Caribbean Fishery Management Council; Public Meetings
The Caribbean Fishery Management Council's Scientific and Statistical Committee (SSC) will hold a five-day meeting in San Juan, Puerto Rico.
Mid-Atlantic Fishery Management Council (MAFMC); Public Meetings
The Mid-Atlantic Fishery Management Council (Council) will hold public meetings of the Council and its Committees.
Granular Polytetrafluoroethylene Resin From Italy: Rescission of Antidumping Duty Administrative Review; 2015-2016
The Department of Commerce (the Department) is rescinding the administrative review of the antidumping duty order on granular polytetrafluoroethylene (PTFE) resin from Italy, for the period of review (POR) August 1, 2015, through July 18, 2016, based on the timely withdrawal of request for review by Polis S.r.l., (Polis).
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Award Management Requirements: Availability of Final Circular
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.
Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request For Scientific Data, Information, and Comments; Reopening of Comment Period
The Food and Drug Administration (FDA or we) is reopening the comment period for the document requesting scientific data, information, and comments entitled ``Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates'' that appeared in the Federal Register of November 23, 2016 (81 FR 84595). In the document, we requested scientific data, information, and comments to help us determine whether a particular isolated or synthetic non-digestible carbohydrate should be added to our definition of ``dietary fiber'' for purposes of being declared as dietary fiber on a Nutrition Facts or Supplement Facts label. We also announced in the document the availability for comment of a scientific literature review document that we conducted that summarizes clinical studies associated with 26 specific isolated or synthetic non- digestible carbohydrates. We are taking this action in response to requests to allow interested persons additional time to submit comments.
Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry; Extension of Comment Period
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.
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities; Final Guidance for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled ``Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.'' This guidance describes the conditions under which FDA does not intend to take action for violations of certain provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), when a State-licensed pharmacy, a Federal facility, or an outsourcing facility repackages certain human drug products.
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry; Availability
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.
Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry and other stakeholders entitled ``Emergency Use Authorization of Medical Products and Related Authorities.'' The purpose of this guidance is to explain FDA's current thinking on the authorization of the emergency use of certain medical products under certain sections of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended or added by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). The provisions in PAHPRA include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats.
The Benefits, Challenges, and Potential Roles for the Government in Fostering the Advancement of the Internet of Things
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.
Affirmatively Furthering Fair Housing: Announcement of Renewal of Approval of the Assessment Tool for Local Governments
This notice announces that the Office of Management and Budget (OMB) has approved HUD's request to renew for approval under the Paperwork Reduction Act (PRA), the Assessment Tool developed by HUD for use by local governments that receive Community Development Block Grants (CDBG), HOME Investment Partnerships Program (HOME), Emergency Solutions Grants (ESG), or Housing Opportunities for Persons with AIDS (HOPWA) formula funding from HUD when conducting and submitting their own Assessment of Fair Housing (AFH). This Assessment Tool, referred to as the Local Government Assessment Tool, is used for AFHs conducted by joint and regional collaborations between: (1) Such local governments; (2) one or more such local governments with one or more public housing agency (PHA) partners, including qualified PHAs (QPHAs); and (3) other collaborations in which such a local government is designated as the lead for the collaboration. Through the notice and comment process required by the PRA, HUD did make changes to the Local Government Assessment Tool approved by OMB in 2015. HUD's Web page at https:// www.hudexchange.info/programs/affh/ highlights the differences between the 2015 Local Government Assessment Tool and this 2016 Local Government Assessment Tool. This notice also highlights significant issues raised by commenters on the 30-day notice published in the Federal Register on August 23, 2016.
Affirmatively Furthering Fair Housing Assessment Tool for Public Housing Agencies: Announcement of Final Approved Document
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.
North Carolina Disaster Number NC-00086
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of North Carolina (FEMA-4285-DR), dated 11/10/2016. Incident: Hurricane Matthew. Incident Period: 10/04/2016 through 10/24/2016. Effective Date: 01/04/2017. Physical Loan Application Deadline Date: 01/09/2017. Economic Injury (EIDL) Loan Application Deadline Date: 08/10/2017.
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.
Tenth RTCA SC-229 406 MHz ELT Plenary Joint With WG-98; Correction
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Information Collection for Importation of On-Highway Vehicles and Motorcycles and Nonroad Engines, Vehicles, and Equipment
The Environmental Protection Agency has submitted an information collection request (ICR), ``Importation of On-highway Vehicles and Motorcycles and Nonroad Engines, Vehicles, and Equipment'' EPA ICR Number 2583.01, OMB Control Number 2060-NEW 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 new ICR is the consolidation of two individual ICRS that are currently approved by OMB. EPA currently has an approved collection that covers the information requirements for importation of on-highway vehicles which expires on February 28, 2017 (OMB Control Number 2060-0095, ICR Number 0010.14). EPA also has an approved collection for information requirements for importation of nonroad engines and recreational vehicles (OMB Control Number 2060-0320, ICR Number 1723.07), which expires February 28, 2017. Public comments were requested via the Federal Register on September 16, 2016 (81 FR 63758) 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.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Performance Evaluation Studies on Wastewater Laboratories (Renewal)
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.
