2015 – Federal Register Recent Federal Regulation Documents

This rule sets forth the Gulf Coast Ecosystem Restoration Council's (Council) regulation to implement the Spill Impact Component of the Resources and Ecosystems Sustainability, Tourist Opportunities, and Revived Economies of the Gulf Coast States Act of 2012 (RESTORE Act). This rule establishes the formula allocating funds made available from the Gulf Coast Restoration Trust Fund among the Gulf Coast States of Alabama, Florida, Louisiana, Mississippi and Texas (``State'' or ``States'') pursuant to Sec. 1603(3) of the RESTORE Act.

The Transportation Security Administration (TSA) invites public comment on one currently approved Information Collection Request (ICR), OMB control number 1652-0040, abstracted below that we will submit to the Office of Management and Budget (OMB) for a revision in compliance with the Paperwork Reduction Act. The ICR describes the nature of the information collection and its expected burden. This ICR involves three broad categories of affected populations operating under a security program: Aircraft operators, foreign air carriers, and indirect air carriers. The collections of information that make up this ICR include security programs, security threat assessments (STA) on certain individuals, known shipper data via the Known Shipper Management System (KSMS), Indirect Air Carrier Management System (IACMS), and evidence of compliance recordkeeping. TSA seeks continued OMB approval in order to secure passenger aircraft carrying cargo as authorized in the Aviation and Transportation Security Act.

The FAA is issuing this notice to advise the public of the Second RTCA Special Committee 235 meeting.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Head Lice Infestation: Developing Drugs for Topical Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of head lice infestation. This draft guidance addresses the Agency's current thinking regarding the overall development program and clinical trial designs of drugs to support approval of an indication for topical treatment of head lice infestation. The information presented will help sponsors plan clinical trials, design clinical protocols, and conduct and appropriately monitor clinical trials.

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy.'' The purpose of this workshop is to discuss and receive input from stakeholders regarding approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy in addition to describing the FDA's process for facilitating the development of safe and effective POC and patient self-testing PT/INR devices. The goal of the workshop is to seek and identify potential solutions to address the scientific and regulatory challenges associated with POC PT/INR devices to ensure safety and effectiveness.

The Food and Drug Administration (FDA) has determined the regulatory review period for VIZAMYL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for TRIVASCULAR OVATION ABDOMINAL STENT GRAFT SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The National Park Service hereby gives public notice that it proposes to extend the following expiring concession contracts for a period of up to one (1) year, or until the effective date of a new contract, whichever occurs sooner.

The NTSB is publishing an amendment to its regulations concerning notification and reporting requirements with regard to aircraft accidents or incidents, titled, ``Immediate notification.'' The regulation currently requires reports of Airborne Collision and Avoidance System (ACAS) advisories issued under certain specific circumstances. The NTSB now narrows the ACAS reporting requirement, consistent with the agency's authority to issue non-controversial amendments to rules, pursuant to the direct final rulemaking procedure. The NTSB also updates its contact information for notifications.

The Broadcasting Board of Governors (Board) will be meeting at the time and location listed above. The Board will vote on a consent agenda consisting of the minutes of its Oct. 8, 2015 meeting, a resolution honoring the 55th anniversary of Voice of America's (VOA) French-to-Africa Service, a resolution honoring the 55th anniversary of VOA's Spanish Service, a resolution honoring first anniversary of Current Timethe joint production of VOA and Radio Free Europe/Radio Liberty, and a resolution honoring Carlos Garcia-Perez. The Board will receive a report from the Chief Executive Officer and Director of BBG. The Board will also receive a review of Radio Free Asia. This meeting will be available for public observation via streamed webcast, both live and on-demand, on the agency's public Web site at www.bbg.gov. Information regarding this meeting, including any updates or adjustments to its starting time, can also be found on the agency's public Web site. The public may also attend this meeting in person at the address listed above as seating capacity permits. Members of the public seeking to attend the meeting in person must register at https:// bbgboardmeetingdecember2015.eventbrite.com by 12:00 p.m. (EST) on December 15. For more information, please contact BBG Public Affairs at (202) 203-4400 or by email at pubaff@bbg.gov.

