May 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is republishing in its entirety a final order entitled ``Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton'' that published in the Federal Register on February 24, 2015. FDA is republishing to correct an inadvertent omission of information. FDA is classifying the powered lower extremity exoskeleton into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the powered lower extremity exoskeleton's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

We propose to adopt a new airworthiness directive (AD) for all Dassault Aviation Model FAN JET FALCON, FAN JET FALCON SERIES C, D, E, F, and G airplanes; Model MYSTERE-FALCON 200 airplanes; and Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes. This proposed AD was prompted by reports of defective fire extinguisher tubes. It was determined the defects were caused by corrosion. This proposed AD would require repetitive general visual inspections of the fire extinguisher tubes for cracking and corrosion, and replacement of any cracked tube with a serviceable tube, if necessary. We are proposing this AD to detect and correct cracking and corrosion in the fire extinguisher tubes, which could impact the capability to extinguish an engine fire, and possibly result in damage to the airplane and injury to the passengers.

National Geospatial-Intelligence Agency (NGA) is updating the NGA Privacy Act Program by adding the (k)(2) and (k)(5) exemptions to accurately describe the basis for exempting the records in the system of records notice NGA-010, National Geospatial-Intelligence Agency Security Financial Disclosure Reporting Records System. In this rulemaking, the NGA proposes to exempt portions of this system of records from one or more provisions of the Privacy Act because of criminal, civil and administrative enforcement requirements.

FMCSA proposes to permit drivers with stable, well-controlled insulin-treated diabetes mellitus (ITDM) to be qualified to operate commercial motor vehicles (CMVs) in interstate commerce. Currently, drivers with ITDM are prohibited from driving CMVs in interstate commerce unless they obtain an exemption from FMCSA. This NPRM would enable individuals with ITDM to obtain a Medical Examiner's Certificate (MEC), from a medical examiner (ME) at least annually in order to operate in interstate commerce if the treating clinician (TC) who is the healthcare professional responsible for prescribing insulin for the driver's diabetes, provides documentation to the ME that the condition is stable and well-controlled.

The U.S. Small Business Administration (SBA) proposes to amend its regulations to implement section 825 of the National Defense Authorization Act for Fiscal Year 2015 (2015 NDAA). Section 825 of the 2015 NDAA included language granting contracting officers the authority to award sole source contracts to Women- Owned Small Businesses (WOSBs) and Economically Disadvantaged Women- Owned Small Businesses (EDWOSBs). Section 825 of the 2015 NDAA also changed the deadline for SBA to conduct a study to determine the industries in which WOSBs are underrepresented to January 2, 2016. As a result, SBA is proposing to amend its definitions of underrepresentation and substantial underrepresentation.

The Environmental Protection Agency (EPA) is extending the comment period for a proposed rule to establish a Clean Air Act (CAA) Federal Implementation Plan (FIP) to address regional haze and visibility transport requirements for the State of Arkansas. EPA is extending the public comment period until July 15, 2015. The extension also is to allow comments on EPA supplemental modeling for the Entergy Independence plant.

The Coast Guard is removing the existing drawbridge operation regulation for the Wisconsin Central Railroad Bridge, mile 0.91, across Manitowoc River, at Manitowoc, Manitowoc County, Wisconsin. The drawbridge was removed in its entirety in 2012 and the operating regulation is no longer applicable or necessary.

This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https:// www.fema.gov/fema/csb.shtm.

The Coast Guard proposes temporary safety zones in the Port of Dutch Harbor, Broad Bay, and adjacent navigable waters in the Dutch Harbor area on June 15, 2015. The temporary safety zones would encompass the navigable waters within a 25-yard radius of moored or anchored offshore exploration or support vessels, and the navigable waters within a 100-yard radius of underway offshore exploration or support vessels. The purpose of the safety zones is to protect persons and vessels during an unusually high volume of vessel traffic in the Port of Dutch Harbor, and the adjacent territorial sea due to additional vessel traffic associated with exploratory drilling operations in the Chukchi and Beaufort seas during the summer of 2015. Lawful demonstrations are permitted outside of the temporary safety zones so long as they do not endanger the safety of vessels either moored or anchored within the port, transiting through the port, or transiting through the adjacent waters of the territorial sea.

