December 12, 2019 – Federal Register Recent Federal Regulation Documents
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Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT ORAL SOLUTION, New Drug Application 205838
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRIVIACT ORAL SOLUTION 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT ORAL TABLETS, New Drug Application 205836
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRIVIACT ORAL TABLETS 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT INJECTION New Drug Application 205837
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRIVIACT INJECTION 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.
Agency Information Collection Activities: Information Collection Renewal; Comment Request; Extensions of Credit to Insiders and Transactions With Affiliates
The OCC, 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 continuing information collection, as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning its information collection titled, ``Extensions of Credit to Insiders and Transactions with Affiliates.''
Agency Information Collection Activities: Information Collection Renewal; Comment Request; Financial Management Policies-Interest Rate Risk
The OCC, 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 continuing information collection as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning renewal of its information collection titled, ``Financial Management PoliciesInterest Rate Risk,'' which is applicable only to Federal savings associations.
Agency Information Collection Activities: Information Collection Renewal; Comment Request; Guidance on Sound Incentive Compensation Policies
The OCC, 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 the renewal of an information collection as required by the Paperwork Reduction Act of 1995 (PRA). An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning renewal of an information collection titled, ``Guidance on Sound Incentive Compensation Policies.''
Petition for Exemption; Summary of Petition Received; Daniel Orcutt
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations
In this advance notice of proposed rulemaking (ANPRM), the U.S. Environmental Protection Agency (EPA) is soliciting information that will aid in potential future revisions to the Ethylene Oxide Emission Standards for Sterilization Facilities. The EPA is soliciting information and requesting comment on potential control measures for reducing ethylene oxide (EtO) emissions from commercial sterilization facilities. These control measures include controls for fugitive emissions of EtO, safety measures for the chamber exhaust vents (CEVs), process equipment improvements, and advances in add-on control technologies for point sources. In addition, the EPA is considering, and requesting comment on, how best to assess potential impacts on small businesses. The EPA is also taking comment on the available EtO usage data for individual facilities and on additional data contained in the modeling file that will be used to evaluate the impact of emissions from commercial EtO sterilizers.
Submission for Review: Survey on Practices and Policies Related to the Treatment of Opioid Use Disorders
In accordance with the Paperwork Reduction Act of 1995, the Office of National Drug Control Policy (ONDCP) announces it will submit to the Office of Management and Budget (OMB) and Office of Information and Regulatory Affairs (OIRA) an information collection request. This proposed information collection was previously published in the Federal Register of October 8, 2019 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Petroleum Refineries in Foreign Trade Sub-Zones
The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies.
Agency Information Collection Activities: Prior Disclosure
The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies.
Certain Hot-Rolled Steel Flat Products From the Republic of Korea: Preliminary Results of Countervailing Duty Administrative Review, 2017
The Department of Commerce (Commerce) preliminarily finds that Hyundai Steel Co., Ltd. (Hyundai Steel), a producer/exporter of certain hot-rolled steel flat products (hot-rolled steel) from the Republic of Korea (Korea), received countervailable subsidies that are de minimis. The period of review (POR) is January 1, 2017 through December 31, 2017. We invite interested parties to comment on these preliminary results.
1-Hydroxyethylidene-1, 1-Diphosphonic Acid From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2016-2018
The Department of Commerce (Commerce) finds that exporters of 1-Hydroxyethylidene-1, 1-Diphosphonic Acid (HEDP) from the People's Republic of China (China) sold subject merchandise in the United States at prices below normal value during the period of review (POR) November 4, 2016 through April 30, 2018.
Fisheries of the Gulf of Mexico and the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Public Meeting
The SEDAR 64 assessment process of Gulf of Mexico and South Atlantic yellowtail snapper will consist of a Data Workshop, and a series of assessment webinars, and a Review Workshop. See SUPPLEMENTARY INFORMATION.
Fisheries of the Gulf of Mexico and South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Public Meeting
The SEDAR 68 assessment of Gulf of Mexico and Atlantic scamp will consist of a Data workshop, a series of assessment webinars, and a Review workshop. See SUPPLEMENTARY INFORMATION.
Submission for Review: Survey on the Treatment of Opioid Use Disorders
In accordance with the Paperwork Reduction Act of 1995, the Office of National Drug Control Policy (ONDCP) announces it will submit to the Office of Management and Budget (OMB) and Office of Information and Regulatory Affairs (OIRA) an information collection request. This proposed information collection was previously published in the Federal Register of October 8, 2019 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
State, Local, Tribal, and Private Sector Policy Advisory Committee (SLTPS-PAC); Meeting
We are announcing an upcoming meeting of the State, Local, Tribal, and Private Sector Policy Advisory Committee (SLTPS-PAC).
