasonable assurance that a device is effective when it can be determined, based upon valid scientific evidence, that in a significant portion of the target population, the use of the device for its intended uses and conditions of use, when accompanied by adequate directions for use and warnings against unsafe use, will provide clinically significant results (see § 860.7(e)(1)). During the 2012 Panel meeting (Ref. 1), the 2012 Panel expressed reservations on classifying CES devices into class III, given that there are limited safety concerns associated with these devices, and because they are not life-supporting or life-sustaining, or of substantial importance in preventing impairment of human health. The 2012 Panel also suggested that the list of significant risks in the 2011 proposed rule (76 FR 48062) was not accurate. There was consensus on the risks of skin irritation, headaches, and dizziness. However, the 2012 Panel did not believe that seizures and blurred vision were risks associated with CES, and also suggested that worsening of the condition being treated, though of concern, could be adequately addressed by a patient being under the supervision of a medical professional. However, the 2012 Panel consensus was that, given the lack of adequate chronic effectiveness data, the benefits of the CES device did not outweigh the risks and the device should remain in class III as use of the device could present a potential unreasonable risk to health. FDA has reexamined the available information, however, including information made available after the 2012 Panel that confirms a level of effectiveness of CES treatment in certain indications, and believes that there is evidence of effectiveness for CES usage in treating patients with insomnia and/or anxiety.
The available information, while limited, consists of valid scientific evidence regarding CES use in treating insomnia and anxiety, which demonstrates basic effectiveness for some indications, as well as a low risk profile. In terms of safety, there is little evidence of device risk. FDA's own records (which include real-world clinical experience) indicate that only a very few adverse events have been reported over the past 10 years, and those reported have generally been minor in nature. It is also unclear how many of those events are attributable to use of the device. In the CES literature, 10 of the references reviewed reported no adverse events had occurred. Other studies reported a number of minor adverse events. More common adverse events reported in the literature include: Blurred vision, headaches, dizziness, tingling on the forehead, and increased situational anxiety. There are very limited reports of significant adverse events. In general, CES devices appear to have a favorable long-term safety profile. If properly manufactured and used as intended, FDA believes that the special controls identified in this proposed order, if finalized, together with general controls (including prescription-use restrictions and 510(k) notification requirements), are sufficient to mitigate the risks associated with CES devices intended to treat insomnia and/or anxiety.
The effectiveness of CES usage in the conditions studied, insomnia, depression, and anxiety, is more difficult to determine, as many of the studies reviewed did not use the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria to diagnose insomnia, depression, and anxiety. Some studies were also limited in terms of sample size, placebo effect (due to either no masking or unsuccessful masking), and inadequate statistical methods. Of the 39 papers included in the literature review presented at the 2012 Panel meeting (Ref. 2), some reported a beneficial effect of CES on certain indications while others demonstrated no effect. Furthermore, the body of research reviews 25 different models of CES devices used, excluding 7 that were custom built, and some studies did not report the CES device model. Because the electrical output characteristics vary across the different CES devices, it is difficult to definitively ensure the effectiveness of any one device. However, the Agency believes that the totality of the results of these studies do provide information on the general effectiveness of CES usage for insomnia and/or anxiety.
FDA's systematic assessment of the published literature, as presented to the 2012 Panel, included 30 studies for “on-label” CES use (tables 14 and 15 of the FDA Executive Summary) (Ref. 2). Study design and methodology varied across the published papers, several different CES devices were evaluated, and the methodology of CES delivery (
There were 24 studies that investigated the impact of CES on anxiety (11 randomized controlled trials (RCTs), 11 observational studies, 1 meta-analysis, and 1 systematic review). Of the RCTs that were evaluated, some trials reported a statistically significant benefit of CES treatment versus placebo in reducing anxiety symptoms (Refs. 3 through 8), while other studies demonstrated no difference in anxiety between the groups (Refs. 9 through 12). Feighner et al. also conducted an RCT and reported a reduction in anxiety at 15 days after CES use, but this effect was no longer significant at 26 days (Ref. 13). The majority of observational studies reported a positive association between CES treatment and reduction in anxiety symptoms (Refs. 14 through 21). In the single-arm observational study by Bystritsky et al., improvements were reported for some but not all measures
FDA's assessment identified 18 studies that evaluated the effectiveness of CES on insomnia. Of the nine RCTs, some reported statistically significant reductions in insomnia symptoms in the CES group compared to placebo (Refs. 3, 4, 13, 27), while others reported no significant differences between the two groups (Refs. 9, 11, 12, 28). A study by Heffernan et al. also reported significant changes between the active CES treatment and placebo groups (Ref. 8). Among the eight observational studies, CES treatment was associated with less frequent (Ref. 15) and less intense (Ref. 18) sleep disturbances, less difficulty falling asleep (Refs. 29, 30), and feeling more rested in the morning (Ref. 29). Two observational studies reported no impact of CES on insomnia (Refs. 31, 32). In a study by Moore et al., subjective measures of insomnia were markedly improved during the first week of CES treatment but were no longer significant at 2 weeks (Ref. 23). A study by Nagata et al reported a significant reduction in sleep latency in insomniacs but not in those without sleep disorders (Ref. 33). Lastly, a meta-analysis with pooled results from two RCTs examining the efficacy of CES for insomnia indicated no difference between the active CES use and sham groups (Ref. 25).
While the available scientific literature for insomnia and anxiety has shortcomings (as described previously) and no individual published study on CES provides definitive evidence of effectiveness of CES for the treatment of insomnia and/or anxiety, it is noteworthy that 18 of the 24 small published studies (those that enrolled fewer than 50 patients) that included assessments of insomnia and/or anxiety had a main finding that indicated a greater benefit of CES versus control for at least 1 of the outcome measures evaluated, and CES treatment group outcomes improved in all large published studies (although not all studies demonstrated improvement compared with control patients), including two studies identified after the 2012 Panel meeting (Refs. 34, 35). It is also worth noting that in a report on pain management (Ref. 36), the Army Surgeon General identifies CES as a potentially useful device for pain management, and argues that even treatments that may be associated with a placebo effect should be clinically exploited, given their effectiveness and safety margin. The report also states that gaps in evidence for such therapies exist due to lack of funded research. Based on the available information, it can be concluded that there is valid scientific evidence of effectiveness for CES in the treatment of insomnia and/or anxiety. Importantly, however, because different CES devices were evaluated and the methodology of CES delivery (
FDA believes that these special controls should include clinical performance data that demonstrates that a device, when used as directed (including instructions for electrode placement, stimulation parameters, duration and frequency of treatment sessions, and other relevant characteristics), will provide clinically meaningful results in the indicated patient population for the intended use. It should be noted that the 2012 Panel asked during its meeting whether clinical data were available as a special control and was told that clinical data would likely not be collected if CES devices were classified in class II (Ref. 1). FDA has since reconsidered this point and believes that the totality of available information demonstrates general effectiveness of CES usage for insomnia and/or anxiety, but clinical data are necessary to demonstrate the clinical effect of specific devices for its labeled intended uses and specific stimulation parameters.
Based on its evaluation of the available information, FDA believes the proposed special controls identified in the next section, including clinical performance data, and in combination with the general controls, will provide reasonable assurance of safety and effectiveness for CES devices in the treatment of insomnia and/or anxiety.
FDA believes that the special controls in § 882.5800(b)(1), in addition to general controls (including applicable prescription-use restrictions and 510(k) notification requirements), address the risks to health and provide reasonable assurance of safety and effectiveness to mitigate the risks to health described in section V for CES devices intended to treat insomnia and/or anxiety and provide a reasonable assurance of safety and effectiveness.
As discussed in the preceding section, each CES device has different technological characteristics, and although sufficient evidence is present to reasonably demonstrate a class effect, a reasonable assurance of the safety and effectiveness of specific CES devices from the existing data is not evident based upon differences in the technological and stimulation parameters for the CES devices. Therefore, FDA believes that additional clinical performance data are necessary to support premarket notifications (510(k)s) for these devices. The intended use population under investigation should correspond to a clinically recognized diagnosis, or symptomatology associated with that diagnosis, and sample sizes should provide adequate statistical power for a reasonable determination of effectiveness. The output and conditions of use (including electrode placement) in any clinical investigation used to support the 510(k) must demonstrate effectiveness for treating insomnia and/or anxiety. In instances where the device output and/or conditions of use are different from a predicate, the 510(k) should contain a complete study report that includes the protocol and clinical study results, including systematic collection of adverse events. A CES device in compliance with the special controls could be used as a benchmark. In instances where the technological and stimulation characteristics are identical, as identified in the labeling, it may be possible to leverage existing clinical data in lieu of providing results from a new clinical study.
A number of comments at the 2012 Panel meeting noted that worsening of a patient's condition during ineffective treatment is mitigated by adequate physician monitoring. FDA agrees with this assessment, and we believe that the labeling must include a warning regarding the need for physician monitoring. FDA also believes that the clinical data collected to support a premarket notification will provide additional information to further characterize this risk and ensure that product labeling informs the user regarding appropriate use of the device and the patient population for which the device has sufficient performance to make a substantial equivalence determination.
The risks of skin irritation can be mitigated with biocompatibility testing to ensure that the materials used in patient-contacting components of the device are safe for skin contact as well as labeling that provides information on validated methods for reprocessing any reusable components between uses.
Headaches due to CES device use are typically transient and this risk can be mitigated by a warning that advises patients to reduce the level of stimulation or discontinue use of the device should a headache occur. The clinical data will also provide evidence regarding the stimulation parameters recommended for use during the study and the rate at which headaches occurred; the results and any observed adverse events must also appear in the labeling.
Some patients experience a feeling of dizziness at certain levels of stimulation. FDA believes this risk can be mitigated by a warning that advises patients to reduce the level of stimulation or discontinue use of the device if dizziness occurs, and to not drive or operate heavy machinery while using the device. The clinical data will also provide evidence regarding the stimulation parameters recommended for use during the study and the rate at which dizziness occurred; the results and any observed adverse events must also appear in the labeling.
Electrical shocks and burns, including unintended electric stimulation, pose risk to the patient. FDA believes this risk can be mitigated through appropriate electrical safety and electromagnetic compatibility (EMC) testing, and also through appropriate software verification, validation, and hazard analysis.
Table 1 shows how FDA believes that the risks to health identified in section V can be mitigated by the proposed special controls:
In addition, under 21 CFR 801.109, the sale, distribution, and use of these devices are restricted to prescription use. Prescription use restrictions are a type of general control in section 513(a)(1)(A)(i) of the FD&C Act. Under § 807.81, the device would continue to be subject to 510(k) notification requirements.
In accordance with section 515(b) of the FD&C Act, FDA is proposing to require that a PMA be filed with the Agency for CES devices intended to treat depression. Under section 501(f)(2)(B) of the FD&C Act, PMAs for currently legally marketed CES devices intended to treat depression are required to be filed on or before 90 days after the effective date of a final order. However, for currently legally marketed CES devices intended to treat depression, FDA does not intend to enforce compliance with this 90-day deadline for an additional 90 days after that deadline (
FDA intends that under § 812.2(d), the preamble to any final order based on this proposal will state that, as of the date on which the filing of a PMA or a notice of completion of a PDP is required to be filed, the exemptions from the requirements of the IDE regulations for preamendments class III devices in § 812.2(c)(1) and (2) will cease to apply to any device that is (1) not legally on the market on or before that date or (2) legally on the market on or before that date but for which a PMA or notice of completion of a PDP is not filed by that date, or for which PMA approval has been denied or withdrawn.
If a PMA for a class III CES device is not filed with FDA within 90 days after the effective date of any final order requiring premarket approval for the device, the device would be deemed adulterated under section 501(f) of the FD&C Act. However, as explained previously, FDA does not intend to enforce compliance with this 90-day deadline for an additional 90 days after that deadline (
The device may be distributed for investigational use only if the requirements of the IDE regulations are met. The requirements for significant risk devices include submitting an IDE application to FDA for its review and approval. An approved IDE is required to be in effect before an investigation of the device may be initiated or continued under § 812.30. FDA, therefore, cautions that IDE applications should be submitted to FDA at least 30 days before the end of the 90-day period after the effective date of the final order to avoid interrupting investigations. In conducting any clinical studies, CES devices intended to treat depression may be distributed for investigational use if the requirements of the IDE regulations (part 812) are met. There will be no extended period for filing an IDE nor exemption from IDE requirements, and studies may not be initiated without appropriate IDE approvals, where necessary.
FDA proposes that the special controls identified in this proposed order take effect on the effective date of any final order, and CES devices intended to treat insomnia and/or anxiety must comply with the special controls following the effective date of the final order. However, FDA does not intend to enforce compliance with the special controls for currently legally marketed CES devices intended to treat insomnia and/or anxiety until 1 year after the effective date of the final order. FDA notes that a firm whose CES device was legally in commercial distribution before May 28, 1976, or whose device was found to be substantially equivalent to such a device and who does not intend to market such device for uses other than use in treating insomnia and/or anxiety, may remove such intended uses from the device's labeling. FDA proposes that for those manufacturers who wish to continue to offer for sale currently legally marketed CES devices intended to treat insomnia and/or anxiety, the manufacturers submit an amendment to their previously cleared 510(k)s for the devices within 1 year after the effective date of the final order that demonstrates compliance with the special controls. Such amendment will be added to the 510(k) file but will not serve as a basis for a new substantial equivalence review. A submitted 510(k) amendment in this context will be used solely to demonstrate to FDA that a CES device is in compliance with the special controls. If a 510(k) amendment for the device is not submitted within 1 year of the effective date of the final order or if FDA determines that the amendment does not demonstrate compliance with the special controls, then this compliance policy would not apply, and FDA would intend to enforce compliance with these requirements. In that case, the device is deemed adulterated under section 501(f)(1)(B) of the FD&C Act as of the date of FDA's determination of noncompliance or 1 year after the effective date of the final order, whichever is sooner.
For models of CES devices intended to treat insomnia and/or anxiety that have not been legally marketed prior to the effective date of the final order, or models that have been legally marketed but are subject to the requirement for a submission of a new 510(k) under § 807.81(a)(3) because the device is about to be significantly changed or modified, manufacturers must obtain 510(k) clearance, among other relevant requirements, and demonstrate compliance with the special controls included in the final order, before marketing the new or changed device.
As required by section 515(b) of the FD&C Act, FDA is publishing its proposed findings regarding (1) the degree of risk of illness or injury designed to be eliminated or reduced by requiring that this device have an approved PMA or a declared completed PDP when intended for use in treating depression and (2) the benefits to the public from the use of CES devices for treating depression.
These findings are based on the reports and recommendations of the advisory committees (panels) for the classification of these devices along with information submitted in response to the FDA Order (74 FR 16214) that was issued under section 515(i) of the FD&C Act and any additional information that FDA has obtained. Additional information regarding the risks as well as classification associated with this device type can be found in 43 FR 55716, 44 FR 51770, 58 FR 45865, and 76 FR 48062.
A cranial electrotherapy stimulator is a prescription device that applies electrical current that is not intended to induce a seizure to a patient's head to treat depression.
For treating depression, FDA concludes that the safety and effectiveness of CES devices have not been established by adequate scientific evidence. Given the FDA analysis and the advisory panel deliberations (Ref. 1), there is insufficient evidence of effectiveness for this indication. The panel recommended class III designation for CES devices in all indications, although as explained previously, FDA is proposing to reclassify CES when intended to treat insomnia and/or anxiety. The body of evidence is not sufficiently robust for FDA to determine that there is a reasonable assurance of safety and effectiveness for CES treatment of depression.
In the Agency's literature assessment, we identified 12 papers that examined the effect of CES on measures of depression (6 RCTs and 6 observational studies). In most RCTs, depression levels did not differ significantly between patients who were treated with active CES compared to those treated with placebo (Refs. 3, 9 through 11, 13), although one randomized trial by Hearst et al. reported fewer depression symptoms in the active CES treatment versus placebo groups (Ref. 12). Of the six observational studies that were reviewed, four studies reported improvement in depression symptoms after treatment with CES (Refs. 14, 15, 18, 19). Moore et al. also reported improvement in depression post- (versus pre-) CES treatment, but the findings were not statistically significant (Ref. 23). Moreover, the observational study by Marshall et al. reported no difference in depressive symptoms between the CES and placebo arms (Ref. 37).
Among the intended uses of insomnia, anxiety, and depression, the evidence supporting the effectiveness of CES for treating depression is the weakest. FDA believes that insufficient information exists regarding the risks and benefits of the device in order for FDA to determine that general and/or special controls will provide reasonable assurance of the safety and effectiveness of CES for treating depression. As established in section 513(a)(1)(C) of the FD&C Act and 21 CFR 860.3(c)(3), a device is in class III if insufficient information exists to determine that general controls and/or special controls are sufficient to provide reasonable assurance of its safety and effectiveness and the device is purported or represented to be for a use that is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury. FDA believes that the risks to health identified in section V for the use of CES devices for treating depression, in the absence of an established positive benefit-risk profile, presents a potential unreasonable risk of illness or injury.
The risks to health for CES devices for treatment of depression are the same as outlined in section V.
As discussed previously, there is inadequate scientific evidence regarding the effectiveness of CES devices for treatment of depression, although the devices have the potential to benefit the public by providing an additional treatment option for depression.
A PMA for CES devices for treatment of depression must include the information required by section 515(c)(1) of the FD&C Act. Such a PMA should also include a detailed discussion of the risks identified previously, as well as a discussion of the effectiveness of the device for which premarket approval is sought. In addition, a PMA must include all data and information on: (1) Any risks known, or that should be reasonably known, to the applicant that have not been identified in this document; (2) the effectiveness of the device that is the subject of the application; and (3) full reports of all preclinical and clinical information from investigations on the safety and effectiveness of the device for which premarket approval is sought.
A PMA must include valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness of the device for its intended use (see § 860.7(c)(1)). Valid scientific evidence is evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use. Isolated case reports, random experience, reports lacking sufficient details to permit scientific evaluation, and unsubstantiated opinions are not regarded as valid scientific evidence to show safety or effectiveness. (§ 860.7(c)(2)).
Before requiring the filing of a PMA or notice of completion of a PDP for a device, FDA is required by section 515(b)(2)(D) of the FD&C Act to provide an opportunity for interested persons to request a change in the classification of the device based on new information relevant to the classification. Any proceeding to reclassify the device will be under the authority of section 513(e) of the FD&C Act.
A request for a change in the classification of CES devices is to be in the form of a reclassification petition containing the information required by § 860.123, including new information relevant to the classification of the device.
Prior to the amendments by FDASIA, section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices. Although section 513(e) as amended requires FDA to issue final orders rather than regulations, FDASIA also provides for FDA to revoke previously issued regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, under section 513(e)(1)(A)(i), as amended by FDASIA, in this proposed order we are proposing to amend § 882.5800 by (1) revoking the requirements in § 882.5800(b) and (c) related to the classification of CES devices intended to treat insomnia and/or anxiety as class III devices and codifying the reclassification of CES devices intended to treat insomnia and/or anxiety to class II (special controls); and (2) retaining the requirements in § 882.5800(b) and (c) related to the classification of CES devices intended to treat depression as class III devices subject to PMAs, as described in section XII.
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This proposed order refers to currently approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subpart B, have been approved under OMB control number 0910-0231; and the collections of information under 21 CFR part 801 have been approved under OMB control number 0910-0485.
The effect of this order, if finalized, is to shift certain devices from the 510(k) premarket notification process to the PMA process. To account for this change, FDA intends to transfer some of the burden from OMB control number 0910-0120, which is the control number for the 510(k) premarket notification process, to OMB control number 0910-0231, which is the control number for the PMA process. As noted previously, FDA estimates that it will receive three new PMAs as a result of this order, if finalized. Based on FDA's most recent estimates, this will result in a 1,040-hour burden increase to OMB control number 0910-0231. FDA also estimates that there will be three fewer 510(k) submissions as a result of this order, if finalized. Based on FDA's most recent estimates, this will result in a 136-hour burden decrease to OMB control number 0910-0120. Therefore, on net, FDA expects a burden hour increase of 904 hours due to this proposed regulatory change.
FDA proposes that any final order based on this proposal become effective on the date of publication of the final order in the
Comments submitted to the previous dockets (2011-N-0504, 2013-N-0195) have been officially noted and do not need to be resubmitted. FDA has considered previous docket comments before issuing this proposed order.
The following references are on display in the Division of Dockets Management (see
Medical devices, Neurological devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 882 be amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
(a)
(b)
(i) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device when intended to treat insomnia and/or anxiety.
(ii) Components of the device that come into human contact must be demonstrated to be biocompatible.
(iii) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC) in its intended use environment.
(iv) Appropriate software verification, validation, and hazard analysis must be performed.
(v) The technical parameters of the device, including waveform, output mode, pulse duration, frequency, train delivery, maximum charge and energy, must be fully characterized and verified.
(vi) The labeling for the device must include the following:
(A) The intended use population and the intended use environment.
(B) A warning that patients should be monitored by their physician for signs of worsening.
(C) A warning that instructs patients on how to mitigate the risk of headaches, and what to do should a headache occur.
(D) A warning that instructs patients on how to mitigate the risk of dizziness, and what to do should dizziness occur.
(E) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device.
(F) Instructions for use that address where to place the electrodes, what stimulation parameters to use, and duration and frequency of treatment sessions. This information must be based on the results of clinical studies for the device.
(G) A detailed summary of the device technical parameters, including waveform, output mode, pulse duration, frequency, train delivery, and maximum charge and energy.
(H) Information on validated methods for reprocessing any reusable components between uses.
(vii) Cranial electrotherapy stimulator devices marketed prior to the effective date of this reclassification must have an amendment submitted to the previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.
(2) Class III (premarket approval) when intended to treat depression.
(c)
Postal Service
Proposed rule.
This proposed rule would remove certain restrictions on the commencement date for the Postal Service's discretionary Semipostal Stamp Program, and clarify how many semipostal stamps issued under that program may be on sale at any one time.
Comments must be received on or before February 22, 2016.
Lori Mazzone, Manager, Stamp Products & Exhibitions, 202-268-6711,
Pursuant to the Semipostal Authorization Act, Public Law 106-253, the Postal Service has been granted discretionary authority to issue and sell semipostal stamps to advance such
The Postal Service now proposes to revise paragraphs (a) and (b) of 39 CFR 551.5. A brief description of each proposed change follows.
The proposed revision of § 551.5(a) would remove certain restrictions on the commencement date of the discretionary Semipostal Stamp Program. Under current regulations, the 10-year period for the discretionary semipostal stamp program commences on a date determined by the Office of Stamp Services, but that date must be after the sales period of the Breast Cancer Research Stamp (BCRS) is concluded. Most recently, Public Law 114-99 (December 11, 2015) extended that sales period to December 31, 2019.
The proposed revision of § 551.5(a) would specify that the 10-year period will commence on a date determined by the Office of Stamp Services, but this date need not be after the BCRS sale period concludes.
The proposed revision of § 551.5(b) would clarify that although only one semipostal stamp under the discretionary Semipostal Stamp Program under 39 U.S.C. 416 (a “discretionary program semipostal stamp”) will be offered for sale at any one time, other semipostal stamps required to be issued by Congress (such as the BCRS) may be on sale when a discretionary program semipostal stamp is on sale. Current regulations state that the Postal Service will offer only one semipostal stamp for sale at any given time during the 10-year period (not specifying whether it is a discretionary program semipostal stamp or a semipostal stamp required by Congress).
The proposed revision of § 551.5(b) would clarify that the one-at-a-time limitation on the sale of semipostal stamps applies only to discretionary program semipostal stamps.
We will publish an appropriate amendment to 39 CFR part 551 to reflect these changes if the proposal is adopted.
Administrative practice and procedure.
In accordance with 39 U.S.C. 416(e)(2), the Postal Service invites public comment on the following proposed amendments to the
39 U.S.C. 101, 201, 203, 401, 403, 404, 410, 414, 416.
(a) The Postal Service is authorized to issue semipostal stamps for a 10-year period beginning on the date on which semipostal stamps are first sold to the public under 39 U.S.C. 416. The Office of Stamp Services will determine the date of commencement of the 10-year period.
(b) The Postal Service will offer only one semipostal stamp pursuant to the discretionary semipostal stamp program under 39 U.S.C. 416 for sale at any given time during the 10-year period.
Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Proposed rule.
DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement a section of the Consolidated and Further Continuing Appropriations Act, 2015, that prohibits the use of funds, appropriated or otherwise made available, for a contract with an entity that requires employees or subcontractors to sign an internal confidentiality agreement that restricts such employees or subcontractors from lawfully reporting waste, fraud, or abuse to a designated Government representative authorized to receive such information.
Interested parties should submit written comments to the Regulatory Secretariat at one of the addresses shown below on or before March 22, 2016 to be considered in the formation of the final rule.
Submit comments in response to FAR Case 2015-012 by any of the following methods:
•
•
Ms. Cecelia L. Davis, Procurement Analyst, at 202-219-0202 for clarification of content. For information pertaining to status or publication schedules, contact the Regulatory Secretariat at 202-501-4755. Please cite FAR Case 2015-012.
This proposed rule revises the FAR to implement section 743 of Division E,
This proposed rule implements section 743 by adding a new FAR section 3.909, Prohibition on contracting with entities that require certain internal confidentiality agreements. The proposed rule is written to also cover future successor provisions in subsequent appropriations acts and perpetuation of the requirement through continuing resolutions. This allows more seamless implementation. If at any point an appropriations act does not include a similar prohibition, the FAR will be modified accordingly.
The proposed rule requires that each offeror, in order to be eligible for award, represent, by submission of its offer, that it does not require employees or subcontractors to sign or comply with such internal confidentiality agreements. The representation is in a new provision at FAR section 52.203-XX, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements—Representation, which must be included in all solicitations, except solicitations for personal services contracts with an individual, using funds subject to the prohibition, except that this requirement is implemented for commercial item solicitations by the part 12 provision at FAR section 52.212-3, paragraph (q). Contracting officers shall not insert this provision in solicitations for personal services contracts with an individual if the services are to be performed entirely by the individual, rather than by an employee of the contractor or a subcontractor.
The new FAR clause 52.203-YY, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements, notifies the contractor of the prohibition on use of funds for the contract, if the contractor is in noncompliance with the requirements of the clause. The clause also requires that contractors notify employees that any such agreements in pre-existing confidentiality agreements are no longer in effect. This notice could be accomplished through normal business communication channels, such as email. This clause must be included in all solicitations and resultant contracts, except for personal services contracts with individuals.
Existing contracts must be modified to include the clause before obligating Fiscal Year (FY) 2015 or subsequent FY funds that are subject to the same prohibition on confidentiality agreements, except for personal services contracts with individuals.
There are also conforming changes at FAR sections 3.900, 4.1202, 52.204-8, and 52.212-5.
DoD, GSA, and NASA are proposing to apply this rulemaking to all solicitations and resultant contracts that are funded with FY 2015 funds or subsequent FY funds that are subject to the same prohibition on confidentiality agreements, including contracts and subcontracts for acquisitions in amounts not greater than the simplified acquisition threshold, and contracts and subcontracts for the acquisition of commercial items, (including commercially available off-the-shelf items).
Because the emphasis of section 743 is to prohibit restrictions on the ability of employees and subcontractors to report waste, fraud, or abuse to appropriate Government authorities, it is not in the best interest of the Federal Government to waive the applicability of section 743 to contracts and subcontracts in amounts not greater than the simplified acquisition threshold, or for the acquisition of commercial items (including commercially available off-the-shelf items).
In making the initial determination to prohibit restrictions on the ability of employees and subcontractors to report waste, fraud, or abuse to appropriate Government authorities, it is not in the best interest of the Federal Government to waive the applicability of section 743 to contracts and subcontracts in amounts not greater than the simplified acquisition threshold, or for the acquisition of commercial items (including commercially available off-the-shelf items), since it would exclude a significant number of acquisitions and thereby further limit the number of contractor and subcontractor employees affected by section 743.
The FAR Council considered the following factors: (1) The benefits of the policy in furthering Administration goals, (2) the extent to which the benefits of the policy would be reduced if an exemption is provided for acquisitions in amounts not greater than the simplified acquisition threshold, or for the acquisition of commercial items (including commercially available off-the-shelf items), and (3) the burden on contractors if the policy is applied to acquisitions in amounts not greater than the simplified acquisition threshold, or for the acquisition of commercial items (including commercially available off-the-shelf items).
With respect of the first factor, the Administration is committed to implementing policy that ensures reducing waste, fraud, or abuse in all Federal acquisitions is achieved. This proposed rule makes certain that there are no restrictions that prevent contractors and subcontractors from reporting these types of situations to a designated Government representative.
With respect to the second factor (the impact of excluding acquisitions in amounts not greater than the simplified acquisition threshold, and contracts and subcontracts for the acquisition of commercial items, (including commercially available off-the-shelf items) on the overall benefits of the underlying policy), the FAR Council believes impact on these benefits may inhibit contractor employees and subcontractors subject to such internal confidentiality agreements from reporting of waste, fraud, or abuse to appropriate Government authorities, thus allowing the perpetuation of such waste, fraud, or abuse.
With respect to the third factor, this proposed rule imposes a minimal burden on offerors and contractors, requiring only that offerors represent by submission of the offer that they do not require certain internal confidentiality agreements, and contractors must notify employees that the prohibition and restrictions of any internal confidentiality agreements covered by the clause are no longer in effect. This proposed rule does not contain any information collection requirements.
Public feedback is welcomed on the analysis and preliminary determination to cover acquisitions in amounts not greater than the simplified acquisition threshold, and contracts and subcontracts for the acquisition of
Executive Orders 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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is a significant regulatory action and, therefore, was subject to review under section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This proposed rule is not a major rule under 5 U.S.C. 804.
DoD, GSA, and NASA do not expect this rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
This action is necessary to implement section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and successor provisions in subsequent appropriations acts (and as extended in continuing resolutions). Section 743 prohibits the use of funds appropriated or otherwise made available by Division E or any other Act for a contract, grant, or cooperative agreement with an entity that requires employees or subcontractors of such entity seeking to report waste, fraud, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.
The objective of the rule is to remove restrictions on the ability of employees and subcontractors to report waste, fraud, or abuse to the appropriate Government authorities. The legal basis for the rule is the above cited statute.
This rule will apply to all small entities that receive Government contracts awarded using funds subject to the restriction of section 743, or successor provisions in subsequent appropriations acts with the same prohibition (and as extended in continuing resolutions). Based on FPDS data for Fiscal Year 2014, this rule may affect up to 108,500 small entities per year (75,000 small entities receiving new awards, 33,500 modifications). However, it is doubtful that most small entities have any such prohibited internal confidentiality agreements with their employees and subcontractors.
The rule has no significant economic impact on small entities. DoD, GSA, and NASA did not identify any significant alternatives that would reduce the impact on small entities and still meet the objectives of the statute.
The Regulatory Secretariat has submitted a copy of the IRFA to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the IRFA may be obtained from the Regulatory Secretariat. DoD, GSA, and NASA invite comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
DoD, GSA, and NASA will also consider comments from small entities concerning the existing regulations in subparts affected by the rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (FAR Case 2015-012), in correspondence.
The proposed rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, DoD, GSA, and NASA are proposing to amend 48 CFR parts 3, 4, and 52 as set forth below:
40 U.S.C. 121(c); 10 U.S.C. chapter 137; and 51 U.S.C. 20113.
(c) Section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and successor provisions in subsequent appropriations acts (and as extended in continuing resolutions), implemented in 3.909, applicable to all agencies.
(a) The Government is prohibited from using certain appropriated funds for a contract with an entity that requires employees or subcontractors of such entity seeking to report waste, fraud, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information. See section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions.)
(b) The prohibition in paragraph (a) of this section does not contravene requirements applicable to Standard Form 312 (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information.
(a) In order to be eligible for contract award, an offeror must represent that it does not require employees or
(b) The contracting officer may rely on an offeror's representation unless the contracting officer has reason to question the representation.
When using funding subject to the prohibitions in 3.909-1(a) of this subpart, the contracting officer shall—
(a)(1) Include the provision at 52.203-XX, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements—Representation, in all solicitations, except as provided in paragraph (a)(2) of this section; and
(2) Do not insert the provision in solicitations for a personal services contract with an individual if the services are to be performed entirely by the individual, rather than by an employee of the contractor or a subcontractor.
(b)(1) Include the clause at 52.203-YY, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements, in all solicitations and resultant contracts, other than personal services contracts with individuals.
(2) Modify existing contracts, other than personal services contracts with individuals, to include the clause before obligating FY 2015 or subsequent FY funds that are subject to the same prohibition on confidentiality agreements.
(a) * * *
(3) 52.203-XX, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements—Representation.
As prescribed in 3.909-3(a), insert the following provision:
(a) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions), Government agencies are not permitted to use funds appropriated (or otherwise made available) for contracts with an entity that requires employees or subcontractors of such entity seeking to report waste, fraud, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.
(b) The prohibition in paragraph (a) of this provision does not contravene requirements applicable to Standard Form 312, (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information.
(c)
(End of provision)
As prescribed in 3.909-3(b), insert the following clause:
(a) The Contractor shall not require employees or subcontractors of such entity seeking to report waste, fraud, or abuse to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.
(b) The Contractor shall notify employees that the prohibitions and restrictions of any internal confidentiality agreements covered by this clause are no longer in effect.
(c) The prohibition in paragraph (a) of this clause does not contravene requirements applicable to Standard Form 312 (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information.
(d) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015, (Pub. L. 113-235), use of funds appropriated (or otherwise made available) under that or any other Act may be prohibited, if the Government determines that the Contractor is not in compliance with the provisions of this clause.
(e) The contractor shall include the substance of this clause, including this paragraph (e), in subcontracts under such contracts.
(End of clause)
The revised and added text reads as follows:
(c)(1) * * *
(iii) 52.203-XX, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements—Representation. This provision applies to all solicitations.
The revised and added text reads as follows:
(r)(1) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions), Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with an entity that requires employees or subcontractors of such entity seeking to report waste, fraud, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.
(2) The prohibition in paragraph (r)(1) of this provision does not contravene requirements applicable to Standard Form 312 (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information.
(3)
The revised and added text reads as follows:
(a) * * *
(1) 52.203-YY, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements (DATE) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
Fish and Wildlife Service, Interior.
Proposed rule; reopening of comment period, and announcement of public information meeting and hearing.
We, the U.S. Fish and Wildlife Service (Service), announce the reopening of the comment period on our September 30, 2015, proposed rule to list 49 species from the Hawaiian Islands, including the Hawaiian distinct population segment of the band-rumped storm-petrel (
(1)
(2)
(3)
We request that you provide comments only by the methods described above. We will post all comments on
Mary Abrams, Field Supervisor, Pacific Islands Fish and Wildlife Office, 300 Ala Moana Boulevard, Honolulu, HI 96850; by telephone at 808-792-9400; or by facsimile at 808-792-9581. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 800-877-8339.
On September 30, 2015, we published in the
For details on specific information that we are requesting, please see the Information Requested section of our proposed rule (80 FR 58820; September 30, 2015). The proposed rule is available at the Federal eRulemaking Portal at
You may submit your comments and materials concerning the proposed rule by one of the methods listed in
If you submit a comment via
Comments and materials we receive, as well as supporting documentation we used in preparing the proposed rule, will be available for public inspection on
We will hold a public information meeting and public hearing on the date listed above in the
Anyone wishing to make an oral statement at a public hearing for the record is encouraged to provide a written copy of their statement to us at the hearing. In the event there is a large attendance, the time allotted for oral statements may be limited. Speakers can sign up at a hearing if they desire to make an oral statement. Oral and written statements receive equal consideration. There are no limits on the length of written comments submitted to us.
People needing reasonable accommodation in order to attend and participate in the public information meeting or public hearing should contact Mary Abrams, Field Supervisor, Pacific Islands Fish and Wildlife Office, as soon as possible (see
The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule, request for comments.
NMFS proposes 2016-2018 specifications for Atlantic mackerel and the river herring and shad catch cap for Atlantic mackerel. NMFS previously set specifications for butterfish, longfin squid, and
Public comments must be received by February 22, 2016.
Copies of supporting documents used by the Mid-Atlantic Fishery Management Council, including the Environmental Assessment (EA) and Regulatory Impact Review (RIR)/Initial Regulatory Flexibility Analysis (IRFA), are available from: Dr. Christopher M. Moore, Executive Director, Mid-Atlantic Fishery Management Council, 800 North State Street, Suite 201, Dover, DE 19901, telephone (302) 674-2331. The EA/RIR/IRFA is also accessible via the Internet at
You may submit comments, identified by NOAA-NMFS-2015-0151, by either of the following methods:
•
•
Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this proposed rule may be submitted to NMFS, Greater Atlantic Regional Fisheries Office and by email to
Carly Bari, Fishery Policy Analyst, (978) 281-9224, fax (978) 281-9135.
This rule proposes specifications, which are the combined suite of commercial and recreational catch levels established for one or more fishing years. The specifications process also allows for the modification of a select number of management measures, such as closure thresholds, gear restrictions, and possession limits. The Mid-Atlantic Fishery Management Council's process for establishing specifications relies on provisions within the Atlantic Mackerel, Squid, and Butterfish Fishery Management Plan (FMP) and its implementing regulations, as well as requirements established by the Magnuson-Stevens Fishery Conservation and Management Act. Specifically, section 302(g)(1)(B) of the Magnuson-Stevens Act states that the Scientific and Statistical Committee (SSC) for each Regional Fishery Management Council shall provide its Council ongoing scientific advice for fishery management decisions, including recommendations for acceptable biological catch (ABC), preventing overfishing, maximum sustainable yield, and achieving rebuilding targets. The ABC is a level of catch that accounts for the scientific uncertainty in the estimate of the stock's defined overfishing level (OFL). The Council's SSC met on May 13 and 14, 2015, to recommend an ABC for the 2016-2018 Atlantic mackerel specifications.
The FMP's implementing regulations require the Council's Atlantic Mackerel, Squid, and Butterfish Monitoring Committee to consider and develop specification recommendations for each species. Since the Magnuson-Stevens Act requirements for the SSC to recommend ABC became effective, the role of all Council monitoring committees has largely been to recommend any reduction in catch limits from the SSC-recommended ABCs to account for management uncertainty, and to recommend other management measures (
The Council considered the recommendations of the SSC, the Monitoring Committee, and public comments at its June 9, 2015, meeting in Virginia Beach, VA, and made its specification recommendations. The Council submitted the recommendations, along with the required analyses, for agency review on August 24, 2015, with final submission on December 11, 2015. NMFS must review the Council's recommendations for the compliance with the FMP and applicable law, and conduct notice-and-comment rulemaking to propose and implement the final specifications.
The regulations for the FMP require the specification of annual catch limits (ACLs) and accountability measure (AM) provisions for mackerel and butterfish. Both squid species are exempt from the ACL/AM requirements because they have a life cycle of less than 1 year. In addition, the regulations require the specification of domestic annual harvest (DAH), domestic annual processing (DAP), total allowable level of foreign fishing (TALFF), joint venture processing (JVP), commercial and recreational annual catch targets (ACT), and the river herring and shad catch cap for mackerel, the butterfish mortality cap in the longfin squid fishery, and initial optimum yield (IOY) for both squid species.
In addition to the specifications, this action will adjust the butterfish mesh requirement, clarify the use of strengtheners in the butterfish fishery, and suspend indefinitely the pre-trip notification system (PTNS) requirement in the longfin squid fishery.
The most recent U.S. stock assessment for Atlantic mackerel was conducted by the Transboundary Resources Assessment Committee (TRAC) in March 2010. The 2010 TRAC Status Report indicated reduced productivity in the stock and a lack of older fish in both the survey and catch data; however, the status of the Atlantic mackerel stock is unknown because biomass reference points could not be determined. Due to this uncertainty in the 2010 assessment, the TRAC Status Report recommended that total annual mackerel catches not exceed 80,000 mt (average total U.S. and Canadian landings from 2006-2008) until new information is available.
Since 2010, the SSC has recommended a stock-wide ABC of 80,000 mt based on the recommendation in the TRAC Status Report. NMFS previously implemented specifications that matched the recommendation in the TRAC Status Report for the 2013-2015 fishing years as part of the 2013 specifications for the FMP (January 16, 2013; 78 FR 3346). However, more recent data has shown that 2006-2008 was a period of unusually high catches. Given the uncertainty in the 2010 mackerel assessment, low U.S. landings since 2011, and results from a 2014 Canadian assessment suggesting the stock is doing poorly, the SSC concluded that the foundation that it used for developing its previous ABC recommendation was inappropriate. In order to capture the highly periodic nature of mackerel catches, NMFS implemented a stock-wide ABC of 40,165 mt for the 2015 fishing year only. 40,165 mt is the median of U. S. and Canadian catches from 1978-2013, a time period during which fisheries operations were relatively consistent and foreign fleets were not in operation.
For 2016-2018, the SSC recommended an ABC of 19,898 mt. The SSC concluded that the mackerel stock is in a depleted state relative to historical levels of abundance, and that the foundation (which assumed sustainable catch in the period 1978-2013) previously used to establish the ABC was no longer valid. The SSC used 50 percent of the median catch to calculate the new ABC, because the SSC's review of a management strategy evaluation concluded that this method came closest to meeting (while not exceeding) the acceptable probability of overfishing under the Council's risk policy. The median value of the long term mackerel catch series (1978-2014) is 39,797 mt. Accordingly, the SSC recommended an ABC of half that, or 19,898 mt, for 2016-2018.
According to the FMP, the mackerel ABC must be calculated using the formula: U.S. ABC = Stock-wide ABC−C, where C is the estimated catch of mackerel in Canadian waters for the upcoming fishing year. Canadian catch was estimated at 8,889 mt, which is the Canadian quota (8,000 mt) plus 10 percent to account for management uncertainty (the same ratio that the Council has used for management uncertainty in the U.S. fishery). The Council deducted estimated Canadian catch from the stock-wide ABC to recommend a U.S. ABC of 11,009 mt (19,898 mt minus 8,889 mt).
The Council recommended a recreational allocation of 683 mt (6.2 percent of the U.S. ABC). The Recreational ACT is equal to the Recreational Harvest Limit (RHL), the effective cap on recreational catch. The proposed Recreational ACT of 614 mt (90 percent of 683 mt) accounts for uncertainty in recreational catch and discard estimates.
For the commercial mackerel fishery, the Council recommended a commercial fishery allocation of 10,327 mt (93.8 percent of the U.S. ABC, the portion of the ACL that was not allocated to the recreational fishery). The recommended Commercial ACT of 9,294 mt (90 percent of 10,327 mt) compensates for management uncertainty, uncertainty in discard estimates, and possible misreporting of mackerel catch. The Commercial ACT would be further reduced by a discard rate of 1.26 percent to arrive at the proposed DAH of 9,177 mt. The DAH would be the effective cap on commercial catch.
Consistent with the Council's recommendation, NMFS proposes Atlantic mackerel specifications that would set the U.S. ACL at 11,009 mt, the Commercial ACT at 9,294 mt, the DAH and DAP at 9,177 mt, and the Recreational ACT at 614 mt.
Additionally, as recommended by the Council, NMFS proposes to maintain JVP at zero (the most recent allocation was 5,000 mt of JVP in 2004). In the past, the Council recommended a JVP greater than zero because it believed U.S. processors lacked the ability to process the total amount of mackerel that U.S. harvesters could land. However, for the past 11 years, the Council has recommended zero JVP because U.S. shoreside processing capacity for mackerel has expanded. The Council concluded that processing capacity was no longer a limiting factor relative to domestic production of mackerel.