With this notice, the U.S. Department of Commerce (USDOC), on behalf of the Administration, is seeking public input to identify priority sectors in which the United States and India will pursue cooperative dialogues under the U.S.-India Strategic and Commercial Dialogue (S&CD) to address standards-related trade barriers. The aim of the cooperative dialogues is for the private sector to produce concrete recommendations for the U.S. and Indian governments on breaking down barriers related to standards, regulatory, and conformity assessment practices to increase bilateral trade. Stakeholder input will be used by the USDOC, in consultation with its interagency partners, to identify those sectors where cooperative work will yield the most benefits for bilateral trade from a U.S. perspective. The USDOC will also use stakeholder input to seek agreement from its Indian government counterparts on the sectors in which to begin cooperative work. Criteria for selection include: The nature of the existing standards-related barriers in the sector (medical devices, ICT products, oil and gas, etc.), including whether the standards related measures that are affecting bilateral trade are subject to regulatory discretion or have limited potential for adjustment due to legislated mandates; the relative estimated trade impact of eliminating the standards-related barriers in the sector; and whether private sector representatives from the sectorboth U.S. and Indianare committed to leading a cooperative dialogue to produce concrete recommendations for the U.S. and Indian governments on breaking down barriers in the sector. Selection will also take into account the willingness of U.S. and Indian regulators to become involved in this targeted work, as well as if another bilateral forum relevant to the suggested issue already exists. In order for a sector to be considered, stakeholder input must identify private-sector leaders from the United States and India that have mutually agreed to coordinate and lead a cooperative dialogue among stakeholders in the sector from both the United States and India to develop recommendations for the U.S. and Indian governments on breaking down standards-related barriers in their sector. Confirmation of such agreement is encouraged. See additional requirements for submissions in the contents below. The private sector cooperative dialogue leaders from the selected priority sectors are expected to begin work as early as possible in 2016 and to report their preliminary recommendations to the U.S. and Indian governments at the next meeting of the U.S.-India S&CD, expected to take place in India in mid-2016. At the discretion of the U.S. and Indian private sector cooperative dialogue leads, U.S. and Indian government officials will be available to provide information to facilitate the development of private sector recommendations. Selection of future priority sectors will be evaluated on the basis of the performance of the cooperative dialogues in the initially selected priority sectors.

This notice sets forth the schedule and proposed agenda of a meeting of the Environmental Technologies Trade Advisory Committee (ETTAC).

The Department of Commerce (``the Department'') is conducting the tenth administrative review (``AR'') of the antidumping duty order on wooden bedroom furniture (``WBF'') from the People's Republic of China (``PRC''). The period of review (``POR'') is January 1, 2014, through December 31, 2014. We invite interested parties to comment on these preliminary results.

We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications for recovery permits to conduct activities with the purpose of enhancing the survival of endangered species. The Endangered Species Act of 1973, as amended (Act), prohibits certain activities with endangered species unless a Federal permit allows such activity. The Act also requires that we invite public comment before issuing such permits.

An application for a right-of-way across the Western (Kobuk River) unit of Gates of the Arctic National Preserve has been filed by the Alaska Industrial Development and Export Authority with the National Park Service, pursuant to and consistent with section 1104(b) and (c) of the Alaska National Interest Lands Conservation Act (Pub. L. 96-487). In accordance with section 201(4)(c) of the Alaska National Interest Lands Conservation Act, the National Park Service is giving notice and providing for a thirty-day period for other parties to apply for access across the preserve. Potential applicants for such access need to contact the National Park Service (see the contact information provided below) to obtain the requirements for filing an application for access.

The Department of Commerce (the Department) has completed its administrative review of the countervailing duty (CVD) order on citric acid and certain citrate sales from the People's Republic of China (PRC) for the period January 1, 2013, through December 31, 2013. On June 8, 2015, the Department published in the Federal Register the Preliminary Results of this administrative review.\1\ We completed the Post-Preliminary Results in this administrative review on June 26, 2015.\2\

This final rule addresses recommendations submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board (NOSB) following their October 2014 meeting. These recommendations pertain to the 2015 Sunset Review of substances on the U.S. Department of Agriculture's (USDA) National List of Allowed and Prohibited Substances (National List). Consistent with the recommendations from the NOSB, this final rule removes two nonorganic agricultural substances from the National List for use in organic handling, fortified cooking winesmarsala wine and sherry wine. This final rule also removes two listings for synthetic substances allowed for use in organic crop production on the National List, streptomycin and tetracycline, as their use exemptions expired on October 21, 2014.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.