January 2017 – Federal Register Recent Federal Regulation Documents

The Federal Transit Administration (FTA) has placed in the docket and on its Web site guidance in the form of FTA Circular 5010.1E, ``Award Management Requirements,'' to facilitate implementation of FTA's assistance programs. The final Circular updates the ``Grant Management Requirements'' Circular 5010.1D to reflect various changes in the law, as well as FTA's transition to a new electronic award management system.

The Food and Drug Administration (FDA or we) is extending the comment period for the notice of availability of a draft guidance entitled ``Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition'' that appeared in the Federal Register of November 23, 2016. The draft guidance, when finalized, will describe our views on the scientific evidence needed and the approach to evaluating the scientific evidence on the physiological effects of isolated or synthetic non-digestible carbohydrates that are added to foods that are beneficial to human health. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance for industry entitled ``Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.'' This revised draft guidance describes the conditions under which FDA does not intend to take action against a State-licensed pharmacy, a Federal facility, or an outsourcing facility that mixes, dilutes, or repackages certain biological products outside the scope of an approved biologics license application (BLA). It also describes the conditions under which FDA does not intend to take action when a State-licensed pharmacy, a Federal facility, an outsourcing facility, or a physician prepares prescription sets of allergenic extracts for subcutaneous immunotherapy. This revised draft guidance for industry replaces the draft guidance for industry of the same title issued in February 2015.

Recognizing the vital importance of the Internet to U.S. innovation, prosperity, education, and civic and cultural life, the Department of Commerce (Department) has made it a top priority to encourage growth of the digital economy and ensure that the Internet remains an open platform for innovation. Thus, as part of the Department's Digital Economy Agenda, the National Telecommunications and Information Administration (NTIA) issued a green paper ``Fostering the Advancement of the Internet of Things'' that lays out an approach and areas of engagement for the Department's possible future work on the Internet of Things (IoT). Through this Notice, NTIA seeks broad input from all interested stakeholdersincluding the private industry, researchers, academia, and civil societyon the issues and proposed approach, current initiatives, and next steps laid out in this paper. These comments will help inform Department leadership on possible future Department action regarding IoT.

This notice announces that the Assessment Tool developed by HUD for use by Public Housing Agencies receiving assistance under the United States Housing Act of 1937 has completed the notice and comment process required by the Paperwork Reduction Act (PRA), been reviewed by the Office of Management and Budget and approved. While this Assessment Tool has been approved, this Notice does not trigger the obligation of PHAs to conduct and submit an AFH in accordance with 24 CFR 5.160, as HUD has not yet provided PHAs with the data they will need. As HUD makes data available for certain PHAs, HUD will publish, in the Federal Register, a Notice announcing the availability of data for certain PHAs, triggering their obligation to conduct and submit an AFH, and will post such Notice on the HUD Exchange. HUD also anticipates that, at that time, the online User Interface will be available for use by PHAs. Until such time that PHAs are required to conduct and submit an AFH, HUD notes that PHAs must continue to comply with existing fair housing and civil rights requirements. This Assessment Tool, referred to as the PHA Assessment Tool, was modeled on the Local Government Assessment Tool, first approved by OMB on December 31, 2015 but with modifications to address the different public housing and Housing Choice Voucher operations that PHAs have compared to local governments, and how fair housing planning may be undertaken by PHAs in a meaningful manner. As with the Local Government Assessment Tool, the PHA Assessment Tool allows for collaboration with other PHAs. To reduce burden for PHAs, HUD has increased the threshold for the insert from QPHAs that have 550 units or less to PHAs with 1,250 or fewer combined public housing and HCV units. HUD has also committed to developing an additional Assessment Tool specifically for use by Qualified PHAs (QPHAs) who conduct and submit an individual AFH or collaborate with other QPHAs to conduct and submit a joint AFH to be issued in 2017. Therefore, this PHA Assessment Tool will be for use by PHAs submitting AFHs individually or jointly, and for collaborations among PHAs with 1,250 or fewer units and with PHAs with more than 1,250 units. In addition, to reduce burden further, this Assessment Tool includes an insert with streamlined questions for PHAs with 1,250 or fewer units to use if jointly submitting with PHA with more than 1,250 units. In addition, this Assessment Tool includes revised instructions based on public comments received during the 30-day PRA review that provide more guidance to PHAs in conducting the AFH, including how the regional analysis is to be prepared based on the location of a PHA's geographic region and program type. Through the notice and comment process required by the PRA, HUD made changes to the PHA Assessment Tool from the 30-day notice published in the Federal Register on August 23, 2016.