The Magnuson-Stevens Act provides that the specification of TALFF, if any, shall be the portion of the optimum yield (OY) of a fishery that will not be harvested by U.S. vessels. TALFF would allow foreign vessels to harvest U.S. fish and sell their product on the world market, in direct competition with U.S. industry efforts to expand exports. While a surplus existed between ABC and the mackerel fleet's harvesting capacity for many years, that surplus has disappeared due to downward adjustments of the specifications in recent years. Based on analysis of the global mackerel market and possible increases in U.S. production levels, the Council concluded that specifying a DAH/DAP that would result in zero TALFF would yield positive social and economic benefits to both U.S. harvesters and processors, and to the Nation. For these reasons, consistent with the Council's recommendation, NMFS proposes to specify DAH at a level that can be fully harvested by the domestic fleet, thereby precluding the specification of a TALFF, in order to support the U.S. mackerel industry.
In order to limit river herring and shad catch, Amendment 14 to the FMP (February 24, 2014; 79 FR 10029) allows the Council to set a river herring and shad cap through annual specifications. For 2015, we implemented a cap that was set at 89 mt initially, but if mackerel landing surpass 10,000 mt before closure, then the cap would increase to 155 mt. The 89-mt cap represents the median annual river herring and shad catch by all vessels landing over 20,000 lb (9.08 mt) of mackerel per trip from 2005-2012. These were the years when the fishery caught about 13,000 mt of mackerel. The 155-mt cap was based on the median river herring and shad catch by all vessels landing over 20,000 lb (9.08 mt) of mackerel per trip from 2005-2012, adjusted to the 2015 DAH (20,872 mt). This two-tier system was implemented to encourage the fishery to avoid river herring and shad regardless of the rate of mackerel catches.
For 2016-2018, the Council recommended that the cap be set at 82 mt. For 2016-2018, the proposed mackerel catch limit is 9,177 mt, which is 8.23 percent less than the river herring and shad catch cap increase trigger set in 2015 (10,000 mt). The Council recommended the river herring and shad cap should be reduced by the same proportion as the catch cap increase trigger, resulting in a cap of 82 mt (8.23 percent less than 89 mt). Once the mackerel fishery catches 95 percent of the river herring and shad cap, we will close the directed mackerel fishery and implement a 20,000-lb (9.08-mt) mackerel incidental catch trip limit for the remainder of the year.
The Council recommended increasing the possession limit for vessels fishing with mesh smaller than 3 inches (7.62 cm) from 2,500 lb (1.13 mt) to 5,000 lb (2.27 mt). The 3-inch (7.62-cm) mesh requirement is designed to allow escapement of juvenile butterfish during directed butterfish fishing. Currently, vessels holding a longfin squid and butterfish moratorium permit and fishing with nets that have a mesh size smaller than 3 inches (7.62 cm) are allowed to retain up to 2,500 lb (1.13 mt) of butterfish. This action proposes to increase the possession limit to 5,000 lb (2.27 mt) of butterfish for those vessels fishing with mesh smaller than 3 inches (7.62 cm).
The Council also recommended a clarification regarding net strengtheners used in the butterfish fishery. The regulations do not directly address whether strengtheners are allowed in the operation of the butterfish fishery. This action proposes to amend the regulations to clearly state that 5-inch (12.7-cm) square or diamond, or greater, mesh size strengtheners may be used outside the 3-inch (7.62-cm) mesh to avoid breaking nets during large hauls.
NMFS proposes an indefinite suspension of the longfin squid PTNS requirement for vessels with longfin squid moratorium permits that want to retain more than 2,500 lb (1,13 mt) of longfin squid. This requirement was implemented via Amendment 10 to the Atlantic Mackerel, Squid, and Butterfish FMP (75 FR 11441, March 11, 2010) to improve the selection process of vessels being observed for purposes of monitoring the longfin squid fishery's butterfish cap. However, the new Standardized Bycatch Reporting Methodology (SBRM) requires observers to adhere to a region/gear intercept selection procedure that conflicts with use of the PTNS for assigning observers. This action proposes to resolve the resulting logistical problems by relying on observer coverage through the new SBRM, and eliminating the PTNS requirement.
This proposed rule contains minor adjustment to existing regulations to correct references to the gear stowage regulations.
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the Atlantic Mackerel, Squid, and Butterfish FMP, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.
This proposed rule has been determined to be not significant for purposes of Executive Order 12866.
An IRFA was prepared, as required by section 603 of the Regulatory Flexibility
This action proposes 2016-2018 specifications for Atlantic mackerel and the river herring and shad catch cap. It also proposes management measures for the butterfish and longfin squid fisheries. The preamble to this proposed rule includes a complete description of the reasons why the Council and NMFS are considering this action, and these are not repeated here.
This action proposes the 2016-2018 specifications for Atlantic mackerel. It also proposes to modify the possession limit for butterfish using a mesh smaller than 3 inches (7.62 cm), and to suspend PTNS requirements for vessels targeting longfin squid. The preamble to this proposed rule includes a complete description of the reasons why this action is being considered, and the objectives of and legal basis for this action, and these are not repeated here.
The proposed alternatives apply to vessels that hold Atlantic mackerel, squid, and butterfish limited access permits. Based on permit data for 2014, 370 separate vessels hold Atlantic mackerel, squid, and butterfish limited access permits, 271 entities own those vessels, and, based on current Small Business Administration (SBA) definitions, 259 of these are small entities. Of the 259 small entities, 25 had no revenue in 2014 and those entities with no revenue are considered small entities for the purpose of this analysis. All of the entities that had revenue fell into the finfish or shellfish categories, and the SBA definitions for those categories for 2014 are $20.5 million for finfish fishing and $5.5 million for shellfish fishing.
The only proposed alternative that involves increased restrictions applies to Atlantic mackerel limited access permits so those numbers are listed separately (they are a subset of the above entities). Based on permit data for 2014, 139 separate vessels hold Atlantic mackerel limited access permits, 105 entities own those vessels, and based on current SBA definitions, 97 are small entities. Of the 97 small entities, 3 had no revenue in 2014 and those entities with no revenue are considered small entities for the purpose of this analysis. Of the entities with revenues, their average revenues in 2014 were $1,212,230. Sixty entities had primary revenues from finfish fishing and 34 had their primary revenues from shellfish fishing.
The proposed action contains collection-of-information requirements subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA). This requirement has been submitted to OMB for approval under Control Number 0648-0679.
Under the proposed action, all limited access longfin squid vessels intending to land more than 2,500 lb (1.13 mt) of longfin squid will no longer be required to call PTNS to request an observer. This would remove the information collection requirement to reduce logistical issues for the Northeast Fishery Observer Program and reduce burden for industry participants. The reduction in burden estimates for these new requirements apply to all limited access longfin squid vessels. In a given fishing year, NMFS estimates that removal of this reporting requirement will reduce time burden by 256 hours and reduce cost to the government by $25,943 from that which was previously approved under OMB Control Number 0648-0679.
Public comment is sought regarding: Whether this proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the burden estimate; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology. Send comments on these or any other aspects of the collection of information to the Regional Administrator (see
Notwithstanding any other provisions of the law, no person is required to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number. All currently approved NOAA collections of information may be viewed at:
This action contains no other compliance costs. It does not duplicate, overlap, or conflict with any other Federal law.
The Atlantic mackerel commercial DAH proposed in this action (9,177 mt) represents a reduction from status quo (2015 DAH = 20,872 mt). Despite the reduction, the proposed DAH is above recent U.S. landings; mackerel landings for 2012-2014 averaged 5,136 mt. Thus, the reduction should not have more than minimal impact on the affected small entities compared to recent operation of the fishery (2012-2014, and 2015 landings to date appear similar to 2014). Even though the proposed 2016-2018 quota is lower than 2015, it would still allow more catch compared to any year from 2012-2014.
The proposed river herring and shad catch cap in the Atlantic mackerel fishery has the potential to limit the fishery from achieving its full mackerel quota if the river herring and shad encounter rates are high, but it is very unlikely that this fishery would close before exceeding the levels of landings experienced since 2010, when landing have been less than 11,000 mt. Based on the operation of the cap in 2014 and first half of 2015 (the first years of the cap), as long as the fishery can maintain relatively low river herring and shad catch rates, the proposed lower cap should not negatively impact fishery participants. However, a few large river herring and shad bycatch events could potentially shut down the mackerel fishery early. At 2014 prices ($491/mt), the proposed mackerel quota (9,177 mt) could potentially generate about $4.5 million. While the performance of the cap in 2014-2015 suggests that the fishery can operate with very low river herring and shad catch rates, if river herring and shad catch rates happen to be relatively high then most of the mackerel catch, and associated revenues could be forgone.
The proposed butterfish mesh requirement adjustment would allow more butterfish to be retained with small mesh gear; therefore, there should be no negative impacts on the relevant entities.
The proposed suspension of PTNS requirement for longfin squid would reduce administrative burden, so there should be no negative impacts on the relevant entities.
Fisheries, Fishing, Recordkeeping and reporting requirements.
For the reasons set out in the preamble, 50 CFR part 648 is proposed to be amended as follows:
16 U.S.C. 1801
(n) * * *
(1) * * *
(i) A vessel issued a limited access Atlantic mackerel permit, as specified at § 648.4(a)(5)(iii), must, for the purposes of observer deployment, have a representative provide notice to NMFS of the vessel name, vessel permit number, contact name for coordination of observer deployment, telephone number or email address for contact; and the date, time, port of departure, gear type, and approximate trip duration, at least 48 hr, but no more than 10 days, prior to beginning any fishing trip, unless it complies with the possession restrictions in paragraph (n)(1)(iii) of this section.
(ii) A vessel that has a representative provide notification to NMFS as described in paragraph (n)(1)(i) of this section may only embark on a mackerel trip without an observer if a vessel representative has been notified by NMFS that the vessel has received a waiver of the observer requirement for that trip. NMFS shall notify a vessel representative whether the vessel must carry an observer, or if a waiver has been granted, for the specific mackerel trip, within 24 hr of the vessel representative's notification of the prospective mackerel trip, as specified in paragraph (n)(1)(i) of this section. Any request to carry an observer may be waived by NMFS. A vessel that fishes with an observer waiver confirmation number that does not match the mackerel trip plan that was called in to NMFS is prohibited from fishing for, possessing, harvesting, or landing mackerel except as specified in paragraph (n)(1)(iii) of this section. Confirmation numbers for trip notification calls are only valid for 48 hr from the intended sail date.
(iii)
(iv) If a vessel issued a limited access Atlantic mackerel permit, as specified in § 648.4(a)(5)(iii), intends to possess, harvest, or land more than 20,000 lb (9.07 mt) of mackerel per trip or per calendar day, and has a representative notify NMFS of an upcoming trip, is selected by NMFS to carry an observer, and then cancels that trip, the representative is required to provide notice to NMFS of the vessel name, vessel permit number, contact name for coordination of observer deployment, and telephone number or email address for contact, and the intended date, time, and port of departure for the cancelled trip prior to the planned departure time. In addition, if a trip selected for observer coverage is cancelled, then that vessel is required to carry an observer, provided an observer is available, on its next trip.
(g) * * *
(2) * * *
(ii) * * *
(E) Possess more than 5,000 lb (2.27 mt) of butterfish, unless the vessel meets the minimum mesh requirements specified in § 648.23(a).
(iii) * * *
(A) Fish with or possess nets or netting that do not meet the gear requirements for Atlantic mackerel, longfin squid,
(C) Enter or fish in the mackerel, squid, and butterfish bottom trawling restricted areas, as described in § 648.23(a)(5).
(iv)
(a)
(1)
(2)
(ii)
(3)
(ii) Owners or operators of otter trawl vessels fishing for and/or possessing longfin squid shall not use any device, gear, or material, including, but not limited to, nets, net strengtheners, ropes, lines, or chafing gear, on the top of the regulated portion of a trawl net that results in an effective mesh opening of less than 2
(iii) The owner or operator of a fishing vessel shall not use any mesh construction, mesh configuration, or other means that effectively decreases the mesh size below the minimum mesh size, except that a liner may be used to close the opening created by the rings in the aftermost portion of the net, provided the liner extends no more than 10 meshes forward of the aftermost portion of the net. The inside webbing of the codend shall be the same circumference or less than the outside webbing (strengthener). In addition, the inside webbing shall not be more than 2 ft (61 cm) longer than the outside webbing.
(4)
(5)
(ii)
(b) * * *
(2) During a closure of the directed fishery for longfin squid for Trimester II, a vessel with a longfin squid/butterfish moratorium permit that is on a directed
(d) * * *
(2) A vessel issued longfin squid/butterfish moratorium permit fishing with mesh less than 3 inches (76 mm) may not fish for, possess, or land more than 5,000 lb (2,27 mt) of butterfish per trip at any time, and may only land butterfish once on any calendar day, provided that butterfish harvest has not reached the DAH limit and the reduced possession limit has not been implemented, as described in § 648.24(c)(1). When butterfish harvest is projected to reach the DAH limit (as described in § 648.24(c)(1)), these vessels may not fish for, possess, or land more than 600 lb (0.27 mt) of butterfish per trip at any time, and may only land butterfish once on any calendar day.
(a) * * *
(4) * * *
(iv) * * *
(B) * * *
(
(g) * * *
(5) * * *
(i)
(a) * * *
(5) * * *
(i) * * *
(D) * * *
(
(
In proposed rule document 2015-32742 appearing on pages 81262-81271 in the issue of Tuesday, December 29, 2015 make the following corrections:
1. On page 81263, in the first column, in the second paragraph, beginning on the eighth line, “February 29, 2016” should read “December 17, 2015”.
2. In the same paragraph, in the 10th line, “February 29, 2016” should read “February 16, 2016”.
3. In the same paragraph, in the 13th line, “February 29, 2016” should read “February 16, 2016”.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are required regarding (1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by February 22, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725-17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by February 22, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Forest Service, USDA.
Notice of meeting.
The Gallatin County Resource Advisory Committee (RAC) will meet in Bozeman, MT. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. Additional RAC information, including the meeting agenda and the meeting summary/minutes can be found at the following Web site:
The meeting will be held March 10 from 12:30-5:30 p.m.
All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under
The meeting will be held at the Bozeman Public Library, Small Community Room, 626 E Main St. Bozeman, MT 59715.
Written comments may be submitted as described under
Mariah Leuschen-Lonergan, Public Affairs Specialist and RAC Coordinator by phone at 406-587-6735 or via email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is:
1. Review and recommend 2016 project proposals to Designated Federal Official.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by February 19 to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Attn: Mariah Leuschen, RAC Coordinator, 10 E Babcock, Bozeman, MT 59105 or by email to
Forest Service, USDA.
Notice of meeting.
The El Dorado County Resource Advisory Committee (RAC) will meet in Placerville, California. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L. 110-343) (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with the title II of the Act.
The meeting will be held at 6:00 p.m. on February 8, 2016.
All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under
The meeting will be held at the El Dorado Center of Folsom Lake College, Community Room, 6699 Campus Drive, Placerville, California.
Written comments may be submitted as described under
Jennifer Chapman, RAC Coordinator, by phone at 530-621-5280 or via email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is the initial review and discussion of project proposals.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing at least 7 days in advance of the meeting date to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Jennifer Chapman, RAC Coordinator, Eldorado NF Supervisor's Office, 100 Forni Road, Placerville, California 95667; by email to
Forest Service, USDA.
Notice of meeting.
The Southern Montana Resource Advisory Committee (RAC) will meet in Columbus, Montana. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. Additional RAC information, including the meeting agenda and the meeting summary/minutes can be found at the following Web site:
The meeting will be held on February 26, 2016, at 9:00 a.m.
All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under
The meeting will be held at Columbus Fire Rescue, Community Room, 944 East Pike Avenue, Columbus, Montana. No additional call in number, VTC, or field trips are planned.
Written comments may be submitted as described under
Mariah Leuschen-Lonergan, RAC Coordinator, by phone at 406-587-6735 or via email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is to:
1. Review and recommend project submissions for the 2016 field season; and
2. Recommendations will be passed onto the Designated Federal Officer for approval and signature.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by February 12 to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Mariah Leuschen-Lonergan, RAC Coordinator, Custer Gallatin Forest Supervisors Office, 10 East Babcock, P.O. Box 130, Bozeman, Montaan 59771; by email to
Forest Service, USDA.
Notice of meeting.
The Forest Resource Coordinating Committee (Committee) will meet via teleconference. The Committee is established consistent with the Federal Advisory Committee Act of 1972 (FACA) (5 U.S.C. App. II),
The teleconference will be held on February 17, 2016 from 12:00 p.m. to 1:30 p.m., Eastern Standard Time (EST).
All meetings are subject to cancellation. For status of the meeting prior to attendance, please contact the person listed under
The meeting will be held via teleconference. For anyone who would like to attend the teleconference, please visit the Web site listed in the
Written comments may be submitted as described under
Andrea Bedell-Loucks, Designated Federal Officer, at 202-205-1190.
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is to:
1. Learn about extension and university landowner outreach efforts;
2. Work group report outs on outreach efforts;
3. Develop future meeting topics; and
4. Develop April meeting agenda.
The teleconference is open to the public. However, the public is strongly encouraged to RSVP prior to the teleconference to ensure all related documents are shared with public meeting participants. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should submit a request in writing 10 days before the planned meeting to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the Committee may file written statements with the Committee staff before or after the meeting. Written comments and time requests for oral comments must be sent to Laurie Schoonhoven, 1400 Independence Avenue SW., Mailstop 1123, Washington, DC 20250; or by email to
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by February 22, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725-17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
NIFA is requesting to continue to collect an update to the 5-Year Plan of Work which began with the Fiscal Year 2007, and as a result no longer needs to collect the initial 5-Year Plan. Also, as required by the Food Conservation and Energy Act of 2008 (FCEA) (Pub. L. 110-246, Sec. 7505), NIFA is working with the university partners in extension and research to review and identify measures to streamline the submission, reporting under, and implementation of plan of work requirements.
January 28, 2016, 6:00 p.m. CST
Hilton Waco—113 S. University Parks Dr., Waco, TX 76701
Open to the public.
Pursuant to the Government in the Sunshine Act, 5 U.S.C. 552b, the Chemical Safety and Hazard Investigation Board (CSB) will convene a public meeting on January 28, 2016, starting at 6:00 p.m. CST at the Hilton Waco, 113 S. University Parks Dr., Waco, TX 76701. The Board will discuss the investigation into the April 17, 2013, ammonium nitrate explosion at the West Fertilizer facility that claimed the lives of twelve volunteer firefighters and at least two members of the public. CSB staff will present the final investigation report and proposed recommendations for the Board's review and approval. The Board will hear public comments on the investigation. CSB staff will also present to the Board details of a proposed study on land use planning.
The meeting is free and open to the public. If you require a translator or interpreter, please notify the individual listed below as the “Contact Person for Further Information,” at least three business days prior to the meeting.
This meeting will be webcast for those who cannot attend in person. Please visit
The CSB is an independent federal agency charged with investigating accidents and hazards that result, or may result, in the catastrophic release of extremely hazardous substances. The agency's Board Members are appointed by the President and confirmed by the Senate. CSB investigations look into all aspects of chemical accidents and hazards, including physical causes such as equipment failure as well as inadequacies in regulations, industry standards, and safety management systems.
The time provided for public statements will depend upon the number of people who wish to speak. Speakers should assume that their presentations will be limited to three minutes or less, but commenters may submit written statements for the record.
Shauna Lawhorne, Public Affairs Specialist,
GE Generators (Pensacola) L.L.C. (GE Generators), operator of Subzone 249A, submitted a notification of proposed production activity to the FTZ Board, for its facility located in Pensacola, Florida. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on January 8, 2016.
GE Generators already has authority to produce wind turbines and related blades within Subzone 249A. The current request would add finished products (nacelle assemblies and hubs) and foreign-status components to the scope of authority. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt GE Generators from customs duty payments on the foreign status components used in export production. On its domestic sales, GE Generators would be able to choose the duty rates during customs entry procedures that apply to nacelle assemblies and hubs (duty rates—free, 2.5%) for the foreign-status inputs noted below and in the existing scope of authority. Customs duties also could possibly be deferred or reduced on foreign status production equipment.
The components sourced from abroad include: Pitch bearings; hub castings; pitch cabinets; pitch drives; gearboxes; main shafts; yaw drives; bed plates; yaw bearings; top boxes; main bearings; pillow blocks; generator frames; flex couplings; gearbox coolers; gearbox isolation pedestals; pillow block housing covers; generator frames and legs; blade root spacers; and, elastomeric gearbox mounts (duty rate ranges from free to 5.8%).
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is March 2, 2016.
A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via
For further information, contact Pierre Duy at
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration, Commerce.
Notice of initiation of a 5-year review and notice of intent to update a recovery plan; request for information.
We, NMFS, announce the initiation of a 5-year review for the U.S. distinct population segment (DPS) of smalltooth sawfish (hereafter referred to as `smalltooth sawfish'), and our intent to update the smalltooth sawfish recovery plan. A 5-year review is a periodic process conducted to ensure that the listing classification of a species is accurate. Recovery plans are guides to rebuild and assure the long-term viability of protected species in the wild. Each document is based on the best scientific and commercial data available at the time of the review/update. Therefore, we are requesting submission of any information on the status of smalltooth sawfish that has become available since the previous iterations of these documents in 2010 and 2009 respectively.
Information regarding the status of smalltooth sawfish must be received by March 22, 2016.
You may submit information by either of the following methods:
•
•
Adam Brame, Protected Resources Division, 727-209-5958.
Section 4(c)(2)(A) of the Endangered Species Act of 1973 (ESA), as amended, requires that we conduct a review of listed species at least once every five years. The regulations in 50 CFR 424.21 require that we publish a notice in the
Section 4(f) of the ESA requires NMFS to develop and implement recovery plans for the conservation and survival of federally-listed species. Section 4(f) also requires that a public notice and opportunity to review and comment be provided during recovery plan development.
Recovery means that listed species and their ecosystems are restored, and their future secured, so that the protections of the ESA are no longer necessary. The ESA specifies that recovery plans must include: (1) A description of management actions necessary to achieve the plan's goals for
The U.S. DPS of smalltooth sawfish (
To ensure that the 5-year review is complete and based on the best available scientific and commercial information, we are soliciting new information from the public, governmental agencies, Tribes, the scientific community, industry, environmental entities, and any other interested parties concerning the status of smalltooth sawfish in U.S. waters. Categories of requested information include: (1) Species biology including, but not limited to, population trends, distribution, abundance, demographics, and genetics; (2) habitat conditions including, but not limited to, amount, distribution, and suitability; (3) conservation measures that have been implemented that benefit the species; (4) status and trends of threats; and (5) other new information, data, or corrections. Any new information will be considered during the 5-year review and will also be incorporated, as appropriate, into the recovery plan update.
In regards to the recovery plan, we are soliciting relevant information related to smalltooth sawfish and their habitats, including: (1) Criteria for removing smalltooth sawfish from the list of threatened and endangered species; (2) human activities that contribute to the ESA listing factors (section 4(a)(1)(A)-(E)); (3) strategies and/or actions necessary to recover smalltooth sawfish; (4) critical knowledge gaps and/or uncertainties that need to be resolved to better inform recovery efforts; and (5) research, monitoring and evaluation needs to address knowledge gaps and uncertainties, to assess the species' status, or to evaluate progress in addressing the ESA listing factors relative to recovery goals. Upon completion, the updated recovery plan will be available for public review and comment through the publication of a
The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before March 22, 2016.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Kristy Wallmo, 301-427-8190 or
This request is for a new collection of information.
The objective of the survey will be to understand divers' and snorkelers' expenditures associated with recreational coral reef diving activities in South Florida. The survey will also collect information on divers' attitudes, preferences, and concerns about recreational diving and coral reefs health in South Florida. We are conducting this survey to improve our understanding of divers' expenditure patterns and to estimate the economic impact of coral reef related spending. Results of the survey will be used to inform coastal resource management planning and establish a baseline for outreach and education. The expenditure survey is also expected to provide useful information for local economic and business interests.
The survey will be conducted using two modes: Mail and Internet.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Mid-Atlantic Fishery Management Council (Council) will hold a three-day meeting.
The meeting will be held Tuesday, Wednesday, and Thursday, February 9-11, 2016 beginning at 9 a.m. on Tuesday, February 9, 2016 and ending at 1 p.m. on Thursday, February 11, 2016.
The meeting will be held at Double Tree by Hilton New Bern, 100 Middle Street, New Bern, NC 28560; telephone: (252) 638-3585.
Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526-5255.
The Executive Committee will hold a closed session to discuss Scientific and Statistical Committee membership and process. The Collaborative Research Committee will review and discuss preliminary alternatives for long-term collaborative research. The Council will convene to consider comments from the Unmanaged Forage Fish Fishery Management Team, Ecosystems and Ocean Planning Advisory Panel, and Ecosystems and Ocean Planning Committee meetings on list of species, management alternatives, and other aspects of the amendment and review and approve the public hearing document. A presentation will be offered to the Council on the Northeast Regional Ocean Council Party/Charter Electronic Reporting Project.
The Council will convene to review the Ecosystem Approach to Fisheries Management Interactions White Paper and discuss the first draft of the Ecosystems Approach to Fisheries Management Guidance Document. The Fisheries Dependent Data Project will be presented. Ricks E Savage Award will be presented. The Law Enforcement reports will be presented by NOAA Office of Law Enforcement and the U.S. Coast Guard. The Council will review the Advisory Panel input for Scup Gear Restricted Areas (Framework Meeting 2), review analysis of the impacts, and select the final alternative. The Council will select preferred alternatives for the Omnibus Industry Funded Monitoring Amendment for standard cost responsibilities, framework provisions for Industry Funded Monitoring Programs, service provider requirements, a prioritization process to allocate federal funding, and monitoring set-asides.
The Council will receive an update on implementation activities for the Marine Recreational Information Program. The Naming of the Deep Sea Coral Protection Areas will be discussed. The day will conclude with brief reports from the National Marine Fisheries Service's GARFO and the Northeast Fisheries Science Center, NOAA's Office of General Counsel, the Atlantic States Marine Fisheries Commission (ASMFC), the New England and South Atlantic Fishery Council's liaisons and the Regional Planning Body Report. The Council will also receive the Council's Executive Director's Report, the Science Report, and a Committee Report for the Collaborative Research Committee, and discuss any continuing and/or new business.
Although other non-emergency issues not contained in this agenda may come before this Council for discussion, those issues may not be the subjects of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens act, provided that the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.
Committee for Purchase From People Who Are Blind or Severely Disabled.
Addition to and Deletions from the Procurement List.
This action adds a service to the Procurement List that will be provided by the nonprofit agency employing persons who are blind or have other severe disabilities, and deletes products and a service from the Procurement List previously furnished by such agencies.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 7/17/2015 (80 FR 42481-42483), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed addition to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agency to provide the service and impact of the addition on the current or most recent contractors, the Committee has determined that the service listed below is suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or
2. The action will result in authorizing a small entity to provide the service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the service proposed for addition to the Procurement List.
Accordingly, the following service is added to the Procurement List:
On 12/18/2015 (80 FR 79031-79032), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List.
After consideration of the relevant matter presented, the Committee has determined that the products and service listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entities to furnish the products and service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products and service deleted from the Procurement List.
Accordingly, the following products and service are deleted from the Procurement List:
Wednesday January 27, 2016, 9:30 a.m.-11:00 a.m.
Room 837-C, Enter on the Fourth Floor, Bethesda Towers, 4330 East West Highway, Bethesda, Maryland.
Commission Meeting—Open to the Public.
Matter To Be Considered:
A live webcast of the Meeting can be viewed at
Wednesday, January 27, 2016; 11:00 a.m.-12:00 p.m.
Room 837-C, Bethesda Towers, 4330 East West Highway, Bethesda, Maryland.
Commission Meeting—Closed to the Public.
Todd A. Stevenson, Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814, (301) 504-7923.
Copyright Royalty Board, Library of Congress.
Public notice.
The Copyright Royalty Judges announce receipt of a notice of intent to audit the 2012, 2013, and 2014 statements of account of DMX concerning the royalty payments its New Subscription Service made pursuant to two statutory licenses.
LaKeshia Keys, Program Specialist, by telephone at (202) 707-7658 or by email at
The Copyright Act, title 17 of the United States Code, grants to copyright owners of sound recordings the exclusive right to publicly perform sound recordings by means of certain digital audio transmissions, subject to certain limitations. Specifically, the right is limited by the statutory license in section 114 which allows nonexempt noninteractive digital subscription services and eligible nonsubscription services to perform publicly sound recordings by means of digital audio transmissions. 17 U.S.C. 114(f). In addition, a statutory license in section 112 allows a service to make necessary ephemeral reproductions to facilitate the digital transmission of the sound recording. 17 U.S.C. 112(e).
Licensees may operate under these licenses provided they pay the royalty fees and comply with the terms set by the Copyright Royalty Judges. The rates and terms for the section 112 and 114 licenses are set forth in 37 CFR parts 380 and 382-84. As part of the terms set for these licenses, the Judges designated SoundExchange, Inc. as the Collective,
On December 23, 2015, SoundExchange filed with the Judges a notice of intent to audit DMX's New Subscription Service for the years 2012, 2013, and 2014.
Section 382.15(c) requires the Judges to publish notice in the
Copyright Royalty Board, Library of Congress.
Public notice.
The Copyright Royalty Judges announce receipt of a notice of intent to audit the 2012, 2013, and 2014 statements of account of Muzak LLC concerning the royalty payments its Preexisting Subscription Service made pursuant to two statutory licenses.
LaKeshia Keys, Program Specialist, by telephone at (202) 707-7658 or by email at
The Copyright Act, title 17 of the United States Code, grants to copyright owners of sound recordings the exclusive right to publicly perform sound recordings by means of certain digital audio transmissions, subject to certain limitations. Specifically, the right is limited by the statutory license in section 114 which allows nonexempt noninteractive digital subscription services and eligible nonsubscription services to perform publicly sound recordings by means of digital audio transmissions. 17 U.S.C. 114(f). In addition, a statutory license in section 112 allows a service to make necessary ephemeral reproductions to facilitate the digital transmission of the sound recording. 17 U.S.C. 112(e).
Licensees may operate under these licenses provided they pay the royalty fees and comply with the terms set by the Copyright Royalty Judges. The rates and terms for the section 112 and 114 licenses are set forth in 37 CFR parts 380 and 382-84. As part of the terms set for these licenses, the Judges designated SoundExchange, Inc. as the Collective,
On December 23, 2015, SoundExchange filed with the Judges a notice of intent to audit Muzak LLC's Preexisting Subscription Service for the years 2012, 2013, and 2014.
Section 382.6(c) requires the Judges to publish notice in the
Copyright Royalty Board, Library of Congress.
Public notice.
The Copyright Royalty Judges announce receipt of two notices of intent to audit the 2012, 2013, and 2014 statements of account submitted by DMX and Muzak LLC concerning the royalty payments their Business Establishment Services made pursuant to two statutory licenses.
LaKeshia Keys, Program Specialist, by telephone at (202) 707-7658 or by email at
The Copyright Act, title 17 of the United States Code, grants to copyright owners of sound recordings the exclusive right to publicly perform sound recordings by means of certain digital audio transmissions, subject to certain limitations. Specifically, the right is limited by an exception that allows noninteractive public performances by means of a digital audio transmission that are part of a transmission to a business establishment for use in the ordinary course of its business. 17 U.S.C. 114(d)(1)(C)(iv). In addition, a statutory license in section 112 allows a service to make necessary ephemeral reproductions to facilitate the digital transmission of the sound recording, including the ephemeral recordings made by entities that transmit performances of sound recordings to business establishments (Business Establishment Services).
Licensees may operate under this license provided they pay the royalty fees and comply with the terms set by the Copyright Royalty Judges. The rates and terms for the section 112 license for Business Establishment Services is set forth in 37 CFR part 384. As part of the terms set for this license, the Judges designated SoundExchange, Inc. as the Collective,
On December 23, 2015, SoundExchange filed with the Judges a notice of intent to audit the Business Establishment Services of DMX and
Section 384.6(c) requires the Judges to publish notice in the
Copyright Royalty Board, Library of Congress.
Public notice.
The Copyright Royalty Judges announce receipt of five notices of intent to audit the 2012, 2013, and 2014 statements of account submitted by broadcasters Beasley Broadcast Group Inc., Greater Media Inc., Saga Communications Inc., and Univision Communications Inc. and the 2013 and 2014 statements of account submitted by broadcaster Townsquare Media Broadcasting concerning royalty payments each made pursuant to two statutory licenses.
LaKeshia Keys, Program Specialist, by telephone at (202) 707-7658 or by email at
The Copyright Act, title 17 of the United States Code, grants to copyright owners of sound recordings the exclusive right to publicly perform sound recordings by means of certain digital audio transmissions, subject to certain limitations. Specifically, the right is limited by the statutory license in section 114 which allows nonexempt noninteractive digital subscription services and eligible nonsubscription services to perform publicly sound recordings by means of digital audio transmissions. 17 U.S.C. 114(f). In addition, a statutory license in section 112 allows a service to make necessary ephemeral reproductions to facilitate the digital transmission of the sound recording. 17 U.S.C. 112(e).
Licensees may operate under these licenses provided they pay the royalty fees and comply with the terms set by the Copyright Royalty Judges. The rates and terms for the section 112 and 114 licenses are set forth in 37 CFR parts 380 and 382-84. As part of the terms set for these licenses, the Judges designated SoundExchange, Inc. as the Collective,
On December 23, 2015, SoundExchange filed with the Judges five separate notices of intent to audit Beasley Broadcast Group Inc., for the years 2012-14, Greater Media Inc. for the years 2012-14, Saga Communications Inc. for the years 2013-14, Townsquare Media Broadcasting for the years 2012-14, and Univision Communications Inc. for the years 2012-14.
Section 380.15(c) requires the Judges to publish notice in the
Copyright Royalty Board, Library of Congress.
Public notice.
The Copyright Royalty Judges announce receipt of four notices of intent to audit the 2012, 2013, and 2014 statements of account submitted by commercial webcasters Batanga, DMX, Muzak Inc., and the 2013 and 2014 statements of account submitted by commercial webcaster Pandora Media Inc., concerning the royalty payments each made pursuant to two statutory licenses.
LaKeshia Keys, Program Specialist, by telephone at (202) 707-7658 or by email at
The Copyright Act, title 17 of the United States Code, grants to copyright owners of sound recordings the exclusive right to publicly perform sound recordings by means of certain digital audio transmissions, subject to certain limitations. Specifically, the right is limited by the statutory license in section 114 which allows nonexempt noninteractive digital subscription services and eligible nonsubscription services to perform publicly sound recordings by means of digital audio transmissions. 17 U.S.C. 114(f). In addition, a statutory license in section 112 allows a service to make necessary ephemeral reproductions to facilitate the digital transmission of the sound recording. 17 U.S.C. 112(e).
Licensees may operate under these licenses provided they pay the royalty fees and comply with the terms set by the Copyright Royalty Judges. The rates and terms for the section 112 and 114 licenses are set forth in 37 CFR parts 380 and 382-84. As part of the terms set for these licenses, the Judges designated SoundExchange, Inc. as the Collective,
On December 23, 2015, SoundExchange filed with the Judges notices of intent to audit Batanga, DMX, and Muzak Inc., for the years 2012, 2013, and 2014 and Pandora Media Inc. for the years 2013 and 2014.
Sections 380.6(c) requires the Judges to publish notice in the
Department of the Air Force, DoD.
Notice to delete a System of Records.
The Department of the Air Force is deleting a system of records notice in its existing inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended. The system notice is F035 AFAPO A, entitled “Air Force Art Program”.
Comments will be accepted on or before February 22, 2016. The proposed action will be effective the day following the end of the comment period unless comments are received which result in a contrary determination.
You may submit comments, identified by docket number and title, by any of the following methods:
*
*
Ms. Bao-Anh V. Trinh, Department of the Air Air Force Privacy Act Office, Office of Warfighting Integration and Chief Information officer, ATTN: SAF/CIO A6, 1800 Air Force Pentagon, Washington, DC 20330-1800, or telephone: (703) 614-8500.
The Department of the Air Force systems of records notices subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
The Department of the Air Force proposes to delete a system of records notices from its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended. The proposed deletions are not within the purview of subsection (r) of the Privacy Act of 1974 (5 U.S.C. 552a), as amended, which requires the submission of a new or altered system report.
Reason: The Air Force Art Program system of records notice, F035 AFAPO A, can be deleted. The records were no longer needed, and all records have been destroyed. The program no longer maintains sensitive personal information of the artists for travel purposes. DHRA 08 DoD, entitled Defense Travel System (March 24, 2010, 75 FR 14142) covers all travel. This system does not have an OMB control number associated with this collection.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of public workshop.
The Department of Energy (DOE) is announcing the following web-based public workshop entitled, “Field Testing and Verification for Project DE-EE0006789, [Assimilation of Wave Imaging Radar Observations for Real-time Wave-by-Wave Forecasting]”. The purpose of the meeting is for DOE to obtain industry feedback regarding field testing and verification of the wave-by-wave forecasting system under development.
The public workshop will be held via webinar on Tuesday, February 16, from 1:00 p.m. EST-4:00 p.m. EST.
The meeting will be held via webinar. Please register for the webinar in advance at
Questions may be directed to Tim Ramsey, Department of Energy at (240) 562-1758 or
The DOE is supporting a project through Oregon State University (OSU) to develop and assess the performance of a method for using wave-resolving marine radar to provide all weather, large-area, phase-resolved, wave forecasts for wave energy converter control applications. The target time horizon for the forecasts will be 3-5 minutes (min) and the target spatial domain will be approximately 3-5 kilometers (km) on a side. A wave forecasting system based on wave-resolving marine radar data will be developed and implemented. The main components of the system are a wave imaging marine radar, a phase-resolving linear wave model based on Mild Slope Equations (Polar-MSE), and a variational inversion algorithm which produces the wave forecast via estimation of the offshore wave boundary conditions. Presently, the algorithm is being validated via testing using synthetic data and comparison to a limited set of in situ observations. The purpose of the meeting is for DOE and OSU to obtain feedback from the marine renewable energy industry regarding field testing and verification of the wave-by-wave forecasting system under development.
Members of the public are welcome to attend the workshop. Registration is free and persons interested in attending this public workshop must register online by 1:00 p.m. EST, February 16, 2016. To register for the public workshop, please visit
The objective of the meeting is to ask for public input regarding the project described above. To that end, it would be most helpful if members of the public provide information based on their personal experience, individual advice, and facts regarding this topic. It is not the objective of this meeting to obtain any group position or consensus. Rather, the DOE is seeking as many recommendations as possible from all individuals at this meeting.
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. Deadline for filing comments, motions to intervene, and protests, is 30 days from the issuance date of this notice by the Commission. The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, and recommendations, using the Commission's eFiling system at
k.
l. 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 Web site at
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o.
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following 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:
This notice identifies the Federal Energy Regulatory Commission (Commission or FERC) staff's revised schedule for the completion of the environmental assessment (EA) for Texas Gas Transmission, LLC's Northern Supply Access Project. The previous notice of schedule, issued on December 23, 2015, identified February 4, 2016 as the issuance date.
If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.
In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. Go to
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared an environmental assessment (EA) for the Jacksonville Expansion Project, proposed by the Florida Gas Transmission Company, LLC (FGT) in the above-referenced docket. FGT requests authorization to construct about 8.7 miles of natural gas pipeline and associated aboveground facilities in Suwannee, Columbia, Bradford, and Clay Counties, Florida. The purpose is to provide a total of approximately 75,000 MMBtu/d of natural gas capacity to be delivered at various amounts at several points throughout Florida.
The EA assesses the potential environmental effects of constructing and operating the Jacksonville Expansion Project in accordance with the requirements of the National Environmental Policy Act (NEPA). The FERC staff concludes that approval of the proposed project, with appropriate mitigating measures, would not constitute a major federal action significantly affecting the quality of the human environment.
The proposed Jacksonville Expansion Project includes the following facilities:
• Approximately 3.0 miles of 30-inch-diameter looping pipeline and associated facilities
• one new compressor unit, re-wheel an existing turbine compressor unit, and construct and modify piping and valves at Compressor Station 16 in Bradford County;
• approximately 5.7 miles of 20-inch-diameter looping pipeline and associated facilities in Bradford and Clay Counties; and
• a new regulation station in Bradford County.
The FERC staff mailed copies of the EA to federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; potentially affected landowners and other interested individuals and groups; newspapers and libraries in the project area; and parties to this proceeding. In addition, the EA is available for public viewing on the FERC's Web site (
Any person wishing to comment on the EA may do so. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. The more specific your comments, the more useful they will be. To ensure that the Commission has the opportunity to consider your comments prior to making its decision on this project, it is important that we receive your comments in Washington, DC on or before February 15, 2016.
For your convenience, there are three methods you can use to file your comments to the Commission. In all instances, please reference the project docket number (CP15-144-000) with your submission. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or
(1) You can file your comments electronically using the
(2) You can also file your comments electronically using the
(3) You can file a paper copy of your comments by mailing them to the following address: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC 20426.
Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR 385.214).
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC Web site (
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
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 Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, or recommendations using the Commission's eFiling system at
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o.
Environmental Protection Agency (EPA).
Notice.
EPA is announcing its receipt of test data submitted pursuant to a test rule issued by EPA under the Toxic Substances Control Act (TSCA). As required by TSCA, this document identifies each chemical substance and/or mixture for which test data have been received; the uses or intended uses of such chemical substance and/or mixture; and describes the nature of the test data received. Each chemical substance and/or mixture related to this announcement is identified in Unit I. under
Information about the following chemical substances and/or mixtures is provided in Unit IV.:
Section 4(d) of TSCA (15 U.S.C. 2603(d)) requires EPA to publish a notice in the
A docket, identified by the docket identification (ID) number EPA-HQ-OPPT-2013-0677, has been established for this
The docket for this
This unit contains the information required by TSCA section 4(d) for the test data received by EPA.
1.
2.
3.
15 U.S.C. 2601
Environmental Protection Agency (EPA).
Notice.
This notice announces EPA's order for the cancellations, voluntarily requested by the registrants and accepted by the Agency, of the products listed in Table 1 of Unit II., pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This cancellation order follows a June 16, 2015
The cancellations are effective January 22, 2016.
Michael Yanchulis, Information Technology and Resources Management Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 347-0237; email address:
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0321, is available at
This notice announces the cancellation, as requested by registrant, of products registered under FIFRA section 3 (7 U.S.C. 136a). These registrations are listed in sequence by registration number in Table 1 of this unit.
Table 2 of this unit includes the names and addresses of record for all registrants of the products in Table 1 of this unit, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed in Table 1 of this unit.
During the public comment period, EPA received one comment. The comment was from AMVAC Chemical Corporation requesting that EPA Reg. No. WA090021 be retained because the voluntary cancellation request was made in error. As a result of this comment, the Agency is retaining the registration of EPA Reg. No. WA090021.
Pursuant to FIFRA section 6(f) (7 U.S.C. 136d(f)), EPA hereby approves the requested cancellations of the registrations identified in Table 1 of Unit II. Accordingly, the Agency hereby orders that the product registrations identified in Table 1 of Unit II. are canceled. The effective date of the cancellations that are the subject of this notice is January 22, 2016. Any distribution, sale, or use of existing stocks of the products identified in Table 1 of Unit II. in a manner inconsistent with any of the provisions for disposition of existing stocks set forth in Unit VI. will be a violation of FIFRA.
Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the
Existing stocks are those stocks of registered pesticide products which are currently in the United States and which were packaged, labeled, and released for shipment prior to the effective date of the cancellation action. The existing stocks provisions for the products subject to this order are as follows.
The registrants may continue to sell and distribute existing stocks of products listed in Table 1 of Unit II. until January 15, 2016 or the date of publication of this
7 U.S.C. 136
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before March 22, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email to
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before March 22, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before February 22, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the
Pursuant to the provisions of the “Government in the Sunshine Act” (5 U.S.C. 552b), notice is hereby given that the following matter will be added to the “Discussion Agenda” for consideration at the open meeting of the Board of Directors of the Federal Deposit Insurance Corporation scheduled to be held at 10:00 a.m. on Thursday, January 21, 2016, in the Board Room on the sixth floor of the FDIC Building located at 550—17th Street NW., Washington, DC:
Memorandum and resolution re: Interim Final Rule with Request for Comments: Expanded Exam Cycle for Certain Small Insured Depository Institutions and U.S. Branches and Agencies of Foreign Banks.
