June 5, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations), one of which was amended after initial issuance, for in vitro diagnostic devices for detection of the Ebola virus in response to the Ebola virus outbreak in West Africa. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Corgenix, Inc. (Corgenix), and Cepheid. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the September 22, 2006, determination by then- Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Blood Establishment Registration and Product Listing, Form FDA 2830'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

An open meeting of the Taxpayer Advocacy Panel Special Projects Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.

An open meeting of the Taxpayer Advocacy Panel Tax Forms and Publications Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas and suggestions on improving customer service at the Internal Revenue Service.

An open meeting of the Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.

The Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the Eastern Kern Air Pollution Control District (EKAPCD) and Mojave Desert Air Quality Management District (MDAQMD) portions of the California State Implementation Plan (SIP). These revisions concern volatile organic compound (VOC) emissions from polyester resin operations and oil-water separators. The EPA is approving local rules that regulate these emission sources under the Clean Air Act (CAA or the Act).

The EPA Science Advisory Board (SAB) Staff Office announces a public meeting and three teleconferences of the SAB Hydraulic Fracturing Research Advisory Panel to conduct a review of the EPA draft report, Assessment of the Potential Impacts of Hydraulic Fracturing for Oil and Gas on Drinking Water Resources, (May, 2015 External Review Draft, EPA/600/R-15/047).

Overview Information: Investing in Innovation FundValidation grants. Notice inviting applications for new awards for fiscal year (FY) 2015. Catalog of Federal Domestic Assistance (CFDA) Number: 84.411B (Validation grants).

EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 22 chemical substances which were the subject of premanufacture notices (PMNs). Two of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture (including import) or process any of these 22 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.

The National Indian Gaming Commission (NIGC or Commission) makes corrections to various regulations previously issued. The Commission recently moved its headquarters resulting in the need to update the Commission's mailing address. Additionally, the current regulations contain outdated references to previous regulations that no longer exist. The amendments also correct various minor grammatical errors.

On April 29, 2015, the Rural Housing Service (RHS) published a final rule to create a certified loan application packaging process for the direct single family housing loan program. The effective date was listed as July 28, 2015 and is being deferred to October 1, 2015.

The Environmental Protection Agency (EPA) is taking final action to approve elements of a State Implementation Plan (SIP) submission from the State of Kansas addressing the applicable requirements of Clean Air Act (CAA) section 110 for the 2010 National Ambient Air Quality Standards (NAAQS) for Sulfur Dioxide (SO2), which requires that each state adopt and submit a SIP to support implementation, maintenance, and enforcement of each new or revised NAAQS promulgated by EPA. These SIPs are commonly referred to as ``infrastructure'' SIPs. The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA.

We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 757-200 series airplanes modified by particular STCs. This proposed AD was prompted by reports of a main cargo door being blown past its full open position while on the ground during gusty wind conditions, which resulted in uncontrolled fall down to its closed position. This proposed AD would require installing a new placard and bracket, replacement of an existing placard, and replacement of the main cargo door control panel. We are proposing this AD to prevent damage to the main cargo door, which could result in rapid decompression, leading to in-flight breakup.

We propose to supersede Airworthiness Directive (AD) 98-18-26, for certain Airbus Model A320 series airplanes. AD 98-18-26 currently requires repetitive inspections to detect fatigue cracking of the front spar vertical stringers on the wings; and repair, if necessary. Since we issued AD 98-18-26, we have received reports that indicate new repetitive inspections having new thresholds and intervals are needed and that additional work is needed to accomplish the inspections on airplanes on which a previous modification has been accomplished. This proposed AD would require repetitive high frequency eddy current (HFEC) inspections for cracking of the radius of the front spar vertical stringers and the horizontal floor beam on frame 36, and a rototest inspection for cracking of the fastener holes of the front spar vertical stringers on frame 36, and repair if necessary. We are proposing this AD to detect and correct fatigue cracking of the front spar vertical stringers on the wings, which could result in the reduced structural integrity of the airframe.

We propose to adopt a new airworthiness directive (AD) for all Lockheed Martin Corporation/Lockheed Martin Aeronautics Company Model 188 series airplanes. This proposed AD was prompted by an evaluation by the design approval holder (DAH) indicating the left and right lower surface panels of the wings are subject to widespread fatigue damage (WFD). This proposed AD would require repetitive inspections for cracking at these panels, and repair if necessary. The proposed AD would also require a one-time bolt-hole eddy current inspection of all open holes for cracking, repair if necessary, and modification. We are proposing this AD to prevent fatigue cracking of the left and right lower surface panels of the wings, which could result in reduced structural integrity of the airplane.

We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 767-300 and -300F series airplanes. This proposed AD was prompted by reports of fatigue cracking on airplanes with Aviation Partners Boeing winglets installed. This proposed AD would require a high frequency eddy current (HFEC) inspection for cracking of the lower outboard wing skin, and repair or modification if necessary. This proposed AD would also require one of three follow-on actions: Repeating the HFEC inspections; modifying certain internal stringers and oversizing and plugging the existing fastener holes of the lower wing; or modifying the external doubler/ tripler and doing repetitive post-modification inspections. We are proposing this AD to prevent fatigue cracking in the lower outboard wing skin, which could result in failure and subsequent separation of the wing and winglet and consequent reduced controllability of the airplane.