Safety zone; Tennessee River, Mile 446.0 to 454.5
The Coast Guard proposes to establish a safety zone for all waters of the Tennessee River, beginning at mile marker 446.0 and ending at mile marker 454.5 during periods of high water flow. High water flow is determined by flow rates that have reached or exceeded 100,000 cubic feet per second at Chickamauga lock and dam on the Tennessee River at mile marker 471.0. This proposed safety zone is necessary to provide safety for mariners transiting on the Tennessee River during periods of high water flow. Entry into this area will be prohibited unless specifically authorized by the Captain of the Port Ohio Valley or designated representative. We invite your comments on this proposed rulemaking.
Multiple Endpoints in Clinical Trials; Draft Guidance for Industry; Availability
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.
Nonproprietary Naming of Biological Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Nonproprietary Naming of Biological Products.'' The guidance describes our current thinking on the need for biological products previously and newly licensed under the Public Health Service Act (PHS Act) to bear nonproprietary names that include FDA-designated suffixes. Accordingly, we intend to designate nonproprietary names for originator biological products, related biological products, or biosimilar products which will include a core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters. This guidance finalizes the draft guidance issued on August 28, 2015. FDA is also 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.
Establishment of an Emergency Relief Docket for Calendar Year 2017
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.
Certain Magnesia Carbon Bricks From the People's Republic of China: Rescission of Countervailing Duty Administrative Review; 2014
On September 13, 2016, the Department of Commerce (the Department) published the preliminary results of the administrative review of the countervailing duty (CVD) order on certain chemically- bonded magnesia carbon bricks (MCBs) from the People's Republic of China (PRC). The period of review (POR) is January 1, 2014, through December 31, 2014. The Department preliminarily found no evidence of any reviewable entries and received no comments on the preliminary results. Therefore, the Department is rescinding the administrative review of the CVD order on MCBs from the PRC.
Procurement List; Additions and Deletions
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.
General Services Administration Acquisition Regulation; Information Collection; Industrial Funding Fee and Sales Reporting
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division is submitting a request to the Office of Management and Budget (OMB) to review and approve an extension of a previously approved information collection associated with General Services Administration Acquisition Regulation clause 552.238-74, Industrial Funding Fee and Sales Reporting. GSA uses this information to collect the Industrial Funding Fee and administer the Federal Supply Schedule (FSS) program.
Duke Energy Progress; Combined License Applications for Shearon Harris Nuclear Plant Units 2 and 3
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.
Notice of Initiating the Assessment Phase of the Forest Plan Revision for the Salmon-Challis National Forest
The Salmon-Challis National Forest, located in east central Idaho, is initiating the first phase of the forest planning process pursuant to the 2012 National Forest System Land Management Planning rule. This process will result in a revised forest land management plan (Forest Plan) which describes the strategic direction for management of forest resources on the Salmon-Challis National Forest for the next ten to fifteen years. The planning process encompasses three-stages: assessment, plan revision, and monitoring. The first stage of the planning process involves assessing ecological, social, and economic conditions of the planning area, which is documented in an assessment report. The Forest is inviting the public to contribute in the development of the Assessment. The Forest will be hosting public forums near the end of February into early March 2017 with a second set of meetings forthcoming in June 2017. We will invite the public to share information relevant to the assessment including existing information, current trends, and local knowledge. Public engagement opportunities associated with the development of the Assessment will be announced on the Web site cited below.
Southern Nuclear Operating Company, Inc., Vogtle Electric Generating Plant, Units 3 and 4; Debris Screen Related Dimensions
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.
Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Rescission, in Part, of Antidumping Duty Administrative Review; 2015-2016
On August 11, 2016, the Department of Commerce (Department) initiated an administrative review of the antidumping duty order on tapered roller bearings and parts thereof, finished and unfinished (TRBs) from the People's Republic of China (PRC) for eight companies. Based on timely withdrawal of requests for review, we are now rescinding this administrative review with respect to two of these companies, Changshan Peer Bearing Co. Ltd. (CPZ/SKF) and GGB Bearing Technology (Suzhou) Co., Ltd. (GGB).
Procurement List; Proposed Additions and Deletions
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.
Initiation of Antidumping and Countervailing Duty Administrative Reviews
The Department of Commerce (``the Department'') has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with November anniversary dates. In accordance with the Department's regulations, we are initiating those administrative reviews.
Agency Information Collection Activities: Proposed Collection; Comment Request; National Flood Insurance Program Claims Forms
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.
Reopening of the Period for Comments on a Preliminary Draft Convention on the Recognition and Enforcement of Foreign Judgments Currently Being Negotiated at The Hague Conference on Private International Law
The United States Patent and Trademark Office is publishing this notice to reopen the comment period provided in its notice of November 18, 2016, entitled Request for Comments and Notice of Public Meeting on a Preliminary Draft Convention on the Recognition and Enforcement of Foreign Judgments Currently Being Negotiated at the Hague Conference on Private International Law. The new deadline for public comments is January 18, 2017.