Requests for further information concerning the meeting may be directed to Mr. Robert E. Feldman, Executive Secretary of the Corporation, at 202-898-7043.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than February 8, 2016.
A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:
1.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than February 4, 2016.
A. Federal Reserve Bank of St. Louis (Yvonne Sparks, Community Development Officer) P.O. Box 442, St. Louis, Missouri 63166-2034:
1.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than February 18, 2016.
A. Federal Reserve Bank of Atlanta (Chapelle Davis, Assistant Vice President) 1000 Peachtree Street NE., Atlanta, Georgia 30309. Comments can also be sent electronically to
1.
Board of Governors of the Federal Reserve System, January 19, 2016.
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC), announces the following meeting for the aforementioned subcommittee:
In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to CDC. NIOSH implements this responsibility for CDC. The charter was issued on August 3, 2001, renewed at appropriate intervals, and will expire on August 3, 2017.
The agenda is subject to change as priorities dictate.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices.” This draft guidance informs industry and FDA staff of the Agency's recommendations for identifying, addressing, and monitoring cybersecurity vulnerabilities and exploits for postmarket management of medical devices. This draft guidance is neither final nor is it in effect at this time.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 21, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the guidance to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002 or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Suzanne Schwartz, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5418, Silver Spring, MD 20993-0002, 301-796-6937; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
This draft guidance proposes to inform industry and FDA staff of the Agency's recommendations as it relates to monitoring, identifying, and addressing cybersecurity vulnerabilities and exploits as part of manufacturers' postmarket management of medical devices. A growing number of medical devices are designed to be networked to facilitate patient care. Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats. The exploitation of vulnerabilities may represent a risk to the safety and effectiveness of medical devices and typically requires continual maintenance throughout the product life cycle to assure an adequate degree of protection against such exploits. Proactively addressing cybersecurity risks in medical devices reduces the patient safety impact and the overall risk to public health.
For the majority of cases, actions taken by manufacturers to address cybersecurity vulnerabilities and exploits are considered “cybersecurity routine updates and patches,” for which the FDA does not require advance notification or reporting under 21 CFR part 806. For a small subset of cybersecurity vulnerabilities and exploits that may compromise the essential clinical performance of a device and present a reasonable probability of serious adverse health consequences or death, the FDA would require medical device manufacturers to notify the Agency.
In February 2013, the President issued Executive Order 13636 (E.O. 13636), “Improving Critical Infrastructure Cybersecurity,” which recognized that resilient infrastructure is essential to preserving national security, economic stability, and public health and safety in the United States. Furthermore, Presidential Policy Directive-21 (PPD-21) tasks Federal Government entities to strengthen the security and resilience of critical infrastructure against physical and cyber threats such that these efforts reduce vulnerabilities, minimize consequences, and identify and disrupt threats.
In addition, Executive Order 13691, released in February 2015, encourages the development of Information Sharing Analysis Organizations (ISAOs) to serve as focal points for cybersecurity information sharing and collaboration within the private sector and between the private sector and the government.
FDA believes that, in alignment with E.O. 13636 and PPD-21, stakeholders should collaborate to leverage available resources and tools to establish a common framework among the information technology community, healthcare delivery organizations (HDOs), clinical user community, and medical device community. These collaborations can lead to the consistent assessment and mitigation of cybersecurity threats, and their impact on medical device safety and effectiveness.
FDA plans to hold a public workshop entitled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity” on January 20-21, 2016 (80 FR 76022, December 7, 2015). FDA, in collaboration with the National Health Information Sharing Analysis Center, the Department of Health and Human Services, and the Department of Homeland Security, seek to bring together diverse stakeholders to discuss complex challenges in medical device cybersecurity that impact the medical device ecosystem. The purpose of this workshop is to highlight past collaborative efforts; increase awareness of existing maturity models (
In the last few years, Healthcare and Public Health Critical Infrastructure Sector stakeholders have been engaged in many collaborative activities that seek to strengthen medical device cybersecurity and, therefore, enhance patient safety. FDA has contributed to these efforts through guidance, multistakeholder engagement, outreach, and by hosting a 2014 public workshop on cybersecurity entitled “Collaborative Approaches for Medical Device and Healthcare Cybersecurity” (79 FR 56814, September 23, 2014). The 2016 public workshop will build upon previous work by featuring some of the collaborative efforts that address medical device cybersecurity through education and training, information sharing, standards, risk assessment, and tools development.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on postmarket management of cybersecurity in medical devices. It neither creates nor confers any rights for or on any person and is not binding on FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 803 (medical device reporting) have been approved under OMB control number 0910-0437; the collections of information in 21 CFR part 806 (reports of corrections and removals) have been approved under OMB control number 0910-0359; the collections of information in 21 CFR part 810 (medical device recall authority) have been approved under OMB control number 0910-0432; the collections of information in 21 CFR part 814 (premarket approval) have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820 (quality system regulations) have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 822 (postmarket surveillance of medical devices) have been approved under OMB control number 0910-0449.
The Agency invites comments on the “Postmarket Management of Cybersecurity in Medical Devices” draft guidance, in general, and on the following questions, in particular:
• What factors contribute to a manufacturer's decision whether or not to participate in an ISAO?
• In the draft guidance, the FDA is proposing its intention to not enforce certain regulatory requirements for manufacturer's that are “participating members ” of an ISAO. Should FDA define what it means to be a “participating member” of an ISAO and if so, how should such participation be verified?
• What are the characteristics (participation, expertise, policies, and practices) of an ISAO that would make it qualified to participate in the sharing and analysis of medical device cybersecurity vulnerabilities? What are the benefits and disadvantages of FDA “recognizing” specific ISAOs as possessing specialized expertise relevant to sharing and analysis of medical device vulnerabilities and what should such recognition entail?
• When cybersecurity vulnerability information is not reported to FDA, what information should be reported to the ISAO, and when?
• How should the FDA interact with ISAOs, manufacturers, HDOs, security researchers and other stakeholders to maximize the sharing of information concerning cybersecurity threats while maintaining confidentiality and protecting commercial confidential information?
Food and Drug Administration, HHS.
Notice; correction.
The Food and Drug Administration (FDA) is correcting a notice that appeared in the
Stephanie L. Begansky, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533.
In FR Doc. 2016-00823, appearing on page 2873 in the
1. On page 2873, in the third column, in the “
2. On page 2873, in the third column, in the “
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the renewal of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee (formerly known as the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology) by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the January 22, 2018.
Authority for the Pharmaceutical Science and Clinical Pharmacology Advisory Committee will expire on January 22, 2018, unless the Commissioner formally determines that renewal is in the public interest.
Jennifer Shepherd, Center for Drug Evaluation and Research, Food and
Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. The committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Pharmaceutical Science and Clinical Pharmacology Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility.
The Committee reviews and evaluates scientific, clinical, and technical issues related to the safety and effectiveness of drug products for use in the treatment of a broad spectrum of human diseases; the quality characteristics which such drugs purport or are represented to have, and as required, any other product for which the Food and Drug Administration has regulatory responsibility; and makes appropriate recommendations to the Commissioner of Food and Drugs. The Committee may also review Agency sponsored intramural and extramural biomedical research programs in support of FDA's drug regulatory responsibilities and its critical path initiatives related to improving the efficacy and safety of drugs and improving the efficiency of drug development.
The Committee shall consist of a core of 14 voting members including two Chairpersons. Members and Chairpersons are selected by the Commissioner or designee from among authorities knowledgeable in the fields of pharmaceutical sciences (pharmaceutical manufacturing, bioequivalence research, laboratory analytical techniques, pharmaceutical chemistry, physiochemistry, biochemistry, molecular biology, immunology, microbiology); clinical pharmacology (dose-response, pharmacokinetics-pharmacodynamics, modeling and simulation, pharmacogenomics, clinical trial design, pediatrics and special populations and innovative methods in drug development); biostatistics, related biomedical and pharmacological specialties, current good manufacturing practices, and quality systems implementation. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include up to three non-voting members who are identified with industry interests.
Further information regarding the most recent charter and other information can be found at:
This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at
Indian Health Service, HHS.
Notice and request for comments. Request for extension of approval.
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, “IHS Forms to Implement the Privacy Rule (45 CFR parts 160 and 164),” Office of Management and Budget (OMB) Control Number 0917-0030.
Send your written comments, requests for more information on the collection, or requests to obtain a copy of the data collection instrument and instructions to Tamara Clay by one of the following methods:
•
•
•
•
This previously approved information collection project was last published in the
(a) Whether the information collection activity is necessary to carry out an agency function;
(b) whether the agency processes the information collected in a useful and timely fashion;
(c) the accuracy of the public burden estimate (the estimated amount of time needed for individual respondents to provide the requested information);
(d) whether the methodology and assumptions used to determine the estimates are logical;
(e) ways to enhance the quality, utility, and clarity of the information being collected; and
(f) ways to minimize the public burden through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose 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.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of an emergency declaration for the State of Missouri (FEMA-3374-EM), dated January 2, 2016, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
Notice is hereby given that the incident period for this emergency is closed effective January 9, 2016.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Mississippi (FEMA-4248-DR), dated January 4, 2016, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Mississippi is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of January 4, 2016.
Federal Emergency Management Agency, DHS.
Committee Management; Notice of Federal Advisory Committee Meeting.
The Federal Emergency Management Agency (FEMA) National Advisory Council (NAC) will meet in person on February 9, 10, and 11, 2016 in Raleigh, N.C. The meeting will be open to the public.
The NAC will meet on Tuesday, February 9, 2016, from 8:30 a.m. to 2:45 p.m., on Wednesday, February 10, 2016 from 8:30 a.m. to 5:30 p.m., and on Thursday, February 11 from 8:30 a.m. to 12:00 p.m. Eastern Standard Time (EST). Please note that the meeting may close early if the NAC has completed its business.
The meeting will be held at the North Carolina Office of Emergency Management located at 1636 Gold Star Drive in Raleigh, NC, 27607. All attendees must provide a valid government I.D., such as a driver's license, to access the building. It is recommended that attendees register with FEMA prior to the meeting by providing your name, telephone number, email address, title, and organization to the person listed in
For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact the person listed in
To facilitate public participation, members of the public are invited to provide written comments on the issues to be considered by the NAC. The “Agenda” section below outlines these issues. Written comments must be submitted and received by 5:00 p.m. EST on February 8, 2016, identified by Docket ID FEMA-2007-0008, and submitted by one of the following methods:
•
•
•
•
A public comment period will be held on Wednesday, February 10 from 4:00 p.m. to 4:15 p.m. EST. All speakers must limit their comments to 3 minutes. Comments should be addressed to the committee. Any comments not related to the agenda topics will not be considered by the NAC. To register to make remarks during the public comment period, contact the individual listed below by February 8, 2016. Please note that the public comment period may end before the time indicated, following the last call for comments.
Alexandra Woodruff, Designated Federal Officer, Office of the National Advisory Council, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472-3184, telephone (202) 646-2700, fax (540) 504-2331, and email
Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. Appendix.
The NAC advises the FEMA Administrator on all aspects of emergency management. The NAC incorporates state, local, and tribal government, and private sector input in the development and revision of FEMA plans and strategies. The NAC includes a cross-section of officials, emergency managers, and emergency response providers from state, local, and tribal governments, the private sector, and nongovernmental organizations.
On Wednesday, February 10, the NAC will hear from a FEMA Regional Administrator about activities in the FEMA Regions and engage in an open discussion with the FEMA Administrator. The three NAC subcommittees: Federal Insurance and Mitigation Subcommittee, Preparedness and Protection Subcommittee, and Response and Recovery Subcommittee, will then provide reports to the NAC about their work, whereupon the NAC will deliberate on any recommendations presented in the subcommittees' reports, and, if appropriate, vote on recommendations for the FEMA Administrator. The subcommittee reports will be posted on the NAC Web page by 8:30 a.m. on Wednesday, February 10. The NAC will receive a briefing about the FEMA Youth Preparedness Council and engage in a facilitated discussion of the status of previously submitted NAC recommendations.
On Thursday, February 11, the NAC will hear remarks from the NAC Chair and Vice Chair, review agreed upon recommendations and confirm charges for the subcommittees, and engage in an open discussion with the FEMA Deputy Administrator. The meeting will conclude with two NAC member presentations.
The full agenda and any related documents for this meeting will be posted by Friday, February 5 on the NAC Web site at
Privacy Office, Department of Homeland Security.
Notice of Privacy Act System of Records.
In accordance with the Privacy Act of 1974, the Department of Homeland Security (DHS) proposes to update and reissue a current Department-wide system of records titled, “Department of Homeland Security(DHS)/ALL-030 Use of the Terrorist Screening Database (TSDB) System of Records,” 76 FR 39408, July 6, 2011. This system of records allows the DHS to maintain a synchronized copy of the Department of Justice's (DOJ) Federal Bureau of Investigation's (FBI) Terrorist Screening Database (TSDB), which includes categories of individuals covered by DOJ/FBI-019, “Terrorist Screening Records Center System,” 72 FR 77846, Dec. 14, 2011. DHS maintains a synchronized copy to automate and simplify the transmission of information in the Terrorist Screening Database to DHS and its components. With this updated notice, DHS is adding two new consumers, Customs and Border Protection (CBP) Automated Targeting System (ATS) and U.S. Citizenship and Immigration Services (USCIS) Fraud Detection and National Security (FDNS) Directorate, to the “DHS Watchlist Service.” The DHS Watchlist Service is the technological mechanism used to transmit Terrorist Screening Database information from the Department of Justice to the Department of Homeland Security, and to DHS components thereafter. DHS is also clarifying an existing category of individuals, adding two new categories of individuals, and clarifying the categories of records maintained in this system. Additionally, this notice includes non-substantive changes to simplify the formatting and text of the previously published notice.
DHS is also issuing a new notice of proposed rulemaking to cover the exemptions applied to these new categories of individuals covered by this system of records notice. The notice of proposed rulemaking will be published concurrently with this notice. The existing Final Rule for Privacy Act exemptions will continue to apply until the new Final Rule is published. This updated system will be included in DHS's inventory of record systems.
Submit comments on or before February 22, 2016. This updated system will be effective February 22, 2016.
You may submit comments, identified by docket number DHS-2016-0002 by one of the following methods:
•
•
•
For general questions and privacy issues please contact: Karen L. Neuman (202-343-1717), Chief Privacy Officer, Privacy Office, Department of Homeland Security, Washington, DC 20528.
In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the Department of Homeland Security (DHS) proposes to update and reissue the current system of records titled, “Department of Homeland Security (DHS)/ALL-030 Use of the Terrorist Screening Database (TSDB) System of Records.” DHS maintains a synchronized copy of the Department of Justice's (DOJ) Federal Bureau of Investigation's (FBI) Terrorist Screening Database (TSDB), which includes individuals covered by DOJ/FBI-019, “Terrorist Screening Records Center System,” 72 FR 77846, Dec. 14, 2011, via a technological mechanism called the “DHS Watchlist Service (WLS).” The DHS WLS disseminates received TSDB records to authorized DHS components.
Homeland Security Presidential Directive 6 (HSPD-6), issued in September 2003, called for the establishment and use of a single, consolidated watchlist to improve the identification and screening of known or suspected terrorists and their supporters. The FBI's Terrorist Screening Center (TSC) maintains and distributes TSDB as the U.S. Government's consolidated terrorist watchlist system. DHS and the FBI/TSC developed the WLS in order to automate and simplify the method for transmitting TSDB records from the FBI/TSC to DHS and its authorized components.
The WLS supports an automated and centralized data transmission of TSDB data to DHS and its components. The WLS replaced multiple data feeds from the FBI/TSC to DHS and its components, which were documented by information sharing agreements. The WLS is a system-to-system secure connection with no direct user interface.
DHS and its components are authorized to access TSDB records via the WLS pursuant to the terms of information sharing agreements with FBI/TSC. DHS is updating this SORN and has published privacy impact assessments to provide additional transparency into how DHS has implemented WLS. DHS will review and update this SORN no less than every two years as new DHS systems are interconnected with the WLS and are approved, consistent with the terms of agreements with FBI/TSC. There are currently six DHS systems authorized to receive TSDB data directly from the FBI/TSC via WLS, including two systems new to this SORN. The following systems have existing SORNs that permit the use of the TSDB:
(1) Transportation Security Administration (TSA): “DHS/TSA-002 Transportation Security Threat Assessment System (T-STAS),” 79 FR 46862, Aug. 11, 2014;
(2) TSA Secure Flight Program: “DHS/TSA-019 Secure Flight Records,” 80 FR 233 Jan. 5, 2015;
(3) U.S. Customs and Border Protection (CBP) Passenger Systems Program, as included in TECS: “DHS/CBP-011 TECS”, 73 FR 77778, Dec. 19, 2008;
(4) Office of Biometric Identity Management (OBIM), as included in the DHS Automated Biometric Identification System (IDENT): DHS/US-VISIT-004, “DHS Automated Biometric Identification System (IDENT),” 72 FR 31080, June 5, 2007.
DHS is expanding the use of the WLS within the Department to include two new systems with existing SORNs that cover the use of the TSDB:
(5) CBP, DHS/CBP-006, “Customs and Border Protection Automated Targeting System”, 77 FR 30297, May 22, 2012;
(6) U.S. Citizenship and Immigration Services (USCIS) Fraud Detection and National Security (FDNS) Directorate, as included in the FDNS-Data System, “DHS/USCIS-006 Fraud Detection and National Security Records” 77 FR 47411, Aug. 8, 2012.
Two other DHS components are authorized to receive TSDB data via the WLS in the form of a computer readable extract. The components' use of the TSDB data is covered by existing SORNs:
(1) DHS/IA-001, “Office of Intelligence and Analysis (I&A) Enterprise Records System,” 73 FR 28128, May 15, 2008; and
(2) DHS/ICE-009, U.S. Immigration and Customs Enforcement's (ICE) “ICE External Investigations,” 75 FR 404, Jan. 5, 2010.
Transactional Information stored in the WLS may be shared with the FBI/TSC in order to ensure that DHS and the FBI/TSC can reconcile any differences in the database and ensure DHS has the most up-to-date and accurate version of TSDB records, such as through automated response messages from WLS to TSC. All other sharing will be conducted pursuant to the programmatic system of records notices.
DHS is also updating this system of records to clarify one category of individuals and add two new categories of individuals whose information is currently included in, or is contemplated for inclusion in, the TSDB. These categories of information have been included in the TSDB to in support of the White House's “Strategy to Combat Transnational Organized Crime” (July 19, 2011), and National Security Presidential Directive-59/Homeland Security Presidential Directive-24, “Biometrics for Identification and Screening to Enhance National Security” (June 5, 2008). These executive strategies are relevant to DHS's vetting and screening operations.
DHS is clarifying the category of individuals to explicitly include relatives, associates, or others closely connected with a known or suspected terrorist who are excludable from the United States based on these relationships by virtue of Section 212(a)(3)(B) of the Immigration and Nationality Act, as amended, and do not otherwise satisfy the requirements for inclusion in the TSDB.
DHS is adding two new categories of individuals to include: (1) Individuals who were officially detained during military operations, but not as enemy prisoners of war, and who have been identified as possibly posing a threat to national security, and who do not otherwise satisfy the requirements for inclusion in the TSDB (“military detainees”), consistent with E.O. 12333 (or successor order) and the DOJ/FBI-019; and (2) individuals who may pose a threat to national security because they are (a) known or suspected to be or have been engaged in conduct constituting, in aid of, or related to transnational organized crime, thereby posing a possible threat to national security, and (b) do not otherwise satisfy the requirements for inclusion in the TSDB (“transnational organized crime actors”), consistent with E. O. 12333 (or successor order) (“national security threats”) and in support of the White House's “Strategy to Combat
DHS is updating this system of records to clarify and expand the categories of records maintained by the Department. These categories of records are types of data elements included in the TSDB and are shared with DHS and have been deemed relevant to supporting DHS's vetting and screening operations.
1. Identifying biographic information, such as name, date of birth, place of birth, passport or driver's license information, and any other available identifying particulars used to compare the identity of an individual being screened with a subject in the TSDB;
2. Biometric information, such as photographs, fingerprints, or iris images, and associated biographic and contextual information;
3. References to, or information from, other government law enforcement and intelligence databases, or other relevant databases that may contain terrorism and/or national security information, such as unique identification numbers used in other systems;
4. Information collected and compiled to maintain an audit trail of the activity of authorized users of WLS information systems; and
5. System-generated information, including metadata, archived records and record histories from WLS.
DHS is planning future enhancements to the WLS that will provide for a central mechanism to receive information from DHS components when they encounter a potential match to the TSDB and send this information to the FBI/TSC. DHS will update this SORN to reflect such enhancements to the WLS once that capability is implemented. All encounter-related information sharing from DHS to the FBI/TSC will be conducted pursuant to the programmatic system of records notices outlined above.
DHS previously published a Final Rule in the
The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which Federal government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. As a matter of policy, DHS extends administrative Privacy Act protections to all individuals when systems of records maintain information on U.S. citizens, lawful permanent residents, and visitors.
Below is the description of the DHS/ALL-030 Use of the Terrorist Screening Database (TSDB) System of Records.
In accordance with 5 U.S.C. § 552a(r), DHS has provided a report of this system of records to the Office of Management and Budget and to Congress.
Department of Homeland Security (DHS)/ALL-030.
DHS/ALL-030 Use of the Terrorist Screening Database (TSDB) System of Records.
Unclassified.
Records are maintained at DHS and Component Headquarters in Washington, DC and field offices.
Categories of individuals covered by this system include:
(a) Individuals known or suspected to be or have been engaged in conduct constituting, in preparation for, in aid of, or related to terrorism (“known or suspected terrorists”);
(b) Individuals who are foreign nationals or lawful permanent resident aliens and who are excludable from the United States based on their familial relationship, association, or connection with a known or suspected terrorist as described in Section 212(a)(3)(B) of the Immigration and Nationality Act of 1952 (“INA exceptions”);
(c) Individuals who were officially detained during military operations, but not as Enemy Prisoners of War, and who have been identified to pose an actual or possible threat to national security (“military detainees”); and
(d) Individuals known or suspected to be or have been engaged in conduct constituting, in aid of, or related to transnational organized crime, thereby posing a possible threat to national security (“transnational organized crime actors.”)
Categories of records in this system include:
1. Identifying biographic information, such as name, date of birth, place of birth, passport and/or driver's license information, and other available identifying particulars used to compare the identity of an individual being screened with a subject in the TSDB;
2. Biometric information, such as photographs, fingerprints, or iris images, and associated biographic and contextual information;
3. References to or information from other government law enforcement and intelligence databases, or other relevant databases that may contain terrorism or national security information, such as unique identification numbers used in other systems;
4. Information collected and compiled to maintain an audit trail of the activity of authorized users of WLS information systems; and
5. System-generated information, including metadata, archived records and record histories from WLS.
Homeland Security Act of 2002, Public Law 107-296, 116 Stat. 2135; The Tariff Act of 1930, Public Law 71-361, 46 Stat. 741, as amended; The Immigration and Nationality Act; 49 U.S.C. 114, 5103a, 40113, ch. 49 and 46105; Homeland Security Presidential Directive/HSPD-6, “Integration and Use of Screening Information to Protect Against Terrorism” (Sept. 16, 2003); Homeland Security Presidential Directive/HSPD-11, “Comprehensive Terrorist-Related Screening Procedures” (Aug. 27, 2004); National Security Presidential Directive/NSPD-59/Homeland Security Presidential Directive/HSPD-24, “Biometrics for Identification and Screening to Enhance National Security” (June 5, 2008); E.O. 13388, “Further Strengthening the Sharing of Terrorism Information to Protect Americans,” 70 FR 62023 (Oct. 25, 2005); Intelligence Reform and
DHS and its components collect, use, maintain, and disseminate information in the DHS Watchlist Service (WLS) to facilitate DHS mission-related functions, such as counterterrorism, law enforcement, border security, and inspection activities. TSDB data, which includes personally identifiable information (PII), is necessary for DHS to effectively and efficiently assess the risk or threat posed by a person for the conduct of its mission.
The Federal Bureau of Investigation's (FBI) Terrorist Screening Center (TSC) provides a near real time, synchronized version of the TSDB to DHS in order to improve the timeliness and governance of watchlist data exchanged between the FBI's TSC and DHS and its component systems that currently use TSDB data.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act all or a portion of the records or information contained in this system may be disclosed outside DHS as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
A. To the Department of Justice (DOJ)/FBI/TSC in order to receive confirmations that the information has been appropriately transferred and any other information related to the reconciliation process so that DHS is able to maintain a synchronized copy of the TSDB.
DHS will share information contained in this system to components internal to DHS pursuant to subsection 552a(b)(1) of the Privacy Act, and subsequently may be shared externally outside DHS at the programmatic level pursuant to routine uses described in the following published system of records notices:
(1) DHS/TSA-002 Transportation Security Threat Assessment System (T-STAS), 79 FR 46862, Aug. 11, 2014;
(2) DHS/TSA-019 Secure Flight Records, 80 FR 223, Jan. 5, 2015;
(3) DHS/CBP-011 TECS, 73 FR 77778, Dec. 19, 2008;
(4) DHS/CBP-006, Customs and Border Protection Automated Targeting System, 77 FR 30297, May 22, 2012;
(5) DHS/US-VISIT-004, DHS Automated Biometric Identification System (IDENT), 72 FR 31080, June 5, 2007;
(6) DHS/IA-001, Office of Intelligence and Analysis (I&A) Enterprise Records System, 73 FR 28128, May 15, 2008;
(7) DHS/ICE-009, ICE External Investigations, 75 FR 404, Jan. 5, 2010; and
(8) DHS/USCIS-006 Fraud Detection and National Security Records, 77 FR 47411, Aug. 8, 2012.
None.
DHS stores records in this system electronically or on paper in secure facilities in a locked drawer behind a locked door. The records are stored on servers, magnetic disc, tape, digital media, and CD-ROM.
DHS may retrieve records by name or other personal identifier.
DHS safeguards records in this system in accordance with applicable rules and policies, including all applicable DHS automated systems security and access policies. Strict controls have been imposed to minimize the risk of compromising the information that is being stored. Access to the computer system containing the records in this system is limited to those individuals who have a need to know the information for the performance of their official duties and who have appropriate clearances or permissions.
The WLS maintains a near real time feed of the TSDB, and does not retain historical copies of the TSDB. The WLS is synchronized with the TSDB. When the FBI/TSC adds, modifies, or deletes data from the TSDB, the WLS duplicates these functions almost simultaneously, and that information is then passed to DHS and its authorized component systems. DHS does not manipulate the data within the TSDB feed received by WLS. The authorized DHS component that is screening individuals will maintain, separate from the WLS, a record of a match or possible match with the TSDB and DHS will retain this information in accordance with the DHS component specific SORNs identified in this notice.
Executive Director, Passenger Systems Program Directorate, Office of Information and Technology, U.S. Customs and Border Protection, 7400 Fullerton Rd, Springfield, VA 22153.
The Secretary of Homeland Security has exempted this system from the notification, access, and amendment procedures of the Privacy Act because it is a law enforcement system. However, DHS and its components will consider individual requests to determine whether or not information may be released. Thus, individuals seeking notification of and access to any record contained in this system of records, or seeking to contest its content, may submit a request in writing to the Headquarters or component FOIA Officer, whose contact information can be found at
When seeking records about yourself from this system of records or any other Departmental system of records, your request must conform with the Privacy Act regulations set forth in 6 CFR part 5. You must first verify your identity, meaning that you must provide your full name, current address, and date and place of birth. You must sign your request, and your signature must either be notarized or submitted under 28 U.S.C. 1746, a law that permits statements to be made under penalty of perjury as a substitute for notarization. While no specific form is required, you may obtain forms for this purpose from the Chief Privacy Officer and Chief Freedom of Information Act Officer,
• Explain why you believe the Department would have information on you;
• Identify which component(s) of the Department you believe may have the information about you;
• Specify when you believe the records would have been created; and
• Provide any other information that will help the FOIA staff determine which DHS component agency may have responsive records.
If your request is seeking records pertaining to another living individual, you must include a statement from that individual certifying his/her agreement for you to access his/her records.
Without the above information, the component(s) may not be able to
In addition, if individuals are uncertain what agency handles the information, they may seek redress through the DHS Traveler Inquiry Redress Program (DHS TRIP), 72 FR 2294, Jan. 18, 2007. Individuals who believe they have been improperly denied entry, refused boarding for transportation, or identified for additional screening by DHS may submit a redress request through DHS TRIP. The DHS TRIP is a single point of contact for individuals who have inquiries or seek resolution regarding difficulties they experienced during their travel screening at transportation hubs such as airports and train stations or crossing U.S. borders. Redress requests should be sent to: DHS Traveler Redress Inquiry Program, 601 South 12th Street, TSA-901, Arlington, VA 20598 or online at
See “Notification procedure” above.
See “Notification procedure” above.
Records are received from the FBI's Terrorist Screening Center, specifically records covered by DOJ/FBI-019 Terrorist Screening Records System, 72 FR 47073, Aug. 22, 2007.
The Secretary of Homeland Security has exempted this system from the following provisions of the Privacy Act, subject to the limitations set forth in 5 U.S.C. 552a(c)(3) and (c)(4); (d); (e)(1), (e)(2), (e)(3), (e)(4)(G), (e)(4)(H), (e)(4)(I), (e)(5), (e)(8); (f); and (g) pursuant to 5 U.S.C. 552a(j)(2). Additionally, the Secretary of Homeland Security has exempted this system from the following provisions of the Privacy Act, subject to the limitation set forth in 5 U.S.C. 552a(c)(3); (d); (e)(1), (e)(4)(G), (e)(4)(H), (e)(4)(I); and (f) pursuant to 5 U.S.C. 552a(k)(1) and (k)(2).
Office of the Chief Information Officer, HUD.
Notice.
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Comments Due Date: February 22, 2016.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email:
Anna P. Guido, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Anna P. Guido at
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) 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) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.
Juanita Perry, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7262, Washington, DC 20410; telephone (202) 402-3970; TTY number for the hearing- and speech-impaired (202) 708-2565, (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800-927-7588.
In accordance with the December 12, 1988 court order in
Office of the Chief Information Officer, HUD.
Notice.
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email:
Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) 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) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of the Chief Information Officer, HUD.
Notice.
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email:
Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) 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) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Fish and Wildlife Service, Interior.
Notice of availability.
We, the U.S. Fish and Wildlife Service, are making available the final environmental assessment and finding of no significant impact under the National Environmental Policy Act regarding a permit application submitted by Dallas Zoo Management, on behalf of the Dallas Zoo, Sedgwick County Zoo, and Omaha's Henry Doorly Zoo. The three zoos have requested authorization under the Convention on International Trade in Endangered Species of Wild Fauna and Flora to import up to 18 live African elephants from Swaziland.
Timothy Van Norman, Chief, Branch of Permits, Division of Management Authority, 5275 Leesburg Pike, MS-IA, Falls Church, VA 22041; or by phone at (703) 358-2350.
We are making available the final environmental assessment (EA) and finding of no significant impact (FONSI) under the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321
The African elephant is also classified as threatened under the U.S. Endangered Species Act (ESA) (16 U.S.C. 1531
Issuance of a CITES import permit is categorically excluded under Department of the Interior internal agency policy and procedures from requiring completion of an EA under NEPA (Departmental Manual Part 516, Chapter 8.5(C)(1)). However, we decided to prepare an EA in this case to help ensure that we have conducted a thorough review of all relevant factors and potential impacts on the quality of the human environment as envisioned under NEPA.
We announced the availability of the draft EA in a notice published in the
The proposed action is the issuance of a CITES permit by the Service for the importation of up to 18 African elephants from Swaziland. The elephants are currently housed in an enclosure at the Mkhaya Game Reserve, Swaziland. The elephants were removed from Mkhaya Game Reserve and Hlane National Park, Swaziland, due to overpopulation of elephants within the two protected areas and the negative impact the elephants were having on the vegetation and other wildlife species. Big Game Parks (BPG), the delegated authority responsible for implementation of Swaziland's Game Act of 1953, has determined that the number of elephants in the two protected areas must be reduced. Further, the reduction in the number of elephants within each of the protected areas will facilitate BGP's efforts to increase the population of black rhinoceros (
We also considered two alternatives to the proposed action:
1. No Action—No CITES import permit would be issued. According to the applicant and BGP, the 18 elephants will not be returned to the two protected areas. Instead, if importation is not authorized, BGP has stated that they have no option but to cull the animals.
2. Issue a CITES import permit for a reduced number of elephants—This alternative is similar to the Proposed Action, in that the Service would issue an import permit, but the number of elephants authorized for import would be reduced. This alternative could result in some elephants being imported into the United States and housed at one or more of the three zoos. However, according to the applicant and BGP, the elephants that are not imported into the United States would be culled.
The proposed action of issuing the import permit for the 18 elephants is the preferred action. As evaluated in the EA, the proposed action is not expected to result in significant effects to the human environment within the meaning of NEPA and the regulations of the Council on Environmental Quality. Although we describe potential actions and consequences that could flow from each of the alternatives, we find there is no basis to infer that any such effects, even viewed broadly, will be significant. Therefore, based on a review and evaluation of the information contained in the EA, it is the Service's determination that the issuance of a permit authorizing the import of 18 African elephants from Swaziland will not have a significant effect on the quality of the human environment under the meaning of section 102(2)(c) of the National Environmental Policy Act of 1969 (as amended). As such, an Environmental Impact Statement is not required.
We provide this notice under NEPA and its implementing regulations (40 CFR 1506.6).
Bureau of Land Management, Interior.
Public Land Order.
This order extends the duration of the withdrawal created by Public Land Order No. 7179 for an additional 20-year period. The extension is necessary to continue protection of the seismic integrity of the University of California-Berkeley Seismic Observatory located in the Klamath National Forest, Siskiyou County which will expire on January 24, 2016, unless extended.
This withdrawal extension is effective on January 25, 2016.
Nathan Price, United States Forest Service, Regional Office, R5, 1323 Club Drive, Vallejo, California 94592, 707-562-8963, or Elizabeth Easley, Bureau of Land Management California State Office (CA-930), Federal Building (Room W-1928), 2800 Cottage Way, Sacramento, California 95825-1886; 916-979-4673. Persons who use a
The purpose for the extension of the duration of the withdrawal created by Public Land Order No. 7179 is to continue protecting seismic monitoring instruments and the seismic integrity of the University of California-Berkeley Seismic Observatory, located on 45 acres of National Forest System land, from future mining activities that either disturb the seismic equipment or create seismic noise in the general area that would interfere with the accuracy of the seismograph.
By virtue of the authority vested in the Secretary of the Interior by Section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714, it is hereby ordered as follows:
Public Land Order No. 7179 (61 FR 2137 (1996)) which withdrew 45 acres of National Forest System land from location and entry under the United States mining laws, but not from leasing under the mineral leasing laws to protect the seismic integrity of the University of California-Berkeley Seismic Observatory, is hereby extended for an additional 20-year period. This withdrawal will expire on January 24, 2036, unless, as a result of a review conducted before the expiration date pursuant to Section 204(f) of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714(f), the Secretary determines that the withdrawal shall be further extended.
United States International Trade Commission.
Expansion of scope of the investigation.
Following receipt of an amended request on January 12, 2016, from the United States Trade Representative (USTR), the U.S. International Trade Commission (Commission) has expanded the scope of investigation No. 332-556,
All Commission offices, including the Commission's hearing rooms, are located in the United States International Trade Commission Building, 500 E Street SW., Washington, DC. All written submissions should be addressed to the Secretary, United States International Trade Commission, 500 E Street SW., Washington, DC 20436. The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at
Information specific to this investigation may be obtained from Mahnaz Khan, Project Leader, Office of Industries (202-205-2046 or
The Commission initially instituted this investigation in response to a request letter from the USTR dated December 30, 2015. The Commission published notice of institution of this investigation and the scheduling of a public hearing in the
The Commission expects to transmit its report to the USTR by April 28, 2016, the date indicated in the earlier notice).
By order of the Commission.
Notice is hereby given that, on December 8, 2015, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Pursuant to Section 6(b) of the Act, the identities of the parties to the venture are: Consortium Management Group, Inc. on behalf of Medical Countermeasure Systems Consortium, Washington, DC; ABL, Inc., Rockville, MD; Altimmune, Inc., Gaithersburg, MD; AEQUOR, Inc., Oceanside, CA; Appili Therapeutics, Inc., Halifax, Nova Scotia; BalinBac Therapeutics, Inc., Princeton, NJ; Battelle, Columbus, OH; Bavarian Nordic, Kvistgard, DENMARK; Chemapotheca LLC, Delamar, NY; CONTINUUS Pharmaceuticals, Inc., Woburn, MA; Creare LLC, Hanover, NH; CUBRC, Inc., Buffalo, NY; Dyne Immune Institute for Translational Medicine and Research, Wurtsboro, NY; DynPort Vaccine Company LLC, a CSC Company, Frederick, MD; Elusys Therapeutics, Inc., Pine Brook, NJ; Emergent Biosolutions Inc., Gaithersburg, MD; First Line Technology, LLC, Chantilly, VA; GenArraytion, Inc., Rockville, MD; Ginkgo Bioworks, Boston, MA; IIT Research Institute, Chicago, IL; Institute for Therapeutic Innovation, University of Florida, Orlando, FL; InvivoSciences, Inc. Madison, WI; Lovelace Biomedical and Environmental Research Institute (LBERI), Albuquerque, NM; Luminex Corporation, Austin, TX; Maurer & Hutson Consulting, Seattle, WA; MediVector, Inc., Boston, MA; Mesa Science Associates, Inc., Frederick, MD; Molecular Engineering & Sciences Institute, Seattle, WA; Murtech, Inc., Glen Burnie, MD; Nanotherapeutics, Inc., Alachua, FL; Noninvasix, Inc., Galveston, TX; Philips Healthcare, Andover, MA; PnuVax Incorporated, Kingston, CANADA; The Preclinical Radiobiology Laboratory, Division of Translational Radiation Sciences, Department of Radiation Oncology, University of Maryland, School of Medicine, Baltimore, MD; Quintiles, Inc., Durham, NC; Science Applications International Corporation, McLean, VA; Smart Consulting Group, West Chester, PA; Southern Research, Birmingham, AL; Southwest Research Institute, San Antonio, TX; Spero Therapeutics, Cambridge, MA; Therabron Therapeutics, Inc., Rockville, MD; Trideum Biosciences LLC, Huntsville, AL; University of Pittsburgh Center for Military Medicine Research, Pittsburgh, PA; Vaxess Technologies, Inc., Cambridge, MA; and Washington to Washington Consulting, Seattle, WA.
The general area of the CMG-MCSC's planned activity is (a) to enter into an Other Transaction Agreement (“OTA”) with the U.S. Government (“Government”) for the funding of certain research, development, testing and evaluation of prototypes to be conducted as a collaboration between the Government and Consortium Members, to enhance the capabilities of the Government and its departments and agencies in the field of countermeasures against chemical, biological, radiological and nuclear threats; (b) to develop countermeasures, first response and resilient systems; (c) to participate in the establishment of sound technical and programmatic performance goals based on the needs and requirements of the Government's Technology Objectives; (d) to provide a unified voice to effectively articulate the global and strategically important role medical countermeasures play in current and future national security objectives; and (e) to maximize the utilization of the Government's and Members' capabilities to effectively develop critical technologies which can be deployed and transitioned.
Notice is hereby given that, on December 29, 2015, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Saylor Foundation, Washington, DC; and Blue Canary, Chandler, AZ, have withdrawn as parties to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and IMS Global intends to file additional written notifications disclosing all changes in membership.
On April 7, 2000, IMS Global filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on October 13, 2015. A notice was published in the
Notice is hereby given that, on December 18, 2015, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Grid2Home, San Diego, CA; Ping Identity, Denver, CO; Quanta Computer Inc., Kuei Shan, Tao Yuan, TAIWAN; and Verisign Inc., Reston, VA, have withdrawn as parties to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and AllSeen Alliance intends to file additional written notifications disclosing all changes in membership.
On January 29, 2014, AllSeen Alliance filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on September 23, 2015. A notice was published in the
Notice is hereby given that, on December 21, 2015, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Lockheed Martin Corporation, Arlington, VA; TeraLogics, LLC, Ashburn, VA; Paula Moss (individual member), Fort Wayne, IN; and Tom Forrest, LLC, Thousand Oaks, CA, have withdrawn as parties to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and NCOIC intends to file additional written notifications disclosing all changes in membership.
On November 19, 2004, NCOIC filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on June 17, 2015. A notice was published in the
Notice is hereby given that, on December 23, 2015, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
On June 6 2012, AGA filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on August 12, 2013. A notice was published in the
Notice is hereby given that, on January 6, 2016, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Contextream, Inc., Mountain View, CA; and 6Wind, Montigny-le-Bretonneux, FRANCE, have withdrawn as parties to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and OpenDaylight intends to file additional written notifications disclosing all changes in membership.
On May 23, 2013, OpenDaylight filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on October 22, 2015. A notice was published in the
Notice is hereby given that, on December 3, 2015, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Pursuant to Section 6(b) of the Act, the identities of the parties to the venture are: Advanced Nuclear Devices Corporation, Hilton Head Island, SC; Alabama A&M University—RISE Foundation, Huntsville, AL; Alabama A&M University College of Engineering, Technology, and Physical Sciences, Huntsville, AL; Aleta Technologies, Inc., Madison, AL; ALION Science & Technology, McLean, VA; Altron, Inc., Mount Pleasant, SC; Alutiiq Business Services, LLC, North Charleston, SC; AMSEC LLC, Virginia Beach, VA; Auburn Research & Development Institute, Auburn, AL; Auburn University, Montgomery, AL; Binera, Inc., Yorktown, PA; Centurum Information Technology, Inc., North Charleston, SC; CGI Federal, Inc., Huntsville, AL; CKQ Technologies LLC, Charleston, SC; Clear Ridge Defense, LLC, Hanover, MD; Cognitio Corp., McLean, VA; deciBel Research, Huntsville, AL; Defense Engineering Services LLC, Daniel Island, SC; Deloitte & Touche LLP, Alexandria, VA; DESE Research, Inc., Huntsville, AL; Dilks—Simone Enterprises, Inc., Mount Pleasant, SC; Dispersive Technologies, Inc., Alpharetta, SC; Dynetics, Inc., Huntsville, AL; Emergent, Inc., North Charleston, SC; Enlogica Solutions, LLC, Huntsville, AL; Enterprise Integration, Inc., Huntsville, AL; EnVention LLC, Huntsville, AL; EOIR Technologies, Inc., Fredericksburg, VA; EpiQ, Inc., Huntsville, AL; Exodus Technology Corporation, Huntsville, AL; Forager Systems, Inc., Charleston, SC; GeoWireless Inc., North Charleston, SC; GPH Consulting, LLC., Charleston, SC; Honeywell Technology Solutions, Inc., North Charleston, SC; Imagine One, Hanahan, SC; Insight Through Analysis, LLC, McLean, VA; Integrated Technology Services, LLC, Summerville, SC; IronMountain Solutions, Huntsville, AL; IT Security, Inc., Pittsburgh, PA; Jacobs, Huntsville, AL; JB Management, Inc., Alexandria, VA; Lewis Innovative Technologies, Inc., Decatur, AL; LSINC Corporation, Huntsville, AL; Mission Multiplier Consulting, Huntsville, AL; Modulant, Inc., North Charleston, SC; Modus21, Mount Pleasant, SC; Network Security Systems Plus, Inc., Falls Church, VA; Northrop Grumman Corporation—Huntsville, Huntsville, AL; nou Systems, Inc., Huntsville, AL; On-Line Applications Research Corporation, Huntsville, AL; Open Source Systems, LLC, Charleston, SC; ORBIS Sibro, Inc. (dba ORBIS), Mount Pleasant, SC; Peregrine Technical Solutions, Yorktown, VA; Pillar Global Solutions, Inc., Stafford, VA; Prime Technical Services, Inc., Atlanta, GA; PROJECTXYZ, Inc., Huntsville, AL; ProModel Corporation, Allentown, PA; Quantam Dynamics, Macon, GA; Recorded Future, Charleston, SC; Rollout Systems LLC, California, MD; Science Applications International Corporation, McLean, VA; Sea Island Technical Service LLC, Charleston, SC; Secturion Systems, Inc., Clearfield, UT; SiloSmashers, Inc., Herndon, VA; Soteria LLC, Lorton, VA; South Central Tennessee Development, Mount Pleasant, TN; STIMULUS Engineering Services, Inc., Loogootee, IN; Systems Technology Forum, Ltd., Charleston, SC; The University of Alabama, Tuscaloosa, AL; Trideum Corporation, Huntsville, AL; Trinary Software, Ashland, OR; University of Alabama—Huntsville, Huntsville, AL; University of South Carolina, Columbia, SC; VarnerMiller, LLC, Mount Pleasant, SC; ViON Corporation, Herndon, VA.
