April 7, 2020 – Federal Register Recent Federal Regulation Documents

The U.S. Army Corps of Engineers (Corps), Galveston District, has received a permit application for a U.S. Department of the Army (DA) permit pursuant to Section 10 of the Rivers and Harbors Act of 1899 and Section 404 of the Clean Water Act from Dow Chemical Company (Dow) (SWG-2016-01027) for the Harris Reservoir Expansion Project (proposed Project). The proposed Project site is located between the Brazos River and Oyster Creek approximately 8 miles northwest of the City of Angleton in Brazoria County, Texas. The primary federal involvement associated with the proposed action (proposed Project) is the discharge of dredged or fill material into waters of the United States (U.S.), and the construction of structures and/or work that may affect navigable waters. Federal authorizations for the Project would constitute a major federal action. Based on the potential impacts, both individually and cumulatively, the Corps intends to prepare an environmental impact statement (EIS) in compliance with the National Environmental Policy Act (NEPA) to render a final decision on the permit applications. The Corps' decision will be to issue, issue with modification, or deny DA permits for the proposed action. The EIS will assess the potential social, economic, and environmental impacts of the construction and operation of the proposed project, and is intended to be sufficient in scope to address federal, state, and local requirements; environmental and socioeconomic issues concerning the proposed action; and permit reviews.

The U.S. Army Corps of Engineers, Galveston District (Corps), has received a permit application for a Department of the Army (DA) Permit pursuant to Section 10 of the Rivers and Harbors Act of 1899, Section 404 of the Clean Water Act, and Section 103 of the Marine Protection, Research and Sanctuaries Act from the Port of Corpus Christi Authority (PCCA) (SWG-2019-00067) for the deepening of the Corpus Christi Ship Channel (CCSC). The primary Federal involvement associated with the proposed action is the discharge of dredged or fill material into waters of the United States, the construction of structures and/or work that may affect navigable waters, and ocean disposal of dredged material. Federal authorizations for the proposed project would constitute a ``major federal action.'' Based on the potential impacts, both individually and cumulatively, the Corps intends to prepare an Environmental Impact Statement (EIS) in compliance with the National Environmental Policy Act (NEPA) to render a final decision on the permit application. The Corps' decision will be to issue, issue with modification, or deny DA permits for the proposed action. The EIS will assess the potential social, economic, and environmental impacts of the proposed project and is intended to be sufficient in scope to address Federal, State and local requirements, environmental and socioeconomic issues concerning the proposed action, and permit reviews.

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order embodied in the consent agreementthat would settle these allegations.

The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 1 to Regulatory Guide (RG) 8.39, ``Release of Patients Administered Radioactive Material.'' This RG (Revision 1) provides licensees with more detailed instructions to provide to patients before and after they have been administered radioactive material than was in Revision 0. In addition, the guide includes a new section on ``Death of a Patient Following Radiopharmaceutical or Implants Administrations,'' as well as requirements for recordkeeping. Also, Table 3, ``Activities of Radiopharmaceuticals That Require Instructions and Records When Administered to Patients Who Are Breastfeeding an Infant or Child,'' has been revised.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Board of Scientific Counselors (BSC), National Institute for Occupational Safety and Health (NIOSH), National Firefighter Registry Subcommittee. This meeting is open to the public via webcast and by teleconference. If you wish to attend by webcast or teleconference, please register at the NIOSH website https:/ /www.cdc.gov/niosh/bsc/nfrs/registration.html or call (513-841-4203) at least five business days in advance of the meeting. Adobe Connect webcast will be available at https://niosh-connect.adobeconnect.com/ nfrs/event/event_info.html for participants wanting to connect remotely, teleconference is available toll-free at (855) 644-0229, and the participant pass code is 9777483. This meeting is open to the public, limited only by the number of adobe license seats available, which is 1,000. The public is welcome to participate during the public comment period, from 11:15 a.m. to 12:00 p.m., EDT, on May 15, 2020. Please note that the public comment period ends at the time indicated above.

The Commission states that it will expeditiously review and act on requests for relief in response to the national emergency caused by COVID-19, and that it will give its highest priority to processing filings made for the purpose of assuring the business continuity of regulated entities' energy infrastructure during this extraordinary time.

The Department of Commerce (Commerce) finds that revocation of the antidumping duty order on calcium hypochlorite from the People's Republic of China (China) would be likely to lead to continuation or recurrence of dumping at the levels indicated in the ``Final Results of Sunset Review'' section of this notice.

