April 2016 – Federal Register Recent Federal Regulation Documents

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.

The Environmental Protection Agency (EPA) is taking final action to approve a revision to the San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD) portion of the California State Implementation Plan (SIP). This revision concerns emissions of volatile organic compounds (VOCs), oxides of nitrogen (NOX), and particulate matter (PM) from internal combustion engines. We are approving a local rule that regulates these emission sources under the Clean Air Act (CAA or the Act).

This final rule updates the meal pattern requirements for the Child and Adult Care Food Program to better align them with the Dietary Guidelines for Americans, as required by the Healthy, Hunger-Free Kids Act of 2010. This rule requires centers and day care homes participating in the Child and Adult Care Food Program to serve more whole grains and a greater variety of vegetables and fruit, and reduces the amount of added sugars and solid fats in meals. In addition, this final rule supports mothers who breastfeed and improves consistency with the Special Supplemental Nutrition Program for Women, Infants, and Children and with other Child Nutrition Programs. Several of the changes are extended to the National School Lunch Program, School Breakfast Program, and Special Milk Program. These changes are based on the Dietary Guidelines for Americans, science-based recommendations made by the National Academy of Medicine (formerly the Institute of Medicine of the National Academies), cost and practical considerations, and stakeholder's input. This is the first major revision of the Child and Adult Care Food Program meal patterns since the Program's inception in 1968. These improvements to the meals served in the Child and Adult Care Food Program are expected to safeguard the health of young children by ensuring healthy eating habits are developed early, and improve the wellness of adult participants.

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).

The Office of the Director of National Intelligence (ODNI) is publishing this direct final rule pursuant to Executive Order 13526, relating to classified national security information. It provides procedures for members of the public to request from ODNI a Mandatory Declassification Review (MDR) of information classified under the provisions of Executive Order 13526 or predecessor orders such that the agency may retrieve it with reasonable effort. This rule also informs requesters where to send requests for an MDR.

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.

On February 25, 2016, the Bureau of Land Management (BLM) published in the Federal Register a proposed rule to amend existing regulations that establish the procedures used to prepare, revise, or amend land use plans pursuant to the Federal Land Policy and Management Act (FLPMA). The proposed rule would enable the BLM to more readily address landscape-scale resource issues, such as wildfire, habitat connectivity, or the demand for renewable and non-renewable energy sources and to respond more effectively to environmental and social changes. The proposed rule would further emphasize the role of science in the planning process and the importance of evaluating the resource, environmental, ecological, social, and economic conditions at the onset of planning. The proposed rule would affirm the important role of other Federal agencies, State and local governments, Indian tribes, and the public during the planning process, and would enhance opportunities for public involvement and transparency during the preparation of resource management plans. Finally, the proposed rule would make revisions to clarify existing text and use plain language to improve the readability of the planning regulations. This notice extends the public comment period for 30 days beyond the initial comment-period deadline.

The Food and Drug Administration (FDA or Agency) is announcing a 2-day public hearing to obtain input on four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). FDA had announced a 1-day public hearing for April 13, 2016, to obtain input on the guidances, but on February 29, 2016, announced that due to considerable interest in the public hearing and to give stakeholders additional time to provide comments to the Agency, the hearing was postponed. FDA also stated its intent to extend the comment period for the four draft guidance documents and to schedule a scientific workshop to identify and discuss the scientific considerations and challenges to help inform the development of HCT/Ps subject to premarket approval, including stem cell-based products. FDA will consider information it obtains from the public hearing in the finalization of the four draft guidance documents.

NASA is proposing to amend the NASA Federal Acquisition Regulation Supplement (NFS) to clarify NASA's award fee process by incorporating terms used in award fee contracting; guidance relative to final award fee evaluations; release of source selection information; and the calculation of the provisional award fee payment percentage in NASA end-item award fee contracts.

The Coast Guard is establishing a temporary safety zone on the waters of the Intracoastal Waterway in Myrtle Beach, South Carolina on Sunday, April 24, 2016 for the Xterra Swim. 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 a portion of the Intracoastal Waterway, preventing non-participant vessels from entering, transiting through, anchoring in, or remaining within the regulated area unless authorized by the Captain of the Port Charleston or a designated representative.

These special conditions are issued for the Gulfstream Aerospace Corporation (Gulfstream) Model GVII-G500 airplane. These airplanes will have a digital-systems network architecture composed of several connected networks that may allow access to or by external computer systems and networks, and may result in airplane electronic system- security vulnerabilities. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

These special conditions are issued for the Dassault Aviation (Dassault) Model Falcon 5X airplane. This airplane will have a novel or unusual design feature associated with go-around performance credit when using an automatic takeoff thrust-control system. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Lehigh Valley Drawbridge across the Newark Bay, mile 4.3, at Jersey City, New Jersey. This deviation is necessary to allow the bridge owner to replace rails and ties at the bridge. This deviation allows the bridge to remain closed for 26 hours for two days.