Deepwater Port Pre-Application Meeting Guidance
The Maritime Administration (MARAD) and the United States Coast Guard (USCG) encourage parties planning to submit an application for a license to own, construct, and operate a deepwater port under the Deepwater Port Act of 1974 (DWPA) to meet with MARAD and USCG staff at least six months in advance of submitting an application in order to provide an overview of their proposed project, to discuss the details of the federal and state application and licensing process, and to introduce key personnel. As the application is developed, additional status meetings/work sessions prior to submittal are also encouraged to review progress and to address questions. At least two weeks prior to application submittal, the applicant and the USCG selected third party environmental contractor should meet with MARAD and USCG in a final pre-application project kick-off meeting to ensure all parties understand the project, review process, and roles and responsibilities, and are prepared for the application distribution for completeness review and scoping preparation. The contents of this policy notice do not have the force and effect of law and are not meant to bind the public in any way. This document is intended only to provide clarity to the public regarding agency policy.
Notice of OFAC Sanctions Actions
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (the SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them. OFAC is also publishing an update to the identifying information of persons currently included in the SDN List.
Notice of OFAC Sanctions Actions
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
60-Day Notice of Intent To Seek Extension of Approval: System Diagram Maps
As required by the Paperwork Reduction Act of 1995 (PRA), the Surface Transportation Board (STB or Board) gives notice of its intent to seek approval from the Office of Management and Budget (OMB) for an extension of the collection of system diagram maps, described below.
60-Day Notice of Intent to Seek Extension of Approval: Rail Depreciation Studies
As required by the Paperwork Reduction Act of 1995 (PRA), the Surface Transportation Board (STB or Board) gives notice of its intent to seek approval from the Office of Management and Budget (OMB) for an extension of the collection of Rail Depreciation Studies, described below.
60-Day Notice of Intent To Seek Extension of Approval: Arbitration “Opt-In” Notices
As required by the Paperwork Reduction Act of 1995 (PRA), the Surface Transportation Board (STB or Board) gives notice of its intent to seek approval from the Office of Management and Budget (OMB) for an extension of the collection of Arbitration ``Opt-in'' Notices, described below.
60-Day Notice of Intent To Seek Extension of Approval: Information Collection Activities-Recordations (Rail and Water Carrier Liens), Water Carrier Tariffs, and Agricultural Contract Summaries
As required by the Paperwork Reduction Act of 1995 (PRA), the Surface Transportation Board (STB or Board) gives notice of its intent to seek approval from the Office of Management and Budget (OMB) for an extension of the collection required by statute for rail or water carrier equipment liens (recordations), water carrier tariffs, and rail agricultural contract summaries, as described in more detail below.
Agency Information Collection Activities; Comment Request; Formula Grant EASIE Electronic Application System for Indian Education
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Proposed Extension of Information Collection Request Submitted for Public Comment; Comment Request Relating to Constructive Transfers and Transfers of Property to a Third Party on Behalf of a Spouse
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the 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. Currently, the IRS is soliciting comments concerning the requirements relating to the constructive transfers and transfers of property to a third party on behalf of a spouse.
Proposed Information Collection; Comment Request; National Oceanic and Atmospheric Administration, Office of Education, Educational Partnership Program (EPP) and Ernest F. Hollings Undergraduate Scholarship Program
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Proposed Information Collection; Comment Request; Report of Requests for Restrictive Trade Practice or Boycott
The Department of Commerce, 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.
Proposed Information Collection; Comment Request; Foreign Availability Procedures
The Department of Commerce, 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.
Crystalline Silicon Photovoltaic Cells, Whether or Not Partially or Fully Assembled Into Other Products; Monitoring Developments in the Domestic Industry; Amendment
The Commission published a noticed in the Federal Register on August 1, 2019, concerning the institution and scheduling of investigation no. TA-201-75 (Monitoring) pursuant to section 204(a)(2) of the Trade Act of 1974 on its monitoring of developments in the domestic industry following the President's decision to impose a safeguard measure on imports of certain crystalline silicon photovoltaic (``CSPV'') cells, whether or not partially or fully assembled into other products (including, but not limited to, modules, laminates, panels, and building-integrated materials)(``CSPV products''), as described in Proclamation 9693 of January 23, 2018. 84 FR 37674. This amended notice provides for limits on page lengths for posthearing briefs.
Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: “Myaamia Ribbonwork” Exhibition
Notice is hereby given of the following determinations: I hereby determine that certain objects to be exhibited in the exhibition ``Myaamia Ribbonwork'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit objects at the Miami University Art Museum, in Oxford, Ohio, from on or about January 28, 2020, until on or about June 13, 2020, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.
Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: “Degas at the Opera” Exhibition
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``Degas at the Opera,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the National Gallery of Art, Washington, District of Columbia, from on or about March 1, 2020, until on or about July 5, 2020, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.
Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978
The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act in the Code of Federal Regulations. This is the required notice of permit applications received.
Agency Information Collection Activities: Proposed Collection; Comment Request; Monitoring Bank Secrecy Act Compliance
The National Credit Union Administration (NCUA), as part of a continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the following extension of a currently approved collection, as required by the Paperwork Reduction Act of 1995.
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