The Bureau of Indian Affairs (BIA) has updated its Fee-to- Trust Handbook to include procedural guidance for its employees on processing reservation proclamations, including simultaneous requests for trust acquisition and reservation proclamations.

The Federal Aviation Administration published a document in the Federal Register of January 9, 2017, concerning the Tenth RTCA SC- 229 406 MHz ELT Plenary Joint with WG-98. The document contained the incorrect location.

The Environmental Protection Agency has submitted an information collection request (ICR), ``Performance Evaluation Studies on Wastewater Laboratories (Renewal)'' (EPA ICR No. 0234.12, OMB Control No. 2080-0021) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through March 31, 2017. Public comments were previously requested via the Federal Register (81 FR 44017) on July 6, 2016 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Multiple Endpoints in Clinical Trials.'' This draft guidance provides sponsors and review staff with the Agency's thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products. Most clinical trials performed in drug development contain multiple endpoints to assess the effects of the drug and to document the ability of the drug to favorably affect one or more disease characteristics. The purpose of this guidance is to describe various strategies for grouping and ordering endpoints for analysis and applying some well- recognized statistical methods for managing multiplicity within a study to control the chance of making erroneous conclusions about a drug's effects.

This Notice announces the establishment of FRA's emergency relief docket (ERD) for calendar year 2017. The designated ERD for calendar year 2017 is Docket Number FRA-2017-0001.

This action adds products and a service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and a service from the Procurement List previously furnished by such agencies.

The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption in response to an October 13, 2016, letter from Duke Energy Progress (DEP). On May 2, 2013, DEP requested that the NRC suspend review of its combined license (COL) application until further notice. On October 13, 2016, DEP requested an exemption from certain regulatory requirements which, if granted, would allow them to revise their COL application for Shearon Harris Nuclear Plant (Harris) Units 2 and 3 in order to address enhancements to the Emergency Preparedness (EP) rules by December 31, 2019, rather than by December 31, 2016, as the regulations currently require. The NRC staff reviewed this request and determined that it is appropriate to grant the exemption to the EP update requirements until December 31, 2019, but stipulated that the updates to the Final Safety Analysis Report must be submitted prior to requesting the NRC resume its review of the COL application, or by December 31, 2019, whichever comes first.

The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption to allow a departure from the certification information of Tier 1 of the generic design control document (DCD) and is issuing License Amendment No. 63 to Combined Licenses (COL), NPF-91 and NPF-92. The COLs were issued to Southern Nuclear Operating Company, Inc., and Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC, MEAG Power SPVJ, LLC, MEAG Power SPVP, LLC, Authority of Georgia, and the City of Dalton, Georgia (the licensee); for construction and operation of the Vogtle Electric Generating Plant (VEGP) Units 3 and 4, located in Burke County, Georgia. The granting of the exemption allows the changes to Tier 1 information asked for in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.

The Committee is proposing to add products and a service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products previously furnished by such agencies.

The Federal Emergency Management Agency, 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 a revision of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the collection of information related to the flood insurance claims process.

The U.S. Department of Energy (DOE) is designing a consent- based siting process to establish an integrated waste management system to transport, store, and dispose of commercial spent nuclear fuel and high-level radioactive waste. In a consent-based siting approach, DOE will work with communities, tribal governments and states across the country that express interest in hosting federal consolidated interim storage facilities and disposal facilities for spent nuclear fuel and high-level radioactive waste as part of an integrated waste management system. The Department is seeking input on the Draft Consent-Based Siting Process for Consolidated Storage and Disposal Facilities for Spent Nuclear Fuel and High-Level Radioactive Wastes.

On December 16, 2016, the Department of Commerce (``Department'') published a notice of initiation of an administrative review of the antidumping duty order on steel wire garment hangers from the People's Republic of China (``PRC''). Based on M&B Metal Products Co., Ltd.'s (``Petitioner'') timely withdrawal of the requests for review of certain companies, we are now rescinding this administrative review with respect to 42 companies.

The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.

We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications for a permit to conduct activities intended to enhance the survival of endangered or threatened species. Federal law prohibits certain activities with endangered species unless a permit is obtained.