2016 – Federal Register Recent Federal Regulation Documents

The Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) by adding eighty-one entities under eighty-six entries to the Entity List. The eighty-one entities who are added to the Entity List have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. BIS is taking this action to ensure the efficacy of existing sanctions on the Russian Federation (Russia) for violating international law and fueling the conflict in eastern Ukraine. These entities will be listed on the Entity List under the destinations of the Crimea region of Ukraine, Hong Kong, India, and Russia.

The Coast Guard is changing the comment period on the advance notice of proposed rulemaking (ANPRM) it published June 9, 2016, regarding anchorage grounds on the Hudson River from Yonkers, NY, to Kingston, NY. Comments will now be due on or before December 6, 2016 instead of September 7, 2016. As of August 29, 2016, the Coast Guard has received more than 2,100 public submissions from many interested persons commenting on the ANPRM. We are extending the comment period to continue encouraging this important public discussion.

This document seeks comment on the proposed amendment of Title X regulations specifying the requirements Title X projects must meet to be eligible for awards. The amendment precludes project recipients from using criteria in their selection of subrecipients that are unrelated to the ability to deliver services to program beneficiaries in an effective manner.

The Surface Transportation Board (Board) is seeking comments and suggestions through this Advance Notice of Proposed Rulemaking (ANPR) regarding the Board's effort to develop a new rate reasonableness methodology for use in very small disputes, which would be available to shippers of all commodities.

The Federal Trade Commission (``FTC'' or ``Commission'') requests public comment on its Standards for Safeguarding Customer Information (``Safeguards Rule'' or ``Rule''). The Commission is soliciting comment as part of the FTC's systematic review of all current Commission regulations and guides.

NHTSA and FMCSA are proposing regulations that would require vehicles with a gross vehicle weight rating of more than 11,793.4 kilograms (26,000 pounds) to be equipped with a speed limiting device initially set to a speed no greater than a speed to be specified in a final rule and would require motor carriers operating such vehicles in interstate commerce to maintain functional speed limiting devices set to a speed no greater than a speed to be specified in the final rule for the service life of the vehicle. Specifically, NHTSA is proposing to establish a new Federal motor vehicle safety standard (FMVSS) requiring that each new multipurpose passenger vehicle, truck, bus and school bus with a gross vehicle weight rating (GVWR) of more than 11,793.4 kilograms (26,000 pounds) be equipped with a speed limiting device. The proposed FMVSS would also require each vehicle, as manufactured and sold, to have its device set to a speed not greater than a specified speed and to be equipped with means of reading the vehicle's current speed setting and the two previous speed settings (including the time and date the settings were changed) through its On-Board Diagnostic connection. FMCSA is proposing a complementary Federal motor carrier safety regulation (FMCSR) requiring each commercial motor vehicle (CMV) with a GVWR of more than 11,793.4 kilograms (26,000 pounds) to be equipped with a speed limiting device meeting the requirements of the proposed FMVSS applicable to the vehicle at the time of manufacture, including the requirement that the device be set to a speed not greater than a specified speed. Motor carriers operating such vehicles in interstate commerce would be required to maintain the speed limiting devices for the service life of the vehicle. Based on the agencies' review of the available data, limiting the speed of these heavy vehicles would reduce the severity of crashes involving these vehicles and reduce the resulting fatalities and injuries. We expect that, as a result of this joint rulemaking, virtually all of these vehicles would be limited to that speed.

We are revising Airworthiness Directive (AD) 2016-17-04, which applies to all hot air balloons equipped with BAL[Oacute]NY KUB[Iacute][Ccaron]EK spol. s r.o. Model Kub[iacute][ccaron]ek burners. Both the original and revised AD result from mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. This AD action revises AD 2016-17-04 to eliminate certain unnecessary documentation requirements.

With the issuance of this final rule, the Drug Enforcement Administration places quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC), quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3- carboxylate (5-fluoro-PB-22; 5F-PB-22), N-(1-amino-3-methyl-1-oxobutan- 2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) and N- (1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3 - carboxamide (ADB-PINACA), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle PB-22, 5F-PB-22, AB- FUBINACA, or ADB-PINACA.

The Food and Drug Administration (FDA, we, or the Agency) is issuing this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to throughout this document as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC consumer antiseptic wash products that have come to the Agency's attention. This final rule amends the 1994 tentative final monograph (TFM) for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA.

NMFS is opening directed fishing for Pacific cod by catcher/ processors using trawl gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to fully use the 2016 total allowable catch apportioned to catcher/processors using trawl gear in the Central Regulatory Area of the GOA.

The U.S. Office of Government Ethics is issuing this interim final rule to make a technical modification to the definition of ``employee'' in its regulations implementing the federal criminal conflict of interest statute concerning acts affecting a personal financial interest, in order to ensure their continued applicability to all individuals subject to requirements of the statute.

The Coast Guard is establishing a temporary moving safety zone during the Swim Around Charleston, a swimming race occurring on the Wando River, the Cooper River, Charleston Harbor, and the Ashley River, in Charleston, South Carolina on September 25, 2016. The temporary safety zone is necessary for the safety of the swimmers, participant vessels, spectators, and the general public during the event. The temporary safety zone will restrict vessel traffic in portions of the Charleston Harbor and surrounding rivers. Persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the safety zone unless authorized by the Captain of the Port Charleston or a designated representative.

