December 15, 2015 – Federal Register Recent Federal Regulation Documents

The National Labor Relations Board published a document in the Federal Register of November 25, 2015, giving notice that certain named individuals had been appointed to serve as members of performance review boards in the National Labor Relations Board for the rating year beginning October 1, 2014 and ending September 30, 2015. The document failed to list one of the individuals so appointed.

The U.S. Copyright Office is undertaking a study at the request of Congress to review the role of copyright law with respect to software-enabled consumer products. The topics of public inquiry include whether the application of copyright law to software in everyday products enables or frustrates innovation and creativity in the design, distribution and legitimate uses of new products and innovative services. The Office also is seeking information as to whether legitimate interests or business models for copyright owners and users could be improved or undermined by changes to the copyright law in this area. This is a highly specific study not intended to examine or address more general questions about software and copyright protection.

The FAA is issuing this notice to advise the public of the Sixth RTCA Special Committee 230 meeting.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices.'' This leapfrog guidance document was developed to notify manufacturers of the recommended non-clinical and clinical studies to support a premarket approval application (PMA) for implantable MIGS devices.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry.'' The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps with recommendations for testing living donors for West Nile Virus (WNV). The draft guidance recommends the use of an FDA- licensed nucleic acid test (NAT) to test living donors of HCT/Ps for evidence of infection with WNV. The guidance does not provide recommendations regarding testing of cadaveric HCT/P donors for WNV. The draft guidance replaces the draft guidance entitled ``Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated October 2013. The donor testing recommendations in the draft guidance, when finalized, will supplement the donor screening recommendations for WNV (which will remain in place) and supersede the ``West Nile Virus (WNV)'' section in Appendix 6 of the guidance entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated August 2007 (2007 Donor Eligibility Guidance).

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 bar code label requirements for human drug and biological products.

The Food and Drug Administration (FDA) has determined the regulatory review period for RAXIBACUMAB 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 biological product.

We, the U.S. Fish and Wildlife Service (Service), announce the reopening of the public comment period on our April 7, 2015, proposed rule to list the Big Sandy crayfish (Cambarus callainus) and the Guyandotte River crayfish (C. veteranus) as endangered species under the Endangered Species Act of 1973, as amended. We are taking this action to make the results of the 2015 summer surveys available for public review and comment. The surveys provide updated information on the two species' distribution and abundance. Comments previously submitted on the April 7, 2015, proposed rule need not be resubmitted, as they will be fully considered in preparation of the final listing determination.

The Environmental Protection Agency (EPA or the Agency) is issuing this final rule to change the name of the Office of Solid Waste and Emergency Response (OSWER) to the Office of Land and Emergency Management (OLEM). This action is being taken to more accurately reflect the nature of the work that this office does to protect human health and the environment. In addition, technical corrections are made to more accurately state the laws implemented previously by OSWER (now OLEM), and to reflect prior organizational changes.

Publication of the Unified Agenda of Regulatory and Deregulatory Actions and the Regulatory Plan represent key components of the regulatory planning mechanism prescribed in Executive Order 12866, ``Regulatory Planning and Review'' (58 FR 51735) and incorporated in Executive Order 13563, ``Improving Regulation and Regulatory Review'' issued on January 18, 2011 (76 FR 3821). The fall editions of the Unified Agenda include the agency regulatory plans required by E.O. 12866, which identify regulatory priorities and provide additional detail about the most important significant regulatory actions that agencies expect to take in the coming year. In addition, the Regulatory Flexibility Act requires that agencies publish semiannual ``regulatory flexibility agendas'' describing regulatory actions they are developing that will have significant effects on small businesses and other small entities (5 U.S.C. 602). The Unified Agenda of Regulatory and Deregulatory Actions (Unified Agenda), published in the fall and spring, helps agencies fulfill all of these requirements. All federal regulatory agencies have chosen to publish their regulatory agendas as part of this publication. The complete Unified Agenda and Regulatory Plan can be found online at https://www.reginfo.gov and a reduced print version can be found in the Federal Register. Information regarding obtaining printed copies can also be found on the Reginfo.gov Web site (or below, VI. How Can Users Get Copies of the Plan and the Agenda?). The fall 2015 Unified Agenda publication appearing in the Federal Register consists of The Regulatory Plan and agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act. The complete fall 2015 Unified Agenda contains the Regulatory Plans of 30 Federal agencies and 59 Federal agency regulatory agendas.