We are proposing to amend the fruits and vegetable regulations to allow citrus fruit from the entire country of Peru into the continental United States. Currently, the regulations allow the importation of citrus fruit to the United States from five approved citrus-producing zones in Peru, subject to a systems approach. However, based on the findings of a pest list and commodity import evaluation document, we have determined that this systems approach also mitigates the plant pest risk associated with citrus fruit produced in all other areas of Peru. This action would allow the importation of citrus fruit from the entire country of Peru while continuing to provide protection against the introduction of plant pests into the continental United States.

The Food and Drug Administration (FDA) 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 antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are generally recognized as safe and effective. In the 1994 TFM, certain antiseptic active ingredients were proposed as being generally recognized as safe for use in health care settings 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, we are now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for these uses. We also are proposing that all health care antiseptic 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.

The Department of Veterans Affairs (VA) amends its medical regulations concerning eligibility for the Health Care for Homeless Veterans (HCHV) program. The HCHV program provides per diem payments to non-VA community-based facilities that provide housing, outreach services, case management services, and rehabilitative services, and may provide care and/or treatment to homeless veterans who are enrolled in or eligible for VA health care. The rule modifies VA's HCHV regulations to conform to changes enacted in the Honoring America's Veterans and Caring for Camp Lejeune Families Act of 2012. Specifically, the rule removes the requirement that homeless veterans be diagnosed with a serious mental illness or substance use disorder to qualify for the HCHV program. This change makes the program available to all homeless veterans who are enrolled in or eligible for VA health care. The rule also updates the definition of homeless to match in part the one used by the Department of Housing and Urban Development (HUD). The rule further clarifies that the services provided by the HCHV program through non-VA community-based providers must include case management services, including non-clinical case management, as appropriate.

NMFS implements management measures described in a framework action to the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP) prepared by the Gulf of Mexico (Gulf) Fishery Management Council (Council). The final rule increases commercial and recreational quotas for red snapper in the Gulf of Mexico reef fish fishery for the 2015, 2016, and 2017 fishing years. Quotas for subsequent fishing years would remain at 2017 levels unless changed by future rulemaking. This rule also announces the closure dates for the red snapper recreational sector components (private angling and for- hire components) in the Gulf. The private angling component will close at 12:01 a.m., local time, June 11, 2015, and the for-hire component will close at 12:01 a.m., local time, on July 15, 2015. This rule is intended to help achieve optimum yield for the Gulf red snapper resource without increasing the risk of red snapper experiencing overfishing.

We propose to adopt a new airworthiness directive (AD) for Pilatus Aircraft Ltd. Model PC-12/47 and PC-12/47E airplanes. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as the aileron trim tab disconnecting above 10,000 feet altitude. We are issuing this proposed AD to require actions to address the unsafe condition on these products.

We are adopting a new airworthiness directive (AD) for all The Boeing Company Model 787 airplanes. This AD requires a repetitive maintenance task for electrical power deactivation on Model 787 airplanes. This AD was prompted by the determination that a Model 787 airplane that has been powered continuously for 248 days can lose all alternating current (AC) electrical power due to the generator control units (GCUs) simultaneously going into failsafe mode. This condition is caused by a software counter internal to the GCUs that will overflow after 248 days of continuous power. We are issuing this AD to prevent loss of all AC electrical power, which could result in loss of control of the airplane.

The Environmental Protection Agency (EPA) is proposing to approve the Commonwealth of Pennsylvania's April 30, 2014 request to redesignate to attainment the Lancaster nonattainment area (Lancaster Area or Area) for both the 1997 annual and the 2006 24-hour fine particulate matter (PM2.5) National Ambient Air Quality Standards (NAAQS or standards). EPA is also proposing to determine that the Area continues to attain the 1997 annual and the 2006 24-hour PM2.5 NAAQS. In addition, EPA is proposing to approve as a revision to the Pennsylvania State Implementation Plan (SIP) the associated maintenance plan that was submitted with the redesignation request, to show maintenance of the 1997 annual and the 2006 24-hour PM2.5 NAAQS through 2025 for the Area. The maintenance plan includes the 2017 and 2025 PM2.5 and nitrogen oxides (NOX) motor vehicle emissions budgets (MVEBs) for the Area for both NAAQS, which EPA is proposing to approve for transportation conformity purposes. Furthermore, EPA is proposing to approve as a revision to the Pennsylvania SIP the 2007 emissions inventory that is also included in the maintenance plan for the Area for both NAAQS. This rulemaking action to propose approval of the 1997 annual and 2006 24- hour PM2.5 NAAQS redesignation request and associated maintenance plan for the Lancaster Area is based on EPA's determination that Pennsylvania has met the criteria for redesignation to attainment specified in the Clean Air Act (CAA) for both NAAQS.