The general area of NCC's planned activity is to assist in maturing Army Cyberspace Operations through re-use and augmenting existing cyber technologies and fostering relevant cyber weapons systems and awareness in the newly established Cyber domain.
Notice is hereby given that, on December 23, 2015, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Rohde & Schwarz DVS GmbH, Hanover, GERMANY; and Savis Vietnam Corp., Hanoi, VIETNAM, have withdrawn as parties to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Advanced Media Workflow Association, Inc. intends to file additional written notifications disclosing all changes in membership.
On March 28, 2000, Advanced Media Workflow Association, Inc. filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on September 24, 2015. A notice was published in the
Occupational Safety and Health Administration (OSHA), Labor.
Notice.
In this notice, OSHA announces its final decision expanding the scope of recognition for SGS North America, Inc., as a Nationally Recognized Testing Laboratory (NRTL). Additionally, OSHA announces its final decision to add a new test standard to the NRTL list of appropriate test standards.
The expansion of the scope of recognition becomes effective on January 22, 2016.
Information regarding this notice is available from the following sources:
The Occupational Safety and Health Administration hereby gives notice of the expansion of the scope of recognition of SGS North America, Inc. (SGS), as an NRTL. SGS's expansion covers the addition of five recognized testing and certification sites and fourteen additional test standards to its NRTL scope of recognition, including one test standard that will be added to the NRTL Program List of Appropriate Test Standards.
OSHA recognition of an NRTL signifies that the organization meets the requirements in Section 1910.7 of Title 29, Code of Federal Regulations (29 CFR 1910.7). Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within its scope of recognition and is not a delegation or grant of government authority. As a result of recognition, employers may use products properly approved by the NRTL to meet OSHA standards that require testing and certification.
The Agency processes applications by an NRTL for initial recognition, or for expansion or renewal of this recognition, following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the Agency publish two notices in the
SGS currently has one facility (site) recognized by OSHA for product testing and certification, with its headquarters located at: 620 Old Peachtree Road, Suwanee, Georgia 30024. A complete list of SGS's scope of recognition is available at:
SGS submitted an application, dated October 1, 2014 (OSHA-2006-0040-0023), to expand its recognition to include the addition of five recognized testing and certification sites located at: SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou Branch, 198 Kezhu Road, Scientech Park Guangzhou Economic & Technology Development District, Guangzhou, Guangdong, China, 510663; SGS-CSTC Standards Technical Services Co., Ltd. Shunde Branch, 198 Kezhu Road,
OSHA published the preliminary notice announcing SGS's expansion application in the
To obtain or review copies of all public documents pertaining to the SGS's application, go to
OSHA staff examined SGS's expansion application, conducted a detailed on-site assessment, and examined other pertinent information. Based on its review of this evidence, OSHA finds that SGS meets the requirements of 29 CFR 1910.7 for expansion of its recognition, subject to the limitations and conditions listed below. OSHA, therefore, is proceeding with this final notice to grant SGS's scope of recognition expansion. OSHA limits the expansion of SGS's recognition to include the sites at Shanghai, China; Ningbo, China; Shenzhen, China; Guangzhou, China and Shunde, China as listed above. OSHA's recognition of these sites limits SGS to performing product testing and certifications only to the test standards for which the site has the proper capability and programs, and for test standards in SGS's scope of recognition. This limitation is consistent with the recognition that OSHA grants to other NRTLs that operate multiple sites. OSHA limits the expansion of SGS's recognition to testing and certification of products for demonstration of conformance to the test standards listed in Table 1 below.
OSHA's recognition of any NRTL for a particular test standard is limited to equipment or materials for which OSHA standards require third-party testing and certification before using them in the workplace. Consequently, if a test standard also covers any products for which OSHA does not require such testing and certification, an NRTL's scope of recognition does not include these products.
The American National Standards Institute (ANSI) may approve the test standards listed above as American National Standards. However, for convenience, we may use the designation of the standards-developing organization for the standard as opposed to the ANSI designation. Under the NRTL Program's policy (see OSHA Instruction CPL 1-0.3, Appendix C, paragraph XIV), any NRTL recognized for a particular test standard may use either the proprietary version of the test standard or the ANSI version of that standard. Contact ANSI to determine whether a test standard is currently ANSI-approved.
In addition to those conditions already required by 29 CFR 1910.7, SGS also must abide by the following conditions of the recognition:
1. SGS must inform OSHA as soon as possible, in writing, of any change of ownership, facilities, or key personnel, and of any major change in its operations as an NRTL, and provide details of the change(s);
2. SGS must meet all the terms of its recognition and comply with all OSHA policies pertaining to this recognition; and
3. SGS must continue to meet the requirements for recognition, including all previously published conditions on SGS's scope of recognition, in all areas for which it has recognition.
OSHA also is making a final determination to add a new standard to the NRTL Program's list of appropriate test standards. OSHA determines that this test standard is an appropriate test standard. Table 2 below lists the test standard that will be added to the NRTL Program's list of Appropriate Test Standards.
Pursuant to the authority in 29 CFR 1910.7, OSHA hereby expands the recognition of SGS, subject to the limitations and conditions specified above.
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, 200 Constitution Avenue NW., Washington, DC 20210, authorized the preparation of this notice. Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.
Occupational Safety and Health Administration (OSHA), Labor.
Notice.
The New Jersey Department of Labor and Workforce Development (LWD) submitted timely documentation attesting to the completion of all structural and developmental aspects of its State Plan for State and Local Government Employees as approved by the Occupational Safety and Health Administration (OSHA). After extensive review of the submissions and opportunity for correction, Plan supplements constituting an updated and revised State Plan were submitted. OSHA is approving the revised State Plan, which documents the satisfactory completion of all structural and developmental aspects of New Jersey's approved State Plan, and certifying this completion. This certification attests to the fact that New Jersey now has in place those structural components necessary for an effective State Plan for State and Local Government Employees. (Enforcement of occupational safety and health standards with regard to private sector employers and employees in the State of New Jersey remains the responsibility of the U.S. Department of Labor, OSHA).
For general information and press inquiries, contact Frank Meilinger, Director, Office of Communications, Room N-3647, OSHA, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-1999; email:
Section 18 of the Occupational Safety and Health Act of 1970 (the “OSH Act;” 29 U.S.C. 667) provides that a state which desires to assume responsibility for the development and enforcement of occupational safety and health standards may submit for OSHA review and approval a State Plan for such development and enforcement. Regulations at 29 CFR part 1956 provide that a state may voluntarily submit a State Plan for the development and enforcement of occupational safety and health standards applicable only to employers and employees of the state and its political subdivisions. State and local government employers are excluded from federal OSHA coverage under section 3(5) of the OSH Act.
Under these regulations, the Assistant Secretary of Labor for Occupational Safety and Health (“Assistant Secretary”) may approve a State Plan for State and Local Government Employees, if the Plan provides for the development and enforcement of standards relating to hazards in employment covered by the Plan which are or will be at least as effective in providing safe and healthful employment and places of employment for public employees as standards promulgated and enforced by federal OSHA under section 6 of the OSH Act, giving due consideration to differences between public and private sector employment. Following initial approval, the state may begin enforcement of its safety and health standards in the public sector and receive up to 50 percent federal funding for the cost of Plan operations.
A State Plan for State and Local Government Employees may receive initial approval even though at the time of submission not all essential components of the Plan are in place. Pursuant to 29 CFR 1956.2(b), the Assistant Secretary may initially approve the submission as a “developmental plan,” and a schedule within which the state must complete all “developmental steps” within a three year period is issued as part of the initial approval decision. 29 CFR part 1953 provides procedures for the review and approval of changes and progress in the development and implementation of the State Plan.
When the Assistant Secretary has reviewed and approved all developmental submissions and finds that the state has satisfactorily completed all developmental steps specified in the initial approval decision, a notice certifying such completion is published in the
In 1965, the Governor of the State of New Jersey issued Executive Order No. 20, establishing a safety and health program for state employees. In the early 1970s New Jersey developed a State Plan under the OSH Act. The Plan provided for a safety and health program which would cover state and local government employees and all employees in the private sector in the state. In 1975, New Jersey was preempted in the safety and health field by the federal program because state legislation was not provided as required by the federal program. In 1984, the New Jersey Public Employees Occupational Safety and Health Act (PEOSH Act) was signed into law by Thomas H. Kean, Governor of the State of New Jersey. This act empowered the Department of Labor and Workforce Development, the Department of Health, and the Department of Community Affairs to inspect and enforce the PEOSH Act. Because the PEOSH Act, as structured, presented several obstacles to receive federal funding for a State and Local Government Employees Plan, a revision was signed into law by Governor Whitman in 1995.
The New Jersey State Plan for State and Local Government Employees is operated by the New Jersey Department of Labor and Workforce Development, Public Employees Occupational Safety and Health (PEOSH) Program. This limited scope State Plan was initially approved as a developmental plan under section 18 of the OSH Act, and 29 CFR part 1956, on January 11, 2001 (66 FR 2265). After the initial approval of the State Plan for State and Local Government Employees in 2001, New Jersey successfully submitted all of its developmental plan change supplements.
In July 2013, PEOSH submitted a completely revised State Plan which provided updated documentation on all its developmental steps, including those previously approved, for OSHA review and consideration. After extensive review of those documents and opportunity for state correction, New Jersey submitted further revisions in December 2013, May 2014, and July 2014.
New Jersey submitted plan supplements constituting a revised State Plan document with subsequent revisions dated December 2013, May 2014 and July 2014. The revised State Plan updates and documents all structural components of the New Jersey program. This includes a revised narrative description of the current program, legislation, administrative rules, standards, a compliance manual, and current copies of all key documents relating to New Jersey's State Plan for State and Local Government Employees. These documents are described below and are being approved in this notice.
The Plan designates the New Jersey Department of Labor and Workforce Development (LWD), through the Public Employees Occupational Safety and Health (PEOSH) program, as the state agency responsible for administering the Plan throughout the state. The New Jersey PEOSH Act, N.J.S.A. 34:6A-25
The Plan narrative provides a general overview of PEOSH's legal authority, standards and variances, regulations, enforcement policies and procedures (the “Field Operations Manual” or “FOM”), voluntary compliance activities (including consultative services and training and outreach programs), an occupational safety and health laboratory, personnel policies and procedures, recordkeeping and reporting requirements, budget, staffing and funding, all of which, together with the supporting documents contained in various appendices, have been determined to provide authority which is “at least as effective as” that of the OSH Act and to meet the criteria and indices for plan approval contained in 29 CFR part 1956.
The State Plan appendices contain a variety of state statutes and other documents related to the PEOSH program and its authority, contest procedures, and personnel policies, including: N.J. PEOSH Act—N.J.S.A.34:6A-25 thru 34:6A-50; 1995 N.J. Laws Chapter 186 (amendments to PEOSH Act); 1995 N.J. Laws Chapter 186—Governor's Signature; Memorandum of Understanding (MOU) between LWD & DOH; N.J. Admin. Code Title 1, Chapter 30—Rules for Agency Rulemaking; Administrative Procedures Act—N.J.S.A. 52:14B.
The appendices also contain the following regulations: Procedural Standards for N.J. State Plan—N.J.A.C.12:110; Safety & Health Standards for Public Employees—N.J.A.C.12:100; Standard for Hazard Communication—N.J.A.C.12:100 Chapter #7; Hazard Communication Alternative Std. Proposal; Hazard Communication Alternative Std. Adoption; Standards for Indoor Firing Ranges for Public Employees—N.J.A.C.12:100 Chapter 8; Standards for Firefighters—N.J.A.C.12:100 Chapter 10; Fire Brigade Std. Comparison; Indoor Air Quality Standard—N.J.A.C.12:100 Chapter 13; Review Commission Rules of Procedure—N.J.A.C.12:112; Discrimination against Employees—N.J.A.C.12:110 Chapter 7; Inspection Scheduling System; On-Site Consultations—N.J.A.C.12:110 Chapter 8.; Consultation Policies and Procedures Manual, Chapter 3, III; 5yr. Strategic Plan—2014-2019; and Informational, Educational, & Training Materials.
The Plan includes legislation, the New Jersey PEOSH Act—N.J.S.A.34:6A-25 thru 34:6A-50 as enacted in 1984 and amended in 1995 and 1997. Pursuant to this law, the State Plan provides coverage for all state and local government employment in New Jersey. The PEOSH Act defines covered employers as “public employer[s] and shall include any person acting directly on behalf of, or with the knowledge and ratification of: (1) The state, or any department, division, bureau, board, council, agency or authority of the state, except any bi-state agency; or (2) any county, municipality, or any department, division, bureau, board, council, agency or authority of any county or municipality, or of any school district or special purposes district created pursuant to law.” N.J.S.A.34:6A-27(c). It defines covered employees as “any public employee, any person holding a position by appointment or employment in the service of an `employer' as that term is used in this act and shall include any individual whose work has ceased as a consequence of, or in connection with, any administrative or judicial action instituted under this act; provided, however, that elected officials, members of boards and commissions and managerial executives as defined in the `New Jersey Employer-Employee Relations Act,' P.L.1941, c. 100, C. 34:13A-1
1. Penalties. Section 34:6A-41(d) of the PEOSH Act establishes a penalty structure which provides for failure-to-abate penalties of up to $7,000 per day for serious violations and other-than-serious violations. This authority, together with follow-up inspections and judicial enforcement, is the primary means of compelling the abatement of hazards by state and local government employers under the New Jersey State Plan.
2. Split Enforcement. Section 34:6A-35 of the PEOSH Act establishes enforcement by two departments: DOH, which conducts inspections under health regulations in the workplace; and LWD, which conducts inspections under safety regulations in the workplace; but it is LWD that issues Order to Comply.
3. Advisory Board. Section 34:6A-28 of the PEOSH Act establishes the Public Employees Occupational Safety and Health Advisory Board (“Advisory Board”) consisting of several New Jersey department Commissioners and 18 members who represent state and local government employers and employees. The Advisory Board assists the Commissioner of Labor and Workforce Development (“Commissioner of Labor”) in establishing standards for the occupational safety and health of public employees and receives information regarding matters of concern to public employees in the areas of occupational safety and health.
The PEOSH Act, section 34:6A-30(a) mandates that the Commissioner of Labor adopt all applicable safety and health standards promulgated under the OSH Act, which are in effect on the effective date of the PEOSH Act (January 17, 1984). The New Jersey Plan has adopted all federal OSHA standards since the inception of the OSH Act (N.J.A.C. 12:100) with the exception of Subpart L—Fire Protection, 29 CFR 1910.155 and 1910.156 (N.J.A.C. 12:100-10), and the Hazard Communication Standard, 29 CFR 1910.1200 (N.J.A.C.12:100-7). The New Jersey Plan assures the incorporation of any subsequent revisions or additions to standards in a timely manner, including in response to federal OSHA emergency temporary standards. The procedure for adoption of federal OSHA standards is provided in the New Jersey State Administrative Procedures Act, which requires submission of the standard to the New Jersey Office of Administrative Law and publication of the standard in the New Jersey State Register. Permanent standards adopted by OSHA will be adopted by the Commissioner of Labor within six (6) months from the federal promulgation date (N.J.A.C. 12:100-3A.1).
Under the Plan, the Commissioner of Labor, in consultation with the Commissioner of Health and the Commissioner of Community Affairs, and with the advice of the Advisory Board, on his/her own initiative, can propose additional or alternative occupational safety and health standards if no federal standards are applicable or where standards more stringent than the federal standards are deemed advisable (N.J.S.A. 34:6A-30). The Advisory Board can also, after public hearings, recommend such standards to the Commissioner of Labor. The State Plan provides for the development and consideration of expert technical information in the formulation of standards and allows interested persons to submit information requesting development or promulgation of any standard and to participate in any hearing for the development, modification or establishment of standards. In addition, the State Administrative Procedures Act requires public notice and comment for all proposed rules, and provides opportunity for public participation in related hearings. A notice of proposed rulemaking is published in the New Jersey Register. The notice shall invite comments from interested persons, and other such submissions, in accordance with N.J.A.C. 1:30-1, Rules for Agency Rulemaking. The Plan includes the state safety and health standards regulation, which codifies PEOSH's adoption by reference of all federal OSHA safety and health standards applicable to public employees. New Jersey standards are identical to the federal standards with the following exceptions and additions. The state promulgated and retained N.J.A.C. 12:100 Subchapter 8—Standard for Indoor Firing Ranges for Public Employees, N.J.A.C. 12:100 Subchapter 13—Indoor Air Quality Standard and N.J.A.C. 12:100 Subchapter 10—Standards for Firefighters. On May 3, 2004, New Jersey adopted a hazard communication standard with several additional provisions which are more stringent than OSHA's Hazard Communication Standard. These different or additional state requirements have been reviewed and determined to be “at least as effective” as the comparable federal standards.
Section 34:6A-39 of the PEOSH Act, the Administrative Procedure Act (N.J.S.A.52:14B-1
The Plan provides for notification to employees of their protections and obligations under the Plan by such means as the “You Have the Right to a Safe and Healthful Workplace. It's the Law!” poster (which is included in the Plan documents and also available electronically on the PEOSH Web site) and required posting of notices of violations. Section 34:6A-45 of the PEOSH Act provides for protection of employees against discharge or
The Commissioner of Labor and the Commissioner of Health are charged with making inspections in their jurisdictional areas as specified in the PEOSH Act (N.J.S.A.34:6A-30, 35). The Commissioners may call on the professional staff of other departments whenever they deem their assistance necessary. Inspection and enforcement policies and procedures provided in the Plan are established by the PEOSH Act, 34:6A-35, and the PEOSH FOM. Each Commissioner obtains the right of immediate entry at reasonable hours and without advance notice into any workplace to conduct such investigations as he/she may deem necessary. The authority of each Commissioner to inspect any premises for purposes of investigating an alleged violation under his/her jurisdiction is not limited to the alleged violation but shall extend to any other area of the premises in which he/she has reason to believe that a violation of any provision of the PEOSH Act under his/her jurisdiction exists. The Commissioner of Health shall make his/her inspection records available to the Commissioner of Labor for purposes of enforcement. Any employee, group of employees or employee representative who believes that a violation of a safety standard exists, or that an imminent danger exists, may request an inspection by giving notice to the Commissioner of the violation or danger. Complaints must be filed in writing and signed. Upon the request of the person giving the notice, his/her name or the name of any employee representative giving the notice may be withheld. The appropriate Commissioner shall conduct an appropriate inspection at the earliest time possible. The Plan also includes a prohibition of advance notice of inspections, a mechanism for employees of the employer and their representatives to accompany the inspector during the physical inspections, and opening, informal, and closing conferences. If the Commissioner of Labor, or the Commissioner of Health, concludes that conditions or practices in violation exist in any workplace, the Commissioner of Labor shall, with reasonable promptness, and in no case more than six months after his/her determination or the receipt of the certificate or report, issue a written Order to Comply to the employer (N.J.S.A.34:6A-41(a)).
Significant differences between federal OSHA and PEOSH inspection, enforcement, and discrimination include the following:
1. Penalties. Section 34:6A-41(d) of the PEOSH Act establishes a penalty structure which provides for failure-to-abate penalties of up to $7,000 per day for serious violations and other-than-serious violations. If the time for compliance with an Order of the Commissioner of Labor elapses, and the employer has not made a good faith effort to comply, the Commissioner of Labor shall issue a second Order to Comply imposing a civil administrative penalty of up to $7,000 per day for each violation not abated. If the employer contests the proposed daily penalties, a follow-up inspection shall still be scheduled. If an Order and daily penalties are not to be proposed because of an employer's flagrant disregard of an Order, the Director of PEOSH shall immediately contact the Commissioner of Labor, in writing, detailing the circumstances so that the matter can be referred to the State Attorney General's Office for issuance of a restraining order. Procedures for follow-up inspections are established in the PEOSH FOM Chapter 7, Section XII.
2. Whistleblower (Discrimination). The period fixed in the Plan for filing eligible complaints is 180 days, and the procedure in the Plan for enforcing merit determinations is through Orders to Comply (N.J.S.A 34:6A-45).
The PEOSH FOM, first issued in April 2009, replaces the New Jersey Field Inspection Reference Manual (FIRM) and is available to the public on the LWD Web site. The New Jersey compliance manual parallels federal OSHA's revised Field Operations Manual, CPL 02-00-150, and incorporates other policies parallel to federal compliance directives and unique state requirements. The PEOSH FOM provides guidance to PEOSH compliance staff concerning general staff responsibilities, pre-inspection procedures (including inspection scheduling and priorities, complaints and other unprogrammed inspections and inspection preparation), inspection procedures (including conduct of the inspection, opening conference, closing conference, physical examination of the workplace, follow-up inspections, fatality/catastrophe investigations, imminent danger investigations, and construction inspections), inspection documentation (including types of violations, violations of the general duty clause, writing citations, and grouping/combining violations), post-inspection procedures (including abatement, citations, penalties, and post-citation processes), discrimination investigation procedures (set forth in more detail in the PEOSH Whistleblower (Discrimination) Investigations Manual, which parallels the relevant portions of federal OSHA's Whistleblower Investigations Manual, CPL 02-03-003), and disclosure of information under the New Jersey Open Public Records Act (N.J.S.A. 47:1A-
Section 34:6A-42 of the PEOSH Act establishes an Occupational Safety and Health Review Commission (“Review Commission”) within LWD to hear appeals regarding Orders to Comply and penalties.
Under the Plan, both public employers and employees may seek formal administrative review of LWD citations and penalties, as well as the reasonableness of the abatement period, before the Review Commission (N.J.S.A. Sections 34:6A-36, 41 and N.J.A.C. 12:110-4.13). The notice of contest must be filed with the Commissioner of Labor within 15 working days of the issuance of an Order to Comply. The Commissioner of Labor must immediately advise the Review Commission of the notification, and the Review Commission will afford an opportunity for a hearing. After hearing an appeal, the Review Commission may sustain, modify or dismiss an Order or penalty, and the Review Commission's decision shall become final 45 days after its issuance (N.J.S.A. 34:6A-42).
Appeals from decisions of the Review Commission are to the Appellate Division of the Superior Court (N.J.S.A. 34:6A-43).
The Plan includes the FY 2015 grant application under section 23(g) of the OSH Act, which includes a current organizational chart and detailed information on staffing and funding. The state has given satisfactory assurances of adequate funding to support the Plan. In FY 2015, the State Plan was funded at $1,921,400 in federal section 23(g) funds, $1,921,400 in matching state funds, and $911,664 in 100% state funds, for a total federal and state contribution of $4,754,464. The state has given satisfactory assurance (New Jersey State Plan, p.156) that it will meet the staffing requirements of 29 CFR 1956.10. OSHA considers PEOSH's current staffing and funding levels to be adequate and appropriate.
The Plan provides that state and local government employers in New Jersey will maintain appropriate records and make timely reports on occupational injuries and illnesses in a manner substantially identical to and “at least as effective as” that required for private sector employers under federal OSHA. New Jersey participates and has assured that it will continue its participation in the Bureau of Labor Statistics Annual Survey of Injuries and Illnesses in the public sector. The Plan also contains assurances that the Commissioner of Labor will provide reports to OSHA in such form as the Assistant Secretary may require and that New Jersey will continue to participate in the OSHA Information System (OIS). The state adopted federal OSHA's revision of its recordkeeping rules (29 CFR part 1904; 66 FR 5916-6135), January 19, 2001, as well as OSHA's New Reporting Requirements (January 2015).
The state and local government employee consultation program makes available both safety consultants and industrial hygienists to state and local government employers who request such service for the purpose of apprising them of existing hazards and the best means of abatement. The PEOSH consultation program generally follows OSHA's Consultation Policies and Procedures Manual, CSP 02-00-002. The consultation program also provides outreach and training in support of PEOSH's activities. Under the Plan, training is provided to state and local government employers and employees, and seminars are conducted to familiarize affected individuals with applicable safety and health standards and requirements and safe work practices. PEOSH has a variety of public information programs to disseminate information and publications on important safety and health concerns. Policies and procedures for outreach programs, including training, educational and informational services, as well as voluntary compliance programs, are described in the Consultation Policies and Procedures Manual.
With the approval of the revised State Plan in today's action, all developmental steps specified in the January 11, 2001 notice of initial approval of the New Jersey State Plan for State and Local Government Employees, and other relevant steps, have been successfully completed and approved as follows:
A. In accordance with New Jersey development step (a), the State of New Jersey has promulgated standards identical to all federal OSHA standards with the exception of Subpart L—Fire Protection and the Hazard Communication Standard (both include provisions which are more stringent than federal OSHA's). New Jersey has also established state standards on issues for which no federal standards are applicable. The state standards are the Indoor Firing Ranges for Public Employees Standard, and the Indoor Air Quality Standard. These four state-specific standards are approved by the Assistant Secretary in today's notice.
B. In accordance with New Jersey development step (b), New Jersey has promulgated regulations for inspections, citations, and abatement equivalent to 29 CFR part 1903, as supplemented by the PEOSH Act and the PEOSH FOM, all of which are approved by the Assistant Secretary in today's notice.
C. In accordance with New Jersey development step (c), New Jersey has developed a five-year strategic plan which is approved in today's notice.
D. In accordance with New Jersey development step (d), the state has developed a Field Operations Manual which parallels the OSHA Field Operations Manual, CPL 02-00-150, and incorporates other federal compliance policy directives and unique state requirements. The state's Field Operations Manual is approved in today's notice.
E. In accordance with New Jersey development step (e), the state has implemented a state and local government employer/employee consultation, training, and education program equivalent to 29 CFR part 1908 which is approved in today's notice.
F. In accordance with New Jersey development step (f), the state developed and adopted employee non-discrimination procedures equivalent to 29 CFR part 1977 which are approved in today's notice.
G. In accordance with New Jersey development step (g), the State Plan promulgated regulations for granting variances equivalent to 29 CFR part 1905 which are approved in today's notice.
H. In accordance with New Jersey development step (h), the state has promulgated regulations regarding recordkeeping equivalent to 29 CFR 1904, including the new recordkeeping rule, revised on January 1, 2015, which are approved in today's notice.
After careful review, opportunity for state correction, and subsequent revision, the plan supplements constituting a revised New Jersey State Plan for State and Local Government Employees and its components described above are found to be in substantial conformance with comparable federal provisions and the requirements of 29 CFR part 1956 and are hereby approved under 29 CFR part 1953 as providing a revised State Plan for the development and enforcement of standards which is “at least as effective as” the federal program, as required by section 18 of the OSH Act and 29 CFR part 1956. The right to reconsider this approval of the revised State Plan supplements is reserved should substantial objections or other information become available to the Assistant Secretary regarding any components of the Plan changes.
With the approval of a revised State Plan as noted above, all developmental steps have now been successfully completed, documented, and approved. In accordance with 29 CFR 1956.23, the New Jersey State Plan for State and Local Government Employees is certified as having successfully completed all developmental steps. This certification attests to the structural completeness of the State Plan and that it has all the necessary authorities and procedures to provide “at least as effective” standards, enforcement, and compliance assistance to the employees of the State of New Jersey and its
Copies of the revised New Jersey State Plan for State and Local Government Employees are available on the State Plan's Web site or upon request. Contact the Regional Administrator, U.S. Department of Labor, Occupational Safety and Health Administration, 201 Varick Street, Room 670, New York, New York 10014; or the New Jersey Public Employee Occupational Safety and Health Program, 1 John Fitch Plaza, P.O. Box 386, Trenton, NJ 08625-0386.
Components of the New Jersey State Plan, including the Field Operation Manual, recordkeeping regulations and instructions, complaint forms, and other program information are posted on the New Jersey Department of Labor & Workforce Development, Public Employee Occupational Safety and Health Web site at:
The PEOSH Act is administered by two departments: the New Jersey Department of Health enforces health regulations in the workplace; and the New Jersey Department of Labor & Workforce Development enforces safety regulations in the workplace. To obtain information, visit the NJDLWD PEOSH Program Web site at:
Information on PEOSH laws and regulations can be found on the New Jersey Web site at:
Information on the New Jersey Department of Labor and Workforce Development, Office of Administrative Law and Review Commission can be found on the New Jersey Labor and Workforce Development Web site at:
Electronic copies of this
This document was prepared under the direction of David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health. It is issued under section 18 of the Occupational Safety and Health Act of 1970, 84 Stat. 1608 (29 U.S.C. 667); 29 CFR part 1956; and Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012).
Occupational Safety and Health Administration (OSHA), Labor.
Notice.
In this notice, OSHA announces the application of MET Laboratories, Inc. for expansion of its recognition as a Nationally Recognized Testing Laboratory (NRTL) and presents the Agency's preliminary finding to grant the application. Additionally, OSHA proposes to add three new test standards to the NRTL Program's list of appropriate test standards.
Submit comments, information, and documents in response to this notice, or requests for an extension of time to make a submission, on or before February 8, 2016.
Submit comments by any of the following methods:
1.
2.
3.
4.
5.
6.
Information regarding this notice is available from the following sources:
The Occupational Safety and Health Administration is providing notice that MET Laboratories, Inc. (MET), is applying for expansion of its current recognition as an NRTL. MET requests the addition of five test standards to its NRTL scope of recognition.
OSHA recognition of an NRTL signifies that the organization meets the requirements specified in 29 CFR 1910.7. Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within its scope of recognition. Each NRTL's scope of recognition includes (1) the type of products the NRTL may test, with each type specified by its applicable test standard; and (2) the recognized site(s) that has/have the technical capability to perform the product-testing and product-certification activities for test standards within the NRTL's scope. Recognition is not a delegation or grant of government authority; however, recognition enables employers to use products approved by the NRTL to meet OSHA standards that require product testing and certification.
The Agency processes applications by an NRTL for initial recognition and for an expansion or renewal of this recognition, following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the Agency publish two notices in the
MET currently has one facility (site) recognized by OSHA for product testing and certification, with its headquarters located at: MET Laboratories, Inc., 914 West Patapsco Avenue, Baltimore, Maryland 21230. A complete list of MET's scope of recognition is available at
MET submitted five applications, two dated April 6, 2015 (OSHA-2006-0028-0020) and three dated May 29, 2015 (OSHA-2006-0028-0021), to expand its recognition to include five additional test standards. OSHA staff performed a detailed analysis of the application packet and reviewed other pertinent information. OSHA did not perform any on-site reviews in relation to this application.
Table 1 below lists the appropriate test standards found in MET's applications for expansion for testing and certification of products under the NRTL Program. As discussed below, OSHA is proposing to add three of these test standards to the appropriate test standard list by this notice.
Periodically, OSHA will propose to add new test standards to the NRTL list of appropriate test standards following an evaluation of the test standard document. To qualify as an appropriate test standard, the Agency evaluates the document to (1) verify it represents a product category for which OSHA requires certification by an NRTL, (2) verify the document represents an end product and not a component, and (3) verify the document defines safety test specifications (not installation or operational performance specifications).
In this notice, OSHA proposes to add three new test standards to the NRTL Program's list of appropriate test standards. Table 2, below, lists the test standards new to the NRTL Program. OSHA preliminarily determined that these test standards are appropriate test standards and proposes to include these test standards in the NRTL Program's list of appropriate test standards. OSHA seeks public comment on this preliminary determination.
MET submitted acceptable applications for expansion of its scope of recognition. OSHA's review of the application files and pertinent documentation indicate that MET can meet the requirements prescribed by 29 CFR 1910.7 for expanding its recognition to include the addition of these five test standards for NRTL testing and certification listed above.
OSHA welcomes public comment as to whether MET meets the requirements of 29 CFR 1910.7 for expansion of its recognition as an NRTL.
Comments submitted in response to this notice should consist of pertinent written documents and exhibits. Commenters needing more time to comment must submit a request in writing, stating the reasons for the request. Commenters must submit the written request for an extension by the due date for comments. OSHA will limit any extension to 10 days unless the requester justifies a longer period. OSHA may deny a request for an extension if the request is not adequately justified. To obtain or review copies of the exhibits identified in this notice, as well as comments submitted to the docket, contact the Docket Office, Room N-2625, Occupational Safety and Health Administration, U.S. Department of Labor, at the above address. These materials also are available online at
OSHA staff will review all comments to the docket submitted in a timely manner and, after addressing the issues raised by these comments, will recommend to the Assistant Secretary for Occupational Safety and Health whether to grant MET's application for expansion of its scope of recognition and to add the new test standards to the NRTL Program's List of Appropriate Test Standards. The Assistant Secretary will make the final decision on granting the application. In making this decision, the Assistant Secretary may undertake other proceedings prescribed in Appendix A to 29 CFR 1910.7.
OSHA will publish a public notice of its final decision in the
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, 200 Constitution Avenue NW., Washington, DC 20210, authorized the preparation of this notice. Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.
Occupational Safety and Health Administration (OSHA), Labor.
Notice.
In this notice, OSHA announces the application of QPS Evaluation Services Inc. for expansion of its recognition as a Nationally Recognized Testing Laboratory (NRTL) and presents the Agency's preliminary finding to grant the application.
Submit comments, information, and documents in response to this notice, or requests for an extension of time to make a submission, on or before February 8, 2016.
Submit comments by any of the following methods:
1.
2.
3.
4.
5.
6.
Information regarding this notice is available from the following sources:
The Occupational Safety and Health Administration is providing notice that QPS Evaluation Services Inc. (QPS), is applying for expansion of its current recognition as an NRTL. QPS requests the addition of one test standard to its NRTL scope of recognition.
OSHA recognition of an NRTL signifies that the organization meets the requirements specified in 29 CFR 1910.7. Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within its scope of recognition. Each NRTL's scope of recognition includes (1) the type of products the NRTL may test, with each type specified by its applicable test standard, and (2) the recognized site(s) that has/have the technical capability to perform the product-testing and product-certification activities for test standards within the NRTL's scope. Recognition is not a delegation or grant of government authority; however, recognition enables employers to use products approved by the NRTL to meet OSHA standards that require product testing and certification.
The Agency processes applications by an NRTL for initial recognition and for an expansion or renewal of this recognition, following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the Agency publish two notices in the
QPS currently has one facility (site) recognized by OSHA for product testing and certification, with its headquarters located at: QPS Evaluation Services, Inc. 81 Kelfield Street, Unit 8, Toronto, Ontario, M9W 5A3, Canada. A complete list of QPS's scope of recognition is available at
QPS submitted an application, dated July 28, 2014 (OSHA-2010-0046-0005), to expand its recognition to include one additional test standard. OSHA staff performed a detailed analysis of the application packet and reviewed other pertinent information. OSHA performed an on-site review in relation to this application on July 16-17, 2015.
Table 1 below lists the appropriate test standard found in QPS's application for expansion for testing and certification of products under the NRTL Program.
QPS submitted an acceptable application for expansion of its scope of recognition. OSHA's review of the application file, and pertinent documentation, indicate that QPS can meet the requirements prescribed by 29 CFR 1910.7 for expanding its recognition to include the addition of this one test standard for NRTL testing and certification listed above. This preliminary finding does not constitute an interim or temporary approval of QPS's application.
OSHA welcomes public comment as to whether QPS meets the requirements of 29 CFR 1910.7 for expansion of its recognition as an NRTL. Comments should consist of pertinent written documents and exhibits. Commenters needing more time to comment must submit a request in writing, stating the reasons for the request. Commenters must submit the written request for an extension by the due date for comments. OSHA will limit any extension to 10 days unless the requester justifies a longer period. OSHA may deny a request for an extension if the request is not adequately justified. To obtain or review copies of the exhibits identified in this notice, as well as comments submitted to the docket, contact the Docket Office, Room N-2625, Occupational Safety and Health Administration, U.S. Department of Labor, at the above address. These materials also are available online at
OSHA staff will review all comments to the docket submitted in a timely manner and, after addressing the issues raised by these comments, will recommend to the Assistant Secretary for Occupational Safety and Health whether to grant QPS's application for expansion of its scope of recognition. The Assistant Secretary will make the final decision on granting the application. In making this decision, the Assistant Secretary may undertake other proceedings prescribed in Appendix A to 29 CFR 1910.7.
OSHA will publish a public notice of its final decision in the
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, 200 Constitution Avenue NW., Washington, DC 20210, authorized the preparation of this notice. Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.
Occupational Safety and Health Administration (OSHA), Labor.
Notice.
In this notice, OSHA announces the application of TUV SUD America, Inc. for expansion of its recognition as a Nationally Recognized Testing Laboratory (NRTL) and presents the Agency's preliminary finding to grant the application.
Submit comments, information, and documents in response to this notice, or requests for an extension of time to make a submission, on or before February 8, 2016.
Submit comments by any of the following methods:
1.
2.
3.
4.
5.
6.
Information regarding this notice is available from the following sources:
The Occupational Safety and Health Administration is providing notice that TUV SUD America, Inc. (TUVAM), is applying for expansion of its current recognition as an NRTL. TUVAM requests the addition of one test standard to its NRTL scope of recognition.
OSHA recognition of an NRTL signifies that the organization meets the requirements specified in 29 CFR 1910.7. Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within its scope of recognition. Each NRTL's scope of recognition includes (1) the type of products the NRTL may test, with each type specified by its applicable test standard; and (2) the recognized site(s) that has/have the technical capability to perform the product-testing and product-certification activities for test standards within the NRTL's scope. Recognition is not a delegation or grant of government authority; however, recognition enables employers to use products approved by the NRTL to meet OSHA standards that require product testing and certification.
The Agency processes applications by an NRTL for initial recognition and for an expansion or renewal of this recognition, following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the Agency publish two notices in the
TUVAM currently has three facilities (sites) recognized by OSHA for product testing and certification, with its headquarters located at: TUV SUD America, Inc., 10 Centennial Drive, Peabody, MA 01960. A complete list of TUVAM's scope of recognition is available at
TUVAM submitted an application, dated August 10, 2015 (Exhibit 15-1, Application for One Test Standard Expansion, OSHA-2007-0043), to expand its recognition to include one additional test standard. OSHA staff performed detailed analysis of the application packet and reviewed other pertinent information. OSHA did not perform any on-site reviews in relation to this application.
Table 1 below lists the appropriate test standard found in TUVAM's application for expansion for testing and certification of products under the NRTL Program.
TUVAM submitted an acceptable application for expansion of its scope of recognition. OSHA's review of the application file indicates that TUVAM can meet the requirements prescribed by 29 CFR 1910.7 for expanding its recognition to include the addition of this one test standard for NRTL testing and certification listed above. This preliminary finding does not constitute an interim or temporary approval of TUVAM's application.
OSHA welcomes public comment as to whether TUVAM meets the requirements of 29 CFR 1910.7 for expansion of its recognition as an NRTL. Comments should consist of pertinent written documents and exhibits. Commenters needing more time to comment must submit a request in writing, stating the reasons for the request. Commenters must submit the written request for an extension by the due date for comments. OSHA will limit any extension to 10 days unless the requester justifies a longer period. OSHA may deny a request for an extension if the request is not adequately justified. To obtain or review copies of the exhibits identified in this notice, as well as comments submitted to the docket, contact the Docket Office, Room N-2625, Occupational Safety and Health Administration, U.S. Department of Labor, at the above address. These materials also are available online at
OSHA staff will review all comments to the docket submitted in a timely manner and, after addressing the issues raised by these comments, will recommend to the Assistant Secretary for Occupational Safety and Health whether to grant TUVAM's application for expansion of its scope of recognition. The Assistant Secretary will make the final decision on granting the application. In making this decision, the Assistant Secretary may undertake other proceedings prescribed in Appendix A to 29 CFR 1910.7.
OSHA will publish a public notice of its final decision in the
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, 200 Constitution Avenue NW., Washington, DC 20210, authorized the preparation of this notice. Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.
Occupational Safety and Health Administration (OSHA), Labor.
Request for nominations to serve on NACOSH.
The Assistant Secretary of Labor for Occupational Safety and Health requests nominations for membership on NACOSH.
Nominations for NACOSH must be submitted (postmarked, sent or received) by March 22, 2016.
You may submit nominations for NACOSH, which must include the docket number for this
The Assistant Secretary of Labor for Occupational Safety and Health invites interested individuals to submit nominations for membership on NACOSH.
NACOSH was established by Section 7(a) of the Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651, 656) to advise, consult with and make recommendations to the Secretary of Labor (Secretary) and the Secretary of Health and Human Services (HHS Secretary) on matters relating to the administration of the OSH Act. NACOSH is a continuing advisory committee of indefinite duration.
NACOSH operates in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2), its implementing regulations (41 CFR part 102-3), and OSHA's regulations on NACOSH (29 CFR part 1912a).
NACOSH is comprised of 12 members, all of whom the Secretary appoints. The terms of six NACOSH members expire on December 31, 2016. OSHA invites nominations for the following NACOSH positions:
• Two public representatives;
• One management representative;
• One labor representative;
• One occupational safety professional representative; and
• One occupational health professional representative.
Pursuant to 29 CFR 1912a.2, the HHS Secretary designates the two occupational health professional representatives and two of the four public representatives for the Secretary's consideration and appointment. OSHA will provide to HHS all nominations and supporting materials for the membership categories the HHS Secretary designates.
NACOSH members serve two-year staggered terms, unless the member becomes unable to serve, resigns, ceases to be qualified to serve, or is removed by the Secretary. The Secretary may appoint NACOSH members to successive terms. The Committee must meet at least two times a year (29 U.S.C. 656(a)(1)).
Any interested person or organization may nominate one or more qualified persons for membership on NACOSH. Nominations must include the nominee's name, occupation or current position, and contact information. The nomination also must identify the category that the candidate is qualified to represent, and include a resume of the nominee's background, experience, and qualifications. In addition, the nomination must state that the nominee is aware of the nomination, and is willing to serve and regularly attend NACOSH meetings.
The Secretary will appoint NACOSH members on the basis of their experience and competence in the field of occupational safety and health (29 CFR 1912a.2). The information OSHA receives through this nomination process, in addition to other relevant sources of information, will assist the Secretary in appointing members to serve on NACOSH. In appointing NACOSH members, the Secretary will consider individuals nominated in response to this
The U.S. Department of Labor (Department) is committed to equal opportunity in the workplace and seeks a broad-based and diverse NACOSH membership. The Department will conduct a public records check of nominees before their appointment using publicly available sources.
You may submit nominations using one of the methods listed in the
OSHA posts submissions, including any personal information you provide, in the NACOSH docket, without change. Those documents also may be available online at
All documents in the NACOSH docket, including materials not available through
Electronic copies of this
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice under the authority granted by 29 U.S.C. 656, 5 U.S.C. App. 2; 29 CFR part 1912a; 41 CFR part 102-3; and Secretary of Labor's Order No. 1-2012 (77 FR 3912).
Legal Services Corporation.
Request for comments.
The Legal Services Corporation (“LSC”) Board of Directors (“Board”) is in the process of updating LSC's strategic plan for the years 2017-2020. The LSC Board is soliciting comments on the current LSC Strategic Plan 2012-2016 and whether the current goals remain suitable and timely and if new goals should be implemented.
All comments and recommendations must be received on or before the close of business on February 29, 2016.
