November 24, 2014 – Federal Register Recent Federal Regulation Documents

This technical amendment corrects codification, terminology, and technical errors in the requirements for suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) at 42 CFR 424.57.

The Industry Trade Advisory Committee on Small and Minority Business (ITAC-11) will hold a meeting on Monday, December 8, 2014. The meeting will be open to the public from 1:00 p.m. to 3:30 p.m.

The Food and Drug Administration (FDA) is announcing the availability for public comment of Demographic Subgroup Data for FDA Approved Products on FDA's Internet Web site. This new posting implements Action 3.1 from Priority 3 of the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 Action Plan designed to improve the availability and transparency of clinical trial demographic subgroup data. FDA is requesting comments on the format, content, and overall usability of the site to determine whether this approach is user friendly to the public.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on September 19, 2014, at 79 FR 56384, allowing for a 60-day public comment period. USCIS received a comment in connection with the 60-day notice.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on July 16, 2014, at 79 FR 41585, allowing for a 60-day public comment period. USCIS did receive a comment in connection with the 60-day notice.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on August 21, 2014, at 79 FR 49529, allowing for a 60-day public comment period. USCIS did receive two comments in connection with the 60-day notice.

The Sabine Pass to Galveston Bay, Texas, study area encompasses six coastal counties on the upper Texas Gulf coastOrange, Jefferson, Chambers, Harris, Galveston and Brazoria. The Draft Integrated Feasibility Report and Environmental Impact Statement (DIFR- EIS) will evaluate structural and non-structural alternatives which address coastal storm risk management (CSRM) and ecosystem restoration (ER) impacts in the study area. The environmental impact study will focus on environmental and social conditions currently present and those likely to be affected by potential future impacts of storm surge and ecosystem restoration opportunities. Several major historical surge events have occurred in the study area in the past 120 years. The most notable is perhaps the 1900 Storm, which inundated most of the island city of Galveston, TX, and adjacent areas on the mainland. The storm was responsible for over eight thousand deaths and up to $30 million in property damage. Hurricane Rita in 2005 resulted in storm surge of 9.2 feet in Port Arthur, TX, and just over 8 feet in Sabine Pass. Most recently, Hurricane Ike in 2008 produced storm surges of 14 feet near Sabine Pass and 11 to 12 feet across Sabine Lake. The City of Port Arthur was spared from the impacts of storm surge thanks to its existing 14- to 17-foot hurricane flood protection system. However, the remaining southern half of Jefferson County was inundated, with estimated high water marks reaching 18 to19 feet to the south and east of High Island. The City of Galveston was protected from Hurricane Ike's high energy surge impacts by the Galveston Seawall, but much of the City of Galveston was later flooded by about 6 to 10 feet of surge coming from the bay. The City of Texas City was protected from Ike's surge impacts by its existing hurricane flood protection system. At risk within the study area are approximately 2.26 million people living within the storm-surge inundation zone, three of the nine largest oil refineries in the world, 40 percent of the nation's petrochemical industry, 25 percent of the nation's petroleum-refining capacity, and three of the ten largest U.S. seaports.

The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on this continuing information collection, as required by the Paperwork Reduction Act of 1995. Under the Paperwork Reduction Act, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information. An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment on proposed revisions to the regulatory reporting templates and documentation for covered institutions with total consolidated assets of $10 billion to $50 billion.

The Commander of the Northwestern Division of the U.S. Army Corps of Engineers (Corps) is soliciting applications to fill vacant stakeholder representative member positions on the Missouri River Recovery Implementation Committee (MRRIC). Members are sought to fill vacancies on a committee to represent various categories of interests within the Missouri River basin. The MRRIC was formed to advise the Corps on a study of the Missouri River and its tributaries and to provide guidance to the Corps with respect to the Missouri River recovery and mitigation activities currently underway. The Corps established the MRRIC as required by the U.S. Congress through the Water Resources Development Act of 2007 (WRDA), Section 5018.

This notice is issued in accordance with 51 U.S.C. 20144(c). The Cube Quest (CQ) Challenge is scheduled and teams that wish to compete may now register. Centennial Challenges is a program of prize competitions to stimulate innovation in technologies of interest and value to NASA and the nation. The Cube Quest Challenge is a prize competition designed to encourage development of new technologies or application of existing technologies in unique ways to advance cubsat communication and propulsion systems. NASA is providing the prize purse.

The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG), DG-1309, ``Guidelines for Evaluating the Effects of Light-Water Reactor Coolant Environments in Fatigue Analyses of Metal Components.'' This guide, Revision 1 of Regulatory Guide 1.207 has been revised to consolidate, update, and replace previous NRC staff guidance on the effects of light-water reactor coolant environments on the fatigue lives of nuclear power plant components. This proposed revision provides an alternative to previous guidance provided for new reactors in Revision 0 of this guide, as well as to previous guidance provided for license renewal of operating reactors in the Generic Aging Lessons Learned (GALL) Report and the Standard Review Plan for License Renewal (SRP-LR). This guide supports reviews of applications for new nuclear reactor construction that are licensed under the NRC's regulations.

Summary of Application: Applicants request an order to permit a business development company (``BDC'') to co-invest in portfolio companies with affiliated investment funds.

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act.'' The guidance is intended for entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Quality and Security Act (DQSA). Entities that elect to register as outsourcing facilities must pay certain fees to be considered outsourcing facilities. This guidance describes the annual establishment fee, the reinspection fee, annual adjustments to fees required by law, how to submit payment, the effect of failure to pay fees, and how to qualify as a small business to obtain a reduction of the annual establishment fee.

In accordance with the Paperwork Reduction Act of 1995, PHMSA invites comments on certain information collections pertaining to hazardous materials transportation for which PHMSA intends to request renewal from the Office of Management and Budget (OMB).

The Department of Commerce (``Department'') is conducting the administrative review of the antidumping duty order on magnesium metal from the People's Republic of China (``PRC''). The period of review (``POR'') is April 1, 2013, through March 31, 2014. This review covers two PRC companies, Tianjin Magnesium International, Co., Ltd. (``TMI'') and Tianjin Magnesium Metal, Co., Ltd. (``TMM''). The Department preliminarily finds that TMI and TMM did not have reviewable entries during the POR. We invite interested parties to comment on these preliminary results.

The Environmental Protection Agency (EPA) is taking final action finding that the District of Columbia and seven states (Alaska, Arkansas, Hawaii, Minnesota, New Jersey, Vermont and Washington) have not submitted complete infrastructure State Implementation Plans (SIPs) that provide the basic Clean Air Act (CAA) program elements necessary to implement the 2010 nitrogen dioxide (NO2) primary national ambient air quality standard (NAAQS). Three out of the seven states (Alaska, Arkansas and Vermont) have not made any submittals. The District of Columbia and the remaining four out of the seven states (Hawaii, Minnesota, New Jersey and Washington) have made submittals that are partially incomplete due to the lack of complete SIP approved Prevention of Significant Deterioration (PSD) permit programs. The purpose of an infrastructure SIP submission is to assure that a state, local or tribal air agency's SIP contains the necessary structural requirements for any new or revised NAAQS. The remaining 43 states have made complete submissions. Each finding of failure to submit a complete infrastructure SIP establishes a 24-month deadline for the EPA to promulgate a Federal Implementation Plan (FIP) to address the outstanding SIP elements unless, prior to the EPA promulgating a FIP, the affected air agency submits, and the EPA approves, a revised SIP that corrects the deficiency. In those areas without a state-adopted PSD permit program, the FIP obligation has already been met through federal regulations that govern PSD permits issued in some cases by the EPA and in other cases by state or local agencies under delegation agreements.