This action proposes to establish Class E airspace as an extension to the Class D surface area, modify Class D airspace, and Class E airspace extending from 700 feet above the surface at Ogden- Hinckley Airport, Ogden, UT. This action, initiated by the FAA's biennial review of the airspace area, would enhance the safety and management of Instrument Flight Rules (IFR) operations for Standard Instrument Approach Procedures (SIAPs) at the airport. This action would also update the geographic coordinates of Ogden-Hinckley Airport and Hill AFB, Ogden, UT.

Pursuant to the Debt Collection Improvement Act of 1996, the Federal Labor Relations Authority (``FLRA'') is issuing a regulation governing procedures for collecting debts owed to the federal government by present and former FLRA employees. The regulation sets forth the procedures that the FLRA will follow in collecting debts owed to the United States arising from activities under FLRA jurisdiction. These procedures include collection of debts through administrative offset and salary offset. These regulations supersede the FLRA's debt- collection procedures applied under FLRA Internal Regulation 2790, dated December 29, 1986.

This final rule approves and implements Framework Adjustment 53 to the Northeast Multispecies Fishery Management Plan. This rule sets fishing years 2015-2017 catch limits for several groundfish stocks, modifies management measures for Gulf of Maine cod, and adopts other measures to improve the management of the groundfish fishery. This action is necessary to respond to updated scientific information and achieve the goals and objectives of the fishery management plan. The final measures are intended to prevent overfishing, rebuild overfished stocks, achieve optimum yield, and ensure that management measures are based on the best scientific information available.

We have partially approved sector operations plans and contracts for fishing years 2015 and 2016, granting regulatory exemptions for fishing years 2015 and 2016, and providing Northeast multispecies annual catch entitlements to approved sectors for fishing year 2015. Approval of sector operations plans is necessary to allocate annual catch entitlements to the sectors and for the sectors to operate. The Northeast Multispecies Fishery Management Plan allows limited access permit holders to form sectors, and requires sectors to submit their operations plans and contracts to us, NMFS, for approval or disapproval. Approved sectors are exempt from certain effort control regulations and receive allocations of Northeast multispecies based on its members' fishing history.

We propose to adopt a new airworthiness directive (AD) for certain CFM International S.A. (CFM) CFM56-7B series turbofan engines. This proposed AD was prompted by reports of uncommanded in-flight shutdowns (IFSDs) on CFM CFM56-7B engines following rupture of the 73- tooth gearshaft located in the engine accessory gearbox (AGB). This proposed AD would require magnetic chip detector (MCD) inspection of the affected gearshafts until removal. We are proposing this AD to prevent failure of certain engine AGB gearshafts, which could lead to failure of one or more engines, loss of thrust control, and damage to the airplane.

This proposed rule would update the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs) (which are freestanding IPFs and psychiatric units of an acute care hospital or critical access hospital). These changes would be applicable to IPF discharges occurring during the fiscal year (FY) beginning October 1, 2015 through September 30, 2016 (FY 2016). This proposed rule also proposes: A new IPF-specific market basket; to update the IPF labor-related share; a transition to new Core Based Statistical Area (CBSA) designations in the FY 2016 IPF Prospective Payment System (PPS) wage index; to phase out the rural adjustment for IPF providers whose status changes from rural to urban as a result of the proposed wage index CBSA changes; and new quality measures and reporting requirements under the IPF quality reporting program. This proposed rule also reminds IPFs of the October 1, 2015 implementation of the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM), and updates providers on the status of IPF PPS refinements.