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Federal Register Highlights – 6/30/16

June 30, 2016

Unpublished, time-sensitive, and proposed rules for June 30, 2016:

PROPOSED RULE: We are proposing to amend the phytosanitary treatment regulations to establish generic criteria that would allow for the approval of new cold treatment facilities in the Southern and Western States of the United States. These criteria, if met, would allow us to approve new cold treatment facilities without rulemaking and facilitate the importation of fruit requiring cold treatment while continuing to provide protection against the introduction of pests of concern into the United States. We are also proposing to amend the fruit cutting and inspection requirements in the cold treatment regulations in order to expand cutting and inspection to commodities that have been treated for a wider variety of pests of concern. This action would provide for a greater degree of phytosanitary protection. We are also proposing to add requirements concerning the establishment of compliance agreements for all entities that operate fumigation facilities. Finally, we are proposing to harmonize language concerning State compliance with facility establishment and parameters for the movement of consignments from the port of entry or points of origin in the United States to the treatment facility in the irradiation treatment regulations with proposed language in the cold treatment regulations. These actions would serve to codify and make enforceable existing procedures concerning compliance agreements for these facilities. We will consider all comments that we receive on or before August 29, 2016. (To submit comments, visit www.regulations.gov, reference Docket No. APHIS–2013–0081.)

PROPOSED RULE: This rule proposes to update and make revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2017 as well as proposing to implement policies for coverage and payment for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also proposes to set forth requirements for the ESRD Quality Incentive Program, and proposes to establish and revise requirements for quality reporting and measurement, including the inclusion of new quality measures for payment year (PY) 2020 and beyond and updates to programmatic policies for the PY 2018 and PY 2019 ESRD QIP. This rule also proposes to implement statutory requirements for bid surety bonds and state licensure for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). This rule also proposes to expand suppliers’ appeal rights in the event of a breach of contract action by CMS. In particular, this rule proposes a revision to current regulations to provide that the appeals process is applicable to all breach of contract actions taken by CMS, rather than just for the termination of a competitive bidding contract. It also proposes changes to the methodologies for adjusting fee schedule amounts for DMEPOS using information from Competitive Bidding Programs and for submitting bids and establishing single payment amounts under the Competitive Bidding Programs for certain groupings of similar items with different features. Changes are also proposed to the methodology for establishing bid limits for items under the DMEPOS Competitive Bidding Programs. In addition, this rule also solicits comments on the impacts of coordinating Medicare and Medicaid Durable Medical Equipment for dually eligible beneficiaries. Finally, this rule announces a request for information related to the Comprehensive ESRD Care Model and future payment models affecting renal care. To be assured consideration, comments must be received no later than 5 p.m. on August 23, 2016. (To submit comments, visit www.regulations.gov, reference file code CMS–1651–P.)

TEMPORARY RULE: The Coast Guard has issued a temporary deviation from the operating schedule that governs the Chambers Creek Burlington Northern Santa Fe railroad vertical lift railroad bridge across Chambers Creek, mile 0.01, near Steilacoom in Pierce County, WA. This deviation will test a change to the drawbridge operation schedule to determine whether a permanent change to the schedule is appropriate. This test deviation will modify the existing regulation to add an advance notification requirement for obtaining bridge openings during designated evening hours. This deviation is effective from 12:01 on July 1, 2016 to 12:01 on December 27, 2016.

TEMPORARY RULE: The Coast Guard is temporarily establishing a regulated navigation area on Biscayne Bay in Miami, Florida for the Fourth of July, 2016. This regulation is necessary to protect the public during upcoming Fourth of July events, a period during which a significant concentration of persons and vessels historically operate on the waters of Biscayne Bay. To ensure the public’s safety, all vessels within the regulated navigation area are required to transit the regulated navigation area at no more than 15 knots; are subject to control by the Coast Guard officers and petty officers; and are required to follow the instructions of all law enforcement vessels in the area. This rule is effective on July 4th, 2016, from 7 p.m. until 11:59 p.m.

