2023 – Federal Register Recent Federal Regulation Documents

The Coast Guard is establishing a temporary safety zone encompassing the Causton Bluff Bridge, on the Wilmington River, Savannah, GA. This action is necessary to provide for the safety of life on these navigable waters for the planned demolition and removal of structural components of the original bridge, in preparation of the construction of a new span. This rulemaking would prohibit persons and vessels from being in the safety zone unless authorized by the Captain of the Port Savannah or a designated representative.

Veterans Pharmaceuticals, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a revision of a currently approved information collection request (ICR).

Experic LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

The North Pacific Fishery Management Council (Council) and its advisory committees will meet October 2, 2023, through October 10, 2023.

The South Atlantic Fishery Management Council (Council) will hold a meeting of the Outreach and Communications Advisory Panel (AP). The meeting will be held in Charleston, SC. See SUPPLEMENTARY INFORMATION for agenda.

The Food and Drug Administration (FDA or Agency) is announcing the availability of two draft guidances entitled ``Medical Devices with Indications Associated with Weight LossClinical Study and Benefit- Risk Considerations'' and ``Medical Devices with Indications Associated with Weight LossNon-Clinical Recommendations.'' These draft guidance documents provide recommendations regarding clinical study design for devices with indications for use associated with weight loss, include discussion on how FDA considers the benefit-risk analysis to support such indications, and provide recommendations for the non-clinical testing to support premarket submissions for these medical devices. These draft guidances are not final nor are they for implementation at this time.

In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the U.S. Department of the Interior, Bureau of Indian Affairs (BIA) has completed an inventory of an associated funerary object and has determined that there is a cultural affiliation between the associated funerary object and Indian Tribes or Native Hawaiian organizations in this notice. The associated funerary object was removed from Clallam County, WA.

In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the U.S. Department of the Interior, Fish and Wildlife Service (USFWS) has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The human remains and associated funerary objects were removed from Cameron County, TX.

In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Wisconsin-Milwaukee (UWM) has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary object and Indian Tribes or Native Hawaiian organizations in this notice. The human remains and associated funerary object were removed from Henderson County, IL.

In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University (PMAE) has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The human remains and associated funerary objects were removed from Los Angeles and Ventura Counties, CA.

The Department of Labor (DOL) is submitting this Occupational Safety & Health Administration (OSHA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

PCI Synthesis has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

Olon Ricerca Bioscience, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

Veterans Benefits Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a currently approved collection, and allow 60 days for public comment in response to the notice.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Oklahoma (FEMA-4721-DR), dated 07/19/2023. Incident: Severe Storms, Straight-line Winds, and Tornadoes. Incident Period: 06/14/2023 through 06/18/2023.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Florida (FEMA- 4734-DR), dated 09/09/2023. Incident: Hurricane Idalia. Incident Period: 08/27/2023 through 09/04/2023.