You may submit comments by any of the following methods:
Rebecca Fertig Cohen,
As an entity created and funded by Congress, LSC has a duty to the American people to pursue its fundamental mission of equal access to justice. With this primary goal in mind, the LSC Board adopted a plan in 2012 setting forth the strategic goals that would guide LSC for five years, ending in 2016. The LSC Board is now in the process of updating and revising the strategic plan for an additional four year period. As part of this process, the LSC Board is seeking input from the public and interested stakeholders on whether the goals articulated in the current LSC strategic plan for 2012-2016, which is available at
The first and primary goal listed in the LSC strategic plan for 2012-2016 is to maximize the availability, quality, and effectiveness of the civil legal services that LSC's grantees provide to eligible low-income individuals. LSC identifies three avenues through which it can best accomplish this goal: (1) Identifying and replicating best practices associated with delivering high quality civil legal assistance to the poor by its grantees; (2) promoting the development and implementation of technologies that maximize the availability of legal information and assistance; and (3) expanding the availability of civil legal assistance through the most effective use of pro bono services and other private resources by LSC's grantees.
The second goal listed in the LSC strategic plan for 2012-2016 is to become a leading voice for civil legal services for poor Americans by providing national leadership and opportunities for collaboration with others committed to promoting civil legal services, including other funders of legal aid, governmental agencies, and judicial systems throughout the country.
The third and final goal listed in the LSC strategic plan for 2012-2016 is to achieve the highest standards of fiscal responsibility both for itself and its grantees. As a steward of congressional funds collected from the American taxpayer, LSC has a duty to be a prudent with the use of the resources allocated to it. LSC's goal is to comply with the parameters expressed by Congress and conform to the highest professional standards of fiscal transparency and accountability, both within the Corporation and in its fiscal oversight of those who receive funds from LSC.
Electronic meeting of the Board of Trustees to be held via telephone, 10:00 a.m. to 12:00 p.m. (PST-Pacific Standard Time), Wednesday, February 10, 2016.
Board of Trustees Meeting held via telephone.
This special meeting of the Board of Trustees, to be held Electronically (in accordance with the Operating Procedures of the Udall Foundation's Board of Trustees), will be open to the public, unless it is necessary for the Board to consider items in executive session. Members of the public who would like to participate in the open session of this special meeting of the Board of Trustees should email Stephanie Zimmt-Mack, General Counsel, Morris K. Udall and Stewart L. Udall Foundation, at
(1) Officers of the Board and (2) Internal Personnel Matters.
All agenda items except as noted below.
Executive Session to Discuss Internal Personnel Matters.
Stephanie Zimmt-Mack, General Counsel, 130 South Scott Avenue, Tucson, AZ 85701, (520) 901-8500.
National Archives and Records Administration (NARA).
Notice of availability of proposed records schedules; request for comments.
The National Archives and Records Administration (NARA) publishes notice at least once monthly of certain Federal agency requests for records disposition authority (records schedules). Once approved by NARA, records schedules provide agencies with mandatory instructions for what to do with records when agencies no longer need them for current Government business. The instructions authorize agencies to preserve records of continuing value in the National Archives of the United States and to destroy, after a specified period, records lacking administrative, legal, research, or other value. NARA publishes notice in the
NARA must receive requests for copies in writing by February 22, 2016. Once NARA appraises the records, we will send you a copy of the schedule you requested. We usually prepare appraisal memoranda that contain additional information concerning the records covered by a proposed schedule. You may also request these. If you do, we will also provide them once we have completed the appraisal. You have 30 days after we send you these requested documents in which to submit comments.
You may request a copy of any records schedule identified in this notice by contacting Records Management Services (ACNR) using one of the following means:
You must cite the control number, which appears in parentheses after the name of the agency that submitted the schedule, and a mailing address. If you would like an appraisal report, please include that in your request.
Margaret Hawkins, Director, by mail at Records Management Services (ACNR); National Archives and Records Administration; 8601 Adelphi Road, College Park, MD 20740-6001, by phone at 301-837-1799, or by email at
Each year, Federal agencies create billions of records on paper, film, magnetic tape, and other media. To control this accumulation, agency records managers prepare schedules proposing retention periods for records and submit these schedules for NARA's approval. These schedules provide for timely transfer into the National Archives of historically valuable records and authorize disposal of all other records after the agency no longer needs them to conduct its business. Some schedules are comprehensive and cover all the records of an agency or one of its major subdivisions. Most schedules, however, cover records of only one office or program or a few series of records. Many of these update previously approved schedules, and some include records proposed as permanent.
The schedules listed in this notice are media-neutral unless otherwise specified. An item in a schedule is media-neutral when an agency may apply the disposition instructions to records regardless of the medium in which it has created or maintains the records. Items included in schedules submitted to NARA on or after December 17, 2007, are media-neutral unless the item is specifically limited to a specific medium. (See 36 CFR 1225.12(e).)
Agencies may not destroy Federal records without the approval of the Archivist of the United States. The Archivist grants this approval only after thorough consideration of the records' administrative use by the agency of origin, the rights of the Government and of private people directly affected by the Government's activities, and whether or not the records have historical or other value.
In addition to identifying the Federal agencies and any subdivisions requesting disposition authority, lists the organizational unit(s) accumulating
1. Department of Defense, National Geospatial-Intelligence Agency (DAA-0537-2015-0001, 1 item, 1 temporary item). Records include employee financial disclosure forms.
2. Department of Health and Human Services, Indian Health Service (DAA-0513-2016-0001, 1 item, 1 temporary item). Self-governance records to include case files relating to contract agreements allowing Indian Tribes to assume control of programs previously administered by the Federal government.
3. Department of Homeland Security, United States Citizenship and Immigration Services (DAA-0566-2015-0003, 6 items, 6 temporary items). Application, supporting materials, and annual updates for designation as an entity that may sponsor job-creating commercial enterprises that immigrant investors may finance.
4. Department of Homeland Security, Transportation Security Administration (DAA-0560-2014-0002, 3 items, 3 temporary items). Security personnel deployment records to include requests, a tracking database, and performance reports.
5. Department of Justice, Bureau of Prisons (DAA-0129-2015-0003, 1 item, 1 temporary item). Files of escaped inmates who are never recaptured.
6. Department of the Navy, United States Marine Corps (DAA-0127-2015-0009, 1 item, 1 temporary item). Master files of an electronic information system used to manage and disseminate digitized still pictures and video imagery for commands in the field.
7. Department of State, Bureau of Diplomatic Security (DAA-0059-2015-0008, 17 items, 16 temporary items). Records of the High Threat Programs Directorate, including program and agreement files, and routine case files. Proposed for permanent retention are high profile case files related to international incidents.
8. Department of Transportation, National Highway Traffic Safety Administration (DAA-0416-2012-0007, 1 item, 1 temporary item). Master files of an electronic information system tracking the status of state traffic safety projects.
9. Department of Transportation, Surface Transportation Board (DAA-0134-2013-0019, 1 item, 1 temporary item). Records relating to rail line abandonments.
10. Environmental Protection Agency, Agency-wide (DAA-0412-2013-0017, 6 items, 5 temporary items). Compliance and enforcement records including administrative hearing and judicial action case files, incomplete investigation files, legal opinions not related to mission activities, correspondence, and related materials. Proposed for permanent retention are significant compliance and enforcement records including landmark cases concerning environmental laws.
11. Environmental Protection Agency, Agency-wide (DAA-0412-2015-0004, 2 items, 1 temporary item). Chemical Information System records relating to import and export certifications, and related correspondence. Proposed for permanent retention are records about chemicals subject to regulation and actions taken on industry submissions relating to their manufacture and use.
12. Federal Communications Commission, Wireline Competition Bureau (DAA-0173-2016-0005, 2 items, 2 temporary items). Master files of an electronic information system containing information on nationwide study area boundaries of incumbent local exchange carriers for voice and broadband service, and summarized data posted to the agency Web site.
13. National Aeronautics and Space Administration, Agency-wide (DAA-0255-2015-0002, 2 items, 2 temporary items). Education awards activity records including applications, proposals, letters of recommendation, and criteria for significant and non-significant awards.
14. Peace Corps, Office of Volunteer Recruitment and Selection (DAA-0490-2014-0004, 6 items, 4 temporary items). Records of the Office of University and Domestic Partnerships, including routine working files, newsletters, and photographs. Proposed for permanent retention are founding and policy documents for educational opportunity programs for volunteers.
January 19, 2016 (81 FR 2915).
11:45 a.m., Thursday, January 21, 2016.
Board Room, 7th Floor, Room 7047, 1775 Duke Street, Alexandria, VA, 22314-3428.
Closed.
Pursuant to the provisions of the “Government in Sunshine Act” notice is hereby given that the NCUA Board gave previous notice of the regular meeting of the NCUA Board scheduled for January 21, 2016. Prior to the meeting, on January 20, 2016, with less than seven days' notice to the public, the NCUA Board unanimously determined that agency business required changing the previously announced closed meeting time from 11:45 a.m. to 9:00 a.m. No earlier notice of the change was possible.
9:00 a.m., Thursday, January 21, 2016.
Gerard Poliquin, Secretary of the Board, Telephone: 703-518-6304.
National Endowment for the Humanities, National Foundation on the Arts and the Humanities.
Notice of Meeting
Pursuant to the Federal Advisory Committee Act, notice is hereby given that the Federal Council
The meeting will be held on Tuesday, February 9, 2016, from 2:00 p.m. to 5:00 p.m.
The meeting will be held by teleconference originating at the National Endowment for the Arts, Washington, DC 20506.
Lisette Voyatzis, Committee Management Officer, 400 7th Street SW., Room 4060, Washington, DC 20506, (202) 606-8322;
The purpose of the meeting is for panel review, discussion, evaluation, and recommendation on applications for Certificates of Indemnity submitted to the Federal Council on the Arts and the Humanities, for exhibitions beginning on or after April 1, 2016. Because the meeting will consider proprietary financial and commercial data provided in confidence by indemnity applicants, and material that is likely to disclose trade secrets or other privileged or confidential information, and because it is important to keep the values of objects to be indemnified, and the methods of transportation and security measures confidential, I have determined that that the meeting will be closed to the public pursuant to subsection (c)(4) of section 552b of Title 5, United States Code. I have made this determination under the authority granted me by the Chairman's Delegation of Authority to Close Advisory Committee Meetings, dated July 19, 1993.
In accordance with the Federal Advisory Committee Act (Pub., L. 92-463, as amended), the National Science Foundation announces the following meeting:
Proposal Review Panel for Ocean Sciences (#10752)—Site Visit
February 8, 2016; 6:00 p.m.-9:00 p.m.
University of Southern California, Los Angeles, CA.
Partially Open.
David Garrison, Division of Ocean Sciences, National Science Foundation, 4201 Wilson Blvd., Arlington, VA 22230. Telephone (703) 292-7588
Review the Center for Dark Biosphere Investigations (C-DEBI) Science and Technology Center.
Review the C-DEBI Research Accomplishments and Organizational Structure & Partner Involvement to Achieve Center Goals; Planning & Decision-Making; past accomplishments and future plans.
7:00 a.m.-8:00 a.m.: Arrival and Continental Breakfast
8:00 a.m.-9:00 a.m.: Center Overview (Jan Amend)
9:00 a.m.-10:00 a.m.: Education, Outreach, and Diversity (Stephanie Schroeder, Steve Finkel)
10:00 a.m.-10:30 a.m.: Coffee Break
10:30 a.m.-11:00 a.m.: Data Management and Integration (John Heidelberg)
11:00 a.m.-11:30 a.m.: Interactive Discussion with Review Team
11:30 a.m.-12:00 p.m.: Review Team Executive Session (CLOSED SESSION)
12:00 p.m.-1:30 p.m.: Lunch-Review Team Discussion with Students/Postdocs
1:30 p.m.-1:45 p.m.: EAB Report (Susan Humphris)
1:45 p.m.-2:00 p.m.: Field-based Research (Beth Orcutt)
2:00 p.m.-2:15 p.m.: Lab-based Research (Victoria Orphan)
2:15 p.m.-2:30 p.m.: Modeling-based Research (Andy Fisher)
2:30 p.m.-3:00 p.m.: Summary and Q&A (Julie Huber et al.)
3:00 p.m.-3:30 p.m.: Review Team Executive Session (CLOSED SESSION)
3:30 p.m.-5:00 p.m.: Poster Session
5:00 p.m.-6:00 p.m.: Interactive Discussion with Review Team
6:00 p.m.-6:30 p.m.: Review Team Executive Session (CLOSED SESSION)
6:30 p.m.: Feedback Provided to PIs
7:00 p.m.-9:00 p.m.: Review Team Working Dinner (CLOSED SESSION)
7:00 a.m.-8:00 a.m.: Arrival and Continental Breakfast
8:00 a.m.-9:00 a.m.: Review Team Meets with Institution Administrators and Investigators Only
9:00 a.m.-10:00 a.m.: C-DEBI Response to Feedback
10:00 a.m.-4:00 p.m.: Review Team Prepares Report (Working Lunch)
4:00 p.m.: Departures
During closed sessions the review will include information of a confidential or proprietary nature, including technical and financial information; and information on personnel. These matters are exempt under 5 U.S.C. 552b(c), (4) and (6) of the Government in the Sunshine Act.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On January 14, 2016, the Postal Service filed notice that it has entered into an additional Global Expedited
To support its Notice, the Postal Service filed a copy of the Agreement, a copy of the Governors' Decision authorizing the product, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket No. CP2016-95 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than January 25, 2016. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints Katalin K. Clendenin to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2016-95 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, Katalin K. Clendenin is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than January 25, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On January 14, 2016, the Postal Service filed notice that it has entered into an additional Global Expedited Package Services 3 (GEPS 3) negotiated service agreement (Agreement).
To support its Notice, the Postal Service filed a copy of the Agreement, a copy of the Governors' Decision authorizing the product, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket No. CP2016-94 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than January 25, 2016. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints Kenneth R. Moeller to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2016-94 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, Kenneth R. Moeller is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than January 25, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On January 14, 2016, the Postal Service filed notice that it has entered into an additional Global Expedited Package Services 3 (GEPS 3) negotiated service agreement (Agreement).
To support its Notice, the Postal Service filed a copy of the Agreement, a copy of the Governors' Decision
The Commission establishes Docket No. CP2016-96 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than January 25, 2016. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints Curtis E. Kidd to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2016-96 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, Curtis E. Kidd is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than January 25, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an additional Global Reseller Expedited Package Services 2 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On January 15, 2016, the Postal Service filed notice that it has entered into an additional Global Reseller Expedited Package Services 2 (GREPS 2) negotiated service agreement (Agreement).
To support its Notice, the Postal Service filed a copy of the Agreement, a copy of the Governors' Decision authorizing the product, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket No. CP2016-97 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than January 26, 2016. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints Christopher C. Mohr to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2016-97 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, Christopher C. Mohr is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than January 26, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend its Fees Schedule. The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of
The Exchange proposes to make a number of changes to its Fees Schedule, effective January 4, 2016.
The Exchange proposes to adopt the Market-Maker Affiliate Volume Plan (“AVP”). Specifically, under AVP, if a Trading Permit Holder (“TPH”) Affiliate
The Exchange believes AVP will incentivize the routing of orders to CBOE by TPHs that have both Market-Maker and agency operations, as well as incent Market-Makers to tighten market widths due to the reduced costs the incentives will provide. The Exchange notes that in the options industry, many options orders are routed by consolidators, which are firms that have both order router and Market-Maker operations. The Exchange is aware not only of the importance of providing credits on the order routing side in order to encourage the submission of orders, but also of the operations costs on the Market-Maker side. The Exchange believes AVP allows the Exchange to provide further relief to the Market-Maker side via the discount. Additionally, the Exchange believes AVP will attract more volume and liquidity to the Exchange, which will benefit all Exchange participants through increased opportunities to trade as well as enhancing price discovery.
Currently, Footnote 24 provides that if a Market-Maker or its affiliate receive a credit under VIP, that Market-Maker will receive a credit on its Market-Maker Trading Permit fees corresponding to the VIP tier reached (10% Market-Maker Trading Permit fee credit for reaching Tier 2 of the VIP, 20% Market-Maker Trading Permit fee credit for reaching Tier 3 of the VIP, and 30% Market-Maker Trading Permit fee credit for reaching Tier 4 of the VIP) (“Access Credit”). This credit does not apply to Market-Maker Trading Permits used for appointments in SPX, SPXpm, VIX, OEX and XEO. The Exchange proposes to make certain amendments to Footnote 24.
First, the Exchange proposes to clarify that a Market-Maker will receive an Access Credit if its Affiliate, not the Market-Maker itself, reaches certain VIP tiers (
Next, the Exchange proposes to exclude from the Access Credit, Market-Maker Trading Permits used for appointments in the Russell 2000 Index (“RUT”). The Exchange notes that the proposed exclusion is similar to the exclusion of other proprietary and exclusive products. The Exchange notes the Exchange's proprietary, exclusively-listed products are often collectively excluded from certain programs, including the Access Credit, because the Exchange has expended considerable resources developing and maintaining those products and therefore desires not to give a credit related to those products in order to recoup those expenditures. Similar to the products currently excluded from the Access Credit, RUT is no longer listed on any other exchange (other than C2). As such, the Exchange proposes to exclude Market-Maker Trading Permits used for RUT appointments from the Access Credit.
The Exchange also proposes to incorporate the description of the Access Credit within a single Affiliate Volume Plan table, as both the Access Credit and discount on Market-Maker fees under AVP are based upon a Market-Maker Affiliate reaching certain tiers within VIP. The Exchange believes the proposed table alleviates potential confusion and makes the Fees Schedule easier to read.
Footnote 25, which governs rebates on Floor Broker Trading Permits, currently provides that any Floor Broker that executes a certain average of customer open-outcry contracts per day over the course of a calendar month in all underlying symbols excluding Underlying Symbol List A (except RUT), DJX, XSP, XSPAM, mini-options and subcabinet trades, will receive a rebate on that Floor Broker's Trading Permit Holder's Floor Broker Trading Permit Fees. The Exchange notes that although RUT had previously been added to “Underlying Symbol List A”, it had continued to include RUT in the calculation of the qualifying volume for the rebate of Floor Broker Trading Permit fees. The Exchange now seeks to exclude RUT volume from the calculation, similar to the exclusion of all other products in Underlying Symbol List A. As discussed above, the Exchange's proprietary, exclusively-listed products are often collectively excluded from certain programs because the Exchange has expended considerable resources developing and
The Exchange next proposes to increase the Nasdaq-100 Index (“NDX”) and mini-NDX Index (“MNX”) Index License Surcharge. Currently, the Exchange assesses an Index License Surcharge for NDX and MNX of $0.15 per contract for all non-customer orders. The Exchange now proposes to increase the NDX and MNX Surcharge from $0.15 to 0.25 per contract in order to recoup the increased costs associated with the NDX and MNX license. The Exchange will still be subsidizing the costs of the NDX and MNX license. Additionally, like other proprietary index products, the Exchange proposes to except NDX and MNX from VIP and from the Marketing Fee.
The Exchange proposes to waive through March 2016 the VIX Index License Surcharge of $0.10 per contract for Clearing Trading Permit Holder Proprietary (“Firm”) (origin codes “F” or “L”) VIX orders that have a premium of $0.10 or lower and have series with an expiration of less than seven (7) calendar days. Particularly, the Exchange is attempting to reduce transaction costs on expiring, low-priced VIX options in order to encourage Firms to seek to close and/or roll over such positions close to expiration at low premium levels, including facilitating customers to do so, in order to free up capital and encourage additional trading. Currently, Firms are less likely to engage in such activity because the transaction fees are often equivalent [sic] or even exceed the premium level, making such transactions economically unattractive. The Exchange believes that the [sic] lowering costs for VIX options trading with a premium of $0.00-$0.10 and for series with an expiration of less than 7 days will encourage the closing, rolling and trading of such options and new series, as well. The Exchange proposes to waive the surcharge through March 2016, at which time the Exchange will evaluate whether the wavier [sic] has in fact prompted Firms to close and roll over positions close to expiration at low premium levels.
The Exchange proposes to reduce the amount of VIX customer (origin code “C”) transactions [sic] fees [sic] orders with a premium of $0.11 to $0.99 from $0.27 per contract to $0.25 per contract and orders with a premium of above $1.00 from $.048 per contract to $0.45 per contract. The Exchange believes that the lowered costs for VIX options will encourage the trading of such options.
The Exchange assesses a Hybrid 3.0 Execution Fee of $0.20 per contract for all electronic executions in Hybrid 3.0 classes (with some exceptions).
On October 20, 2015, the Exchange began trading options on three FTSE Russell Indexes (
The Customer Large Trade Discount program (the “Discount”) provides a discount in the form of a cap on the quantity of customer (“C” origin code” [sic]) contracts that are assessed transactions fees in certain options classes. The Discount table in the Fees Schedule sets forth the quantity of contracts necessary for a large customer trade to qualify for the Discount, which varies by product. Currently, under the “Products” section in the Discount table, the following S&P products for which the Discount is in effect are listed: “SPX, SPXw, SPXpm, SRO.” Customer transaction fees for each of these products are currently only charged up to the first 15,000 contracts. The Exchange proposes to raise the quantity of SPX, SPXw, SPXpm, and SRO contracts necessary for a large customer trade to qualify for the Discount from 15,000 contracts per order to 20,000 contracts per order. The purpose of the proposed rule change is to moderate the discount level for customer (C) orders in the SPX product group in view of its mature and established position in the industry. The Exchange additionally proposes to raise the quantity of VIX contracts necessary for a large customer trade to qualify for the Discount. Specially [sic], the Exchange proposes to raise the threshold from 10,000 contracts per order to 15,000 contracts per order. The purpose of the proposed change is to moderate the discount level for customer (C) orders in VIX in light of the increased sizes of qualifying Discount VIX orders.
CBOE Rule 8.3(e) provides that the Exchange may establish one or more types of tier appointments. In accordance with CBOE Rule 8.3(e), a tier appointment is an appointment to trade one or more options classes that must be held by a Market-Maker to be eligible to act as a Market-Maker in the options class or options classes subject to that appointment. CBOE currently maintains a tier appointment for Market-Maker Trading Permit Holders trading in RUT, as it does for SPX and VIX. Currently, the Exchange has a Tier Appointment Surcharge for SPX and VIX, but not RUT. The Exchange notes that it has expended considerable resources developing and maintaining its proprietary, exclusively-listed products. To help recoup costs of the license and for further development and maintenance of RUT options, the Exchange is now proposing to also establish a RUT Tier Appointment fee. Specifically, the Exchange proposes to adopt a RUT Tier Appointment fee of $1,000 per month, which will be assessed to any Market-Maker Trading Permit Holder that either (a) has a RUT Tier Appointment at any time during a calendar month and trades at least 100 RUT options contracts electronically while that appointment is active; or (b) trades at least 1,000 RUT options contracts in open outcry during a calendar month. The Exchange notes
In order to promote and encourage trading during the Extended Trading Hours (“ETH”) session, the Exchange currently waives ETH Trading Permit and Bandwidth Packet fees for one (1) of each initial Trading Permits and one (1) of each initial Bandwidth Packet, per affiliated TPH. The Exchange notes that waiver is set to expire December 31, 2015. The Exchange also waives fees through December 31, 2015 for a CMI and FIX login ID if the CMI and/or FIX login ID is related to a waived ETH Trading Permit and/or waived Bandwidth packet. In order to continue to promote trading during ETH, the Exchange wishes to extend these waivers through July 2016.
The Exchange proposes raising the Floor Broker Workstation (“FBW”) and FBW2 fee from $400 per month (per login ID) to $450 per month (per login ID). The total amount charged by the Exchange's vendor that provides the FBW (and FBW2) is more than $450 per month (per login ID) for FBW and FBW2 and the Exchange has been subsidizing those costs for FBW and FBW2 users. As such, the Exchange proposes increasing the FBW fee to $450 per month (per login ID), which still includes a subsidy for FBW users (though smaller).
Additionally, the Exchange notes that for every FBW login a TPH has, the FBW2 monthly fee is currently waived through December 2015 on a one-to-one basis. The Exchange waived the FBW2 fee on a one-to-one basis because it had anticipated new features being launched on FBW2 by the end of the year and the Exchange wanted to encourage FBW users to begin (or continue) transitioning to FBW2 logins while waiting for the new features. Additionally, the Exchange wanted to provide additional time to become acclimated to FBW2 while at the same time being able to use FBW login IDs. The Exchange notes that certain new features on FBW2 have still not launched. As such, the Exchange wishes to extend the FBW2 monthly fee waiver on a one-to-one basis through March 31, 2016. The Exchange therefore proposes to delete now outdated language in the Fees Schedule and provide that for every FBW login a TPH has, the FBW2 fee will be waived for the months of January 2016 through March 2016 on a one-to-one basis.
The Exchange proposes to correct an inadvertent omission to the Fees Schedule with respect to a recent change to Qualified Contingent Cross (“QCC”)
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes that adopting the Affiliate Volume Plan is reasonable because it will allow qualifying Market-Makers to receive a credit on their Market-Maker Sliding Scale transaction fees. The Exchange believes that this proposed change is equitable and not unfairly discriminatory because Market-Makers are valuable market participants that provide liquidity in the marketplace and incur costs that other market participants do not incur. For example, Market-Makers have a number of obligations, including quoting obligations that other market participants do not have. Additionally, the Exchange notes that incentivizing a Market-Maker Affiliate to achieve higher tiers on the VIP, can result in greater customer liquidity, and the resulting increased volume benefits all market participants (including Market-Makers or their affiliates who do not achieve the higher tiers on the VIP; indeed, this increased volume may allow them to reach these tiers). Further, other options exchanges also provide credits to Market-Makers if a Market-Maker's affiliate adds a certain amount of customer liquidity to that exchange.
The Exchange believes that it is reasonable, equitable and not unfairly discriminatory to exclude Market-Maker Trading Permits used for appointments in RUT from the Access Credit because the Exchange has expended considerable resources maintaining RUT as a proprietary and exclusively-listed product and therefore desires not to give a credit related in order to recoup those expenditures. Additionally, the Exchange notes that Trading Permits used for appointments in other proprietary and exclusively listed products are excluded from receiving credits under the Access Credit program
The Exchange believes clarifying in Footnote 24 that only a Market-Maker Affiliate (as opposed to the Market-Maker itself) can receive an Access Credit alleviates potential confusion. The Exchange also believes incorporating into a single table both details of the Access Credit and credits available to Market-Makers under AVP alleviates potential confusion and maintains clarity in the Fees Schedule. The alleviation of potential confusion serves to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest.
The Exchange believes increasing the NDX and MNX Index License Surcharge Fee from $0.15 to $0.25 per contract is reasonable because the Exchange still pays more for the NDX and MNX license than the amount of the proposed NDX Index License Surcharge Fee (meaning that the Exchange will be subsidizing the costs of the NDX and MNX license). Additionally, the Exchange notes that another Exchange also assesses $0.25 per contract for NDX and MNX transactions.
The Exchange believes that excluding NDX and MNX from VIP is reasonable because the VIP is a credit program, and excluding MNX and NDX from the VIP does not impose any extra fee for NDX and MNX trades, it just prevents them from incurring a credit (or counting towards incurring credits). As such, qualifying market participants trading NDX and MNX will merely be required to pay regular transaction fees. The Exchange believes excepting NDX and MNX from VIP is equitable and not unfairly reasonable because other proprietary index products are also excepted from VIP. Similarly, the Exchange believes it's reasonable to except NDX and MNX [sic] the Marketing Fee because other proprietary index products are excepted from those same items. This is equitable and not unfairly discriminatory for the same reason; it seems equitable to except NDX and MNX from items on the Fees Schedule from which other proprietary products are also excepted.
The Exchange believes it's reasonable to waive the VIX Index License Surcharge for Clearing Trading Permit Holder Proprietary VIX orders that have a premium of $0.10 or lower and have series with an expiration of less than 7 calendar days because the Exchange wants to encourage Firms to roll and close over positions close to expiration at low premium levels. The Exchange notes that without the waiver, firms are less likely to engage in these transactions, as opposed to other VIX transactions, due to the associated transaction costs. The Exchange believes it's equitable and not unfairly discriminatory to limit the waiver to Clearing Trading Permit Holder Proprietary orders because they contribute capital to facilitate the execution of VIX customer orders with a premium of $0.10 or lower and series with an expiration of less than 7 days. Finally, the Exchange believes it's reasonable, equitable and not unfairly discriminatory to provide that the surcharge will be waived through March 2016, as it gives the Exchange time to evaluate if the wavier [sic] is in fact having the desired effect of encouraging these transactions and because it applies to all Clearing Trading Permit Holders.
The proposal to reduce VIX customer transactions [sic] is reasonable because it allows customers to pay less for these transactions than they are currently paying. The proposed change to customer VIX options transaction fees is also equitable and not unfairly discriminatory because it applies uniformly to all customers and because this is designed to attract customer VIX orders, which increases liquidity and provides greater trading opportunities to all market participants.
The Exchange believes it's reasonable to increase the Hybrid 3.0 Surcharge because it is merely an increase of $0.01 per contract, and the Exchange uses this fee to cover the costs of operating the Hybrid 3.0 system. The Exchange believes that this proposed increase is also reasonable, equitable and not unfairly discriminatory because it applies to all Hybrid 3.0 executions,
The Exchange believes it is reasonable, equitable and not unfairly discriminatory to extend the waiver of all transaction fees for RUI, RLV and RLG transasctions [sic], including the Floor Brokerage fee, the License Index Surcharge and CFLEX Surcharge Fee, because it promotes and encourages trading of these products which are still new and applies to all TPHs.
The Exchange believes that raising the discount threshold for VIX and SPX (including SPXw), SPXPM and SROs is reasonable because customers will still be receiving a discount for large trades that they would not otherwise receive. This change is equitable and not unfairly discriminatory because all customers whose large trades qualify for the Discount will still receive it. The Exchange believes it's equitable and not unfairly discriminatory to raise the threshold higher for the SPX product group because the SPX product group has reached a mature and established level since its introduction while other products, such as VIX, have not.
The Exchange believes that establishing a RUT Tier Appointment fee is reasonable because the Exchange maintains a similar fee for other exclusively-listed proprietary products for which there is a tier appointment.
The Exchange believes extending the waiver of ETH Trading Permit and Bandwidth Packet fees for one of each type of Trading Permit and Bandwidth Packet, per affiliated TPH through July 31, 2016 is reasonable, equitable and not unfairly discriminatory, because it promotes and encourages trading during the ETH session and applies to all ETH TPHs. The Exchange believes it's also reasonable, equitable and not unfairly discriminatory to waive fees for Login IDs related to waived Trading Permits and/or Bandwidth Packets in order to promote and encourage ongoing participation in ETH and also applies to all ETH TPHs.
Increasing the FBW and FBW2 fee from $400 per month (per login ID) to $450 per month (per login ID) is reasonable because the total amount charged by the Exchange's vendor that provides the FBW (and FBW2) is more than $450 per month (per login ID) for FBW and FBW2 and the Exchange simply wants to reduce the extent to which the Exchange subsidizes such costs. This change is equitable and not unfairly discriminatory because all market participants who desire to use the FBW and FBW2 will be assessed the same fee.
The Exchange believes it is reasonable to extend the waiver of FBW2 fees for each FBW login a TPH has through March 2016 because it encourages users to use and become familiar with the updated FBW2 login IDs while waiting for certain features to be implemented on FBW2. The Exchange believes the proposed changes are equitable and not unfairly discriminatory because it applies to all users of FBW2.
The Exchange believes that correcting an inadvertent failure to update the QCC rate change in the Fee Cap table (in addition to the QCC Rate Table, where it is currently provided for) will alleviate potential confusion and maintain clarity in the Fees Schedule, which serves to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest.
The Exchange does not believe that the proposed rule changes will impose any burden on competition that are not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe that the proposed rule change will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because, while different fees and rebates are assessed to different market participants in some circumstances, these different market participants have different obligations and different circumstances (as described in the “Statutory Basis” section above). For example, Clearing TPHs have clearing obligations that other market participants do not have. Market-Makers have quoting obligations that other market participants do not have. There is a history in the options markets of providing preferential treatment to customers, as they often do not have as sophisticated trading operations and systems as other market participants, which often makes other market participants prefer to trade with customers. Further, the Exchange fees and rebates, both current and those proposed to be changed, are intended to encourage market participants to bring increased volume to the Exchange (which benefits all market participants), while still covering Exchange costs (including those associated with the upgrading and maintenance of Exchange systems).
The Exchange does not believe that the proposed rule changes will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because the proposed changes are intended to promote competition and better improve the Exchange's competitive position and make CBOE a more attractive marketplace in order to encourage market participants to bring increased volume to the Exchange (while still covering costs as necessary). Further, the proposed changes only affect trading on CBOE. To the extent that the proposed changes make CBOE a more attractive marketplace for market participants at other exchanges, such market participants are welcome to become CBOE market participants.
The Exchange neither solicited nor received comments on the proposed rule change.
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 (“Commission”).
Notice of application for an order approving the substitution of certain securities pursuant to Section 26(c) of the Investment Company Act of 1940, as amended (the “1940 Act”).
The Guardian Insurance & Annuity Company (the “Company”), The Guardian Separate Account K, The Guardian Separate Account M, The Guardian Separate Account N (each, a “Life Account”) and The Guardian Separate Account R (the “Annuity Account” and together with the Life Accounts, the “Accounts”) (together, the “Applicants”).
The Applicants seek an order pursuant to Section 26(c) of the 1940 Act approving the substitution of shares issued by certain investment portfolios (the “Existing Funds”) of registered investment companies with shares of certain investment portfolios (the “Replacement Funds”) of registered investment companies, under certain variable life insurance policies and variable annuity contracts issued by the Company (the “Contracts”), each funded through the Accounts.
The application was filed on April 24, 2015, and amended on September 4, 2015, and November 10, 2015.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on February 9, 2016, and should be accompanied by proof of service on applicants, in the form of an affidavit or, for lawyers, a certificate of service. Pursuant to Rule 0-5 under the 1940 Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090; Applicants: Richard T. Potter, The Guardian Insurance & Annuity Company, Inc., 7 Hanover Square, New York, New York 10004.
Elizabeth G. Miller, Senior Counsel, at (202) 551-8707, or Holly L. Hunter-Ceci, Branch Chief, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or an applicant using the Company name box, at
1. The Company is a stock life insurance company incorporated in the State of Delaware. The Company is wholly owned by The Guardian Life Insurance Company of America, a mutual life insurance company organized in the State of New York (“Guardian Life”). Guardian Life does not issue the Contracts and does not guarantee any benefits provided under the Contracts.
2. Each Account is a “separate account” as defined in Rule 0-1(e) under the 1940 Act and is registered with the Commission as a unit investment trust under the 1940 Act. The interests in each Account offered through the Contracts have been registered under the Securities Act of 1933 on Form N-4 for the variable annuity Contracts offered under the Annuity Account, and on Form N-6 for the variable life insurance Contracts offered under the Life Accounts. The application sets forth the registration statement file numbers for the Accounts. Each Account was established by the board of directors of the Company under the laws of the State of Delaware as follows:
3. Each Account supports certain Contracts issued by the Company. Each Account consists of investment divisions, each corresponding to a registered open-end management investment company or series of a registered open-end management investment company in which the Account invests. The assets of each Account equal to its reserves and other liabilities are not chargeable with the Company's obligations except those under Contracts issued through such Account. Income, gains and losses, whether or not realized, of each Account are kept separate from other income, gains or losses of the Company and other separate accounts. The income and capital gains or capital losses of each investment division, whether realized or unrealized, are credited to or charged against the assets held in that division according to the terms of the applicable Contract, without regard to the income, capital gains or capital losses of the other investment divisions of the Company.
4. The Contracts are flexible premium or modified scheduled premium variable life insurance policies and variable annuity contracts. For so long as a variable life insurance Contract remains in force or a variable annuity Contract has not yet been annuitized, a Contract owner may transfer all or part of their accumulation values among the variable investment options under the
5. The Applicants state that under the Contracts, the Company reserves the right, subject to Commission approval and compliance with applicable law, to substitute shares of one registered open-end management investment company available as a variable investment option for shares of another registered open-end management investment company.
6. The Applicants propose the substitution of shares of Existing Funds currently held by the Life Accounts and the Annuity Account to support variable life insurance policies and variable annuity contracts issued by the Company for shares of the Replacement Funds (“Substitutions”):
7. Applicants represent that under the proposed Substitutions, each Existing Fund's shares will be redeemed for cash, and the cash from the redemption will be used to purchase shares of the respective Replacement Fund.
8. The Applicants represent that the proposed Substitutions and the selection of the Replacement Funds were not motivated by any financial consideration paid or to be paid to the Company or its affiliates by the respective Replacement Fund, its adviser or underwriter, or their affiliates.
9. The Applicants represent that each proposed Substitution is appropriate given the substantial similarity between the stated investment objectives and principal investment strategies of each Existing Fund as compared to each corresponding Replacement Fund, which would offer Contract owners continuity of their investment strategies and risks. The Applicants state that the proposed Substitutions are expected to provide competitive long-term returns as compared to the Existing Funds. Additional information for each Existing Fund and the corresponding Replacement Fund, including investment objectives, principal investment strategies, principal risks, and performance can be found in the application.
10. The Applicants represent that the proposed Substitutions will be described to the applicable prospectuses for the Contracts filed with the Commission or in other supplemental disclosure documents for the Contracts (collectively, the “Supplements”). The Supplements will: (a) Give Contract owners notice of the Company's intention to take the necessary actions to substitute shares of the Existing Funds on the Substitution Date (defined herein); (b) advise Contract owners of their pre- and post-Substitution transfer rights; (c) instruct Contract owners how to submit transfer requests in light of the proposed Substitutions; and (d) advise Contract owners that any Contract value remaining in an Existing Fund Subaccount on the Substitution Date will be transferred to a subaccount investing in the corresponding Replacement Fund, and that the Substitutions will take place at relative net asset value. From the date of the Supplements (which will be at least 30 days prior to the Substitution Date) until the Substitution Date, Contract owners will have a pre-Substitution transfer right, the specifics of which will be determined by whether they have selected an optional living benefit rider, as discussed in more detail in the application.
11. The Supplement will also inform Contract owners that, except as described in the market timing limitations section or limitations imposed by any living benefit riders of the relevant prospectus or disclosure document, the Company will not exercise any rights reserved by it under the Contracts to impose additional restrictions on transfers out of a Replacement Fund Subaccount from the date of the Supplements (which will be at least 30 days prior to the Substitution Date) until at least 30 days after the Substitution Date.
12. The Company will send affected Contract owners a written confirmation of the completed proposed Substitutions in accordance with Rule 10b-10 under the Securities Exchange Act of 1934. The Company will deliver to each affected Contract owner within five business days of the date of the proposed Substitutions (the “Substitution Date”) a written confirmation which will include: (a) A confirmation that the proposed Substitutions were carried out as previously notified; (b) a restatement of the information set forth in the Supplements; and (c) before and after account values. The confirmation statement will also include or be accompanied by a statement that reiterates the free transfer rights disclosed in the Supplements. The Company will also send each Contract owner a current prospectus for each Replacement Fund involved in the proposed Substitutions to the extent that such Contract owners have not previously received a copy.
13. Each Substitution will take place at the relative net asset value determined on the Substitution Date pursuant to Section 22(c) of the 1940 Act and Rule 22c-1 thereunder, with no change in the amount of any Contract owner's Contract value or death benefit or in the dollar value of his or her investments in any of the subaccounts. The rights or obligations of the Company under the Contracts will not be altered in any way. The proposed Substitutions will take place with no change to the Contract owner's Contract value, cash value and accumulation value.
14. Applicants will effectuate the Substitutions after the issuance of the requested order by the Commission. As of the Substitution Date, shares of the Existing Fund will be redeemed for cash. The Company, on behalf of the Accounts, will simultaneously place a redemption request with the Existing Fund and a purchase order with the Replacement Fund so that the purchase of the Replacement Fund shares will be for the exact amount of the redemption proceeds.
15. The Company or its affiliates will pay all expenses and transaction costs of the proposed Substitutions, including legal and accounting expenses, any applicable brokerage expenses and other fees and expenses. No fees or charges will be assessed to the Contract owners to effect the proposed Substitutions. The proposed Substitutions will not result in an increase in Contract fees and expenses, including mortality and expense risk fees and administration and distribution fees charged by the Separate Accounts. The proposed Substitutions will not result in adverse tax consequences to Contract owners and will not alter any tax benefits associated with the Contracts. No costs of the proposed Substitutions will be borne directly or indirectly by Contract owners.
16. Applicants will not receive, for three years from the Substitution Date any direct or indirect benefits from the applicable Replacement Fund, its adviser or underwriter (or their affiliates), in connection with assets attributable to Contracts affected by the proposed Substitutions, at a higher rate than they had received from the Existing Fund, its adviser or underwriter (or their affiliates), including without limitation 12b-1 fees, shareholder service, administrative or other service fees, revenue sharing, or other arrangements.
1. Applicants request that the Commission issue an order pursuant to Section 26(c) of the 1940 Act approving the proposed Substitution by the Company of shares of each Replacement Fund for shares of the corresponding Existing Fund. Section 26(c) of the 1940 Act requires the depositor of a registered unit investment trust holding securities of a single issuer to receive Commission approval before substituting the securities held by the trust. Section 26(c) provides that such approval shall be granted by order of the Commission if the evidence establishes that the substitution is consistent with the protection of investors and the purposes of the 1940 Act.
2. The Applicants submit that the proposed Substitutions meet the standards set forth in Section 26(c) and that, if implemented, the Substitutions would not raise any of the concerns that Congress intended to address when the 1940 Act was amended to include this provision. As described in the application, Applicants represent that each Replacement Fund and its corresponding Existing Fund have substantially similar investment objectives and principal investment strategies, which would offer Contract owners continuity of their investment strategies and risks, and that Existing Funds will have lower net operating expenses immediately after the proposed Substitutions.
3. The Contracts will offer Contract owners the opportunity to make at least one transfer of Contract value from the subaccount investing in the Existing Fund (for at least 30 days before the Substitution Date), or the Replacement Fund (for at least 30 days after the Substitution Date) to any other available investment option under the Contract without any cost or limitation other than those disclosed in the applicable prospectuses previously provided to Contract owners.
Applicants agree that any order granting the requested relief will be subject to the following conditions:
1. The proposed Substitutions will not be effected unless the Company determines that: (a) The Contracts allow the substitution of shares of registered open-end investment companies in the manner contemplated by the application; (b) the proposed Substitutions can be consummated as described in the application under applicable insurance laws; and (c) any regulatory requirements in each jurisdiction where the Contracts are qualified for sale have been complied with to the extent necessary to complete the proposed Substitutions.
2. The Company or its affiliates will pay all expenses and transaction costs of the Substitutions, including legal and accounting expenses, any applicable brokerage expenses and other fees and expenses. No fees or charges will be assessed to the Contract owners to effect the proposed Substitutions.
3. The proposed Substitutions will be effected at the relative net asset values of the respective shares in conformity with Section 22(c) of the 1940 Act and Rule 22c-1 thereunder without the imposition of any transfer or similar charges by Applicants. The proposed Substitutions will be effected without change in the amount or value of any Contracts held by affected Contract owners.
4. The proposed Substitutions will in no way alter the tax treatment of affected Contract owners in connection with their Contracts, and no tax liability will arise for Contract owners as a result of the proposed Substitutions.
5. The rights or obligations of the Company under the Contracts of affected Contract owners will not be altered in any way. The proposed Substitutions will not adversely affect any riders under the Contracts since each Replacement Fund is an allowable investment option for use with such riders.