NMFS issues regulations to revise the authorized methods for payment of cost recovery fees for the Halibut and Sablefish Individual Fishing Quota Program and the Bering Sea and Aleutian Islands Crab Rationalization Program. These regulations are necessary to improve data security procedures and to reduce administrative costs of processing cost recovery fee payments. This final rule is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the Northern Pacific Halibut Act of 1982, the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area, the Fishery Management Plan for Groundfish of the Gulf of Alaska, the Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner Crabs, and other applicable laws.

This supplemental notice of proposed rulemaking would establish Class E surface area airspace within a 4.2-mile radius of Truckee-Tahoe Airport, Truckee, CA, to increase safety and enhance existing instrument flight rules (IFR) procedures in the immediate vicinity of Truckee-Tahoe Airport, Truckee, CA. In an NPRM published in the Federal Register on December 18, 2015, the FAA proposed to amend Class E airspace extending upward from 700 feet above the surface at Truckee-Tahoe Airport. The FAA concurs with a comment received regarding the proposal, and finds establishing Class E surface area airspace along with the proposed Class E airspace modification is warranted for the safety and management of IFR operations.

The Office of the Director of National Intelligence (ODNI) is withdrawing a direct final rule that would have provided procedures for members of the public to request from ODNI a Mandatory Declassification Review (MDR) of information classified under the provisions of Executive Order 13526 or predecessor orders such that the agency may retrieve it with reasonable effort.

The Postal Service is revising Mailing Standards of the United States Postal Service, International Mail Manual (IMM[supreg]), to reflect classification changes to Competitive Services, as established by the Governors of the Postal Service.

The Environmental Protection Agency (EPA) is taking direct final action to approve a portion of a revision to the Tennessee State Implementation Plan (SIP) submitted on March 14, 2014, by the State of Tennessee, through the Tennessee Department of Environmental Conservation (TDEC) on behalf of the Knox County Department of Air Quality Management (Knox County) to address changes to a Knox County regulation regarding permits. EPA has determined that Tennessee's requested SIP revision is consistent with the applicable provisions of the Clean Air Act (CAA or Act).

Notice is hereby given of a public hearing to receive evidence on proposed amendments to Marketing Order No. 989 (order) that regulates the handling of raisins grown in California. Five amendments are proposed by the Raisin Administrative Committee (Committee), which is responsible for local administration of the order. These proposed amendments would: Authorize production research; establish new nomination procedures for independent grower member and alternate member seats; add authority to regulate quality; add authority to establish different regulations for different markets; and add a continuance referenda requirement. In addition, the Agricultural Marketing Service (AMS) proposes two amendments. These amendments would remove order language pertaining to volume regulation and reserve pool authority and would establish term limits for Committee members. In addition, AMS proposes to make any such changes as may be necessary to the order to conform to any amendment that may result from the hearing. These proposed amendments are intended to update the order to reflect past changes in the industry and potential future changes, and to improve the operation and administration of the order.

We are adopting a new airworthiness directive (AD) for The Boeing Company Model 787-8 and 787-9 airplanes powered by General Electric (GE) GEnx-1B engines. This AD requires revising the airplane flight manual (AFM) to provide the flight crew a revised fan ice removal procedure and a new associated mandatory flight crew briefing to reduce the likelihood of engine damage due to fan ice shedding. This AD also removes certain dispatch relief. For airplanes with certain engines, this AD also requires reworking or replacing at least one engine. This AD was prompted by a recent engine fan blade rub event that caused an in-flight non-restartable power loss. We are issuing this AD to prevent susceptibility to heavy fan blade rubs, which could result in engine damage and a possible in-flight non-restartable power loss of one or both engines.

This action proposes to remove Class E airspace extending upward from 700 feet above the surface at Byerley Airport, Lake Providence, LA. The decommissioning of non-directional radio beacons (NDB) and cancellation of Standard Instrument Approach Procedures (SIAPs) have made this action necessary for continued safety and management within the National Airspace System.

This action establishes Class E airspace in Moriarty, NM. Controlled airspace is necessary to accommodate new Area Navigation (RNAV) Standard Instrument Approach Procedures at Moriarty Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rule (IFR) operations at the airport.

This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

This NPRM is the third in a series of three related NPRMs that together establishes a set of performance measures for State departments of transportation (State DOT) and Metropolitan Planning Organizations (MPO) to use as required by Moving Ahead for Progress in the 21st Century Act (MAP-21). The measures proposed in this third NPRM would be used by State DOTs and MPOs to assess the performance of the Interstate and non-Interstate National Highway System (NHS) for the purpose of carrying out the National Highway Performance Program (NHPP); to assess freight movement on the Interstate System; and to assess traffic congestion and on-road mobile source emissions for the purpose of carrying out the Congestion Mitigation and Air Quality Improvement (CMAQ) Program. This third performance measure NPRM also includes a discussion that summarizes all three of the national performance management measures proposed rules and the comprehensive regulatory impact analysis (RIA) to include all three NPRMs.