September 2018 – Federal Register Recent Federal Regulation Documents

Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``East Meets West: Jewels of the Maharajas from the Al Thani Collection,'' 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 Fine Arts Museums of San Francisco, Legion of Honor Museum, San Francisco, California, from on or about November 3, 2018, until on or about February 24, 2019, 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 is hereby given of the following determinations: I hereby determine that two objects to be included in exhibitions of the Keir Collection of Art of the Islamic World, re-imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are re-imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the first object at the Dallas Museum of Art, in Dallas, Texas, and at possible additional exhibitions or venues yet to be determined, from on or about September 21, 2018, until on or about May 4, 2020, is in the national interest. I also determine that the exhibition or display of the second object at the Dallas Museum of Art, and at possible additional exhibitions or venues yet to be determined, from on or about September 21, 2018, until on or about October 13, 2020, is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Maritime Illness Database and Reporting System (MIDRS)''. The purpose of this data collection is to provide U.S.-bound passenger vessel operators an electronic reporting system to assist with their legal requirement to notify CDC of the number of passengers and crew members onboard their ship who have reportable acute gastroenteritis (AGE) as defined by federal quarantine regulations.

Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``Underworld: Imagining the Afterlife,'' 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 J. Paul Getty Museum at the Getty Villa, Los Angeles, California, from on or about October 31, 2018, until on or about March 18, 2019, 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.

The Department of State and the Office of the United States Trade Representative (USTR) are providing notice that the United States and Panama intend to hold the second meetings of the Environmental Affairs Council (the ``Council'') and the Environmental Cooperation Commission (the ``Commission'') on October 3, 2018. The public sessions for the Council and Commission will be held on October 3, 2018, in Panama City, Panama. The purpose of the meetings is to review implementation of Chapter 17 (Environment) of the United States-Panama Trade Promotion Agreement (TPA) and the United States-Panama Environmental Cooperation Agreement (ECA). The Department of State and USTR invite interested organizations and members of the public to attend the public sessions and to submit written comments or suggestions regarding topics to be discussed at the meetings. If you would like to attend the public session, please notify Neal Morris and Laura Buffo at the email addresses listed below under the heading ADDRESSES. Please include your full name and any organization or group you represent. In preparing comments, submitters are encouraged to refer to: Chapter 17 of the TPA, https://ustr.gov/sites/default/ files/uploads/agreements/fta/panama/asset_upload_file314_1040 0.pdf; and the ECA https://www.state.gov/documents/organization/ 189455.pdf. These and other useful documents are available at https://ustr.gov/ trade-agreements/free-trade-agreements/panama-tpa and at https:// www.state.gov/e/oes/eqt/trade/panama/index.htm.

This notice announces actions taken by TxDOT and Federal agencies that are final. The environmental review, consultation, and other actions required by applicable Federal environmental laws for these projects are being, or have been, carried-out by TxDOT and a Memorandum of Understanding dated December 16, 2014, and executed by FHWA and TxDOT. The actions relate to various proposed highway projects in the State of Texas. Those actions grant licenses, permits, and approvals for the projects.

We, the U.S. Fish and Wildlife Service (Service), announce a teleconference/web meeting of the Aquatic Nuisance Species (ANS) Task Force, in accordance with the Federal Advisory Committee Act. The ANS Task Force's purpose is to develop and implement a program for U.S. waters to prevent introduction and dispersal of aquatic invasive species; to monitor, control, and study such species; and to disseminate related information.

This public notice provides information on how to apply for the DV-2020 Program and is issued pursuant to the Immigration and Nationality Act.

The Coast Guard is establishing a temporary safety zone for certain navigable waters of the Lower Mississippi River. This action is necessary to provide for the safety of persons, vessels, and the marine environment on these navigable waters near New Orleans, LA, during a fireworks display on October 6, 2018. This regulation prohibits persons and vessels from being in the safety zone unless authorized by the Captain of the Port Sector New Orleans or a designated representative.

The U.S. Nuclear Regulatory Commission (NRC) invites public comment on this proposed collection of information. The information collection is entitled, ``NRC Form 361, Reactor Plant Event Notification Worksheet; NRC Form 361A, Fuel Cycle and Materials Event Notification Worksheet; NRC Form 361N, Non-Power Reactor Event Notification Worksheet.''

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and review staff entitled ``Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.'' This draft guidance describes the fundamental values and operational principles that serve as the foundation for the review process. It also clarifies the roles and responsibilities of review staff and identifies ways in which applicants may support a robust and efficient review process. This draft guidance revises the guidance for review staff and industry entitled ``Good Review Management Principles and Practices for PDUFA Products'' issued April 2005.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.

New York has scheduled a special general election on November 6, 2018, to fill the U.S. House of Representatives seat in the 25th Congressional District of the late Representative Louise Slaughter. Committees required to file reports in connection with the Special General Election on November 6, 2018, shall file a 12-day Pre-General Report, and a 30-day Post-General Report.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect Whole Blood and blood components, including Source Plasma, with recommendations for further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus (anti-HCV). The draft guidance also provides guidance to blood establishments on how to report the implementation of these recommendations. The draft guidance, when finalized, will update the recommendations related to the use of an appropriate multiantigen supplemental test contained in ``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV'' dated December 2010.

Pursuant to provisions under Title IV of the Jobs Through Trade Expansion Act, and under the Federal Advisory Committee Act, the Department of Commerce announces the reestablishment of the Environmental Technologies Trade Advisory Committee (ETTAC), as of August 16, 2018. ETTAC was first chartered on May 31, 1994. ETTAC serves as an advisory body to the Environmental Trade Working Group of the Trade Promotion Coordinating Committee (TPCC), reporting directly to the Secretary of Commerce in his/her capacity as Chairman of the TPCC. ETTAC advises on the development and administration of policies and programs to expand U.S. exports of environmental technologies, goods, and services.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for review of drug or biological products when those applications use a tropical disease priority review voucher. These vouchers are awarded to the applicants of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee submitted to FDA with applications using a tropical disease priority review voucher is determined each fiscal year based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the tropical disease priority review fee rate for FY 2019.

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 collection of information associated with adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA).

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 this notice. This notice solicits comments on the collection of information contained in the Public Health Service (PHS) guideline entitled ``PHS Guideline on Infectious Disease Issues in Xenotransplantation'' dated January 19, 2001.