6. Affected Contract owners will be permitted to make at least one transfer of Contract value from the subaccount investing in the Existing Fund (before the Substitution Date) or the Replacement Fund (after the Substitution Date) to any other available investment option under the Contract without charge for a period beginning at least 30 days before the Substitution Date through at least 30 days following the Substitution Date. Except as described in any market timing/short-term trading provisions of the relevant prospectus, the Company will not exercise any right it may have under the Contract to impose restrictions on transfers between the subaccounts under the Contracts, including limitations on the future number of transfers, for a period beginning at least 30 days before the Substitution Date through at least 30 days following the Substitution Date.
7. All affected Contract owners will be notified, at least 30 days before the Substitution Date about: (a) The intended substitution of the Existing Funds with the Replacement Funds; (b) The intended Substitution Date; and (c) information with respect to transfers as set forth in Condition 6 above. In addition, the Company will deliver to all affected Contract owners, at least 30 days before the Substitution Date, a prospectus for each applicable Replacement Fund.
8. The Company will deliver to each affected Contract owner within five (5) business days of the Substitution Date a written confirmation which will include: (a) A confirmation that the proposed Substitutions were carried out as previously notified; (b) a restatement of the information set forth in the Supplements; and (c) before and after account values.
9. Applicants will not receive, for three years from the Substitution Date, any direct or indirect benefits from the applicable Replacement Fund, its adviser or underwriter (or their
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(7) of the Securities Exchange Act of 1934 (the “Act”),
OneChicago is proposing to amend OCX Rule 717 (Summary Imposition of Fines) and concurrently issue Notice to Members (“NTM”) 2015-48. OCX Rule 717 lays out OneChicago's summary fine procedure. Specifically, OCX Rule 717 lists the violations for which the Exchange may impose summary fines, as well as the process the Exchange must follow to impose such fines. OneChicago proposes to amend Rule 717 to add several rule violations to the list of items for which the Exchange may impose summary fines. In addition to adding several rule violations for which the Exchange may impose summary fines, OCX is also proposing to add a summary fine schedule for each rule violation. The summary fine schedule informs market participants of the fines for each rule violation based on the number of offenses within a rolling twelve month period. OCX developed this summary fine schedule with input from the CFTC staff, and many of the summary fines are in line with summary fines for similar violations at other security futures exchanges.
OneChicago is concurrently issuing NTM 2015-48. The NTM informs market participants that OneChicago is amending OCX Rule 717. Additionally, the NTM lists the violations for which summary fines may be imposed. Then, in order to provide market participants with more clarity regarding the rule violations, guidance is provided regarding what activity or omission the Exchange would consider to constitute a violation of the listed rules.
Finally, OneChicago is also amending OCX Rule 705 (Review of Investigative Reports). OCX Rule 705 describes the process by which the OneChicago Chief Regulatory Officer (“CRO”) will review investigation reports conducted by the Compliance Department. OneChicago proposes to amend OCX Rule 705 to allow the CRO to authorize the summary imposition of fines as a result of an investigation.
The text of the proposed rule change is attached as
In its filing with the Commission, OneChicago included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
OCX Rule 717 lays out the Exchange's summary fine authority. Currently, the Rule describes that the Chief Regulatory Officer may summarily impose a fine against a Member for failing (i) to make timely payments of original or variation margin, options premiums, fees, cost, charges or fines to the Exchange or the Clearinghouse; (ii) to make timely and accurate submissions to the Exchange of notices, reports or other information required by the Rules of the Exchange; and (iii) to keep any books and records required by the Rules of the Exchange.
Additionally, in its current form, the Rule describes what requirements the Exchange must follow when issuing a summary fine pursuant to Rule 717. The Exchange must provide notice of any summary fine imposed, and the notice must contain the violations of the Rules of the Exchange for which the fine was imposed, the violation date, and the amount of the fine. Furthermore, the Rule describes the requirements for the Member or Access Person to pay the fine or to appeal the fine pursuant to OCX Rule 716. Finally, Rule 717 then sets the maximum fine for each violation at $5,000, and explains that the summary imposition of fines does not preclude the Exchange from bringing any other action against the fined market participant.
OneChicago is now proposing to make certain amendments to this Rule 717. Namely, OCX is proposing to add to Rule 717 a list of items for which summary fines may be imposed. The items added generally relate to violations of reporting, audit trail, recordkeeping, and other Exchange Rules. The list of items which OneChicago proposes to add to Rule 717 and their associated proposed summary fines as described below:
• Failure to make timely payments of fees, costs, or charges to the Exchange or Clearinghouse. The proposed summary fines for this rule violation are a warning letter for the first offense, $1,000 fine for the second offense, $2,500 fine for the third offense, and $5,000 for all subsequent offenses within a rolling twelve month period.
• Failure to make timely and accurate submissions to the Exchange of notices, reports or other information required by the Rules of the Exchange. The proposed summary fines for this rule
• Failure to maintain front-end audit trail information for all electronic orders entered into the OneChicago System, including order modifications and cancellations. The proposed summary fines for this rule violation are a warning letter for the first offense, $1,000 fine for the second offense, $2,500 fine for the third offense, and the commencement of disciplinary proceedings for all subsequent offenses within a rolling twelve month period.
• Failure to keep any books and records required by the Rules of the Exchange. The proposed summary fines for this rule violation are a warning letter for the first offense, $1,000 fine for the second offense, $2,500 fine for the third offense, and the commencement of disciplinary proceedings for all subsequent offenses within a rolling twelve month period.
• Failure to comply with order form preparation and recordkeeping requirements relating to orders which cannot be immediately entered into the OneChicago System. The proposed summary fines for this rule violation are a warning letter for the first offense, $1,000 fine for the second offense, $2,500 fine for the third offense, and the commencement of disciplinary proceedings for all subsequent offenses within a rolling twelve month period.
• Failure to comply with exposure requirements related to pre-execution discussions. The proposed summary fines for this rule violation are a warning letter for the first offense, $10,000 fine for the second offense, and a $15,000 fine for all subsequent offenses within a rolling twelve month period. The proposed summary fines for this rule violation are elevated because pre-arranged trading in violation of an exchange's pre-execution discussion policy presents the potential for fraudulent or manipulative behavior on an exchange.
• Failure to comply with Exchange of Future for Physical transaction reporting requirements. The proposed summary fines for this rule violation are a warning letter for the first offense, $7,500 fine for the second offense, $15,000 fine for the third offense, and the commencement of disciplinary proceedings for all subsequent offenses within a rolling twelve month period. The proposed summary fines for this rule violation are elevated because EFPs are bilateral transactions, the price of which remains unknown to the marketplace until the trade is reported by the parties to the transaction.
• Failure to identify correct account designation in order entry into the OneChicago System. The proposed summary fines for this rule violation are a warning letter for the first offense, $1,000 fine for the second offense, $2,500 fine for the third offense, and the commencement of disciplinary proceedings for all subsequent offenses within a rolling twelve month period.
• Failure to comply with order marking requirement for Exchange of Future for Physical transactions or block trades. The proposed summary fines for this rule violation are a warning letter for the first offense, $1,000 fine for the second offense, $2,500 fine for the third offense, and the commencement of disciplinary proceedings for all subsequent offenses within a rolling twelve month period.
• Failure to comply with block trade reporting requirements. The proposed summary fines for this rule violation are a warning letter for the first offense, $7,500 fine for the second offense, $15,000 fine for the third offense, and the commencement of disciplinary proceedings for all subsequent offenses within a rolling twelve month period. The proposed summary fines for this rule violation are elevated because block trades are bilateral transactions, the price of which remains unknown to the marketplace until the trade is reported by the parties to the transaction.
• Failure to comply with the prohibition on netting down concurrent long and short positions during the last five days of trading. The proposed summary fines for this rule violation are a warning letter for the first offense, $2,500 fine for the second offense, $5,000 fine for the third offense, and the commencement of disciplinary proceedings for all subsequent offenses within a rolling twelve month period. The proposed summary fines for this rule violation are elevated because netting down concurrent long and short positions during expiry week may cause a change in open interest in a particular product with no commensurate trading activity.
• Failure to identify correct account type in order entry into the OneChicago System. The proposed summary fines for this rule violation are a warning letter for the first offense, $1,000 fine for the second offense, $2,500 fine for the third offense, and the commencement of disciplinary proceedings for all subsequent offenses within a rolling twelve month period.
• Failure to timely correct an error in the handling of an order via transfer. The proposed summary fines for this rule violation are a warning letter for the first offense, $1,000 fine for the second offense, $2,500 fine for the third offense, and the commencement of disciplinary proceedings for all subsequent offenses within a rolling twelve month period.
• Failure to comply with reporting requirements for reportable positions. The proposed summary fines for this rule violation are a warning letter for the first offense, $2,500 fine for the second offense, $5,000 fine for the third offense, and the commencement of disciplinary proceedings for all subsequent offenses within a rolling twelve month period. The proposed summary fines for this rule violation are elevated because failure to report large trader positions impairs the Exchange's ability to carry out its self-regulatory obligations.
• Failure to submit ownership and control reports. The proposed summary fines for this rule violation are a warning letter for the first offense, $2,500 fine for the second offense, $5,000 fine for the third offense, and the commencement of disciplinary proceedings for all subsequent offenses within a rolling twelve month period. The proposed summary fines for this rule violation are elevated because failure to report ownership and control reports impairs the Exchange's ability to carry out its self-regulatory obligations.
Additionally, Rule 717 is being amended to increase the maximum summary fine from $5,000 to $15,000. This change is being made to accommodate OCX's proposed summary fine schedule, which contains varying levels of fines ranging from $1,000 to $15,000. The level of fines for each rule violation generally depend upon the severity of the rule violation and the potential harm to customers, other market participants, or the marketplace itself.
In addition to the above, OCX is proposing to make several other changes to OCX Rule 717. First, OCX is proposing to add that the CRO may consider the severity of a rule violation in determining whether to impose a summary fine for that violation. OCX is making this change to grant the Exchange flexibility in addressing rule violations based on the severity of the violation. As is more fully explained in OCX Rule 705, the CRO reserves the right to determine whether an investigation should be closed with no further action, by issuing a warning
Rule 717 is also being amended to clarify that OCX may impose summary fines against a Clearing Member, Exchange Member, or Access Person. Finally, OCX is proposing to remove certain items from OCX Rule 717(a)(i). Currently, that subparagraph allows the CRO to impose summary fines for a failure to make timely payments of original or variation margin, options premiums, fees, costs, charges or fines. OCX is proposing to remove original or variation margin and options premiums from this list of items because they are not relevant to OCX. OCX is also removing fines from this list because summary fines would not be an effective deterrent for a market participant that has failed to make timely payment of fines already imposed by the Exchange.
In addition to amending Rule 717, OCX is proposing to concurrently issue NTM 2015-48, which provides notice to OneChicago's market participants of the planned amendments to Rule 717, and provides guidance regarding several of the violations included in the summary fine schedule. The NTM provides guidance by explaining what may constitute a rule violation that may be subject to the imposition of summary fines.
OCX Rule 705 describes the process by which the CRO reviews the Compliance Department's investigative reports in order to determine whether a reasonable basis exists to believe that a violation within the Exchange's jurisdiction has occurred or is about to occur. The Rule then lays out various dispositions the CRO may authorize, including the commencement of disciplinary proceedings, the informal disposition of the investigation, or the closing of the investigation with no further action. OneChicago now proposes to add the summary imposition of fines to the list of dispositions which the CRO may authorize as a result of an investigation.
By way of background, OCX Rule 717 itself does not limit the summary imposition of fines to the conclusion of an investigation. The CRO may authorize summary fines in the absence of an investigation report if a Rule violation is detected. OCX is now clarifying in Rule 705 that the summary imposition of fines is one of the several dispositions the CRO may authorize upon the Compliance Department's completion of an investigation.
OneChicago believes that the proposed rule change is consistent with Section 6(b) of the Act,
• To prevent fraudulent and manipulative acts and practices,
• to promote just and equitable principles of trade,
• to foster cooperation and coordination with persons engaged in facilitating transactions in securities,
• to remove impediments to and perfect the mechanism of a free and open market and a national market system, and in general, to protect investors and the public interest, and
• to provide a fair procedure for the disciplining of market participants.
The Exchange believes that the proposed rule change will strengthen its ability to carry out its responsibilities as a self-regulatory organization. Summary fines provide an efficient an effective way for a self-regulatory organization to penalize rule violations without requiring the commencement of disciplinary proceedings. The broad authority to impose summary fines allows the Exchange to discipline its market participants, and provides a deterrent from futures violations.
Furthermore, the Exchange believes that the proposed summary fine schedule is fair and reasonable in light of each rule violation. OCX has structured its proposed summary fine schedule such that routine or clerical violations warrant lower summary fines, whereas more serious violations, such as the failure to comply with the Exchange's pre-execution discussion policy, warrant higher summary fines.
Finally, the Exchange believes that the proposed rule change and associated NTM are equitable and not unfairly discriminatory because they would apply equally to all market participants that are subject to the applicable requirements of each Rule.
OneChicago does not believe that the rule change and associated NTM will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act, in that the rule change and associated NTM enhances OneChicago's ability to deter and discipline certain rule violations.
OneChicago further notes that the proposed summary fine schedule is consistent with fine schedules established by other domestic futures exchanges. The proposed summary fine schedule distinguishes the severity of rule violations by imposing varying levels of fines for different violations. Specifically, those violations that are generally perceived as more clerical in nature are subject to lower summary fines than those violations that may involve harm to the marketplace.
No written comments were solicited or received with respect to the proposed rule change.
The proposed rule change and NTM will become operative on January 14, 2016.
At any time within 60 days of the date of effectiveness of the proposed rule change, the Commission, after consultation with the CFTC, may summarily abrogate the proposed rule change and require that the proposed rule change be refiled in accordance with the provisions of Section 19(b)(1) 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 Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Securities and Exchange Commission (“Commission”).
Notice of application for an order under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from all provisions of the Act and all rules and regulations thereunder.
Applicant requests an order for an exemption from all provisions of the Act and all rules and regulations thereunder, as Applicant is essentially a closely-held private investment company formed for a limited purpose.
Leaning Pine II, L.L.C. (“Applicant”).
The application was filed on May 26, 2015 and amended on October 22, 2015 and January 13, 2016.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicant with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on February 9, 2016, and should be accompanied by proof of service on applicant, in the form of an affidavit or, for lawyers, a certificate of service. Hearing requests should state the nature of the writer's interest, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, U.S. Securities and Exchange Commission, 100 F St. NE., Washington, DC 20549-1090. Applicant: Leaning Pine II, L.L.C., 315 E. Commerce Street, Suite 300, San Antonio, TX 78205.
Vanessa M. Meeks, Senior Counsel, or Melissa R. Harke, Branch Chief, at (202) 551-6825 (Chief Counsel's Office, Division of Investment Management).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at
1. Applicant is a newly-formed Texas limited liability company. Applicant will be capitalized with assets of individual members of the Hixon family (the “Family”) and other Family Members (as defined below) so that it may serve as a non-charitable endowment for Hobo Lake Club Incorporated (“Hobo Lake Club”), a non-profit corporation organized by the Family, which owns a lakeside property and lodge in Plum Lake, Vilas County, Wisconsin and operates as a recreation club for its members. The land held by Hobo Lake Club was first acquired by members of the Family approximately 100 years ago. As a non-profit corporation, Hobo Lake Club does not have “owners” in the common sense, but instead has “members.” Under Hobo Lake Club's bylaws, members are limited to lineal descendants of Joseph M. Hixon and Irene C. Hixon.
2. As used herein, “Family Members” refers to (i) the descendants (including adopted descendants) of Joseph M. Hixon (deceased) and Irene C. Hixon (deceased); (ii) spouses and former-spouses of any individuals described in clause (i) above; (iii) one descendant of a former spouse who will be admitted as a member of Applicant upon the effectiveness of the Shareholder Agreement (as defined below) and his descendants (including adopted descendants); and (iv) trusts, partnerships and other entities established for the exclusive benefit of, or exclusively owned by, any individuals described in clause (i), (ii) or (iii) above.
3. Applicant anticipates that upon its capitalization Applicant will have approximately 120 members, all of whom will be Family Members. These approximately 120 members will include several trusts for the benefit of individuals who are also members individually. Applicant will be capitalized exclusively by the contribution of a portion of dividend proceeds payable to various Family Members by Hixon Properties Incorporated (“Hixon Properties”), a private company that owns and invests primarily in real estate and related ventures that is controlled by Family Members, such dividend proceeds to be contributed to Applicant pursuant to an agreement (the “Shareholder Agreement”) among Applicant, Hixon Properties and Applicant's members.
4. Membership interests in Applicant (“Interests”) have not been and will not be offered or sold to the public. Applicant's operating agreement (the “LLC Agreement”) includes a restriction on transfers that prohibits members from transferring Interests to anyone other than Family Members. As a result of this restriction on transfers, no trading market will exist for the Interests. Additionally, any new member (
5. Under the LLC Agreement, Applicant's purpose is to serve as a source of funding for Hobo Lake Club, and Applicant is expressly authorized to make distributions to Hobo Lake Club for the operations, maintenance and improvement of Hobo Lake Club's properties. Applicant is not intended to
6. Applicant will be managed by a body of at least three managers (the “Managers”), each of whom must be a Family Member. Election or removal of a Manager requires the action of Applicant's members holding a majority of the Interests. The Managers may be reimbursed for expenses incurred on behalf of Applicant, but may only receive compensation for their service as Managers in excess of such reimbursements with the consent of the members holding at least 60% of the Interests, which compensation shall not include performance fees or other performance-based compensation.
7. Applicant's assets will be comprised of investments in individual securities and investment funds. The Managers will engage investment advisers registered with the Commission to carry out Applicant's investment policy (the “Policy”).
8. The highest priority of the Policy is to ensure funding for Hobo Lake Club. The registered investment advisers engaged by Applicant will be required to operate within the guidelines established by the Policy and assume a moderate risk posture. Management fees charged must be reasonable and customary, and no performance fees will be permitted.
9. The Managers will supervise all advisers engaged by Applicant and will review Applicant's investment portfolio quarterly to ensure compliance with the Policy. All advisers will be required to provide reports to the Managers at least quarterly. Applicant will provide reports to its members at least annually. On a portfolio-wide basis, the registered investment advisers engaged by Applicant will be subject to quantitative asset allocation, portfolio quality and diversification standards, which will be established by the Managers.
1. Applicant is seeking an order pursuant to section 6(c) of the Act for an exemption from all of the provisions of the Act and all rules and regulations thereunder. Applicant submits that section 3(c)(1) of the Act evidences the intention of Congress to exclude “private” investment companies from the scope of the Act. Under section 6(c) of the Act, the Commission may exempt any person, security, or transaction from any provision of the Act, if and to the extent that such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Applicant submits that the requested exemption from all provisions of the Act and all rules and regulations thereunder meets these standards, as Applicant is essentially a closely-held private investment company formed for a limited purpose.
2. Applicant states that similarly situated companies can typically rely on section 3(c)(1) of the Act for an exclusion from registration under the Act. Section 3(c)(1) excepts from the definition of “investment company” any issuer whose outstanding securities are beneficially owned by not more than 100 persons and which is not making and does not presently propose to make a public offering of its securities. Applicant submits that, as contemplated, there will be over 100 initial investors in Applicant, and the number of members is likely to increase in the future as Interests are passed down to younger generations, meaning it would not qualify for the exception under section 3(c)(1).
3. Applicant submits that the exemption requested is necessary and appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Applicant further submits that the exemption requested is consistent with relief granted by the Commission to other private investment companies that have more than 100 beneficial owners and that are substantially owned and controlled by a single family or that were formed for the limited purpose of aggregating and holding funds pending utilization of those funds by a related private enterprise.
4. Applicant submits that one of the key purposes of the Act is the mitigation of the conflicts of interest between fund investors and the management of the fund. Applicant submits that, in its case, sufficient safeguards exist to protect its investors and such safeguards are consistent with those implemented by similarly situated entities for which relief has previously been granted.
Applicant agrees that the order of the Commission granting the requested relief shall be subject to the following conditions, which conditions shall continue for so long as Applicant seeks to rely on such relief:
1. Interests have not been and will not be offered or sold to the public. The LLC Agreement includes a restriction on transfers that prohibits members from transferring Interests to anyone other than Family Members. Additionally, any new member (
2. Applicant will be managed by Managers, each of whom will be a Family Member.
3. Applicant's Managers will engage only Commission-registered investment advisers and will meet no less frequently than quarterly to review Applicant's investment portfolio to ensure compliance with the Policy.
4. Applicant will not modify its purpose as set forth in the LLC Agreement.
5. Applicant will not knowingly make available to any broker or dealer registered under the Securities Exchange Act of 1934, as amended, any financial information concerning Applicant for the purpose of knowingly enabling such broker or dealer to initiate any regular trading market in the Interests.
6. Applicant will provide each member of Applicant annual financial statements audited by an independent public accountant registered with, and subject to regular inspection by, the Public Company Accounting Oversight Board at such times as Applicant's assets, as reflected on Applicant's year-end balance sheet prepared in accordance with generally accepted accounting principles, equal or exceed $1,000,000. With respect to any year for which audited annual financial statements are not provided in accordance with the foregoing limitation, Applicant will provide unaudited annual financial statements to each member of Applicant.
7. Applicant will comply with the provisions set forth in subparagraphs (A)(i) and (B)(i) of section 12(d)(1) of the Act, as if Applicant were an investment company relying on the exemption set forth in section 3(c)(1) of the Act.
For the Commission, by the Division of Investment Management, under delegated authority.
The Department of State will conduct an open meeting at 9:30 a.m. on Wednesday, February 24, 2016, at the headquarters of the Radio Technical Commission for Maritime Services (RTCM) in Suite 605, 1611 N. Kent Street, Arlington, Virginia 22209. The primary purpose of the meeting is to prepare for the third Session of the International Maritime Organization's (IMO) Sub-Committee on Navigation, Communication, and Search and Rescue to be held at the IMO Headquarters, United Kingdom, from February 29 to March 4, 2016.
The agenda items to be considered include:
Members of the public may attend this meeting up to the seating capacity of the room. To facilitate the building security process, and to request reasonable accommodation, those who plan to attend should contact the meeting coordinator, George Detweiler, by email at
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The Department of State will conduct an open meeting at 10:00 a.m. on Wednesday, February 10, 2016, in the Oklahoma Room of the U.S. Department of Transportation Headquarters, 1200 New Jersey Ave. SE., Washington, DC 20590. The primary purpose of the meeting is to prepare for the third Session of the International Maritime Organization (IMO) Sub-Committee on Pollution Prevention and Response (PPR 3) to be held at the IMO Headquarters, United Kingdom, from February 15-19, 2016.
The agenda items to be considered include:
Members of the public may attend this meeting up to the seating capacity of the room. They may also contact the meeting coordinator to request a call-in number, in order to ensure adequate teleconference capacity, or to submit written comments and related material ahead of time. To facilitate the building security process, and to request reasonable accommodation, those who plan to attend should contact the meeting coordinator, Ms. Regina Bergner, by email at
Please note that in the case of inclement weather, the meeting will not be rescheduled. Refer to the Office of Personnel Management Web site for the operational status of federal agencies (
Directions to DOT Headquarters may be found at:
The Department of State will conduct an open meeting at 10:00 a.m. on Tuesday, March 8, 2016, at the offices of the Radio Technical Commission for Maritime Services (RTCM), 1611 N. Kent Street, Suite 605, Arlington, VA 22209. The primary purpose of the meeting is to prepare for the third session of the International Maritime Organization's (IMO) Sub-Committee on Ship Systems and Equipment to be held at the IMO Headquarters, United Kingdom, March 14-18, 2016.
The agenda items to be considered include:
Members of the public may attend this meeting up to the seating capacity of the room. In order to ensure reasonable accommodation for the full number of meeting participants, those who plan to attend should contact the meeting coordinator, LT Brian Hall, by email at
Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice of limitation of claims for judicial review of actions by FHWA and other federal agencies.
This notice announces actions taken by the FWHA that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to the proposed 1800 North (SR-37) 2000 West to I-15, Davis County improvements in the State of Utah. These actions grant approvals for the project.
By this notice, the FHWA is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the FHWA actions on the highway project will be barred unless the claim is filed on or before June 20, 2016. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
Mr. Paul Ziman, Area Engineer, Region 1, FHWA Utah Division, 2520 West 4700 South, Suite 9A, Salt Lake City, Utah 84129; telephone at 801-955-3525, or via email at
Notice is hereby given that the FHWA has taken final agency action subject to 23 U.S.C. 139(l)(1) by issuing licenses, permits, and approvals for the 1800 North (SR-37) 2000 West to I-15 project in the State of Utah. The 1800 North (SR-37) 2000 West to I-15 project proposes to provide transportation improvements on 1800 North (SR-37) between 2000 West and Interstate 15 (I-15) in Davis County, Utah, within the cities of Clinton and Sunset. The project consists of the following improvements: Widen 1800 North between Main Street and 2000 West to a five-lane cross-section (two travel lanes in each direction with a two-way left-turn lane) with additional lanes to accommodate turning movements as 1800 approaches Main Street and 2000 West; construct a grade-separated railroad crossing on 1800 North that would take 1800 North over the Union Pacific Railroad and Utah Transit Authority tracks; and construct a new interchange on I-15 at 1800 North that would provide flyover ramps to the east side of I-15. The directional flyover ramps would be shifted to the south to avoid the Army Rail Shop (a Section 4(f) property). The actions by the FHWA and the laws under which such actions were taken are described in the Environmental Impact Statement and Section 4(f) Evaluation issued on December 21, 2015.
This notice applies to all FHWA decisions as of the issuance date of this notice and all laws under which such actions were taken. Laws generally applicable to such actions include but are not limited to:
1. General: National Environmental Policy Act (42 U.S.C. 4321-4351); Federal-aid Highway Act (23 U.S.C. 109).
2. Wildlife: Endangered Species Act (16 U.S.C. 1531-1544 and 1536); Fish and Wildlife Coordination Act (16 U.S.C. 661-667(d)); Migratory Bird Treaty Act (16 U.S.C. 703-712).
3. Cultural Resources: Section 106 of the National Historic Preservation Act of 1966, as amended (16 U.S.C. 470(f)
4. Wetlands and Water Resources: Clean Water Act (Sections 319, 401, and 404) (33 U.S.C. 1251-1387); Land and Water Conservation Fund (16 U.S.C. 4601-4604); Safe Drinking Water Act (42 U.S.C. 300f through 300j-26); Rivers and Harbors Act of 1899 (33 U.S.C. 401-406); Wild and Scenic Rivers Act (16 U.S.C. 1271-1287); Emergency Wetlands Resources Act, (16 U.S.C. 3901, 3921); Wetlands Mitigation (23 U.S.C. 119(g) and 133(b)(14)); Flood Disaster Protection Act (42 U.S.C. 4012a, 4106).
5. Section 4(f) Land: Department of Transportation Act of 1966 (49 U.S.C. 303; 23 U.S.C. 138).
6. Noise: Federal-Aid Highway Act of 1970 (Pub. L. 91-605, 84 Stat. 1713); 23 U.S.C. 109(h) and (i); 42 U.S.C. 4441, 4332; sec. 339(b), Public Law 104-59, 109 Stat. 568, 605; 23 CFR part 772 (Procedures for Abatement of Highway Traffic Noise and Construction Noise); 49 CFR 1.48(b).
7. Executive Orders: E.O. 11593 Protection and Enhancement of Cultural Resources; E.O. 13287 Preserve America.
23 U.S.C. 139(l)(1).
Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice of limitation on claims for judicial review of actions by FHWA and other federal agencies.
This notice announces actions taken by the FHWA and other Federal Agencies that are final within the meaning of 23 U.S.C. 139(I)(1). The actions relate to the Cross Harbor Freight Program (CHFP) Tier I Final Environmental Impact Statement (Tier I FEIS), and consist of the issuance by FHWA of a record of decision (ROD), dated December 9, 2015, with respect to the Tier I FEIS . The Federal actions, taken as a result of a tiered environmental review process under the National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4351) and implementing regulations on tiering (40 CFR 1502.20, 40 CFR 1508.28, and 23 CFR part 771), determined certain issues relating to the proposed projects. Those Tier 1 decisions will be used by Federal agencies in subsequent proceedings, including decisions whether to grant licenses, permits, and approvals for highway, rail, and transit projects. Tier 1 decisions may also be relied upon by State and local agencies in proceedings on the proposed projects.
By this notice, the FHWA is advising the public that it has made decisions that are subject to 23 U.S.C. 139(l)(1) and are final within the meaning of that law. A claim seeking judicial review of the Tier 1 Federal agency decisions on the proposed highway, rail, and transit projects will be barred unless the claim is filed on or before June 20, 2016.
For FHWA: Mr. Peter W. Osborn, Division Administrator, Federal Highway Administration, Leo W. O'Brien Federal Building, Albany, New York 12207; telephone (518) 431-4127;
Notice is hereby given that the FHWA has issued a Tier 1 FEIS and an ROD in connection with the proposed CHFP that aims to improve the movement of goods in the greater New York/New Jersey region by enhancing the transportation of freight across New York Harbor (Harbor). As part of the CHFP, FHWA and the Port Authority of New York and New Jersey (PANYNJ) are undertaking a tiered environmental impact statement process, pursuant to the NEPA, which studies the goods movement system serving the region today, and considers how that system could be improved through various alternatives for the transportation of freight across the Harbor.
Tier I broadly examined the potential transportation and environmental effects from a range of alternatives, with the goal of selecting those alternative(s) for further study and potential implementation.
FHWA and the PANYNJ issued a Tier I Draft Environmental Impact Statement (Tier I DEIS) in November 2014 for public review and comment. The Tier I DEIS analyzed 10 Build Alternatives and a No Action Alternative. The project team used a variety of forums to engage stakeholders and solicit public comment on the Tier I DEIS, including scoping meetings; public hearings; briefings for elected officials, community groups, business, environmental, and transportation advocates, and other stakeholders; workshops for Federal, State, and local government agencies having regulatory jurisdiction over, or expertise with respect to, the Alternatives under review; a project Web site; and informational materials made available in English, Chinese, Spanish, and Yiddish.
Based on the findings in the Tier I DEIS, and in consideration of the written and oral comments received from the public, FHWA and PANYNJ issued a Tier I FEIS in September 2015, which included a Response to Comments chapter, and identified two of the Build Alternatives (the Enhanced Carfloat Alternative and the Rail Tunnel Alternative) as Preferred Alternatives that are recommended for more detailed, site-specific review and analysis in a Tier II level of study.
As Federal lead agency, FHWA issued a ROD on December 9, 2015, adopting the recommendations made in the Tier I FEIS and closing out Tier I of the study. It is important to note that neither the Tier I FEIS, nor the ROD, constitute a decision to implement any of the Alternatives that have been advanced for further consideration.
The actions by FHWA and the laws under which such actions were taken, are described in the Tier I FEIS, the ROD issued on December 9, 2015, and in other documents in the FHWA administrative record. The Tier I FEIS, the ROD, and other documents in the FHWA administrative record file are available by contacting FHWA at the address provided above. The Tier I FEIS and the ROD can be viewed and downloaded from the project Web site at
This notice applies to all Federal agency Tier 1 decisions that are final within the meaning of 23 U.S.C. 139(l)(1) as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
1. General: National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4351); Federal-Aid Highway Act (23 U.S.C. 109 and 23 U.S.C. 128).
2. Air: Clean Air Act (42 U.S.C. 7401-7671(q)).
3. Land: Section 4(f) of the Department of Transportation Act of 1966 (49 U.S.C. 303 and 23 U.S.C. 138).
4. Wildlife: Endangered Species Act (16 U.S.C. 1532-1544 and Section 1536); Fish and Wildlife Coordination Act (16 U.S.C. 661-667(d)); and Migratory Bird Treaty Act (16 U.S.C. 703-712).
5. Wetlands and Water Resources: Safe Drinking Water Act (42 U.S.C. 300(f)-300(j)(6)); Wild and Scenic Rivers Act (16 U.S.C. 1271-1287); and Wetlands Mitigation (23 U.S.C. 103(b)(6)(M) and 133(b)(11)).
6. Historic and Cultural Resources: Section 106 of the National Historic Preservation Act of 1966, as amended (16 U.S.C. 470(f) et seq).
7. Social and Economic: Civil Rights Act of 1964 (42 U.S.C. 2000(d)-2001(d)(1)); and American Indian Religious Freedom Act (42 U.S.C. 1966).
8. Executive Orders: E.O. 11990 Protection of Wetlands; E.O. 11988 Floodplain Management; E.O. 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations; E.O. 11593 Protection and Enhancement of Cultural Resources; and E.O. 11514 Protection and Enhancement of Environmental Quality.
9. Hazardous Materials: Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) (42 U.S.C. 9601-9675); Superfund Amendments and
23 U.S.C. 139(I)(1).
Federal Transit Administration (FTA), DOT.
Notice of random drug and alcohol testing rates for 2016.
This notice announces the random testing rates for employers subject to the Federal Transit Administration's (FTA) drug and alcohol rules for 2016.
Iyon Rosario, Drug and Alcohol Program Manager for the Office of Safety and Oversight, 1200 New Jersey Avenue SE., Washington, DC 20590 (telephone: 202-366-2010 or email:
On January 1, 1995, FTA required large transit employers to begin drug and alcohol testing employees performing safety-sensitive functions and submit annual reports by March 15 of each year beginning in 1996. The annual report includes the number of employees who had a verified positive for the use of prohibited drugs, and the number of employees who tested positive for the misuse of alcohol during the reported year. Small employers commenced their FTA-required testing on January 1, 1996, and began reporting the same information as the large employers beginning March 15, 1997. The testing rules were updated on August 1, 2001, and established a random testing rate for prohibited drugs and the misuse of alcohol.
The rules require that employers conduct random drug tests at a rate equivalent to at least 50 percent of their total number of safety-sensitive employees for prohibited drug use and at least 25 percent for the misuse of alcohol. However, the rules provide that the drug random testing rate may be lowered to 25 percent if the positive rate for the entire transit industry is less than one percent for two preceding consecutive years. Once lowered, the random rates may be raised to 50 percent if the positive rate equals or exceeds one percent for any one year (positive rate means the number of positive results for random drug tests conducted under 49 CFR 655.45 plus the number of refusals of random tests required by 49 CFR 655.49, divided by the total number of random drug tests, plus the number of refusals of random tests required by 49 CFR part 655).
The alcohol provisions provide that the random rate may be lowered to 10 percent if the violation rate for the entire transit industry is less than 0.5 percent for two consecutive years. It will remain at 25 percent if the violation rate is equal to or greater than 0.5 percent but less than one percent, and it will be raised to 50 percent if the violation rate is one percent or greater for any one year (violation rate means the number of covered employees found during random tests administered under 49 CFR 655.45 to have an alcohol concentration of .04 or greater, plus the number of employees who refuse a random test required by 49 CFR 655.49, divided by the total reported number of random alcohol tests plus the total number of refusals of random tests required by 49 CFR part 655).
Pursuant to 49 CFR 655.45(b), the Administrator's decision to increase or decrease the minimum annual percentage rate for random drug and alcohol testing is based, in part, on the reported positive drug and alcohol violation rates for the entire industry. The information used for this determination is drawn from the drug and alcohol Management Information System (MIS) reports required by 49 CFR part 655. In determining the reliability of the data, the Administrator considers the quality and completeness of the reported data, or may obtain additional information or reports from employers, and make appropriate modifications in calculating the industry's verified positive results and violation rates.
The Administrator has determined the random drug testing rate will remain at 25 percent for 2016 due to an industry positive rate lower than 1.0 percent for random drug test data for the two preceding calendar years. The random drug rates for the two preceding years are .87 percent for 2014 and .90 percent for 2015.
The Administrator has also determined the random alcohol testing rate for 2016 will remain at 10 percent because the random alcohol violation rate for the industry was again lower than 0.5 percent for the two preceding consecutive years. The random alcohol rates for the two preceding years are 0.14 percent for 2014 and 0.14 percent for 2015.
Detailed reports on the FTA drug and alcohol testing data collected from transit employers may be obtained from the FTA, Office of Safety and Oversight, 1200 New Jersey Avenue SE., Washington, DC 20590, (202) 366-2010 or at
Issued in Washington, DC, pursuant to authority under 49 CFR 1.91.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Receipt of petition.
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that model year (MY) 2008-2010 Alfa Romeo 8C Spider passenger cars (PC) that were not originally manufactured to comply with all applicable Federal Motor Vehicle Safety Standards (FMVSS) are eligible for importation into the United States because they have safety features that comply with, or are capable of being altered to comply with, all such standards.
The closing date for comments on the petition is February 22, 2016.
Comments should refer to the docket and notice numbers above and be submitted by any of the following methods:
•
•
•
•
George Stevens, Office of Vehicle Safety Compliance, NHTSA (202-366-5308).
Under 49 U.S.C. 30141(a)(1)(B), a motor vehicle that was not originally manufactured to conform to all applicable FMVSS, and has no substantially similar U.S.-certified counterpart, shall be refused admission into the United States unless NHTSA has decided that the motor vehicle has safety features that comply with, or are capable of being altered to comply with, all applicable FMVSS based on destructive test data or such other evidence as NHTSA decides to be adequate.
Petitions for eligibility decisions may be submitted by either manufacturers or importers who have registered with NHTSA pursuant to 49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice in the
Wallace Environmental Testing Laboratories (WETL), Inc. of Houston, Texas (Registered Importer R-90-005) has petitioned NHTSA to decide whether nonconforming 2008-2010 Alfa Romeo 8C Spider PCs are eligible for importation into the United States.
In its petition, WETL notes that the original manufacturer, Alfa Romeo, certified the MY 2008 and 2009 8C Spider PCs to all applicable FMVSS and offered those vehicles for sale in the United States. WETL contends that the non-U.S certified MY 2010 Alfa Romeo 8C Spider PC shares the same platform with the U.S.-certified 2008 and 2009 model Alfa Romeo 8C Spider PC, and on that basis compares the non-U.S. certified model to those vehicles to establish its conformity with many applicable FMVSS. Because there is no U.S.-certified counterpart for the 2010 Alfa Romeo 8C Spider PC, the petitioner acknowledged that it could not base its petition solely on the substantial similarity of those vehicles to the U.S.-certified 2008 and 2009 Alfa Romeo 8C Spider PC in light of the petitioning requirements of 49 U.S.C. 30141(a)(1)(A), as set forth in 49 CFR part 593. Instead, the petitioner chose to establish import eligibility on the basis that the vehicles have safety features that comply with, or are capable of being modified to comply with, the FMVSS based on destructive test data or such other evidence that NHTSA decides to be adequate as set forth in 49 U.S.C. 30141(a)(1)(B). Nevertheless, the petitioner contends that the non-U.S. certified 2010 Alfa Romeo 8C Spider PCs use the same components as the U.S.-certified MY 2008 and 2009 Alfa Romeo 8C Spider PCs in virtually all of the systems subject to applicable FMVSS.
WETL submitted information with its petition intended to demonstrate that non-U.S. certified MY 2008 and 2009 Alfa Romeo 8C Spider PCs conform to many FMVSS and are capable of being altered to comply with all other standards to which they were not originally manufactured to conform.
Specifically, the petitioner claims that non-U.S. certified MY 2008, 2009 and 2010 Alfa Romeo 8C Spider PCs, as originally manufactured, conform to: Standard Nos. 102
The petitioner also contends that the subject non-U.S. certified vehicles are capable of being readily altered to meet the following standards, in the manner indicated:
Standard No. 101
Standard No. 108
Standard No. 110
Standard No. 111
Standard No. 114
Standard No. 118
Standard No. 138
Standard No. 208
The petitioner additionally states that a vehicle identification plate must be affixed to the vehicle near the left windshield pillar to meet the requirements of 49 CFR part 565.
All comments received before the close of business on the closing date indicated above will be considered, and will be available for examination in the docket at the above addresses both before and after that date. To the extent possible, comments filed after the closing date will also be considered. Notice of final action on the petition will be published in the
49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49 CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Receipt of petition.
Van Hool N.V. (Van Hool), has determined that certain model year (MY) 2015-2016 Van Hool Double Deck buses do not fully comply with paragraph S5.3.4 of Federal Motor Vehicle Safety Standard (FMVSS) No. 121,
The closing date for comments on the petition is February 22, 2016.
Interested persons are invited to submit written data, views, and arguments on this petition. Comments must refer to the docket and notice number cited in the title of this notice and submitted by any of the following methods:
•
•
•
Comments must be written in the English language, and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that comments you have submitted by mail were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to
The petition, supporting materials, and all comments received before the close of business on the closing date indicated above will be filed in the docket and will be considered. All comments and supporting materials received after the closing date will also be filed and will be considered to the extent possible.
When the petition is granted or denied, notice of the decision will also be published in the
All documents submitted to the docket may be viewed by anyone at the address and times given above. The documents may also be viewed on the Internet at
DOT's complete Privacy Act Statement is available for review in the
Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule at 49 CFR part 556), Van Hool submitted a petition for an exemption from the notification and remedy requirements of 49 U.S.C. Chapter 301 on the basis that this noncompliance is inconsequential to motor vehicle safety.
This notice of receipt of Van Hool's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any agency decision or other exercise of judgment concerning the merits of the petition.
Affected are approximately 48 MY 2015-2016 Van Hool Double Deck buses that were manufactured between December 13, 2014 and October 22, 2015.
Van Hool explains that the noncompliance is that brake release times slightly exceed the requirements as specified in paragraph S5.3.4 of FMVSS No. 121.
Paragraph S5.3.4 of FMVSS No. 121 requires in pertinent part:
S5.3.4
Van Hool described the subject noncompliance and stated its belief that the noncompliance is inconsequential to motor vehicle safety based on the following reasoning:
(1) Based on the results of testing that Van Hool conducted on some of the affected buses, it determined that the brake release times, on average,
(2) Van Hool determined that this noncompliance may be due to the change of fitting for this type of vehicle. These new fittings for the Double Deck buses were introduced in production in September 2014. The classic brass couplings were replaced with push-in tube connections made of composite material to remedy certain complaints of air loss. The effect of minimal loss of internal air flow was misjudged, which caused the brake release time to exceed the requirements.
However, Van Hool believes that there is no safety issue, nor unnecessary brake drag during acceleration after brake release due to the reaction time of the driver (moving foot from brake pedal to throttle pedal) and the reaction time of the complete driveline being longer than the brake release time.
(3) Van Hool stated its belief that because the brake actuation time on the subject buses fulfilled the requirements as specified in paragraph S5.3.3 of FMVSS No. 121, that the noncompliance has no effect on the brake performance. Van Hool found that its testing showed a margin on the required brake actuation time of 11% for the front axle, 20% for the drive axle and 17% for the tag axle. For this reason Van Hool is convinced that the noncompliance will not show significant differences in dynamic brake test and will have no influence on the motor vehicle safety. Thus, Van Hool did not repeat the dynamic brake test. Also, the dynamic brake test was not repeated on any of the subject vehicles because Van Hool's dynamic brake test showed a minimum 25% margin for the brake stopping distance requirement.
(4) Van Hool made reference to previous inconsequential noncompliance petitions that it believes are similar to its petition and that were granted by NHTSA.
Van Hool additionally informed NHTSA that the noncompliance has been corrected on vehicles in subsequent production and that all future vehicles will be in full compliance with FMVSS No. 121.
In summation, Van Hool believes that the described noncompliances are inconsequential to motor vehicle safety, and that its petition, to exempt Van Hool from providing recall notification of noncompliances as required by 49 U.S.C. 30118 and remedying the recall noncompliance as required by 49 U.S.C. 30120 should be granted.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, any decision on this petition only applies to the subject buses that Van Hool no longer controlled at the time it determined that the noncompliance existed. However, any decision on this petition does not relieve equipment distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant buses under their control after Van Hool notified them that the subject noncompliance existed.
49 U.S.C. 30118, 30120: Delegations of authority at 49 CFR 1.95 and 501.8.
Department of Veterans Affairs (VA).
Notice of Amendment to Systems of Records.
As required by the Privacy Act of 1974 (5 U.S.C. 552a(e)(4)), notice is hereby given that the Department of Veterans Affairs (VA) is amending the system of records entitled “Customer User Provisioning System (CUPS)-VA” (87VA005OP). VA is re-publishing the system notice in its entirety.
