June 5, 2013 – Federal Register Recent Federal Regulation Documents

We propose to adopt a new airworthiness directive (AD) for certain Agusta Model A109C, A109E, A109S, A109K2, and AW109SP helicopters. This proposed AD would require inspecting the lock wires securing the tail rotor (T/R) duplex bearing locking nut (locking nut) to determine whether any lock wires are missing or damaged. This proposed AD is prompted by reports of loosening T/R locking nuts, which if not corrected, could result in failure of the T/R and subsequent loss of control of the helicopter.

This document delays the effective date of the final rule published November 30, 2011, and scheduled to take effect on July 1, 2013. The final rule mandates that roadway workers comply with specified on-track safety procedures that railroads must adopt to protect those workers from the movement of trains or other on-track equipment on ``adjacent controlled track.'' FRA received two petitions for reconsideration of the final rule, and five comments in response to the March 8, 2012, final rule that requested comments on the petitions for reconsideration. The petitions and comments raised a number of substantive issues requiring a detailed response. As FRA's response to those petitions and comments is still being reviewed, this document delays the effective date of the final rule until July 1, 2014.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in all phases of development of antiretroviral drugs for the treatment of HIV. This draft guidance revises the guidance for industry entitled ``Antiretroviral Drugs Using Plasma HIV RNA MeasurementsClinical Considerations for Accelerated and Traditional Approval'' issued in October 2002.

The Coast Guard is establishing a special local regulation on the Intracoastal Waterway in Atlantic City, NJ. This special local regulation will restrict vessel traffic on a portion of the Intracoastal Waterway from operating while a swim event is taking place. This special local regulation is necessary to protect the swimmers from the hazards associated with passing vessel traffic.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the reporting of biological product deviations in manufacturing and human cells, tissues, and cellular and tissue- based product (HCT/P) deviations, and Forms FDA 3486 and 3486A.

The Bureau of Industry and Security (BIS) publishes this final rule to amend the Export Administration Regulations (EAR) to implement the understandings reached at the June 2012 plenary meeting of the Australia Group (AG) and the 2012 AG intersessional decisions. Specifically, this rule amends the Commerce Control List (CCL) entry in the EAR that controls human and zoonotic pathogens and ``toxins'' to reflect changes to the AG ``List of Biological Agents for Export Control'' that were made based on the understandings adopted at the June 2012 AG plenary meeting. These changes included the addition of three pathogens and clarifications to two other items. This rule also amends the CCL entry in the EAR that controls plant pathogens to reflect: The 2012 AG Plenary agreement to add five pathogens to the AG ``List of Plant Pathogens for Export Control;'' and the AG intersessional clarifications to six pathogens identified on this AG list. In addition, the CCL entry in the EAR that controls equipment capable of handling biological materials is amended to reflect the 2012 AG intersessional decision to add certain spray-drying equipment to the AG ``Control List of Dual-Use Biological Equipment and Related Technology and Software.'' This rule also removes the CCL entry that controls select agents not identified on any of the AG common controls lists, but identified on the CCL because they are (or were, until recently) subject to controls maintained by the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, and the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, on their possession, use, and transfer within the United States. Rather than continuing to control these select agents in a separate CCL entry, this rule adds those select agents that remain subject to the CDC/APHIS controls (as well as a recent addition to the list of select agents) to the AG-related CCL entries that control human and zoonotic pathogens and ``toxins'' and plant pathogens, respectively.

We, the U.S. Fish and Wildlife Service (``Service''), announce 12-month findings on two petitions to remove the U.S. captive-bred and U.S. captive ``populations'' of three antelope species, the scimitar- horned oryx (Oryx dammah), dama gazelle (Gazella dama), and addax (Addax nasomaculatus), from the List of Endangered and Threatened Wildlife as determined under the Endangered Species Act of 1973, as amended (Act). Based on our review, we find that delisting the U.S. captive animals or U.S. captive-bred members of these species is not warranted.

Notice is hereby given of the following hearing of the U.S.- China Economic and Security Review Commission. Name: William A. Reinsch, Chairman of the U.S.-China Economic and Security Review Commission. The Commission is mandated by Congress to investigate, assess, and report to Congress annually on ``the national security implications of the economic relationship between the United States and the People's Republic of China.'' Pursuant to this mandate, the Commission will hold a public hearing in Washington, DC on June 6, 2013, ``China and the Middle East.'' Background: This is the sixth public hearing the Commission will hold during its 2013 report cycle to collect input from academic, industry, and government experts on national security implications of the U.S. bilateral trade and economic relationship with China. This hearing will explore patterns of Chinese investment in the U.S. and the implications of that investment for U.S. policymakers. The hearing will be co-chaired by Commissioners Jeffrey L. Fiedler and Sen. James Talent. Any interested party may file a written statement by June 6, 2013, by mailing to the contact below. A portion of each panel will include a question and answer period between the Commissioners and the witnesses. Location, Date and Time: Dirksen Senate Office Building, Room 608. Thursday, June 6, 2013, 9:00 a.m.-2:00 p.m. Eastern Time. A detailed agenda for the hearing is posted to the Commission's Web site at www.uscc.gov. Also, please check our Web site for possible changes to the hearing schedule. Reservations are not required to attend the hearing.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 5306-A, Application for Approval of Prototype Simplified Employee Pension (SEP) or Savings Incentive Match Plan for Employees of Small Employers (SIMPLE IRA Plan).