TEMPORARY RULE: The Coast Guard is establishing temporary safety zones for multiple locations and dates within the Captain of the Port New Orleans zone. These safety zones are necessary to protect persons and vessels from potential safety hazards associated with fireworks displays on or over federal waterways. Entry into these zones is prohibited unless specifically authorized by the Captain of the Port New Orleans or a designated representative. This rule is effective without actual notice from June 30, 2016 through September 23, 2016.

TEMPORARY RULE: The Coast Guard is establishing a safety zone in Lake Superior near Bayfield, WI. This safety zone is intended to restrict vessels from specified waters in Lake Superior during the Bayfield Fourth of July Fireworks Display. This safety zone is necessary to protect spectators from the hazards associated with the fireworks display. This rule is effective from 9 p.m. through 11 p.m. July 4, 2016.

TEMPORARY RULE: The Coast Guard is establishing a temporary safety zone for all waters of the Ohio River, surface to bottom, extending 500 feet from the Kentucky shoreline, from mile 408 to 409. This action is necessary to provide for the safety of life on these navigable waters near Maysville, KY, during the City of Maysville Fireworks Display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port, Ohio Valley (COTP) or a designated representative. This rule is effective from 10:00 p.m. to 11:00 p.m. on July 4, 2016

TEMPORARY RULE: The Coast Guard is establishing a temporary safety zone for all waters of the Ohio River, surface to bottom, from mile 469.6 to 470.2. This action is necessary to provide for the safety of life on these navigable waters near Newport, KY, during the City of Newport Fireworks Display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port, Ohio Valley (COTP) or a designated representative. This rule is effective from 10:00 p.m. to 11:00 p.m. on July 3, 2016.

TEMPORARY RULE: The Coast Guard is establishing a temporary safety zone for all waters of the Ohio River from mile 307.8 to mile 308.8, Huntington, WV. This temporary safety zone is necessary to protect persons and property from potential damage and safety hazards during a fireworks display on or over the navigable waterway. During the period of enforcement, entry into this safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Ohio Valley or other designated representative. This rule is effective from 9:30 to 11:00 p.m. on July 1, 2016.

TEMPORARY RULE: The Coast Guard is establishing a temporary safety zone for all waters of the Ohio River from mile 317 to mile 318, Ashland, KY. This temporary safety zone is necessary to protect persons and property from potential damage and safety hazards during a fireworks display on or over a navigable waterway. During the period of enforcement entry into this safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Ohio Valley or a designated representative. This rule is effective from 9:35 to 10:45 p.m. on July 2, 2016.

TEMPORARY RULE: The Coast Guard is establishing a temporary safety zone for all waters of the Ohio River from mile 607.5 to mile 608.6. This temporary safety zone is necessary to protect persons and property from potential damage and safety hazards during a fireworks display on or over the navigable waterway. During the period of enforcement, entry into this safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Ohio Valley or a designated representative. This rule is effective from 10:30 p.m. until 11:00 p.m. on July 3, 2016.

TEMPORARY RULE: The Coast Guard is establishing a temporary safety zone on the navigable waters of the Pamlico Sound in Ocracoke, North Carolina within a 500 yard radius of the National Park Service (NPS) Boat Launch. This action is necessary to provide the safety of mariners on navigable waters to protect the life and property of the maritime public and spectators from the hazards posed by Hyde County 4th of July aerial fireworks display. Entry into or movement within the safety zone during the enforcement period is prohibited without approval of the Captain of the Port. This rule is effective on July 3, 2016, from 9 p.m. through 9:45 p.m.

PROPOSED RULE: DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to revise the estimated administrative cost to award and administer a contract, for the purpose of evaluating bids for multiple awards. Comments on the proposed rule should be submitted in writing on or before August 29, 2016, to be considered in the formation of a final rule. (To submit comments, visit www.regulations.gov, reference  DFARS Case 2016–D020.)

