August 20, 2020 – Federal Register Recent Federal Regulation Documents

Proposal to extend the Memorandum of Understanding Concerning the Imposition of Import Restrictions on Categories of Archaeological and Byzantine Ecclesiastical Ethnological Material Through the 15th Century A.D. of the Hellenic Republic.

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 information collection pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and associated fees.

This action modifies Area Navigation (RNAV) route T-354 in the northcentral United States. The modified T-route expands the availability of RNAV routing in support of the FAA's Next Generation Air Transportation System (NextGen) modernization efforts to transition the National Airspace System (NAS) from a ground-based to satellite- based Performance Based Navigation (PBN) system. The RNAV route T-325 modifications proposed in the notice of proposed rulemaking (NPRM) require additional coordination and flight inspection activities. As such, the T-325 modifications are removed from this rule.

The Pacific Fishery Management Council (Pacific Council) and its advisory entities will hold online public meetings.

This is a notice of an Administrative declaration of a disaster for the State of Florida dated 08/13/2020. Incident: Flash Flooding. Incident Period: 05/26/2020 through 05/27/2020.

The Food and Drug Administration (FDA) is 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.

This notice describes the program rules, statutory and regulatory waivers, and alternative requirements applicable to supplemental Community Development Block Grant (CDBG) funds made available to prevent, prepare for, and respond to coronavirus (CDBG-CV funds) and to annual formula CDBG grants awarded in fiscal years 2019 and 2020. Except as otherwise described in this notice and the CARES Act, the statutory and regulatory provisions governing the CDBG program apply to CDBG-CV and CDBG grants. This notice also describes conforming waivers and alternative requirements for other formula programs included in the consolidated planning regulations in 24 CFR part 91.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VYLEESI 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.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled ``Public Meeting on CDER Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant ProgramSummer 2020.'' The purpose of the public meeting is to ensure that as standard core sets of clinical outcome assessments (COAs) are developed as part of the FDA pilot grant program, the identified concepts, COAs, and endpoints reflect what is most important to patients and relevant to regulatory and potentially other stakeholder decision making. To facilitate this, stakeholders including patients, care partners, FDA reviewers, drug developers, as well as other government and academic researchers, health care providers, health technology assessors and health payers are encouraged to attend the meeting.

The Bishop Museum of Science and Nature Inc., has completed an inventory of human remains, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the Bishop Museum of Science and Nature, Inc. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

The Tennessee Valley Authority (TVA) has completed an inventory of associated funerary objects in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the associated funerary objects and any present-day Indian Tribes or Native Hawaiian organizations. Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these associated funerary objects should submit a written request to the TVA. If no additional requestors come forward, transfer of control of the associated funerary objects to the Indian Tribes or Native Hawaiian organizations stated in this notice may proceed.

The University of California, Davis (UC Davis) has corrected an inventory of human remains and associated funerary objects, published in a Notice of Inventory Completion in the Federal Register on August 13, 2008. This notice corrects the minimum number of individuals and number of associated funerary objects. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to UC Davis. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

Mount Holyoke College has completed an inventory of human remains in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to Mount Holyoke College. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

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.

Pursuant to the provisions of the Privacy Act of 1974, notice is hereby given that the Farm Credit Administration (FCA or Agency) is rescinding the System of Records Notice, FCA-18Inspector General Investigative FilesFCA, which is duplicative of FCA-7Inspector General Investigative FilesFCA.

Pursuant to the provisions of the Privacy Act of 1974, notice is hereby given that the Farm Credit Administration (FCA or Agency) is amending an existing system of records, FCA-8FCA internet Access SystemFCA. The FCA internet Access SystemFCA system is used to monitor FCA and Farm Credit System Insurance Corporation (FCSIC) employees' and contractors' access to the internet. The Agency is updating the notice to broaden the overall purpose of the system, including maintaining account and usage information required for approving, monitoring, facilitating, and disabling access to FCA information technology and is updating the categories of records and individuals maintained in the system to reflect that modified purpose. Additionally, the FCA is making administrative updates as well as non-substantive changes to conform to the system of records notice (SORN) template requirements prescribed in the Office of Management and Budget (OMB) Circular No. A-108.

The Federal Motor Carrier Safety Administration (FMCSA) requests public comment on an application for exemption from Netradyne Inc.(Netradyne) to allow its Driveri[supreg] Dash Cam to be mounted lower in the windshield on commercial motor vehicles than is currently permitted.

FMCSA announces that it has received an application from the Association of American Railroads and American Short Line and Regional Railroad Association (the Associations) on behalf of themselves and member railroads for an exemption from the following hours of service (HOS) provisions: (1) Driving a property-carrying commercial motor vehicle (CMV) without first taking 10 consecutive hours off duty, (2) driving after the 14th hour after coming on duty, (3) driving more than 11 hours during the 14-hour period after coming on duty, (4) driving if more than 8 hours have passed since the end of the last off-duty or sleeper-berth period of at lest 30 minutes, and (5) driving after accumulating 60 hours of on-duty time in 7 consecutive days (60-hour rule), or 70 hours of on-duty time in 8 consecutive days (70-hour rule). The exemption would enable railroad employees subject to the HOS rules to respond to unplanned events that occur outside of or extend beyond the employee's normal work hours. FMCSA requests public comment on the Associations' application for exemption.

Huawei Technologies Co., Ltd. (Huawei) and a number of non- U.S. affiliates have been placed on the Entity List. In order to further address the continuing threat to U.S. national security and foreign policy interests posed by Huawei and its non-U.S. affiliates, the Bureau of Industry and Security (BIS) in this final rule is making three sets of changes to controls for Huawei and its listed non-U.S. affiliates under the Export Administration Regulations (EAR). First, BIS is adding additional non-U.S. affiliates of Huawei to the Entity List because they also pose a significant risk of involvement in activities contrary to the national security or foreign policy interests of the United States. Second, this rule removes a temporary general license for Huawei and its non-U.S. affiliates and replaces those provisions with a more limited authorization that will better protect U.S. national security and foreign policy interests. Third, in response to public comments, this final rule amends General Prohibition Three, also known as the foreign-produced direct product rule, to revise the control over certain foreign-produced items recently implemented by BIS. These revisions are consistent with the authority provided by the Export Control Reform Act of 2018 (ECRA).

The Bureau of Land Management (BLM) Eastern States Office (ESO) announces that an Environmental Assessment (EA) for the Warrior Met Coal, Inc. Coal Lease-by-Application (LBA), serial number ALES- 55797, is available for public review and comment. The BLM is also announcing that it will hold a virtual public hearing to receive comments on the LBA, EA, Fair Market Value (FMV), and Maximum Economic Recovery (MER) of the coal resources contained in the proposed LBA lease tract. You can register to attend the virtual public meeting using the link provided below. Once registered, you will receive instructions for participating online or by phone.

The Department of Health and Human Services proposes to issue regulations governing the agency's release and maintenance of guidance documents. These regulations would help to ensure that the public receives appropriate notice of new guidance and that the Department's guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations lawfully promulgated under them.

The Environmental Protection Agency is planning to submit an information collection request (ICR), ``National Emission Standards for Hazardous Air Pollutants (NESHAP) for Radon Emissions from Operating Mill Tailings (Renewal)'' (EPA ICR No. 2464.03, OMB Control No. 2060- 0706) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through December 31, 2020. 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.