On May 10, 2013, BOEM published a document in the Federal Register (78 FR 27427) entitled ``Outer Continental Shelf Geological and Geophysical Exploration Activities in the Gulf of Mexico.'' This notice corrects the date for closing of the public comment period, as previously published.

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 Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for lung cancer. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of lung cancer on daily life as well as the available therapies for lung cancer.

The National Cemetery Administration (NCA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of a currently approved collection and allow 60 days for public comment in response to the notice. This notice solicits comments on the information needed to determine the number of interments conducted at State Veterans' cemeteries.

The mission of SAMHSA is to reduce the impact of substance abuse and mental illness on America's communities. Established in 1992, the Agency was directed by Congress to target effective substance abuse and mental health services to the people most in need and to translate research in these areas more effectively and more rapidly into the general health care system. NREPP is a key public resource SAMHSA has developed to help meet this directive. As of June 2013, approximately 290 interventions developed in the U.S. and abroad have been reviewed and added to the registry. This notice announces NREPP's open submission period for fiscal year 2014, during which program developers may submit a request to have their intervention reviewed. The notice provides information about the documentation that submissions must include to demonstrate that an intervention meets NREPP's minimum requirements; the responsibilities of the Principal during the review process; and the process for submitting materials for review during the open submission period.

The Commission is noticing a recent Postal Service filing concerning an amendment to Express Mail Contract 11. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The Corporation for National and Community Service (CNCS) has submitted a public information collection request (ICR) entitled [Title] for review and approval in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, (44 U.S.C. Chapter 35). Copies of this ICR, with applicable supporting documentation, may be obtained by calling the Corporation for National and Community Service, Wanda Carney, at (202) 606-6934 or email to wcarney@cns.gov. Individuals who use a telecommunications device for the deaf (TTY-TDD) may call 1-800-833-3722 between 8:00 a.m. and 8:00 p.m. Eastern Time, Monday through Friday.

BOEM has prepared a revised environmental assessment (EA) considering the reasonably foreseeable environmental and socioeconomic impacts of issuing renewable energy leases and subsequent site characterization activities (geophysical, geotechnical, archaeological, and biological surveys needed to develop specific project proposals on those leases) in an identified Wind Energy Area (WEA) on the OCS offshore Rhode Island (RI) and Massachusetts (MA). The revised EA also considers the reasonably foreseeable impacts associated with the approval of site assessment activities (including the installation and operation of meteorological towers and buoys) on the leases that may be issued in the identified WEA. As a result of the analysis in the revised EA, BOEM issued a Finding of No Significant Impact (FONSI). The FONSI concluded that the reasonably foreseeable impacts associated with the preferred alternative would not significantly impact the environment; therefore, the preparation of an environmental impact statement (EIS) is not required. The purpose of this notice is to inform the public of the availability of the revised EA and FONSI, which can be accessed online at: https://www.boem.gov/Renewable-Energy-Program/Smart-from-the-S tart/ Index.aspx.

This regulation establishes a tolerance for residues of propamocarb in or on succulent lima bean. Interregional Research Project Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

EPA is proposing to approve a revision to the Kentucky State Implementation Plan (SIP), submitted to EPA on August 9, 2012, by the Commonwealth of Kentucky, through the Kentucky Energy and Environment Cabinet, Division for Air Quality. Kentucky's August 9, 2012, SIP revision includes changes to the maintenance plan for the Kentucky portion of the Cincinnati-Hamilton, OH-KY-IN, maintenance area for the 1997 8-hour ozone national ambient air quality standard (NAAQS). The Cincinnati-Hamilton, OH-KY-IN, maintenance area for the 1997 8-hour ozone NAAQS includes the counties of Boone, Campbell and Kenton in Kentucky (hereafter also referred to as Northern Kentucky); a portion of Dearborn County, Indiana; and the entire counties of Butler, Clermont, Clinton, Hamilton and Warren in Ohio. Kentucky's August 9, 2012, SIP revision proposes to update the motor vehicle emissions budget using an updated mobile emissions model, the Motor Vehicle Emissions Simulator (also known as MOVES2010a), and to increase the safety margin allocated to motor vehicle emissions budgets for nitrogen oxides and volatile organic compounds for Northern Kentucky to account for changes in the emissions model and vehicle miles traveled projection model. EPA is proposing to approve this SIP revision because the Commonwealth has demonstrated that it is consistent with the Clean Air Act.