The Postal Service proposes a further revision to the rules concerning PC postage payment methodology. This change would add supplementary information to clarify the revenue assurance guidelines.

On August 5, 2016, the Commodity Futures Trading Commission (Commission or CFTC) published in the Federal Register a notice of proposed rulemaking (Proposal) to amend certain of its regulations applicable to the Annual Report that each person registered or required to be registered as a commodity pool operator (CPO) must distribute for each commodity pool that it operates. As is explained below, the Commission is extending for two weeks the comment period for the Proposal.

The Consumer Product Safety Commission (CPSC) has approved a Proposed Statement of Policy regarding the Commission's interpretation of the phrase ``intended to produce audible effects'' that appears in the Commission's fireworks regulations.

This proposed rule sets forth payment parameters and provisions related to the risk adjustment program; cost-sharing parameters and cost-sharing reductions; and user fees for Federally- facilitated Exchanges and State-based Exchanges on the Federal platform. It also provides additional guidance relating to standardized options; qualified health plans; consumer assistance tools; network adequacy; the Small Business Health Options Program; stand-alone dental plans; fair health insurance premiums; guaranteed renewability; the medical loss ratio program; eligibility and enrollment; appeals; and other related topics.

The Department of Health and Human Services (HHS) is issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within HHS. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. In addition, this interim final rule includes updates to certain agency-specific regulations to identify their updated information, and note the location of HHS-wide regulations.

This regulation establishes an exemption from the requirement of a tolerance for residues of butanedioic acid, 2-methylene-, polymer with 1,3-butadiene, ethenylbenzene and 2-hydroxyethyl 2-propenoate; when used as an inert ingredient (emulsifier or binder) in a pesticide chemical formulation. Keller and Heckman on behalf of Trinseo LLC submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of butanedioic acid, 2-methylene-, polymer with 1,3- butadiene, ethenylbenzene and 2-hydroxyethyl 2-propenoate on food or feed commodities.

NMFS announces its approval of the State of North Carolina transferring a portion of its 2016 commercial bluefish quota to the State of New York. This approval of the quota complies with the Atlantic Bluefish Fishery Management Plan quota transfer provision. This announcement also informs the public of the revised commercial quotas for North Carolina and New York.

NMFS announces that the Mid-Atlantic Fishery Management Council has submitted Amendment 16 to the Atlantic Mackerel, Squid, and Butterfish Fishery Management Plan, incorporating the Environmental Assessment and the Initial Regulatory Flexibility Analysis, for review by the Secretary of Commerce, and is requesting comments from the public. Amendment 16 would establish a deep-sea coral protection area in Mid-Atlantic waters where fishing vessels would be prohibited from using most fishing gear that contacts the ocean bottom. The Council developed Amendment 16 to protect deep- sea corals under the Magnuson-Stevens Fishery Conservation and Management Act's discretionary provision for deep-sea coral protection. The coral protection measures would prevent expansion of fisheries using ocean bottom-tending fishing gear in areas where there is a high likelihood of deep-sea coral presence and would prevent damage to deep- sea corals in areas where they been observed.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the US40-322 (Albany Avenue) Bridge across the NJICW (Inside Thorofare), mile 70.0, at Atlantic City, NJ. The deviation is necessary to facilitate the Atlantic City IRONMAN Triathlon. This deviation allows the bridge to remain in the closed-to- navigation position.

We, NMFS, are adjusting the 2016 fishing year sub-annual catch limits for commercial groundfish vessels, including sector allocations based on the final Northeast multispecies sector rosters submitted as of May 1, 2016. The revisions to 2016 catch limits are necessary to account for changes in the number of participants electing to fish in either sectors or the common pool fishery. These adjustments are routine and formulaic, and are required to match allocations to sector enrollment.

This final rule modifies the TRICARE regulation to reduce administrative barriers to access to mental health benefit coverage and to improve access to substance use disorder (SUD) treatment for TRICARE beneficiaries, consistent with earlier Department of Defense and Institute of Medicine recommendations, current standards of practice in mental health and addiction medicine, and governing laws. This rule seeks to eliminate unnecessary quantitative and non-quantitative treatment limitations on SUD and mental health benefit coverage and align beneficiary cost-sharing for mental health and SUD benefits with those applicable to medical/surgical benefits, expand covered mental health and SUD treatment under TRICARE to include coverage of intensive outpatient programs and treatment of opioid use disorder and to streamline the requirements for mental health and SUD institutional providers to become TRICARE authorized providers, and to develop TRICARE reimbursement methodologies for newly recognized mental health and SUD intensive outpatient programs and opioid treatment programs.

This document contains final regulations that reflect the holdings of Obergefell v. Hodges, 576 U.S. , 135 S. Ct. 2584 (2015), Windsor v. United States, 570 U.S. , 133 S. Ct. 2675 (2013), and Revenue Ruling 2013-17 (2013-38 IRB 201), and that define terms in the Internal Revenue Code describing the marital status of taxpayers for federal tax purposes.

This final rule provides various changes and updates to the Department of State passport rules as a result of the passage of two laws: International Megan's Law to Prevent Child Exploitation and Other Sexual Crimes Through Advanced Notification of Traveling Sex Offenders (IML); and the Fixing America's Surface Transportation Act (FAST Act). The final rule incorporates statutory passport denial and revocation requirements for certain covered sex offenders under the IML, those persons with a seriously delinquent tax debt as defined by the FAST Act, and/or those persons who submit a passport application without a correct and valid Social Security number.