PROPOSED RULE: DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) regarding the use of customary contact financing, other than loan guarantees and advance payments, on certain fixed-price contracts. Comments on the proposed rule should be submitted in writing on or before August 29, 2016, to be considered in the formation of a final rule. (To submit comments, visit www.regulations.gov, reference DFARS Case 2015–D026.)

PROPOSED RULE: The Environmental Protection Agency (EPA) is proposing to revise provisions of the Arizona Regional Haze Federal Implementation Plan (FIP) applicable to the Phoenix Cement Company (PCC) Clarkdale Plant and the CalPortland Cement (CPC) Rillito Plant. In response to requests for reconsideration from the plants’ owners, we propose to replace the control technology optimization requirements for nitrogen oxides (NOX) applicable to Kiln 4 at the Clarkdale Plant and Kiln 4 at the Rillito Plant with a series of revised recordkeeping and reporting requirements. We are seeking comment on this proposed action. Written comments must be submitted on or before August 15, 2016. (To submit comments, visit www.regulations.gov, reference Docket No. EPA–R09–OAR–2015–0846.)

PROPOSED RULE: In this action, the Environmental Protection Agency (EPA) is proposing design details of the Clean Energy Incentive Program (CEIP). The CEIP is a program that states have the option to adopt if they wish to incentivize certain early emission reduction projects under the Carbon Pollution Emission Guidelines for Existing Stationary Sources: Electric Utility Generating Units (also known as the Clean Power Plan Emission Guidelines (EGs)). The framework for the CEIP was established in the Clean Power Plan EGs, where the EPA also noted that the design details of the program would be developed in a follow-on action. This proposal addresses those design details. In addition, we are re-proposing the CEIP- related aspects of the proposed rate- based and mass-based model trading rules—referred to in this action as optional example regulatory text. This proposal is consistent with the Supreme Court’s orders staying the Clean Power Plan during judicial review. The timing elements of the CEIP may be adjusted, if necessary, upon resolution of the petitions for review of the Clean Power Plan. Comments must be received on or before August 29, 2016. (To submit comments, visit www.regulations.gov, reference Docket No. EPA–HQ–OAR–2016–0033.)

PROPOSED RULE: The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC consumer antiseptic products intended for use without water (referred to throughout as consumer antiseptic rubs or consumer rubs) are generally recognized as safe and generally recognized as effective (GRAS/ GRAE). In the 1994 TFM, certain antiseptic active ingredients were proposed as being GRAS for antiseptic rub use by consumers based on safety data evaluated by FDA as part of its ongoing review of OTC antiseptic drug products. However, in light of more recent scientific developments and changes in the use patterns of these products, we are now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for this use. We also are proposing that all consumer antiseptic rub active ingredients have in vitro data characterizing the ingredient’s antimicrobial properties and in vivo clinical simulation studies showing that specified log reductions in the amount of certain bacteria are achieved using the ingredient. Submit electronic or written comments by December 27, 2016. (To submit comments, visit www.regulations.gov, reference Docket No. FDA–2016–N–0124.)

PROPOSED RULE: NMFS proposes regulations to implement Regulatory Amendment 1 for the Fishery Management Plan (FMP) for the Dolphin and Wahoo Fishery off the Atlantic States (Regulatory Amendment 1) as prepared and submitted by the South Atlantic Fishery Management Council (Council). If implemented, this proposed rule would establish a commercial trip limit for Atlantic dolphin for vessels with a Federal commercial permit for Atlantic dolphin and wahoo. The purpose of this proposed rule is to reduce the chance of an in-season closure of the dolphin commercial sector as a result of the annual catch limit (ACL) being reached during the fishing year and to reduce the severity of social impacts caused by these closures. Written comments must be received on or before August 1, 2016. (To submit comments, visit www.regulations.gov, reference Docket No. NOAA–NMFS–2016–0033.)

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