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Federal Register Highlights – 4/25/16

April 25, 2016

Unpublished, time-sensitive and proposed rules for April 25, 2016:

PROPOSED RULE: This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2017 as required by the statute. As required by section 1886(j)(5) of the Act, this rule includes the classification and weighting factors for the IRF prospective payment system’s (IRF PPS’s) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2017. We are also proposing to revise and update quality measures and reporting requirements under the IRF quality reporting program (QRP). DATES: To be assured consideration, comments must be received not later than 5 p.m. on June 20, 2016. (To submit comments, visit www.regulations.gov, reference file code CMS–1647–P.)

PROPOSED RULE: This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2017. In addition, it includes a proposal to specify a potentially preventable readmission measure for the Skilled Nursing Facility Value-Based Purchasing Program (SNF VBP), and other proposals for that program aimed at implementing value- based purchasing for SNFs. Additionally, this proposed rule proposes additional polices and measures in the Skilled Nursing Facility Quality Reporting Program (SNF QRP). This proposed rule also includes an update on the SNF Payment Models Research (PMR) project. To be assured consideration, comments must be received no later than 5 p.m. on June 20, 2016. (To submit comments, visit www.regulations.gov, reference file code CMS–1645–P.)

TEMPORARY RULE: The Coast Guard has issued a temporary deviation from the operating schedule that governs the US 165 (Jackson Street) Drawbridge across the Red River, mile 88.6, at Alexandria, Louisiana. The deviation is necessary to allow the bridge owner time to install new pinion bearings essential to the continued safe operation of the drawbridge. This deviation allows the bridge to remain in the closed-to-navigation position for approximately 6 days spanning a 2-week period. This deviation is effective from May 31, 2016 through June 9, 2016.

TEMPORARY RULE: The Coast Guard is establishing a temporary safety zone in the waters of the Newport Harbor Grand Canal on Balboa Island. This temporary safety zone is being established to provide for the safety of the waterway users during bridge construction over a 10-month period. Transiting through or within this temporary safety zone is prohibited unless specifically authorized by the Captain of the Port, Los Angeles-Long Beach, or her designated representative. This rule is effective without actual notice from April 25, 2016 through January 31, 2017.

TEMPORARY RULE: The Coast Guard is establishing a temporary safety zone for the navigable waters of the North Shore of Oahu approximately 2.5NM Northwest of Haleiwa small boat harbor. The safety zone will encompass all waters extending one nautical mile in all directions around the location of ongoing salvage operations, as described below. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards associated with ongoing operations to salvage the remains of two downed helicopters in this area. A temporary safety zone was previously enforced in the same area from March 4, 2016 through April 01, 2016 to protect personnel, vessels, and the marine environment from the potential hazards associated with these salvage operations. A new temporary safety zone in the area is necessary to complete recovery of the debris from the helicopters. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Honolulu or his designated representative. This rule is effective without actual notice from April 25, 2016 through 3:00 p.m. (HST) on April 29, 2016.

RULE: We are superseding Airworthiness Directive (AD) 2010–19– 51 for Bell Helicopter Textron Canada (Bell) Model 222, 222B, 222U, 230, and 430 helicopters. AD 2010–19–51 required inspecting parts of the main rotor hydraulic servo actuator (servo actuator) for certain conditions and replacing any unairworthy parts before further flight. This new AD requires installing a servo actuator with a new stainless steel piston rod. This AD was prompted by a collective servo actuator malfunction. We are issuing this AD to detect corrosion on a piston rod, which could result in failure of the servo actuator and consequent loss of helicopter control. This AD is effective May 31, 2016.

RULE: We are adopting a new airworthiness directive (AD) for Kaman Aerospace Corporation (Kaman) Model K–1200 helicopters. This AD requires revising the “Flight Limitations—NO LOAD” and “Flight Limitations—LOAD” sections of the rotorcraft flight manual (RFM). This AD was prompted by a report of certain flight maneuvers that may lead to main rotor (M/R) blade to opposing hub contact. These actions are intended to prevent damage to the M/R flight controls and subsequent loss of control of the helicopter. This AD is effective May 31, 2016.

PROPOSED RULE: The Food and Drug Administration (FDA or we) is proposing to ban electrical stimulation devices used to treat aggressive or self- injurious behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. FDA is proposing to include in this ban both new devices and devices already in distribution and use. Submit either electronic or written comments on the proposed rule by May 25, 2016. (To submit comments, visit www.regulations.gov, reference Docket No. FDA–2016–N–1111.)

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