May 27, 2015 – Federal Register Recent Federal Regulation Documents

The Office of the Director of National Intelligence (ODNI) proposes to exempt two new systems of records from subsections (c)(3); (d)(1),(2),(3),(4); (e)(1) and (e)(4)(G),(H),(I); and (f) of the Privacy Act. With respect to the existing system of records named ODNI Information Technology Systems Activity and Access Records (ODNI-19), the ODNI proposes to invoke subsection (k)(2) as an additional rationale for exempting records from these provisions of the Privacy Act. The ODNI has previously established a rule, published on March 28, 2008, that will preserve the exempt status of records it receives when the reason for the exemption remains valid.

The Food and Drug Administration (FDA or Agency) is delaying the compliance date for the final rule for the electronic submission of postmarketing safety reports for human drugs and biological products that published in the Federal Register of June 10, 2014. The rule amended FDA's postmarketing safety reporting regulations for human drugs and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is also announcing the availability of the Safety Reporting Portal (SRP), a Web-based electronic submission system, for the electronic submission of postmarketing individual case safety reports (ICSRs) of adverse events for human drug and nonvaccine biological products. The SRP is intended to facilitate the secure electronic submission of postmarketing ICSRs and ICSR attachments to the FDA Adverse Event Reporting System (FAERS) database. The SRP creates a simple and efficient mechanism for electronic reporting of ICSRs that does not require an internal database that is compatible with the International Conference on Harmonisation-based direct submission system. FDA is delaying the compliance date for the final rule because FDA understands that not all persons subject to mandatory postmarketing reporting requirements who wish to use the newly available Safety Reporting Portal (SRP) will have the opportunity to register for an account and test the submission process prior to June 10, 2015, the effective date of the final rule.

The Food and Drug Administration (FDA) is classifying multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures. 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.

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 (COTP) New Orleans or a designated representative.

These special conditions are issued for the Bombardier Aerospace Models BD-500-1A10 and BD-500-1A11 series airplanes. These airplanes will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature is a fly-by-wire electronic flight control system that provides an electronic interface between the pilot's flight controls and the flight control surfaces for both normal and failure states. The system generates the actual surface commands that provide for stability augmentation and control about all three airplane axes. 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 Fish and Wildlife Service (hereinafter Service) will conduct an open meeting on June 25, 2015, to identify and discuss preliminary issues concerning the 2016-17 migratory bird hunting regulations.

The Coast Guard is reopening the public comment period for the notice of proposed rulemaking (NPRM) entitled ``Seafarers' Access to Maritime Facilities,'' which published in the Federal Register on December 29, 2014. The NPRM proposed to require each owner or operator of a facility regulated by the Coast Guard to implement a system that provides seafarers and other individuals with access between vessels moored at the facility and the facility gate, in a timely manner and at no cost to the seafarer or other individual. As originally published, the comment period for the NPRM closed on February 27, 2015. Several members of the public have requested additional time to comment on the NPRM, citing various timing constraints. In order to provide interested members of the public an additional opportunity to submit comments on the NPRM, the Coast Guard is reopening the public comment period for 60 days. We are particularly interested in comments on our estimate that there is a 10.3 percent non-compliance rate of facilities with respect to providing seafarers' access. In addition to comments on this topic, we will consider all public comments on the NPRM received during the reopened comment period. We request that you not re-submit comments already in the docket.

This document contains a correction to the address for service of process on the Department of State (Public Notice 9045).

FMCSA responds to a question whether a commercial driver's license (CDL) passenger endorsement is required for drivers of certain custom motorcoaches designed or used to transport fewer than 16 passengers, including the driver. The guidance explains that a passenger endorsement is required because the vehicle is intended to transport passengers rather than cargo.

DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to remove the distinction between DoD and non-DoD agency areas of operation applicable for the use of FAR clause ``Contractors Performing Private Security Functions Outside the United States'' and provide a definition of ``full cooperation'' within the clause.

This action proposes to modify Class E airspace extending upward from 700 feet above the surface at ChehalisCentralia Airport, Chehalis, WA, to enhance the safety and management of Instrument Flight Rules (IFR) operations for Standard Instrument Approach Procedures (SIAPs) at the airport.

This action proposes to modify Class E airspace extending upward from 700 feet above the surface at Southwest Washington Regional Airport, Kelso, WA, to enhance the safety and management of Instrument Flight Rules (IFR) operations for Standard Instrument Approach Procedures (SIAPs) at the airport.

Currently, an application for a license or experimental permit, or for a safety approval must be submitted to the FAA in paper form. This rule will make the application process more flexible and efficient by providing applicants with an option to submit these applications to the FAA electronically (either via email or on an electronic storage device) rather than submitting a paper application.

We are superseding Airworthiness Directive (AD) 2012-09-09 for all International Aero Engines AG (IAE) V2500-A1, V2525-D5, and V2528- D5 turbofan engines, and certain serial numbers (S/Ns) of IAE V2522-A5, V2524-A5, V2527-A5, V2527E-A5, V2527M-A5, V2530-A5, and V2533-A5 turbofan engines. AD 2012-09-09 required cleaning, eddy current inspection (ECI) or fluorescent penetrant inspection (FPI), and initial and repetitive ultrasonic inspections (USIs) of certain high-pressure compressor (HPC) stage 3 to 8 drums, as well as replacement of the drum attachment nuts. This new AD expands the affected population for initial and repetitive USIs of the HPC stage 3 to 8 drum, revises the inspection intervals, requires performing ECI or FPI, requires removal of the affected attachment nuts and any HPC stage 3 to 8 drum found cracked, and adds a mandatory terminating action. This AD was prompted by the discovery that additional attachment nuts for certain HPC stage 3 to 8 drums are affected. We are issuing this AD to prevent failure of the HPC stage 3 to 8 drum, which could result in uncontained drum failure, damage to the engine, and damage to the airplane.