2024 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, Agency, or we) is classifying the intervertebral body graft containment device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intervertebral body graft containment device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Roche Molecular Systems, Inc, for the cobas SARS-CoV-2 & Influenza A/B nucleic acid test for use on the cobas Liat System, that includes the cobas SARS-CoV-2 & Influenza A/B Quality Control Kit. FDA revoked the Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocation, which includes an explanation of the reasons for revocation, is reprinted at the end of this document.

The Food and Drug Administration (FDA or we) is classifying the external compression device for internal jugular vein compression into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external compression device for internal jugular vein compression's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.

In accordance with the Tariff Act of 1930, as amended (the Act), the U.S. Department of Commerce (Commerce) is automatically initiating the five-year reviews (Sunset Reviews) of the antidumping and countervailing duty (AD/CVD) order(s) and suspended investigation(s) listed below. The U.S. International Trade Commission (the ITC) is publishing concurrently with this notice its notice of Institution of Five-Year Reviews which covers the same order(s) and suspended investigation(s).

This notice announces an in-person meeting of the Basic Energy Sciences Advisory Committee (BESAC). The Federal Advisory Committee Act requires that public notice of these meetings be announced in the Federal Register.

The Environmental Protection Agency (EPA or Agency) is announcing the availability of and seeking public comment on a draft risk evaluation under the Toxic Substances Control Act (TSCA) for di- isononyl phthalate (DINP) (1,2-Benzene- dicarboxylic acid, 1,2- diisononyl ester) (CASRN 28553-12-0). The purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or non-risk factors, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, under the conditions of use (COU). EPA has used the best available science to prepare this draft risk evaluation and to preliminarily determine that DINP poses unreasonable risk to human health.

The Office of Community Services (OCS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is requesting an extension of approval for a recently approved information collection: OCS Affordable Housing and Supportive Services Demonstration (Office of Management and Budget (OMB) #: 0970- 0628, Expiration Date: September 30, 2024). This information collection was originally approved for 6 months as an emergency approval. In addition to extending the approval, OCS seeks to update the burden estimates to accommodate an anticipated increase in the number of grant recipients, as well as to collect additional responses to several of the instruments. OCS also seeks to make updates to approved forms.

The Federal Emergency Management Agency (FEMA), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the extension, without change, of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning FEMA's Individuals and Households Program, providing financial assistance to individuals whose primary residences were destroyed as a result of a Presidentially-declared disaster. This renewal primarily includes the addition of new forms/ form updates from the IA Equity review, the Other Needs Assistance (ONA) Standard Operating Procedures (SOP) update, and a review of all forms from the Office of Management and Budget's (OMB's) Collection Review project that specifically targeted accuracy, plain language, and updates due to policy and business practice changes.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the Commonwealth of KENTUCKY (FEMA-4804-DR), dated 07/23/2024. Incident: Severe Storms, Straight-line Winds, Tornadoes, Landslides, and Mudslides. Incident Period: 05/21/2024 through 05/27/2024.

Pursuant to section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular monthly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration (NSHC), notwithstanding the pendency before the Commission of a request for a hearing from any person.

In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the U.S. Army Corps of Engineers, Omaha District, and the Hood Museum of Art, Dartmouth College, Hanover, NH has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice.

In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), Wesleyan University intends to repatriate certain cultural items that meet the definition of unassociated funerary objects and that have a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice.

In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Denver Museum of Nature & Science intends to repatriate certain cultural items that meet the definition of sacred objects and that have a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice.

In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Eastern Washington University 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.

In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), Indiana University intends to repatriate certain cultural items that meet the definition of unassociated funerary objects or objects of cultural patrimony and that have a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice.

In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Field Museum has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice.

Section 202(f)(3) of the Trade Act of 1974 requires that the United States International Trade Commission ("Commission") publish in the Federal Register a summary of each report that it submits to the President under section 202(f)(1) of the Trade Act of 1974. Set forth below is a summary of the report that the Commission submitted to the President on August 26, 2024, on investigation No. TA-201-78, Fine Denier Polyester Staple Fiber. The Commission conducted the investigation under section 202(b) of the Trade Act of 1974 following receipt of a petition filed on February 28, 2024. The full text of the report (with the exception of confidential business information) will be posted on the Commission's website at https://www.usitc.gov.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) using Urine and the laboratories currently certified to meet the standards of the Mandatory Guidelines using Oral Fluid.

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.