Comments on this new system of records must be received no later than February 22, 2016. If no public comment is received during the period allowed for comment or unless otherwise published in the
Written comments concerning the proposed amended system of records may be submitted by: mail or hand-delivery to Director, Regulations Management (02REG), Department of Veterans Affairs, 810 Vermont Avenue NW., Room 1068, Washington, DC 20420; fax to (202) 273-9026; or email to
Andrea Birkland, Chief, Systems Access Management, Enterprise Operations, Department of Veterans Affairs, 1615 Woodward Street, Austin, Texas 78772, telephone (512) 326-6394.
The Department is proposing to amend its system of records entitled “Customer User Provisioning System (CUPS)” by updating the system manager and address to Deputy Director, Security Systems, 1615 Woodward Street, Austin, Texas 78772. The telephone number is (512) 326-6021; updating the system location name from Corporate Data Center Operations (CDCO) to Enterprise Operations (EO); and changing the information contact to Andrea Birkland, Chief, Systems Access Management, Department of Veterans Affairs, 1615 Woodward Street, Austin, Texas 78772, telephone (512) 326-6394.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Nabors II, Chief of Staff, approved this document on January 11, 2016, for publication.
Customer User Provisioning System (CUPS)-VA.
The automated records are maintained by the Enterprise Operations (EO), 1615 Woodward Street, Austin, TX 78772. The paper records will be maintained at each VA field station that has a responsibility for CUPS input.
All Department of Veterans Affairs employees, employees of other
The records in this system, in both paper and electronic form, will include the names and network user-ID of all personnel who have requested and been granted access to the automated resources at EO. The records will also include business address and telephone number, job title, and information relating to data file and computer system access permissions granted to that individual.
Title 38, United States Code, Section 501.
The purpose of this system of records is to allow EO in Austin, Texas, to maintain a current list of all VA employees, employees of other government agencies, and authorized contractor personnel who require access to the computer resources of EO, in accordance with Federal computer security requirements.
1. At the initiative of VA, pertinent information may be disclosed to appropriate Federal, State or local agencies responsible for investigating, prosecuting, enforcing or implementing statutes, rules, regulations or orders, where VA becomes aware of an indication of a violation or potential violation of civil or criminal law or regulation.
2. Disclosure of specific information may be made to a Federal agency, in response to its request, to the extent that the information requested is relevant and necessary to the requesting agency's decision in connection with hiring or retaining an employee, issuing a security clearance, conducting a security or suitability investigation on an individual, classifying jobs, awarding a contract or issuing a license, grant or other benefit.
3. Disclosure of information may be made to officials of the Merit Systems Protection Board, including the Office of the Special Counsel, the Federal Labor Relations Authority and its General Counsel or the Equal Employment Opportunity Commission, when requested in performance of their authorized duties, and the request is not in connection with a law enforcement investigation.
4. The record of an individual who is covered by this system or records may be disclosed to a member of Congress, or staff person acting for the member when the member or staff person requests the record on behalf of and at the written request of that individual.
5. Disclosure may be made to the National Archives and Records Administration and General Services Administration for record management inspections conducted under Authority of Title 44 U.S.C.
6. VA may disclose information from this system of records to the Department of Justice (DoJ), either on VA's initiative or in response to DoJ's request for the information, after either VA or DoJ determines that such information is relevant to DoJ's representation of the United States or any of its components in legal proceedings before a court or adjudicative body, provided that, in each case, the agency also determines prior to disclosure that release of the records to the DoJ is a use of the information contained in the records that is compatible with the purpose for which VA collected the records. VA, on its own initiative, may disclose records in this system of records in legal proceedings before a court or administrative body after determining that the disclosure of records to the court or administrative body is a use of the information contained in the records that is compatible with the purpose for which VA collected the records.
7. Disclosure of relevant information may be made to individuals, organizations, private or public agencies, or other entities with whom VA has a contract or agreement or where there is a subcontract to perform such services as VA may deem practicable for the purposes of laws administered by VA, in order for the contractor or subcontractor to perform the services of the contract or agreement.
8. VA may disclose on its own initiative any information in this system, except the names and home addresses of veterans and their dependents, that is relevant to a suspected violation or reasonably imminent violation of law, whether civil, criminal or regulatory in nature and whether arising by general or program statute or by regulation, rule or order issued pursuant thereto, to a Federal, State, local, tribal, or foreign agency charged with the responsibility of investigating or prosecuting such violation, or charged with enforcing or implementing the statute, rule, regulation or order. VA may also disclose on its own initiative the names and addresses of veterans with the responsibility of investigating or prosecuting civil, criminal, or regulatory violations if law, or charged with enforcing or implementing the statute regulation, or order issued pursuant thereto.
9. Disclosure to other Federal agencies may be made to assist such agencies in preventing and detecting possible fraud or abuse by individuals in their operations and programs.
10. VA may, on its own initiative, disclose any information or records to appropriate agencies, entities, and persons when (1) VA suspects or has confirmed that the integrity or confidentiality of information in the system of records has been compromised; (2) VA has determined that as a result of the suspected or confirmed compromise, there is a risk of embarrassment or harm to the reputations of the record subjects, harm to the economic or property interests, identity theft or fraud, or harm to security, confidentially, or integrity of this system or other systems or programs (whether maintained by VA or another agency or entity) that rely upon the potentially compromised information; and (3) the disclosure is to agencies, entities, or persons whom VA determines are reasonably necessary to assist or carry out the VA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm. This routine use permits disclosures by VA to respond to a suspected or confirmed data breach, including the conduct of any risk analysis or provision of credit protection services as provided in 38 U.S.C. 5724, as the terms are defined in 38 U.S.C. 5727.
Each field station responsible for inputting records into the system will retain the original signed paper copies of requests for system access in locked containers. Data files supporting the automated system are stored in a secure area located at EO Data files are stored on magnetic disk and, for archival purposes, on magnetic tape.
Paper records are maintained in alphabetical order by last name of the requester. Automated records are retrieved by individual name or by a specific automated resource.
Paper records in progress are maintained in a manned room during working hours. Paper records
Specifically, in order to obtain access to the automated records contained in this system of records, an individual must:
1. Have access to the automated resources of EO An individual may not self-register for this access. Formal documentation of the request for access, signed by the employee's supervisor, is required before an individual may obtain such access. Authorized customers are issued a customer identification code and one-time password.
2. Be an authorized official of the CUPS system. Only two individuals per field station may be designated CUPS officials with access to add, modify or delete records from the system. These individuals require a specific functional task code in their customer profile; this functional task can only be assigned by EO. A limited number of supervisory or managerial employees throughout VA will have read-only access for the purpose of monitoring CUPS activities.
Records will be maintained and disposed of in accordance with the records disposal authority approved by the Archivist of the United States, the National Archives and Records Administration, and published in Agency Records Control Schedules.
Paper records will be destroyed by shredding or other appropriate means for destroying sensitive information. Automated storage records are retained and destroyed in accordance with a disposition authorization approved by the Archivist of the United States.
Officials responsible for policies and procedures; Deputy Director, Security Systems, 1615 Woodward Street, Austin, Texas 78772. The telephone number is (512) 326-6021.
Individuals who wish to determine whether this system of records contains information about them should contact the Deputy Director, Security Systems, 1615 Woodward Street, Austin, Texas 78772. The telephone number is (512) 326-6021.
An individual who seeks access or wishes to contest records maintained under his or her name or other personal identifier may write, call, or visit the system manager.
(See Record Access Procedures above.)
Individuals who have applied for and been granted access permission to the resources of EO.
Fish and Wildlife Service, Interior.
Final rule.
We, the U.S. Fish and Wildlife Service, designate critical habitat for
This rule becomes effective on February 22, 2016.
This final rule is available on the internet at
The coordinates, plot points, or both from which the maps are generated are included in the administrative record for this critical habitat designation and are available at
Roxanna Hinzman, Field Supervisor, U.S. Fish and Wildlife Service, South Florida Ecological Services Office, 1339 20th Street, Vero Beach, FL 32960; by telephone 772-562-3909; or by facsimile 772-562-4288. If you use a telecommunications device for the deaf (TDD), call the Federal Information Relay Service (FIRS) at 800-877-8339.
Previous Federal actions for
We requested written comments from the public on the proposed designation of critical habitat for
We received four comment letters directly addressing the proposed critical habitat designation. All substantive information provided during the comment period is addressed below.
In accordance with our peer review policy published on July 1, 1994 (59 FR 34270), we solicited expert opinions from three knowledgeable individuals with scientific expertise that included familiarity with the species, the geographic region in which the species occurs, and conservation biology principles. We received responses from two of the peer reviewers.
Both peer reviewers noted that the proposal was comprehensive and that the data which the Service relied upon to delineate critical habitat was sound. Peer reviewers did not provide any new information that would necessitate changes to the final rule. Peer reviewer comments are addressed in the following summary.
(1)
(2)
(3)
(4)
(5)
Section 4(b)(5)(A)(ii) of the Act requires the Secretary to give actual notice of any regulation proposed thereunder to the State agency in each State in which the species occur, and to invite comments. Comments received from the State regarding the proposal to designate critical habitat for
(6)
Public and peer review comments did not necessitate any changes to the final rule.
For more information on
Critical habitat is defined in section 3 of the Act as:
(1) The specific areas within the geographical area occupied by the species, at the time it is listed in accordance with the Act, on which are found those physical or biological features
(a) Essential to the conservation of the species, and
(b) Which may require special management considerations or protection; and
(2) Specific areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.
Conservation, as defined under section 3 of the Act, means to use and the use of all methods and procedures that are necessary to bring an endangered or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary. Such methods and procedures include, but are not limited to, all activities associated with scientific resources management such as research, census, law enforcement, habitat acquisition and maintenance, propagation, live trapping, and transplantation, and, in the extraordinary case where population pressures within a given ecosystem cannot be otherwise relieved, may include regulated taking.
Critical habitat receives protection under section 7 of the Act through the requirement that Federal agencies ensure, in consultation with the Service, that any action they authorize, fund, or carry out is not likely to result in the destruction or adverse modification of critical habitat. The designation of critical habitat does not affect land ownership or establish a refuge, wilderness, reserve, preserve, or other conservation area. Such designation does not allow the government or public to access private lands. Such designation does not require implementation of restoration, recovery, or enhancement measures by non-Federal landowners. Where a landowner requests Federal agency funding or authorization for an action that may affect a listed species or critical habitat, the consultation requirements of section 7(a)(2) of the Act would apply, but even in the event of a destruction or adverse modification finding, the obligation of the Federal action agency and the landowner is not to restore or recover the species, but to implement reasonable and prudent alternatives to avoid destruction or adverse modification of critical habitat.
Under the first prong of the Act's definition of critical habitat, areas within the geographical area occupied by the species at the time it was listed are included in a critical habitat designation if they contain physical or biological features (1) which are essential to the conservation of the species and (2) which may require special management considerations or protection. For these areas, critical habitat designations identify, to the extent known using the best scientific and commercial data available, those physical or biological features that are essential to the conservation of the species (such as space, food, cover, and protected habitat). In identifying those physical or biological features within an area, we focus on the principal biological or physical constituent elements (primary constituent elements such as roost sites, nesting grounds, seasonal wetlands, water quality, tide, soil type) that are essential to the conservation of the species. Primary constituent elements are those specific elements of the physical or biological features that provide for a species' life-history processes and are essential to the conservation of the species.
Under the second prong of the Act's definition of critical habitat, we may designate critical habitat in areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species. For example, an area currently occupied by the species but that was not occupied at the time of listing may be essential for the conservation of the species and may be included in the critical habitat designation. We designate critical habitat in areas outside the geographical area occupied by a species only when a designation limited to its range would be inadequate to ensure the conservation of the species.
Section 4 of the Act requires that we designate critical habitat on the basis of the best scientific and commercial data available. Further, our Policy on Information Standards Under the Endangered Species Act (published in the
When we are determining which areas should be designated as critical habitat, our primary source of information is generally the information developed during the listing process for the species. Additional information sources may include, but are not limited to, the recovery plan for the species, articles in peer-reviewed journals, conservation plans developed by States and counties, scientific status surveys and studies, biological assessments, other unpublished materials, or experts' opinions or personal knowledge.
Habitat is dynamic, and species may move from one area to another over time. We recognize that critical habitat designated at a particular point in time may not include all of the habitat areas that we may later determine are necessary for the recovery of the species. For these reasons, a critical habitat designation does not signal that habitat outside the designated area is unimportant or may not be needed for recovery of the species. Areas that are important to the conservation of the species, both inside and outside the critical habitat designation, will continue to be subject to: (1) Conservation actions implemented under section 7(a)(1) of the Act, (2) regulatory protections afforded by the requirement in section 7(a)(2) of the Act for Federal agencies to ensure their actions are not likely to jeopardize the continued existence of any endangered or threatened species, and (3) section 9 of the Act's prohibitions on taking any individual of the species, including taking caused by actions that affect
In accordance with sections 3(5)(A)(i) and 4(b)(1)(A) of the Act and regulations at 50 CFR 424.12(b), in determining which areas within the geographical area occupied by the species at the time of listing may be designated as critical habitat, we consider the physical or biological features that are essential to the conservation of the species and which may require special management considerations or protection. These include, but are not limited to:
(1) Space for individual and population growth and for normal behavior;
(2) Food, water, air, light, minerals, or other nutritional or physiological requirements;
(3) Cover or shelter;
(4) Sites for breeding, reproduction, or rearing (or development) of offspring; and
(5) Habitats that are protected from disturbance or are representative of the historical geographic and ecological distributions of a species.
We derive the specific physical or biological features essential to
The habitats identified above as physical or biological features also provide a plant community with associated plant species that foster a competitive regime suitable to
Under the Act and its implementing regulations, we are required to identify the physical or biological features essential to the conservation of
Based on our current knowledge of the physical or biological features and habitat characteristics required to sustain the species' life-history processes, we determine that the primary constituent elements specific to
(i) Areas of upland habitats consisting of coastal berm, rockland hammocks, and buttonwood forest.
(A) Coastal berm habitat that contains:
(1) Open to semi-open canopy, subcanopy, and understory; and
(2) Substrate of coarse, calcareous, and storm-deposited sediment.
(B) Rockland hammock habitat that contains:
(1) Canopy gaps and edges with an open to semi-open canopy, subcanopy, and understory; and
(2) Substrate with a thin layer of highly organic soil covering limestone or organic matter that accumulates on top of the limestone.
(C) Buttonwood forest habitat that contains:
(1) Open to semi-open canopy and understory; and
(2) Substrate with calcareous marl muds, calcareous sands, or limestone rock.
(ii) A plant community of predominately native vegetation with no invasive, nonnative animal or plant species or such species in quantities low enough to have minimal effect on survival of
(iii) A disturbance regime, due to the effects of strong winds or saltwater inundation from storm surge or infrequent tidal inundation, that creates canopy openings in coastal berm, rockland hammocks, and buttonwood forest.
(iv) Habitats that are connected and of sufficient size to sustain viable populations in coastal berm, rockland hammocks, and buttonwood forest.
(v) Habitats that provide populations of the generalist pollinators that visit the flowers of
When designating critical habitat, we assess whether the specific areas within the geographic area occupied by the species at the time of listing contain features which are essential to the conservation of the species and which may require special management considerations or protection.
Special management considerations or protection are necessary throughout the critical habitat units to avoid further degradation or destruction of the habitat that provides those features essential to the species' conservation. The primary threats to the physical or biological features that
(1) Habitat destruction and modification by development and sea level rise;
(2) Competition with nonnative, invasive plant and animal species;
(3) Wildfire; and
(4) Hurricanes and storm surge.
Some of these threats can be addressed by special management considerations or protection, while others (
The following measures or management activities can ameliorate threats to
(1) Protecting habitats from residential, commercial, or recreational facility development;
(2) Avoiding ditching or filling that may alter hydrological conditions;
(3) Nonnative plant and animal species control programs to reduce competition and predation and prevent habitat degradation; and
(4) Hardwood reduction to maintain the open vegetation structure of the species' habitats.
The reduction of these threats will require the implementation of special management actions within each of the critical habitat areas identified in this final rule. All critical habitat units will need management to address the ongoing threats listed above and those presented in the
The Service, National Park Service (NPS), State of Florida, Miami-Dade and Monroe Counties, and several local governments own and manage conservation lands within the range of
NPS regulations at 36 CFR 2.1 prohibit visitors from harming or removing plants, listed or otherwise, from Everglades National Park (ENP) or Biscayne National Park (BNP).
The Service, NPS, State of Florida, Miami-Dade and Monroe Counties, and several local governments conduct nonnative species control efforts on sites that support or have suitable habitat for
Reintroductions of
As required by section 4(b)(2) of the Act, we use the best scientific data available to designate critical habitat. In accordance with the Act and our implementing regulations at 50 CFR 424.12(b), we review available information pertaining to the habitat requirements of the species and identify occupied areas at the time of listing that contain the features essential to the conservation of the species. If, after identifying currently occupied areas, a determination is made that those areas are inadequate to ensure conservation of the species, in accordance with the Act and our implementing regulations at 50 CFR 424.12(e), we then consider whether designating additional areas—outside those currently occupied—are essential for the conservation of the species.
We are designating critical habitat units throughout the historical range of
The wild populations of
Small plant populations with limited, fragmented distributions, such as
Habitat fragmentation can have negative effects on populations, especially rare plants, and can affect survival and recovery (Aguilar
In selecting areas for critical habitat designation, we utilized the Shaffer and Stein (2000) methodology for conserving imperiled species known as the `three Rs': Representation, resiliency, and redundancy. Representation, or preserving some of everything, means conserving not just a species but its associated plant communities. Resiliency and redundancy ensure there is enough of a species so it can survive into the future. Resiliency means ensuring that the habitat is adequate for a species and its representative components. Redundancy ensures an adequate number of sites and individuals. This methodology has been widely accepted as a reasonable
We have addressed representation through the primary constituent elements (as discussed above) and by identifying areas of habitat for the expansion of
To determine the location and boundaries of critical habitat, the Service used the following sources of information and considerations:
(1) Florida Natural Areas Inventory (FNAI) population records and ArcGIS geographic information system software to spatially depict the location and extent of documented populations of
(2) Reports prepared by botanists with the Institute for Regional Conservation (IRC), NPS, and Florida Department of Environmental Protection (FDEP) (Some of these were funded by the Service; others were requested or volunteered by biologists with the NPS or FDEP.);
(3) Historical records found in reports and associated voucher specimens housed at herbaria, all of which are referenced in the above-mentioned reports from the IRC and FNAI;
(4) Digitally produced habitat maps provided by Monroe County; and
(5) Aerial images of Miami-Dade and Monroe Counties. The presence of primary constituent elements was determined through the use of GIS spatial data depicting the current habitat status. These habitat data for the Florida Keys were developed by Monroe County from 2006 aerial images, and ground conditions for many areas were checked in 2009. Habitat data for BNP were provided by the NPS. The areas that contain the primary constituent elements follow predictable landscape patterns and have a recognizable signature in the aerial imagery.
We have identified areas to include in this designation by applying the following considerations. The amount and distribution of critical habitat being designated allows existing and future established populations of
(1) Maintain their existing distribution;
(2) Expand their distribution into previously occupied areas (needed to offset habitat loss and fragmentation);
(3) Use habitat depending on habitat availability (response to changing nature of coastal habitat including sea level rise) and support genetic diversity;
(4) Increase the size of each population to a level where the threats of genetic, demographic, and normal environmental uncertainties are diminished; and
(5) Maintain their ability to withstand local or unit-level environmental fluctuations or catastrophes.
The critical habitat designation for
(1) The delineation included space to allow for the successional nature of the occupied habitats (
(2) Some areas will require special management to be able to support a higher density of the plant within the occupied space. These areas generally are habitats where some of the primary constituent elements have been lost through natural or human causes. These areas would help to offset the anticipated loss and degradation of habitat occurring or expected from the effects of climate change (such as sea level rise) or due to development.
When determining critical habitat boundaries within this final rule, we made every effort to avoid including developed areas such as lands covered by buildings, pavement, and other structures because such lands lack physical or biological features for
Units were designated based on sufficient elements of physical or biological features being present to support
The critical habitat designation is defined by the map or maps, as modified by any accompanying regulatory text, presented at the end of this document in the rule portion. We include more detailed information on the boundaries of the critical habitat designation in the preamble of this document. We will make the coordinates, plot points, or both on which each map is based available to the public on
We are designating four units as critical habitat for
(1) FSC1 Swan Key in Biscayne National Park, Miami-Dade County, Florida;
(2) FSC2 Key Largo, Monroe County, Florida;
(3) FSC3 Big Pine Key, Monroe County, Florida; and
(4) FSC4 Little Torch Key in Monroe County, Florida.
Two (FSC1 and FSC2) of the four critical habitat units designated for
We present brief descriptions of all units, and reasons why they meet the definition of critical habitat for
Unit FSC1 consists of approximately 37 ac (15 ha) in Miami-Dade County. This unit is composed entirely of lands in Federal ownership, 100 percent of which are located on Swan Key within Biscayne National Park. The unit includes all upland rockland hammock habitat on Swan Key, most of which is located on the eastern side of Swan Key, surrounded by the island's mangrove fringe. A second, smaller area is located on the island's elongate western half and is also surrounded by mangroves.
This unit was occupied at the time the species was listed and contains all the physical or biological features, including suitable climate, hydrology, substrate, associated native plant species, and disturbance regimes, essential to the conservation of the species and the coastal hardwood hammock and buttonwood forest primary constituent elements. The physical or biological features in this unit may require special management considerations or protection to address threats of nonnative plant and animal species and sea level rise. However, in most cases these threats are being addressed or coordinated with BNP to implement needed actions. BNP conducts nonnative species control on Swan Key and monitors
Unit FSC2 consists of approximately 3,434 ac (1,389 ha) in Monroe County. This unit is composed of Federal lands within Crocodile Lake National Wildlife Refuge (NWR) (702 ac (284 ha)); State lands within Dagny Johnson Botanical State Park, John Pennekamp Coral Reef State Park, and the Florida Keys Wildlife and Environmental Area (2,331 ac (943 ha)); lands owned by Monroe County (17 ac (7 ha)); and parcels in private or other ownership (384 ac (155 ha)). This unit extends from near the northern tip of Key Largo, along the length of Key Largo, beginning at the south shore of Ocean Reef Harbor near South Marina Drive and the intersection of County Road (CR) 905 and Clubhouse Road on the west side of CR 905, and between CR 905 and Old State Road 905, then extending to the shoreline south of South Harbor Drive. The unit then continues on both sides of CR 905 through the Crocodile Lake NWR, Dagny Johnson Key Largo Hammock Botanical State Park, and John Pennekamp Coral Reef State Park. The unit then terminates near the junction of U.S. 1 and CR 905 and Garden Cove Drive. The unit resumes on the east side of U.S. 1 from South Andros Road to Key Largo Elementary; then from the intersection of Taylor Drive and Pamela Street to Avenue A; then from Sound Drive to the intersection of Old Road and Valencia Road; then resumes on the east side of U.S. 1 from Hibiscus Lane and Ocean Drive. The unit continues south near the Port Largo Airport from Poisonwood Road to Bo Peep Boulevard. The unit resumes on the west side of U.S. 1 from the intersection of South Drive and Meridian Avenue to Casa Court Drive. The unit then continues on the west side of U.S. 1 from the point on the coast directly west of Peace Avenue south to Caribbean Avenue. The unit also includes a portion of El Radabob Key in Largo Sound located directly east of Avenue A, extending south to a point directly east of Mahogany Drive.
This unit was occupied at the time the species was listed and contains all the physical or biological features, including suitable climate, hydrology, substrate, associated native plant species, and disturbance regimes, essential to the conservation of the species and the rockland hammock and buttonwood forest primary constituent elements. The physical or biological features in this unit may require special management considerations or protection to address threats of nonnative plant species and sea level rise. The CCP for Crocodile Lake NWR promotes the enhancement of wildlife populations by maintaining and enhancing a diversity and abundance of habitats for native plants and animals, especially imperiled species that are found only in the Florida Keys, but does not identify
Unit FSC3 consists of approximately 772 ac (313 ha) in Monroe County. This unit is composed of Federal land within the National Key Deer Refuge (NKDR) (508 ac (205 ha)); State land managed as part of the NKDR (172 ac (70 ha)); lands owned by Monroe County (11 ac (5 ha)); and parcels in private or other ownership (81 ac (33 ha)). This unit extends from near the northern tip of Big Pine Key along the eastern shore to the vicinity of Hellenga Drive and Watson Road; from Gulf Boulevard south to West Shore Drive; Big Pine Avenue and Elma Avenues on the east, Coral and Yacht Club Road, and U.S. 1 on the north, and Industrial Avenue on the east from the southeastern tip of Big Pine Key to Avenue A.
This unit was occupied at the time the species was listed and contains all the physical or biological features, including suitable climate, hydrology, substrate, associated native plant species, and disturbance regimes, essential to the conservation of the species and the coastal berm, rockland hammock, and buttonwood forest primary constituent elements. The physical or biological features in this unit may require special management considerations or protection to address threats of nonnative plant species and sea level rise. The CCP for the Lower Florida Keys NWRs (NKDR, Key West NWR, and Great White Heron NWR) promotes the enhancement of wildlife populations by maintaining and enhancing a diversity and abundance of habitats for native plants and animals, and provides specifically for maintaining and expanding populations of candidate plant species including
Unit FSC4 consists of approximately 168 ac (68 ha) in Monroe County. This unit is composed of State lands (47 ac (19 ha)); lands owned by Monroe County (10 ac (4 ha)); and parcels in private and other ownership (111 ac (45 ha)). This unit extends along State Highway 4A, from Coral Shores Road, south to County Road, resuming at Linda Street and extending south to the Overseas Highway. South of the Overseas Highway, the unit includes areas west of Kings Cove Road, and an area comprising the southern tip of Little Torch Key that includes portions of The Nature Conservancy's (TNC) John J. Pescatello Torchwood Hammock Preserve.
This unit was occupied at the time the species was listed and contains all the physical or biological features, including suitable climate, hydrology, substrate, associated native plant species, and disturbance regimes, essential to the conservation of the species and the coastal hardwood hammock and buttonwood forest primary constituent elements. The physical or biological features in this unit may require special management considerations or protection to address threats of nonnative plant species and sea level rise. TNC's 1994 Management Plan calls for monitoring,
We have determined that the following physical or biological features are essential to the conservation of
The habitats identified above as physical or biological features also provide a plant community with associated plant species that foster a competitive regime that is suitable for
Based on our current knowledge of the physical or biological features and habitat characteristics required to sustain the species' life-history processes, we determine that the primary constituent elements specific to
(i) Areas of upland habitats consisting of coastal strand, coastal grassland, coastal berm, maritime hammocks, and shell mounds.
(A) Coastal strand habitat that contains:
(1) Open to semi-open canopy and understory; and
(2) Substrate of sand and shell fragments of stabilized coastal dunes.
(B) Coastal grassland habitat that contains:
(1) No canopy and an open understory; and
(2) Substrate of sand and shell fragments.
(C) Coastal berm habitat that contains:
(1) Open to semi-open canopy, subcanopy, and understory; and
(2) Substrate of coarse, calcareous, storm-deposited sediment.
(D) Maritime hammock habitat that contains:
(1) Canopy gaps and edges with an open to semi-open canopy, subcanopy, and understory; and
(2) Substrate of calcareous sand and shell fragments.
(E) Shell mound habitat that contains:
(1) Open to semi-open canopy and understory; and
(2) Substrate of soil derived from calcareous shells deposited by Native Americans during prehistoric times.
(ii) A plant community of predominately native vegetation with no invasive, nonnative animal or plant species or such species in quantities low enough to have minimal effect on survival of
(iii) Canopy openings in coastal strand, coastal grassland, coastal berm, maritime hammock, and shell mound habitats that are created by the effects of strong winds or saltwater inundation from storm surge or infrequent tidal inundation.
(iv) Habitats that are connected and of sufficient size to sustain viable populations in coastal strand, coastal grassland, coastal berm, maritime hammock, and shell mound habitats.
(v) Habitats that provide populations of the generalist pollinators that visit the flowers of
Management considerations or protection are necessary throughout the critical habitat units to avoid further degradation or destruction of the habitat that provides those features essential to the species' conservation. The primary threats to the physical or biological features that
(1) Habitat destruction and modification by development and sea level rise;
(2) Competition with nonnative, invasive plant species;
(3) Herbivorous nonnative animal species;
(4) Wildfire; and
(5) Hurricanes and storm surge.
Some of these threats can be addressed by special management considerations or protection while others (
Management activities that could ameliorate these threats include the monitoring and minimization of impacts from recreational activities, nonnative species control, and protection from development. Precautions are needed to avoid the inadvertent trampling of
The Service, State of Florida, and Manatee, Sarasota, Charlotte, and Lee Counties own and manage conservation lands within the historical range of
Nonnative species control is currently lacking at Manasota Beach Park and Kitchen Key in areas that support
We are designating critical habitat in areas within the geographical area occupied by
We have determined that all areas known to be occupied at the time of listing meet the definition of critical habitat and are needed for the conservation of the species. However, we determined that occupied habitat is not adequate for the conservation of
(1) FNAI population records and ArcGIS software to spatially depict the location and extent of documented populations of
(2) Reports prepared by botanists with the IRC and the Service (Some of these were funded by the Service; others were requested or volunteered by biologists with the Service.);
(3) Historical records found in reports and associated voucher specimens housed at herbaria, all of which are also referenced in the above-mentioned reports from the IRC and FNAI;
(4) Digitally produced habitat maps provided by FNAI; and
(5) Aerial images of Manatee, Charlotte, Sarasota, and Lee Counties. The presence of primary constituent elements was determined through the interpretation of aerial imagery. The areas that contain primary constituent elements follow predictable landscape patterns and have a recognizable signature in the aerial imagery.
Only approximately 300 to 500 individuals and 12 populations of
The current distribution of
The occupied critical habitat units were delineated around documented extant populations. These units include the mapped extent of the population that contains one or more of the physical or biological features. We considered the following when
(1) The delineation included space to allow for the successional nature of the occupied habitats (
(2) Some areas will require special management to be able to support a higher density of the plant within the occupied space. These areas generally are habitats where some of the primary constituent elements have been lost through natural or human causes. These areas would help to offset the anticipated loss and degradation of habitat occurring or expected from the effects of climate change (such as sea level rise) or due to development.
After completing the above analysis, we determined that occupied areas were not sufficient for the conservation of the species for the following reasons: (1) Restoring the species to its historical range and reducing its vulnerability to stochastic events such as hurricanes and storm surge requires reintroduction to areas where it occurred in the past but has since been extirpated; (2) providing increased connectivity for populations and areas for small populations to expand requires currently unoccupied habitat; and (3) reintroduction or assisted migration to reduce the species vulnerability to sea level rise and storm surge requires higher elevation sites that are currently unoccupied by
The unoccupied areas are essential for the conservation of the species because they:
(1) Represent the historical range of
(2) Provide areas of sufficient size to support ecosystem processes for populations of
The amount and distribution of designated critical habitat will allow
(1) Maintain its existing distribution;
(2) Expand its distribution into historically occupied areas (needed to offset habitat loss and fragmentation);
(3) Use habitat depending on habitat availability (response to changing nature of coastal habitat including sea level rise) and support genetic diversity;
(4) Increase the size of each population to a level where the threats of genetic, demographic, and normal environmental uncertainties are diminished; and
(5) Maintain its ability to withstand local or unit-level environmental fluctuations or catastrophes.
When determining critical habitat boundaries within this final rule, we made every effort to avoid including developed areas such as lands covered by buildings, pavement, and other structures because such lands lack physical or biological features for
The critical habitat designation is defined by the map or maps, as modified by any accompanying regulatory text, presented at the end of this document in the rule portion. We include more detailed information on the boundaries of the critical habitat designation in the preamble of this document. We will make the coordinates, plot points, or both on which each map is based available to the public on
We are designating 11 units as critical habitat for
(1) Unit APA1 Terra Ceia, Manatee County, Florida;
(2) Unit APA2 Longboat Key, Sarasota County, Florida;
(3) Unit APA3 Osprey, Sarasota County, Florida;
(4) Unit APA4 Manasota Key, Sarasota and Charlotte Counties, Florida;
(5) Unit APA5 Charlotte Harbor, Charlotte County, Florida;
(6) Unit APA6 Gasparilla Island North, Charlotte and Lee Counties, Florida;
(7) Unit APA7 Gasparilla Island South, Lee County, Florida;
(8) Unit APA8 Cayo Pelau, Charlotte and Lee Counties, Florida;
(9) Unit APA9 Cayo Costa, Lee County, Florida;
(10) Unit APA10 Bocilla Island, Lee County, Florida; and
(11) Unit APA11 Sanibel Island and Buck Key, Lee County, Florida.
We present brief descriptions of all units, and reasons why they meet the definition of critical habitat for
Unit APA1 consists of approximately 222 ac (90 ha) in Manatee County, Florida. This unit is composed of State lands within Madira Bickel Mound State Historical Park, Terra Ceia Preserve State Park, Cockroach Bay State Buffer Preserve, and the Tampa Bay Estuarine System (66 ac (27 ha)); Manatee County lands at Emerson Point Preserve and parcels owned by the Manatee County Port Authority (70 ac (28 ha)); and parcels in private or other ownership (87 ac (35 ha)). This unit includes lands west of Highway 41 extending from just south of South Dock Street south to Snead Island. The unit also includes areas of Harbor Key, Mariposa Key, Horseshoe Key, Joe Island, Skeet Key, Paradise Island, Ed's Key, and Rattlesnake Key.
This unit was not occupied at the time the species was listed but is essential for the conservation of the species because it serves to protect habitat needed to recover the species, reestablish wild populations within the historical range of the species, and maintain populations throughout the historic distribution of the species in Manatee County, and will provide population redundancy in the case of stochastic events that otherwise hold the potential to eliminate the species from the one or more locations where it is presently found.
The Management Plan for Madira Bickel Mound State Historical Park, Terra Ceia Preserve State Park, Cockroach Bay State Buffer Preserve, and the Tampa Bay Estuarine System calls for the protection and restoration of habitats, but does not identify actions specific to
Unit APA2 consists of approximately 54 ac (22 ha) in Sarasota County, Florida. This unit is composed entirely of parcels in private or other ownership. This unit includes lands west of Gulf of Mexico Drive, extending from 0.40 miles (mi) (0.6 kilometers (km)) south of the intersection of Bay Isles Parkway and Gulf of Mexico Drive, to the southern tip of Longboat Key. It also includes lands on the north side of Gulf of Mexico Drive, east of Longboat Club Key Drive, on the northwest tip of Longboat Key.
This unit was occupied at the time the species was listed and contains all the physical or biological features, including suitable climate, hydrology, substrate, associated native plant species, and disturbance regimes, essential to the conservation of the species, and the primary constituent elements of coastal strand, coastal berm, and maritime hammock. The physical or biological features in this unit may require special management considerations or protection to address threats of nonnative plant species and sea level rise. Augmentation of the
Unit APA3 consists of approximately 116 ac (47 ha) in Sarasota County, Florida. This unit is composed of Sarasota County lands within Palmer Point County Park (50 ac (20 ha)) and parcels in private or other ownership (66 ac (27 ha)). This unit extends along the barrier island (Casey Key) from the south terminus of Blind Pass Road, south for approximately 1.2 mi (1.9 km) along North Casey Key Road. On the mainland, the unit includes lands bordered on the north by Vamo Way, to the east by Highway 41, and to the south by Palmetto Avenue.
This unit was occupied at the time the species was listed and contains the biological or physical features including suitable climate, hydrology, substrate, associated native plant species, and disturbance regimes essential to the conservation of the species and contains coastal strand, coastal berm, maritime hammock, and shell mound primary constituent elements. The physical or biological features in this unit may require special management considerations or protection to address threats of nonnative plant species, and sea level rise. Augmentation of the
Unit APA4 consists of approximately 415 ac (168 ha) in Sarasota and Charlotte Counties, Florida. This unit is composed of State lands within Stump Pass Beach State Park (58 ac (23 ha));
This unit was occupied at the time the species was listed and contains the physical or biological features, including suitable climate, hydrology, substrate, associated native plant species, and disturbance regimes essential to the conservation of the species and contains coastal strand, coastal berm, and maritime hammock primary constituent elements. The physical or biological features in this unit may require special management considerations or protection to address threats of nonnative plant species and sea level rise. The Management Plan for Stump Pass Beach State Park calls for the protection and restoration of habitats, but does not identify actions specific to
Unit APA5 consists of approximately 51 ac (21 ha) in Charlotte County, Florida. This unit is composed entirely of State lands within the Charlotte Harbor Preserve State Park. This unit includes the Big Mound, Boggess Ridge, and a shell mound located on the east side of Charlotte Harbor, south of the City of Charlotte Park. This unit was occupied at the time the species was listed and contains all the physical or biological features essential to the conservation of the species and contains coastal berm and shell mound primary constituent elements.
The physical or biological features in this unit may require special management considerations or protection to address threats of nonnative plant species and sea level rise. The Management Plan for Charlotte Harbor Preserve State Park calls for the protection and restoration of habitats, and identifies actions specific to
Unit APA6 consists of approximately 98 ac (40 ha) in Charlotte and Lee Counties, Florida. This unit is composed of State land (0.006 ac (0.02 ha)), county land (22 ac (9 ha)), and parcels in private or other ownership (77 ac (31 ha)). This unit includes most of Kitchen Key (Live Oak Key) and the area east of Gasparilla Road, from the intersection of Grouper Hole Road and Grouper Hole Court, south to 0.15 mi (0.24 km) north of Snail Island Court, from approximately 0.10 mi (0.21 km) south of 35th Street to 23rd Street, including the small island separated from Gasparilla Island by a canal; and from 22nd Street to 20th Street.
This unit was occupied at the time the species was listed and contains the physical or biological features including suitable climate, hydrology, substrate, associated native plant species, and disturbance regimes essential to the conservation of the species and contains coastal berm and maritime hammock primary constituent elements. The physical or biological features in this unit may require special management considerations or protection to address threats of nonnative plant species and sea level rise. Augmentation of the
Unit APA7 consists of approximately 92 ac (37 ha) in Lee County, Florida. This unit is composed of Federal land owned by the Service and Bureau of Land Management (BLM) (3 ac (1 ha)), State lands within Gasparilla Island State Park (69 ac (28 ha)), Lee County lands (12 ac (5 ha)), and parcels in private or other ownership (8 ac (3 ha)). This unit includes lands located from south of 1st Street to the southern tip of Gasparilla Island.
This unit was occupied at the time the species was listed and contains the physical or biological features, including suitable climate, hydrology, substrate, associated native plant species, and disturbance regimes essential to the conservation of the species and contains coastal strand, coastal berm, and maritime hammock primary constituent elements. The physical or biological features in this unit may require special management considerations or protection to address threats of nonnative plant species and sea level rise. The Management Plan for Gasparilla Island State Park calls for the protection and restoration of habitats, but does not identify actions specific to
Unit APA8 consists of approximately 25 ac (10 ha) in Charlotte and Lee Counties, Florida. This unit is composed of Lee County lands within Cayo Pelau Preserve, and parcels in private or other ownership (0.6 ac (0.2 ha)). This unit includes lands located from 0.13 mi (0.21 km) south of the northern tip of Cayo Pelau, extending south to the southeastern tip of Cayo Pelau.
This unit was occupied at the time the species was listed and contains the physical or biological features including suitable climate, hydrology, substrate, associated native plant species, and disturbance regimes essential to the conservation of the species and contains coastal berm and shell mound primary constituent elements. The physical or biological features in this unit may require special management considerations or protection to address threats of nonnative plant species and sea level rise. Augmentation of the
Unit APA9 consists of approximately 1,702 ac (689 ha) in Lee County, Florida. This unit is composed of State lands within Cayo Costa State Park (1,379 ac (558 ha)), lands owned by Lee County (94 ac (38 ha)), and parcels in private or other ownership (230 ac (93 ha)). This unit includes lands located from the northern tip to the southern tip of Cayo Costa.
This unit was not occupied at the time the species was listed but is
Unit APA10 consists of approximately 33 ac (13 ha) in Lee County, Florida. This unit is composed of Lee County lands within the Bocilla Preserve (32 ac (13 ha)) and parcels in private or other ownership (0.7 ac (0.3 ha)). This unit includes lands located on the undeveloped portion of Bokeelia Island from 0.02 mi (0.03 km) west of the terminus of Ebbtide Way, extending south and west to the northwest and southeast corners of Bokeelia Island.
This unit was occupied at the time the species was listed and contains the physical or biological features, including suitable climate, hydrology, substrate, associated native plant species, and disturbance regimes essential to the conservation of the species and contains the coastal berm primary constituent element. The physical or biological features in this unit may require special management considerations or protection to address threats of nonnative plant species and sea level rise. The Management Plan for Bocilla Preserve calls for the protection and restoration of habitats and identifies actions specific to
Unit APA11 consists of approximately 635 ac (257 ha) in Lee County, Florida. This unit is composed of Federal lands owned by the Bureau of Land Management, and Service lands within the JDDNWR (373 ac (151 ha)), State lands (47 ac (13 ha)), lands owned by Lee County (90 ac (36 ha)), and parcels in private or other ownership (126 ac (51 ha)). This unit includes lands on Buck Key, Runyan Key, and Sanibel Island. On Sanibel Island, the unit includes a portion of Bowman's Beach, from just south of Silver Key to the western terminus of Water's Edge Lane; uplands within JDDNWR; and a shell mound located near the northern terminus of Tarpon Bay Road.
This unit was occupied at the time the species was listed and contains the physical or biological features, including suitable climate, hydrology, substrate, associated native plant species, and disturbance regimes essential to the conservation of the species and contains the maritime hammock primary constituent elements. The physical or biological features in this unit may require special management considerations or protection to address threats of nonnative plant species and sea level rise. The CCP for JDDNWR promotes the protection and restoration of habitats, and identifies actions specific to
Section 7(a)(2) of the Act requires Federal agencies, including the Service, to ensure that any action they fund, authorize, or carry out is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of designated critical habitat of such species. In addition, section 7(a)(4) of the Act requires Federal agencies to confer with the Service on any agency action that is likely to jeopardize the continued existence of any species proposed to be listed under the Act or result in the destruction or adverse modification of proposed critical habitat.
Decisions by the 5th and 9th Circuit Courts of Appeals have invalidated our regulatory definition of “destruction or adverse modification” (50 CFR 402.02) (see
If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency (action agency) must enter into consultation with us. Examples of actions that are subject to the section 7 consultation process are actions on State, tribal, local, or private lands that require a Federal permit (such as a permit from the U.S. Army Corps of Engineers under section 404 of the Clean Water Act (33 U.S.C. 1251
As a result of section 7 consultation, we document compliance with the requirements of section 7(a)(2) through our issuance of:
(1) A concurrence letter for Federal actions that may affect, but are not likely to adversely affect, listed species or critical habitat; or
(2) A biological opinion for Federal actions that may affect and are likely to adversely affect, listed species or critical habitat.
When we issue a biological opinion concluding that a project is likely to jeopardize the continued existence of a listed species and/or destroy or adversely modify critical habitat, we provide reasonable and prudent alternatives to the project, if any are identifiable, that would avoid the likelihood of jeopardy and/or destruction or adverse modification of critical habitat. We define “reasonable and prudent alternatives” (at 50 CFR 402.02) as alternative actions identified during consultation that:
(1) Can be implemented in a manner consistent with the intended purpose of the action,
(2) Can be implemented consistent with the scope of the Federal agency's legal authority and jurisdiction,
(3) Are economically and technologically feasible, and
(4) Would, in the Director's opinion, avoid the likelihood of jeopardizing the continued existence of the listed species and/or avoid the likelihood of destroying or adversely modifying critical habitat.
