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Federal Register Highlights – 3/1/16

March 1, 2016

Unpublished, time-sensitive and proposed rules for March 1, 2016:

PROPOSED RULE: This proposal invites comments on prescribing late payment and interest charges on past due assessments under the Christmas Tree Promotion, Research, and Information Order (Order). The Order is administered by the Christmas Tree Promotion Board (Board) with oversight by the U.S. Department of Agriculture (USDA). Under the Order, assessments are collected from domestic producers and importers and used for research and promotion projects designed to maintain and expand the market for fresh cut Christmas trees. This proposal would implement authority contained in the Order that allows the Board to collect late payment and interest charges on past due assessments. If this rule is finalized, it is proposed that late payment and interest charges would begin to accrue on unpaid assessments beginning 30 days after the effective date of the final rule. One additional change would provide authority in the Order for the Board to change the crop year and fiscal period through administrative action. This action would contribute to effective administration of the program. Comments must be received by March 16, 2016. (To submit comments, visit www.regulations.gov, reference Document Number AMS–SC–15–0072.)

PROPOSED RULE: This proposed rule would implement sections of the Affordable Care Act that require Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) providers and suppliers to disclose certain current and previous affiliations with other providers and suppliers. This proposed rule would also provide CMS with additional authority to deny or revoke a provider’s or supplier’s Medicare enrollment. In addition, this proposed rule would require that to order, certify, refer or prescribe any Part A or B service, item or drug, a physician or, when permitted, an eligible professional must be enrolled in Medicare in an approved status or have validly opted- out of the Medicare program. To be assured consideration, comments must be received no later than 5 p.m. on April 25, 2016. (To submit comments, visit www.regulations.gov, reference file code CMS–6058–P.)

TEMPORARY RULE: The Coast Guard is establishing a 250 yard temporary safety zone within Sector Boston’s Captain of the Port (COTP) Zone for a sunken vessel located in Boston Harbor’s North Channel. The safety zone will be in effect while the sunken vessel remains on the sea floor to facilitate safe navigation, survey operations, and salvage operations. This action is necessary to ensure that vessels that transit the area are not endangered by hazards associated with a sunken vessel. Entering into, transiting through, mooring or anchoring within this safety zone is prohibited unless authorized by the COTP or the designated on-scene representative. This rule is effective without actual notice from March 1, 2016 through March 31, 2016.

RULE: We are adopting a new airworthiness directive (AD) for certain Dassault Aviation Model FALCON 900EX and FALCON 2000EX airplanes. This AD was prompted by a report of significant fuel leakage at the middle position of the left outboard slat. This AD would require modifying the assembly of the slat extension mechanical stop. We are issuing this AD to prevent failure of the assembly of the slat extension mechanical stop, which if not corrected, could lead to a significant fuel leak and result in an uncontained fire. This AD becomes effective April 5, 2016.

RULE: We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 747–100, –200B, –200C, –200F, –300, –400, –400D, and –400F series airplanes. This AD was prompted by reports of significant fuselage skin damage at certain parts of the dorsal fairing, due to wear from the dorsal fairing. This AD requires repetitive detailed inspections for wear and cracks of the fuselage skin under the dorsal fairing, and related investigative and corrective actions if necessary. This AD also requires repetitive post-repair external surface high frequency eddy current inspections of the blended areas of the skin and detailed inspections of the unrepaired areas, and related investigative and corrective actions if necessary. We are issuing this AD to detect and correct fuselage skin damage of the dorsal fairing area, which could result in skin cracking and consequent depressurization of the airplane. This AD is effective April 5, 2016.

RULE: We are adopting a new airworthiness directive (AD) for all The Boeing Company Model 737–600, –700, –700C, –800, –900, and –900ER series airplanes, Model 757 airplanes, Model 767 airplanes, and Model 777 airplanes. This AD results from fuel system reviews conducted by the manufacturer. This AD requires an inspection to determine if certain motor-operated valve (MOV) actuators for the fuel valves are installed, and replacement of any affected actuators. Previous ADs addressed this Special Federal Aviation Regulation No. 88 (SFAR 88) issue for the majority of the airplanes delivered with these actuators. Since those ADs did not cover all of the airplanes, and for some airplanes delivered with improved actuators, there was no restriction on installation of replacement actuators with the unsafe condition, this additional rulemaking action is required. As with the related ADs, we are issuing this AD to prevent electrical energy from lightning, hot shorts, or fault current from entering the fuel tank through the fuel valve actuator shaft, which could result in fuel tank explosions and consequent loss of the airplane. This AD is effective April 5, 2016.

RULE: We are superseding Airworthiness Directive (AD) 2008–26– 07 for all The Boeing Company Model DC–8–11, DC–8–12, DC–8–21, DC–8–31, DC–8–32, DC–8–33, DC–8–41, DC–8–42, and DC–8–43 airplanes; Model DC–8–50 series airplanes; Model DC–8F–54 and DC–8F–55 airplanes; Model DC–8–60 series airplanes; Model DC–8–60F series airplanes; Model DC–8–70 series airplanes; and Model DC–8–70F series airplanes. AD 2008–26–07 required repetitive inspections of the lower skin and stringers at certain stations, and corrective actions if necessary. This new AD continues to require the actions specified in AD 2008–26–07 and also requires an eddy current high frequency (ETHF) inspection for cracks of the fastener open holes common to the lower skins, stringers, and splice fittings at a certain station; installation of external doublers and fasteners and repetitive eddy current low frequency (ETLF) inspections around the fasteners for any crack; and corrective actions if necessary. This AD was prompted by certain mandated programs intended to support the airplane reaching its limit of validity of the engineering data that support the established structural maintenance program. We are issuing this AD to detect and correct cracks in the lower skins, stringers, and fastener holes of the splice fittings, which could result in the loss of structural integrity of the airplane. This AD is effective April 5, 2016.

PROPOSED RULE: The Food and Drug Administration (FDA, Agency, or we) is proposing to classify the blood establishment computer software (BECS) and BECS accessories into class II (special controls). FDA is identifying proposed special controls for BECS and BECS accessories that are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also giving notice that the Agency does not intend to exempt BECS and BECS accessories from premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA is publishing in this document the recommendations of the Blood Product Advisory Committee regarding the classification of these devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying these device types. Submit either electronic or written comments by May 31, 2016. (To submit comments, visit www.regulations.gov, reference Docket No. FDA–2016–N–0406.)

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