On March 24, 2020, the U.S. Court of International Trade (CIT) sustained the Department of Commerce's (Commerce's) second remand redetermination pertaining to the less-than-fair-value (LTFV) investigation of welded line pipe (WLP) from the Republic of Korea (Korea). Commerce is notifying the public that the final judgment in this case is not in harmony with Commerce's amended final determination in the LTFV investigation of WLP from Korea and that Commerce is amending the amended final determination and antidumping duty order with respect to the weighted-average dumping margin for Hyundai HYSCO Co. Ltd. (Hyundai HYSCO).

The Department of Commerce (Commerce) determines that Jungbunzlauer Canada, Inc. (JBL Canada), a producer/exporter of citric acid and certain citrate salts (citric acid) from Canada, did not sell subject merchandise at prices below normal value (NV) during the period of review (POR) May 1, 2018 through April 30, 2019.

NMFS is holding a meeting to discuss the future management of the U.S. West Coast Pacific bluefin tuna (PBF) fishery, including management objectives and a management framework. Given recent developments related to Coronavirus/COVID-19, we have decided to reschedule this meeting originally planned for April 23, 2020. We are taking this step out of an abundance of caution to consider the safety of our visitors. The new date for this meeting is May 19, 2020.

FMCSA announces its decision to renew exemptions for 13 individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these hard of hearing and deaf individuals to continue to operate CMVs in interstate commerce.

FMCSA announces receipt of applications from 11 individuals for an exemption from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. If granted, the exemptions would enable these hard of hearing and deaf individuals to operate CMVs in interstate commerce.

FMCSA announces its decision to renew exemptions for 12 individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these hard of hearing and deaf individuals to continue to operate CMVs in interstate commerce.

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 the notice. This notice solicits comments on the information collection provisions of our recordkeeping and records access requirements for food facilities.

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division has submitted to the Office of Management and Budget (OMB) a request to review and approve a revision and renewal of a previously approved information collection requirement regarding payments to small business subcontractors.

The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on an extension, without change, of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning information collected for eligible properties insured under the National Flood Insurance Program (NFIP) policies to certify the floodproofing of residential basements.

This notification is to inform the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies the Privacy Rule under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Current regulations allow a HIPAA business associate to use and disclose protected health information for public health and health oversight purposes only if expressly permitted by its business associate agreement with a HIPAA covered entity. As a matter of enforcement discretion, effective immediately, the HHS Office for Civil Rights (OCR) will exercise its enforcement discretion and will not impose potential penalties for violations of certain provisions of the HIPAA Privacy Rule against covered health care providers or their business associates for uses and disclosures of protected health information by business associates for public health and health oversight activities during the COVID-19 nationwide public health emergency.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on January 8, 2020. The document announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of February 7, 2020. The document indicated that FDA was withdrawing approval of the following seven ANDAs after receiving a withdrawal request from CASI Pharmaceuticals, Inc., c/o Target Health, Inc., 261 Madison Ave., 24th Floor, New York, NY 10016: ANDA 073191, Triamterene and Hydrochlorothiazide Capsules USP, 50 milligrams (mg)/25 mg; ANDA 076075, Econazole Nitrate Cream, 1%; ANDA 076192, Ribavirin Capsules USP, 200 mg; ANDA 076514, Midodrine Hydrochloride (HCl) Tablets USP, 2.5 mg, 5 mg, and 10 mg; ANDA 086809, Spironolactone Tablets USP, 25 mg; ANDA 090288, Naratriptan Tablets USP, Equivalent to (EQ) 1 mg base and EQ 2.5 mg base; and ANDA 203384, Epinastine HCl Ophthalmic Solution, 0.05%. Before FDA withdrew the approval of these ANDAs, CASI Pharmaceuticals, Inc., informed FDA that it did not want the approval of the ANDAs withdrawn. Because CASI Pharmaceuticals, Inc., timely requested that approval of these ANDAs not be withdrawn, the approval of ANDAs 073191, 076075, 076192, 076514, 086809, 090288, and 203384 is still in effect.

The U.S. Nuclear Regulatory Commission (NRC) is issuing an order approving the transfer to ADP CR3, LLC (ADP CR3) of the licensed authority of Duke Energy Florida, LLC (DEF) under Facility Operating License No. DPR-72 for the Crystal River Unit 3 Nuclear Generating Plant (CR-3) and the general license for the CR-3 independent spent fuel storage installation (ISFSI) to possess, maintain, and decommission CR-3 and its ISFSI. The order also approves a draft conforming administrative license amendment to reflect the transfer from DEF to ADP CR3. The NRC determined that ADP CR3 is qualified to hold the licenses to the extent proposed, and that the transfer is otherwise consistent with applicable provisions of law, regulations, and orders issued by the Commission pursuant thereto, subject to the condition described in the order. The order became effective on April 1, 2020.