Reasonable and prudent alternatives can vary from slight project modifications to extensive redesign or
Regulations at 50 CFR 402.16 require Federal agencies to reinitiate consultation on previously reviewed actions in instances where we have listed a new species or subsequently designated critical habitat that may be affected and the Federal agency has retained discretionary involvement or control over the action (or the agency's discretionary involvement or control is authorized by law). Consequently, Federal agencies sometimes may need to request reinitiation of consultation with us on actions for which formal consultation has been completed, if those actions with discretionary involvement or control may affect subsequently listed species or designated critical habitat.
The key factor related to the adverse modification determination is whether, with implementation of the proposed Federal action, the affected critical habitat would continue to serve its intended conservation role for the species. Activities that may destroy or adversely modify critical habitat are those that alter the physical or biological features to an extent that appreciably reduces the conservation value of critical habitat for
Section 4(b)(8) of the Act requires us to briefly evaluate and describe, in any proposed or final regulation that designates critical habitat, activities involving a Federal action that may destroy or adversely modify such habitat, or that may be affected by such designation.
Activities that may affect critical habitat, when carried out, funded, or authorized by a Federal agency, should result in consultation for the
(1) Actions that would significantly alter the hydrology or substrate, such as ditching or filling. Such activities may include, but are not limited to, road construction or maintenance, and residential, commercial, or recreational development.
(2) Actions that would significantly alter vegetation structure or composition, such as clearing vegetation for construction of roads, residential and commercial development, and recreational facilities, and trails.
(3) Actions that would introduce nonnative species that would significantly alter vegetation structure or composition. Such activities may include, but are not limited to, residential and commercial development and road construction.
Section 4(a)(3)(B)(i) of the Act (16 U.S.C. 1533(a)(3)(B)(i)) provides that: “The Secretary shall not designate as critical habitat any lands or other geographic areas owned or controlled by the Department of Defense, or designated for its use, that are subject to an integrated natural resources management plan (INRMP) prepared under section 101 of the Sikes Act (16 U.S.C. 670a), if the Secretary determines in writing that such plan provides a benefit to the species for which critical habitat is proposed for designation.” There are no Department of Defense lands with a completed INRMP within the critical habitat for
Section 4(b)(2) of the Act states that the Secretary shall designate and make revisions to critical habitat on the basis of the best available scientific data after taking into consideration the economic impact, national security impact, and any other relevant impact of specifying any particular area as critical habitat. The Secretary may exclude an area from critical habitat if she determines that the benefits of such exclusion outweigh the benefits of specifying such area as part of the critical habitat, unless she determines, based on the best scientific data available, that the failure to designate such area as critical habitat will result in the extinction of the species. In making that determination, the statute on its face, as well as the legislative history, are clear that the Secretary has broad discretion regarding which factor(s) to use and how much weight to give to any factor.
Under section 4(b)(2) of the Act, we consider the economic impacts of specifying any particular area as critical habitat. In order to consider economic impacts, we prepared an incremental effects memorandum (IEM) and screening analysis which together with our narrative and interpretation of effects we consider our draft economic analysis (DEA) of the proposed critical habitat designation and related factors (Industrial Economics, Incorporated (IEc) 2014, entire). The analysis, dated October 15, 2014, was made available for public review from January 22, 2015, through March 23, 2015 (80 FR 3316). The DEA addressed probable economic impacts of critical habitat designation for
The following provides a summary of the DEA. For more information regarding the Service's economic analysis process, please see Consideration of Impacts Under Section 4(b)(2) of the Act in the proposed rule (80 FR 3316, 3331-3334).
In our evaluation of the probable incremental economic impacts that may result from the designation of critical habitat for
(1) Federal lands management (NPS, Service, BLM);
(2) Roadway and bridge construction;
(3) Dredging;
(4) Commercial or residential development;
(5) Recreation (including construction of recreation infrastructure).
We considered each industry or category individually. Additionally, we considered whether these activities have any Federal involvement. Critical habitat designation will not affect activities that do not have any Federal involvement; designation of critical habitat only affects activities conducted, funded, permitted, or authorized by Federal agencies. In areas where
In our IEM, we attempted to clarify the distinction between the effects that will result from the species being listed and those attributable to the critical habitat designation (
The critical habitat designation for
Based on the available information, we anticipate no more than three consultations per year within the critical habitat units. Communications with affected entities indicate that critical habitat designation is likely to result in no more than a few consultations, with minor conservation efforts that would likely result in relatively low probable economic impacts. Unit costs of such administrative efforts range from approximately $410 to $5,000 per consultation (2014 dollars, total cost for all parties participating in a single consultation) (IEc 2014, p. 10). Applying these unit cost estimates, this analysis conservatively estimates that the administrative cost of considering adverse modification in section 7 consultation will result in incremental costs of up to $7,100 (2014 dollars) in a given year for
The entities most likely to incur incremental costs are parties to section 7 consultations, including Federal action agencies and, in some cases, third parties, most frequently State agencies or municipalities. Activities we expect will be subject to consultations that may involve private entities as third parties are residential and commercial development that may occur on private lands. However, based on coordination efforts with State and local agencies, the cost to private entities within these sectors is expected to be relatively minor (administrative costs of $5,000 or less per consultation effort) and, therefore, would not be significant.
The probable incremental economic impacts of
The critical habitat designation for
Based on the available information, we anticipate no more than four consultations per year within the occupied critical habitat units. In the occupied areas, any actions that may affect the species or its habitat would also affect designated critical habitat and it is unlikely that any additional conservation efforts would be recommended to address the adverse modification standard over and above those recommended as necessary to avoid jeopardizing the continued existence of
In the unoccupied areas, any conservation efforts or associated probable impacts would be considered incremental effects attributed to the critical habitat designation. However, within the unoccupied critical habitat, few actions are expected to occur that will result in section 7 consultations or associated project modifications because no Federal lands are included in these units. Based on the results from past consultation history for these areas and communications with potentially affected entities, we anticipate that an additional six projects will result in section 7 consultation (two formal and
The entities most likely to incur incremental costs are parties to section 7 consultations, including Federal action agencies and, in some cases, third parties which will most frequently be State agencies or municipalities. Activities that we expect will be subject to consultations that may involve private entities as third parties are residential and commercial development that may occur on private lands. However, based on coordination efforts with State and local agencies, the cost to private entities within these sectors is expected to be relatively minor (administrative costs of less than $5,000 (occupied) or $15,000 (unoccupied) per consultation effort), and any costs from required conservation measures, therefore, would not be significant.
The probable incremental economic impacts of
For both species, the DEA also discusses the potential for incremental costs to occur outside of the section 7 consultation process, including costs associated with the potential triggering of additional requirements or project modifications under State laws or regulations, and perceptional effects on markets. It is unlikely that the designation of critical habitat will trigger additional State or local restrictions (IEc 2014, pp. 11-12). Public perception of critical habitat may result in landowners or buyers believing that the rule will restrict land or water use activities in some way and, therefore, valuing the resource less than they would have absent critical habitat. This is a perceptional, or stigma, effect of critical habitat on markets. Costs resulting from public perception of the impact of critical habitat, if they occur, are more likely to occur on private lands. However, based on the economic analysis, “possible costs resulting from public perception of the effect of critical habitat designation, when combined with section 7 costs, are unlikely to exceed the threshold for an economically significant rulemaking under [Executive Order] 12866” (IEc 2014, p. 13). Under Executive Order 12866, agencies must assess the potential costs and benefits of regulatory actions and quantify those costs and benefits if that action may have an effect on the economy of $100 million or more annually.
Our economic analysis did not identify any disproportionate costs that are likely to result from the designation. Consequently, the Secretary is not exercising her discretion to exclude any areas from this designation of critical habitat for
A copy of the IEM and screening analysis with supporting documents may be obtained by contacting the South Florida Ecological Services Office (see
Under section 4(b)(2) of the Act, we consider whether there are lands owned or managed by the Department of Defense where a national security impact might exist. In preparing this final rule, we have determined that no lands within the designation of critical habitat for
Under section 4(b)(2) of the Act, we also consider any other relevant impacts resulting from the designation of critical habitat. We consider a number of factors, including whether the landowners have developed any HCPs or other management plans for the area, or whether there are conservation partnerships that would be encouraged by designation of, or exclusion from, critical habitat. In addition, we look at any tribal issues, and consider the government-to-government relationship of the United States with tribal entities. We also consider any social impacts that might occur because of the designation.
We have determined that the Monroe County HCP for Big Pine and No Name Keys is the only HCP or other management plan that will be affected by either species' critical habitat designation. The Monroe County HCP for Big Pine and No Name Keys, which covers a portion of unit FSC3, does not include
Executive Order (E.O.) 12866 provides that the Office of Information and Regulatory Affairs (OIRA) will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.
E.O. 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for
Under the Regulatory Flexibility Act (RFA; 5 U.S.C. 601
According to the Small Business Administration, small entities include small organizations such as independent nonprofit organizations; small governmental jurisdictions, including school boards and city and town governments that serve fewer than 50,000 residents; and small businesses (13 CFR 121.201). Small businesses include manufacturing and mining concerns with fewer than 500 employees, wholesale trade entities with fewer than 100 employees, retail and service businesses with less than $5 million in annual sales, general and heavy construction businesses with less than $27.5 million in annual business, special trade contractors doing less than $11.5 million in annual business, and agricultural businesses with annual sales less than $750,000. To determine if potential economic impacts to these small entities are significant, we considered the types of activities that might trigger regulatory impacts under this designation as well as the types of project modifications that may result. In general, the term “significant economic impact” is meant to apply to a typical small business firm's business operations.
The Service's current understanding of the requirements under the RFA, as amended, and following recent court decisions, is that Federal agencies are required to evaluate the potential incremental impacts of rulemaking only on those entities directly regulated by the rulemaking itself and, therefore, not required to evaluate the potential impacts to indirectly regulated entities. The regulatory mechanism through which critical habitat protections are realized is section 7 of the Act, which requires Federal agencies, in consultation with the Service, to ensure that any action authorized, funded, or carried by the Agency is not likely to destroy or adversely modify critical habitat. Therefore, under section 7 only Federal action agencies are directly subject to the specific regulatory requirement (avoiding destruction and adverse modification) imposed by critical habitat designation. Consequently, it is our position that only Federal action agencies will be directly regulated by this designation. There is no requirement under the RFA to evaluate the potential impacts to entities not directly regulated. Therefore, because no small entities are directly regulated by this rulemaking, the Service certified, in the proposed rule, that, if promulgated, the final critical habitat designation would not have a significant economic impact on a substantial number of small entities.
During the development of this final rule we reviewed and evaluated all information submitted during the comment period that may pertain to our consideration of the probable incremental economic impacts of this critical habitat designation. Based on this information, we affirm our certification that this final critical habitat designation will not have a significant economic impact on a substantial number of small entities, and a regulatory flexibility analysis is not required.
Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use) requires agencies to prepare Statements of Energy Effects when undertaking certain actions. OMB has provided guidance for implementing this Executive Order that outlines nine outcomes that may constitute “a significant adverse effect” when compared to not taking the regulatory action under consideration. The economic analysis finds that none of these criteria are relevant to this analysis. Thus, based on information in the economic analysis, energy-related impacts associated with
In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501
(1) This rule will not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, or tribal governments, or the private sector, and includes both “Federal intergovernmental mandates” and “Federal private sector mandates.” These terms are defined in 2 U.S.C. 658(5)-(7). “Federal intergovernmental mandate” includes a regulation that “would impose an enforceable duty upon State, local, or tribal governments” with two exceptions. It excludes “a condition of Federal assistance.” It also excludes “a duty arising from participation in a voluntary Federal program,” unless the regulation “relates to a then-existing Federal program under which $500,000,000 or more is provided annually to State, local, and tribal governments under entitlement authority,” if the provision would “increase the stringency of conditions of assistance” or “place caps upon, or otherwise decrease, the Federal Government's responsibility to provide funding,” and the State, local, or tribal governments “lack authority” to adjust accordingly. At the time of enactment, these entitlement programs were: Medicaid; Aid to Families with Dependent Children work programs; Child Nutrition; Food Stamps; Social Services Block Grants; Vocational Rehabilitation State Grants; Foster Care, Adoption Assistance, and Independent Living; Family Support Welfare Services; and Child Support Enforcement. “Federal private sector mandate” includes a regulation that “would impose an enforceable duty upon the private sector, except (i) a condition of Federal assistance or (ii) a duty arising from participation in a voluntary Federal program.”
The designation of critical habitat does not impose a legally binding duty on non-Federal Government entities or private parties. Under the Act, the only regulatory effect is that Federal agencies must ensure that their actions do not destroy or adversely modify critical habitat under section 7. While non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for
(2) We do not believe that this rule would significantly or uniquely affect small governments. The government lands being designated as critical habitat are owned by the Town of Longboat Key, the State of Florida, and BLM, NPS, and the Service. None of these government entities fit the definition of “small governmental jurisdiction.” Consequently, we do not believe that the critical habitat designation would significantly or uniquely affect small government entities. As such, a Small Government Agency Plan is not required.
In accordance with Executive Order 12630 (“Government Actions and Interference with Constitutionally Protected Private Property Rights”), we have analyzed the potential takings implications of designating critical habitat for
In accordance with E.O. 13132 (Federalism), this rule does not have significant Federalism effects. A Federalism assessment is not required. In keeping with Department of the Interior and Department of Commerce policy, we request information from, and coordinated development of, this critical habitat designation with appropriate State resource agencies in Florida. We received comments from FDACS DPI and have addressed them in the Summary of Comments and Recommendations section of the rule. From a Federalism perspective, the designation of critical habitat directly affects only the responsibilities of Federal agencies. The Act imposes no other duties with respect to critical habitat, either for States and local governments, or for anyone else. As a result, the rule does not have substantial direct effects either on the States, or on the relationship between the national government and the States, or on the distribution of powers and responsibilities among the various levels of government. The designation may have some benefit to these governments because the areas that contain the features essential to the conservation of the species are more clearly defined, and the physical or biological features of the habitat necessary to the conservation of the species are specifically identified. This information does not alter where and what federally sponsored activities may occur. However, it may assist these local governments in long-range planning (because these local governments no longer have to wait for case-by-case section 7 consultations to occur).
Where State and local governments require approval or authorization from a Federal agency for actions that may affect critical habitat, consultation under section 7(a)(2) would be required. While non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for an action, may be indirectly impacted by the designation of critical habitat, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency.
In accordance with E.O. 12988 (Civil Justice Reform), the Office of the Solicitor has determined that the rule does not unduly burden the judicial system and that it meets the applicable standards set forth in sections 3(a) and 3(b)(2) of the Order. We are designating critical habitat in accordance with the provisions of the Act. To assist the public in understanding the habitat needs of the species, the rule identifies the elements of physical or biological features essential to the conservation of the species. The designated areas of critical habitat are presented on maps, and the rule provides several options for the interested public to obtain more detailed location information, if desired.
This rule does not contain any new collections of information that require approval by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
It is our position that, outside the jurisdiction of the U.S. Court of Appeals for the Tenth Circuit, we do not need to prepare environmental analyses pursuant to the National Environmental Policy Act in connection with designating critical habitat under the Act. We published a notice outlining our reasons for this determination in the
In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with tribes in developing programs for healthy ecosystems, to acknowledge that tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to tribes. As discussed above, we have
A complete list of references cited in this rulemaking is available on the Internet at
The primary authors of this package are the staff members of the South Florida Ecological Services Office.
Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.
Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:
16 U.S.C. 1361-1407; 1531-1544; 4201-4245, unless otherwise noted.
(h) * * *
(a)
(1) Critical habitat units are depicted for Miami-Dade and Monroe Counties, Florida, on the maps below.
(2) Within these areas, the primary constituent elements of the physical or biological features essential to the conservation of
(i) Areas of upland habitats consisting of coastal berm, rockland hammocks, and buttonwood forest.
(A) Coastal berm habitat that contains:
(B) Rockland hammock habitat that contains:
(C) Buttonwood forest habitat that contains:
(ii) A plant community of predominately native vegetation with no invasive, nonnative animal or plant species or such species in quantities low enough to have minimal effect on survival of
(iii) A disturbance regime, due to the effects of strong winds or saltwater inundation from storm surge or infrequent tidal inundation, that creates canopy openings in coastal berm, rockland hammocks, and buttonwood forest.
(iv) Habitats that are connected and of sufficient size to sustain viable populations in coastal berm, rockland hammocks, and buttonwood forest.
(v) Habitats that provide populations of the generalist pollinators that visit the flowers of
(3) Critical habitat does not include manmade structures (such as buildings, aqueducts, runways, roads, and other paved areas) and the land on which they are located that exists within the legal boundaries on February 22, 2016.
(4)
(5) Index map of all critical habitat units for
(6) Unit FSC1: Swan Key, Biscayne National Park, Miami-Dade County, Florida.
(i)
(ii) Map of Unit FSC1 follows:
(7) Unit FSC2: Key Largo, Monroe County, Florida.
(i)
(ii) Index map of Unit FSC2 follows:
(iii) Map A of Unit FSC2 follows:
(iv) Map B of Unit FSC2 follows:
(v) Map C of Unit FSC2 follows:
(vi) Map D of Unit FSC2 follows:
(vii) Map E of Unit FSC2 follows:
(viii) Map F of Unit FSC2 follows:
(8) Unit FSC3: Big Pine Key, Monroe County, Florida.
(i)
(ii) Index map of Unit FSC3 follows:
(iii) Map A of Unit FSC3 follows:
(iv) Map B of Unit FSC3 follows:
(v) Map C of Unit FSC3 follows:
(vi) Map D of Unit FSC3 follows:
(vii) Map E of Unit FSC3 follows:
(9) Unit FSC4: Little Torch Key, Monroe County, Florida.
(i)
(ii) Index map of Unit FSC4 follows:
(iii) Map A of Unit FSC4 follows:
(iv) Map B of Unit FSC4 follows:
(1) Critical habitat units for
(2) Within these areas, the primary constituent elements of the physical or biological features essential to the conservation of
(i) Areas of upland habitats consisting of coastal strand, coastal grassland, coastal berm, maritime hammocks, and shell mounds.
(A) Coastal strand habitat that contains:
(B) Coastal grassland habitat that contains:
(C) Coastal berm habitat that contains:
(D) Maritime hammock habitat that contains:
(E) Shell mound habitat that contains:
(ii) A plant community of predominately native vegetation with no invasive, nonnative animal or plant species or such species in quantities low enough to have minimal effect on survival of
(iii) Canopy openings in coastal strand, coastal grassland, coastal berm, maritime hammock, and shell mound habitats that are created by the effects of strong winds or saltwater inundation from storm surge or infrequent tidal inundation.
(iv) Habitats that are connected and of sufficient size to sustain viable populations in coastal strand, coastal grassland, coastal berm, maritime hammock, and shell mound habitats.
(v) Habitats that provide populations of the generalist pollinators that visit the flowers of
(3) Critical habitat does not include manmade structures (such as buildings, aqueducts, runways, roads, and other paved areas) and the land on which they are located that exists within the legal boundaries on February 22, 2016.
(4)
(5) Index map of all critical habitat units for
(6) Unit APA1: Terra Ceia, Manatee County, Florida.
(i)
(ii) Index map of Unit APA1 follows:
(iii) Map A of Unit APA1 follows:
(iv) Map B of Unit APA1 follows:
(7) Unit APA2: Longboat Key, Sarasota County, Florida.
(i)
(ii) Map of Unit APA2 follows:
(8) Unit APA3: Osprey, Sarasota County, Florida.
(i)
(ii) Map of Unit APA3 follows:
(9) Unit APA4: Manasota Key, Sarasota and Charlotte Counties, Florida.
(i)
(ii) Index map of Unit APA4 follows:
(iii) Map A of Unit APA4 follows:
(iv) Map B of Unit APA4 follows:
(v) Map C of Unit APA4 follows:
(10) Unit APA5: Charlotte Harbor, Charlotte County, Florida.
(i)
(ii) Map of Unit APA5 follows:
(11) Unit APA6: Gasparilla North, Charlotte and Lee Counties, Florida.
(i)
(ii) Map of Unit APA6 follows:
(12) Unit APA7: Gasparilla South, Lee County, Florida.
(i)
(ii) Map of Unit APA7 follows:
(13) Unit APA8: Cayo Pelau, Lee County, Florida.
(i)
(ii) Map of Unit APA8 follows:
(14) Unit APA9: Cayo Costa, Lee County, Florida.
(i)
(ii) Map of Unit APA9 follows:
(15) Unit APA10: Bocilla, Lee County, Florida.
(i)
(ii) Map of Unit APA10 follows:
(16) Unit APA11: Sanibel Island and Buck Key, Lee County, Florida.
(i)
(ii) Index map of Unit APA11 follows:
(iii) Map A of Unit APA11 follows:
(iv) Map B of Unit APA11 follows:
(v) Map C of Unit APA11 follows:
Office of the Under Secretary for Domestic Finance, Department of the Treasury.
Notice and Request for Information.
The Department of the Treasury (“Treasury”) is seeking public comment on structural changes in the U.S. Treasury market and their implications for market functioning; trading and risk management practices across the U.S. Treasury market; considerations with respect to more comprehensive official sector access to Treasury market data; and benefits and risks of increased public disclosure of Treasury market activity.
Comments must be received no later than March 22, 2016.
Comments may be submitted through the Federal eRulemaking Portal (
For general inquiries, submission process questions or any additional information, please email TreasuryMarket
The U.S. Treasury market is the deepest and most liquid market in the world.
The structure of the Treasury market has evolved significantly over the past two decades. In particular, technology advancements, and the associated growth in high-speed electronic trading has contributed to the growing presence of principal trading firms (PTFs),
Trading in the Treasury cash market occurs across a diverse set of venues and modes of execution. Historically, the Treasury cash market has been bifurcated between the interdealer market, in which dealers trade with one another, and the dealer-to-client market, in which dealers trade with their customers (
Trading in the inter-dealer cash market has evolved significantly. Originally, this market had been open almost exclusively to dealers, who transacted with each other by telephone. In the early 2000s this changed, with inter-dealer brokers launching electronic trading platforms and later opening access to those platforms to non-dealers. Trading on these platforms has become increasingly automated, with transactions conducted using algorithmic and other trading strategies involving little or no human intervention. Today, trading on the inter-dealer platforms bears some resemblance to other highly liquid markets, including equities and foreign exchange markets, where PTFs and dealers transact in automated fashion, sometimes in large volumes and at high speed.
In contrast, a significant portion of trading in the dealer-to-customer market occurs on platforms that facilitate the matching of buy and sell orders primarily through request for quote (RFQ) systems, not central limit order books. These platforms are increasingly electronic, but are generally not conducive to automated or high-frequency trading strategies. Dealers also internalize a portion of their customer flow.
Treasury futures are required by law to be traded on a registered exchange, and are traded primarily on the Chicago Board of Trade, part of the CME Group (CME). Futures transactions traded on the CME are centrally cleared at CME's clearinghouse. In the 1990s, futures trading began to transition from manual to electronic processes for the transmission of orders and information, and the execution of trades. Electronic trading eventually became the dominant mode of execution in the futures market. Now, more than 95 percent of all on-exchange futures trading occur on electronic trade-matching platforms, and market participants are increasingly employing automated systems for the generation, transmission, management, and execution of orders.
Non-bank proprietary trading firms have long played a significant role in the futures market. As the market has evolved to greater levels of electronic trading, they have increasingly employed automated trading strategies, and increasingly moved into the Treasury cash market. Today, PTFs represent a majority of trading in Treasury futures and inter-dealer cash markets.
On July 13, 2015, the staffs of the Treasury, the Board of Governors of the Federal Reserve System (“Board”), the Federal Reserve Bank of New York (“FRBNY”), the U.S. Securities and Exchange Commission (“SEC”), and the U.S. Commodity Futures Trading Commission (“CFTC”) (collectively, the “Joint Staffs”), published the Joint Staff Report: The U.S. Treasury Market on October 15, 2014 (“JSR”).
Treasury is seeking public comment on several specific questions that will inform the ongoing work related to the next steps identified in the JSR. This RFI is intended, in part, to seek information and viewpoints from a diverse group of stakeholders, including the general public, buy and sell-side market participants, academics, and industry groups regarding these and other structural changes in the Treasury market, and their implications for the depth, liquidity, and functioning of the market. This RFI is also intended to develop a holistic view of trading and risk management practices across U.S. Treasury futures and cash markets—including the various trading venues and modes of execution present in the cash market—and it seeks input on potential improvements in Treasury market policies, practices, and conduct.
Given the market evolution, access to timely and comprehensive data across related markets is increasingly important to fully assess new developments, and analyze market events. Accordingly, we are interested in the most efficient and effective ways for the official sector to obtain additional market data and in ways to more effectively monitor diverse but related markets. Finally, we are interested in the potential benefits and costs of additional transparency with respect to Treasury market trading activity and trading venue policies and practices.
Treasury developed this RFI in consultation with the Joint Staffs. The responses to this RFI will further enhance our understanding of the changes underway in the Treasury market and will help to inform the ongoing work related to the next steps identified in the JSR as well as any policy responses. This is intended to be a comprehensive list of questions. Depending on your role and/or interest in the Treasury market, you may choose to answer only certain questions.
Treasury is interested in the various factors driving the evolution of the Treasury market discussed above, and their implications for market functioning. These factors include changes in technology, the growing prevalence of automated trading, changes in market making, financial institutions' risk tolerance and business models, shifts in buy and sell-side participation, post-crisis regulatory reforms, as well as any other factors respondents to this RFI may identify. We are also interested in the changing nature of liquidity and liquidity provision in the U.S. Treasury market.
By some metrics, the liquidity and efficiency of trading in the U.S. Treasury market are as robust as they have ever been. For example, bid-ask spreads have remained steady at very low historical levels. But the changes in market structure also raise questions about evolving risks, such as whether an improvement in average liquidity conditions may come at the cost of rare but severe bouts of volatility that coincide with significant strains in liquidity. The changing nature of liquidity also suggests that measures used to estimate liquidity may need to be enhanced in order to broaden our understanding of the state of the market, both during normal and stressed market conditions.
Treasury requests comment on the questions below. These questions are intended to solicit views on the implications of changes to U.S. Treasury market structure, including changes to financing markets (
1.1 Have there been changes in the nature of liquidity provision, or demand for liquidity, in the U.S. Treasury market? If so, are these trends different in the futures, dealer-to-customer, or interdealer broker (“IDB”) market, or in the “on-the-run” and “off-the-run” sectors, or across different types of Treasury securities (
a. How do you define liquidity? How do you define liquidity provision?
b. Which measures are most indicative of the degree of liquidity? How might these measures be refined or expanded, if you were not limited by the availability of data?
c. How do different indicators provide information on different aspects of liquidity, and in what ways?
d. Which measures best represent the resilience of liquidity, or the relationships between liquidity and volatility?
e. To what extent are these measures of liquidity and the resilience of liquidity different from measures used in other markets that have witnessed similar market structure changes? What are the idiosyncratic factors unique to Treasury cash markets that may cause these measures to differ?
f. What changes, if any, have you observed in these measures over recent years? Over recent months?
g. What microstructure features of the U.S. Treasury futures and cash markets, including both IDB venues and dealer-to-client markets, have affected the functioning, liquidity, efficiency and participation in these markets? What features have affected the functioning of the Treasury market as a whole?
1.2 What changes, if any, have you made or observed in investment, hedging, and trading practices in response to shifts in Treasury market structure?
1.3 How does the way in which you transact in or provide liquidity to the U.S. Treasury market change during periods of stress?
1.4 Looking forward, do you anticipate significant changes in the structure of the U.S. Treasury market absent further regulatory changes? What would be the key benefits and/or risks of these changes in market structure? What key factors are likely to drive these changes? What changes are you planning to your firm's investment and trading policies, strategies, and practices?
1.5 What changes to the U.S. Treasury market structure, whether through public or private sector initiatives, might be advisable given the recent and expected future evolution? What role should the public sector play in driving or facilitating these changes?
1.6 What are the benefits and risks from the increased speed with which secondary market transactions take place? Do these benefits and risks differ across individual products (
1.7 To what extent have changes in Treasury financing markets affected liquidity in cash Treasury markets, and what is the best evidence of those effects? Looking forward, do you anticipate major changes in the Treasury financing markets and how would this impact the functioning of the cash Treasury markets? How have firms modified their trading strategies in response to, or in anticipation of, these changes? What changes in Treasury financing markets could improve market efficiency? What are the potential benefits and risks to the Treasury market of increased access to central clearing of Treasury repurchase agreement (“repo”) transactions?
1.8 What share of trading (in the case of dealers, your own trading) is internalized? To what extent does it vary depending on security type (
The introduction and rapid growth of electronic and automated trading protocols by many participants in the U.S. Treasury market over the past two decades have brought benefits as well as challenges to trading practices and risk and internal control systems. Risk controls at firms and trading venues must be able to monitor order and trade activity at the increased speeds made possible by this automation. In recent years, many trading platforms and firms have updated their risk management practices to better align them with a faster and more complex trading environment. The public and private sectors have collaborated to establish best practices for transacting in the modern Treasury market. In particular, the Treasury Market Practices Group (“TMPG”) recently updated its Best Practices for Treasury, Agency Debt, and Agency Mortgage Backed Securities Market by incorporating recommendations related to automated trading in TMPG covered markets.
The trend toward increasingly automated trading, including algorithmic trading strategies, is also being addressed by various regulatory efforts underway, particularly by the SEC and the CFTC. Among the next steps identified in the JSR is a review of the regulatory requirements applicable to the government securities market and its participants. The Government Securities Act (GSA) of 1986, as amended, provides for the registration of government securities brokers and dealers engaging in transactions in government securities and requires Treasury to adopt rules with respect to financial responsibility and related practices of government securities brokers and dealers.
In order to prevent fraudulent and manipulative acts and practices and to promote just and equitable principles of trade, the GSA also authorizes the appropriate regulatory agencies (the SEC and federal bank regulators) to issue regulations, in consultation with Treasury, with respect to transactions in government securities for the entities they regulate.
We request comment on the questions below. We are interested in what further steps the public and private sectors can take to address any outstanding risks, including operational risks to market functioning and risks to market integrity. We are also interested in the extent to which rules and practices applicable in other markets may be effective, in whole or in part, in improving the resilience of U.S. Treasury markets.
2.1 Are the risk management controls currently in place at U.S. Treasury cash and futures trading venues, as well as firms transacting in those venues, properly calibrated to support the health of the U.S. Treasury market? Why or why not? Please list the types of controls that are employed, as well as planned changes or improvements. In addressing these questions, please consider the dealer-to-customer market, trading on IDB platforms, and the futures market, as applicable. In addition, please consider the following questions:
a. What policies and risk management practices at U.S. Treasury cash and futures trading venues, as well as at firms transacting in those venues, could be improved or developed to mitigate potential risks associated with increased automation, speed, and order complexity? Please consider the risks posed by trading, risk transfer, and clearing and settlement.
b. To what extent should venue-level risk management practices be uniform across Treasury cash and futures trading venues? For example, should there be trading halts in the Treasury cash market and should they be coordinated between Treasury cash and futures markets, and if so, how? Should Treasury cash, futures, options, and/or swaps venues coordinate intraday risk monitoring, and if so, at what frequency? If there were trading halts, how should they be implemented for bilateral trading activity in the Treasury cash market? What would be the primary challenges in implementing such trading halts, particularly given that trading in the U.S. Treasury cash market is over-the-counter, global in nature, and conducted on a 24-hour basis?
c. To what extent should U.S. Treasury cash market platforms be responsible for monitoring, identifying, and/or reporting suspicious trading activity?
2.2 What internal risk controls are commonly employed by firms using automated, including algorithmic, trading strategies in the Treasury cash market? Are these different or similar to those used in the Treasury futures markets, and what are the reasons for any differences? How are such controls designed and triggered? How frequently are they triggered? What internal process controls commonly govern the implementation and modifications of trading algorithms?
2.3 What types of algorithmic trading strategies are commonly used by participants in the U.S. Treasury market? What features do those strategies have in common, and what features differ across strategies? What are the potential benefits and risks to an effective U.S. Treasury market functioning resulting from certain algorithmic trading strategies, certain order types, and/or particular trading venue policies or practices.
2.4 How are best practices used in evaluating, and updating, risk management systems at a given firm? How does your firm make use of TMPG's best practices (referenced above) for operations in the Treasury cash market? How can best practice recommendations be utilized in order to reinforce market integrity? What are the benefits and limitations of best practice recommendations?
2.5 What are the benefits and risks associated with the current structure for clearing and settling Treasury securities transactions in the dealer-to-customer market and on IDB platforms, as applicable. For example:
a. Are intraday margining practices in the Treasury cash market for both cleared and non-cleared transactions currently sufficient to protect against counterparty risk, especially in light of the speed at which positions can be accumulated? What options are available to improve margining practices? Should the maximum potential intraday exposure of firms be calibrated relative to their level of capital? If so, how should it be calibrated? Are alternative measures of potential exposure more meaningful for automated trading strategies, and if so, which type of measures?
b. Currently, there are no statutory requirements that require participants to centrally clear cash Treasury transactions. Should such a requirement apply to any participants, particularly those with large trading activity or large positions? Would the secondary market for cash Treasury securities benefit from broader participation in centralized clearing? Why or why not?
2.6 Many of the standards applicable to U.S. securities, commodities, and derivatives markets are not applicable to the U.S. Treasury cash market. Which differences, if any, should be addressed and how should standards be aligned? How will these affect the cost of accessing or participating in these markets, as well as of transacting in these markets? Would there be any implications to U.S. federal government borrowing costs? In addressing these questions, please consider the dealer-to-customer market, trading on IDB platforms, and the futures market, as applicable. In addition, please consider the following:
a. What implications would a registration requirement for firms conducting certain types of automated trading, or certain volume of trading, in the U.S. Treasury market have on market structure and efficiency, investor protection, and oversight?
b. Should firms that conduct certain types of automated trading, or certain volume of trading, in the U.S. Treasury market be subject to capital requirements, examinations and supervision, conduct rules, and/or other standards? What would be the implications of each?
2.7 Should self-trading be expressly prohibited in the cash Treasuries market?
The analysis presented in the JSR was based on cash and futures transactions and order book information, with the cash data provided by the IDB platforms and the futures data obtained through the CFTC as part of its oversight of the CME. Transaction data for the U.S. Treasury futures market is provided daily to the CFTC, and order book data is available to the CFTC upon request. This transaction data includes time, volume, price, and counterparty information. The official sector does not currently receive any regular reporting of Treasury cash market transactions. The JSR did not include any analysis of dealer-to-customer data, although certain dealer-to-customer data was subsequently obtained for the purpose of additional analysis of October 15, 2014 and the control days analyzed in the JSR.
The need for more comprehensive official sector access to data, particularly with respect to U.S. Treasury cash market activity, is clear. Given the benefits of enhanced transparency among all official sector stakeholders into trading activity across both the cash and futures markets, we are interested in views regarding the most efficient and effective way to collect, aggregate, and appropriately monitor U.S. Treasury cash and futures markets data. We are also interested in the additional infrastructure that would be necessary for market participants to begin reporting comprehensive U.S. Treasury market transaction data to the official sector, especially given the diversity of trading venues in the Treasury cash markets. Finally, we are interested in views on how to utilize transmission protocols, data standards, and identifiers to facilitate data integration, and to support continued coordination among the Joint Staffs.
Activity related to U.S. Treasury markets trading often extends beyond
The Inter-Agency Working Group for Treasury Market Surveillance (“IAWG”) was formed to improve monitoring and surveillance, and strengthen interagency coordination with respect to the U.S. Treasury markets following the Salomon Brothers auction bidding scandal in 1992, and today consists of the Joint Staffs.
We request comment on the questions below. The questions in this section of the RFI seek information about which U.S. Treasury market data the official sector should have regular and ongoing access to. We are also interested in views regarding the potential for additional coordination across futures and cash markets, as well as interest rate swaps and options. These questions relate to the provision of U.S. Treasury market data to the official sector. Accordingly, while there may be considerations regarding data dissemination to the public that may be relevant to the answers to the questions posed in this section, those considerations should not factor into the answer to these questions (unless otherwise noted), but should be addressed, to the extent applicable, in Section IV.
3.1 To what extent can trading practices in U.S. Treasury cash and futures markets be effectively monitored using only transaction and/or order data from one, not both, of those markets? Is it necessary for regulators to have visibility across all U.S. Treasury cash and derivative markets in order to more effectively monitor and oversee trading behavior in any one market? What aspects of U.S. Treasury market monitoring require data collection across cash and derivatives markets?
3.2 What frequency and type of additional data reporting to the official sector is necessary for it to effectively monitor functioning of the U.S. Treasury markets, including cash, futures, and financing markets? What level of data granularity is necessary for sufficient monitoring to be performed (
a. Should all transactions in securities issued by Treasury be subject to reporting or should reporting be limited to secondary market transactions, on-the-run benchmark issues, or some other subset of securities?
b. Should repurchase agreement transactions be reportable?
3.3 What criteria should be used to determine who should report to the official sector? Should both counterparties (buyer and seller) be required to report a trade or is one-sided reporting preferable? Should reporting requirements depend on the platform or execution method? Should only a subset of participants, such as brokers, dealers, futures commission merchants (FCMs) and commercial bank dealers be required to report transactions? Should other parties to a transaction, such as banks and PTFs, be required to report? Should trades executed on automated trading venues be reported by those venues and not the individual brokers, dealers, FCMs, bank dealers, etc. transacting on such venues?
3.4 Should transaction reporting include identifiers for categories of end investors? What are the costs and benefits of this approach? What alternatives should be considered to permit monitoring of positions and market activity?
3.5 For those instruments subject to official sector reporting requirements:
a. Should all transactions be subject to the same reporting time requirement? Are the answers different for different types of transactions or instruments?
b. Should cross market transactions have special indicators to link the different legs of the transactions?
c. Are there specific trades and/or trading strategies that should be considered for additional identification to ensure that regulatory organizations can accurately interpret the data (similar to Dollar Rolls or Stipulations on deliverable collateral in mortgage to-be-announced trading)?
d. Are there other industry practices and/or special situation information that should be considered for reporting?
e. Should trade allocations be reported? Are there any special pricing issues that should be considered (
f. Should settlement date and/or other settlement terms be reportable?
g. Are there any special considerations/conditions for determining the time that a trade is executed? Does this differ across trade types or venues?
h. Should transactions executed on an ATS and/or in response to an electronic RFQ be identified as such? Should the specific ATS and/or RFQ platform be identified as part of the transaction report? Are there unique characteristics of such transactions that should be identified? Should the order type giving rise to a particular execution be captured? Are there any other unique methods of transacting in the Treasury market that should be identified?
i. Should transaction counterparties be identified uniquely or categorized by counterparty type? If the latter, what counterparty types should be identified? Are there generally accepted definitions for these categories of counterparties?
j. For transactions that are already subject to reporting requirements to the official sector, are there particular data standards or identifiers that should be used for the reporting of transactions in
k. Should the identification of registered market participants be “normalized” across U.S. Treasury cash and futures transactions such that there is a consistent and unique moniker used to identify each individually registered entity?
3.6 For those securities subject to official sector reporting requirements:
a. Should quotes and/or orders be reported? If so, should special consideration be made for certain types of quotes and/or orders (
b. Should transactions, quotes, and/or orders be reported on a real time basis? If not, what should be the reporting standard? How should orders that are executed over multiple days be handled? Are there other special considerations when defining the time of an order?
c. Are there additional elements that are important for regulators to understand beyond the categories of quote/order originator, price, size and time of the order (
d. Should the submitter of a quote and/or order be identified uniquely or categorized by counterparty type? If the latter, what counterparty types should be identified? Are there generally accepted definitions for these categories of counterparties?
3.7 Is it appropriate to have transactions, orders, and quotes time stamped at a certain clock precision (
3.8 Do commercial bank dealers and broker-dealers have technology infrastructures and order/execution handling in place to report trades on a continuous basis?
3.9 As the official sector begins to collect additional data on the cash U.S. Treasury market, what operational or market factors should be assessed? Are there particular negative consequences from the implementation of data collection? If so, what are they and why do they arise?
a. The official sector may consider different methods for receiving transaction data from Treasury markets. For instance, it may rely on existing reporting regimes, or it may seek to build an alternative reporting system. If the latter, what alternative reporting system should be used? What are the costs and benefits with these different approaches? Would one approach impose fewer burdens on reporters than others? If so, why and by how much?
b. Would one approach impose fewer burdens on smaller reporters than another? If so, why and by how much?
c. Is the answer different for trades, orders, quotes, or execution methods?
3.10 What additional infrastructure would be necessary for market participants to begin reporting comprehensive U.S. Treasury market transaction data? Should reporting requirements be phased in? If yes, how and why? Does phasing affect the cost of implementation for market participants? What transmission protocols, data standards and identifiers should be utilized to minimize reporting burdens?
3.11 Will the requirement to report transactions in the Treasury markets affect competition in this market? Who would be affected and how? What data or empirical evidence support this position?
The extent of publicly available information for U.S. Treasury markets, including that related to market prices, trading volumes, market participant inventories, and trends in market risk and liquidity, is substantially more limited than for many other major asset classes. For example, there are no public reporting requirements for transaction or order book information with respect to transactions in Treasury securities. In addition to obtaining the appropriate data for the official sector, we are committed to continuing to appropriately enhance the information made public about the U.S. Treasury market.
Making appropriate data available to the public more broadly regarding trading activity in the U.S. Treasury market could support investor confidence and the liquidity of these markets. Greater price transparency could improve efficiency, reduce transaction costs, enhance fairness, improve risk management practices and encourage participation by new entrants, who may otherwise be reluctant to engage in a market where they have less information than their counterparties. Greater operational transparency also may be desirable with respect to the practices governing trading and access at the various trading venues. Visibility into order types, access rules, and rulebooks may encourage greater competition and a more level playing field for market participants.
However, the U.S. Treasury cash market is not uniform. More recently-issued on-the-run securities trade largely on electronic platforms that match orders using a central limit order book. Seasoned, or off-the-run, securities generally still rely on dealers to intermediate transactions. Some types of transparency may inhibit the willingness to engage in large so-called “block” trades by large investors and intermediaries. This reluctance may be particularly true in the less liquid parts of the U.S. Treasury market, where concerns about moving prices or revealing positions are stronger. In markets with more formal regulations pertaining to pre- and post-trade transparency, the rules provide flexibility for block-sized trades. For example, trades above a certain size could be executed away from platforms with pre-trade transparency, and such trades could be reported to the marketplace with some delay. Related rules also allow for masking of the size of large transactions to help mitigate the concern of higher market impact costs. The futures markets also require that net positions greater than specified thresholds (for all market participants and not just entities subject to registration requirements) be reported to the market regulator.
We request comment on the questions below. We are interested in the appropriate level and form of data about Treasury market activity that should be made available to the public. This includes use of transmission protocols, data standards and identifiers to facilitate the public's ability to link and integrate data.
4.1 Is the publicly available information for U.S. Treasury market
4.2 What additional information should be made available to the public in order to better assess liquidity conditions in the U.S. Treasury market, and at what frequency? For instance, should there be readily available transaction cost data that accounts for price movements that occur from the initiation of a trade request on RFQ platforms?
4.3 If additional public transparency is necessary at the transaction level, what is the most appropriate level of transparency for publicly available data on trading in the secondary market? Should additional public transparency be phased in over time in any way? Should all quotes and/or orders in the inter-dealer market be made public, or just “top of book”? What characteristics should be reported (
4.4 Is there an existing public reporting model that would be appropriate, in whole or in part, for the U.S. Treasury market (
4.5 What additional information should be available to the public about the operation of trading platforms or trade execution algorithms on trading platforms (for inter-dealer as well as dealer-to-customer platforms)? For example:
a. Should information about order types, agreed upon fee arrangements, user agreements, and/or brokerage agreements be disclosed?
b. Should the degree to which subscribers to the platform may limit their interaction with or exposure to other subscribers be disclosed?
c. Should the degree and extent to which the sponsor of a platform trades on the platform be disclosed?
| 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 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR