Results 8,101 - 8,150 of 586,437
Medical Devices; Orthopedic Devices; Classification of the Intervertebral Body Graft Containment Device
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.
Medical Devices; Dental Devices; Classification of the Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea
The Food and Drug Administration (FDA, Agency, or we) is classifying the neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea 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 neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea'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.
Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
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.
Agency Information Collection Activity Under OMB Review: Trainee Request for Leave (Chapter 31, Veteran Readiness and Employment)
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefit Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden, and it includes the actual data collection instrument.
Medical Devices; Physical Medicine Devices; Classification of the External Compression Device for Internal Jugular Vein Compression
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.
Medical Devices; Neurological Devices; Classification of the Digital Therapy Device for Attention Deficit Hyperactivity Disorder
The Food and Drug Administration (FDA or we) is classifying the digital therapy device for Attention Deficit Hyperactivity Disorder 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 digital therapy device for Attention Deficit Hyperactivity Disorder'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.
Initiation of Five-Year (Sunset) Reviews
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).
Identifying Priority Focus Areas for Future Guidance Development and Engagement With Interested Parties in Model-Informed Drug Development; Request for Information
The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) within the Food and Drug Administration (FDA or Agency) are announcing a request for information (RFI) for advancing model-informed drug development (MIDD). The purpose of this request is to obtain feedback on how to increase application of established MIDD approaches in regulatory decision making, to identify how emerging MIDD approaches are being incorporated within drug product development, and to identify opportunities to enhance interactions with FDA when discussing MIDD approaches. We intend to use the information submitted in response to this request to identify and prioritize potential focus areas for future policy or guidance development and enhance engagement with interested parties, including interactions as part of the MIDD Paired Meeting Program and other formal meetings with drug developers.
Basic Energy Sciences Advisory Committee
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.
Air Plan Approval; New Jersey; NOX SIP Call and Removal of CAIR
The Environmental Protection Agency (EPA) is approving the removal of the New Jersey Clean Air Interstate Rule (CAIR) nitrogen oxides (NOX) Trading Program regulations from the New Jersey State Implementation Plan (SIP) and is conditionally approving the removal of the New Jersey NOX Budget Program regulations from the New Jersey SIP. On August 23, 2018, the New Jersey Department of Environmental Protection (NJDEP) submitted a SIP revision requesting the removal of the State's CAIR NOX Trading Program and NOX Budget Program regulations from the New Jersey SIP. NJDEP submitted a supplement to the revision on May 31, 2024, that commits NJDEP to develop a Memorandum of Agreement with the EPA that indicates how the State of New Jersey will maintain compliance with the State's NOX SIP Call obligations for the types of large non- electricity generating units (non-EGUs) that were previously regulated under the New Jersey NOX Budget Program.
Di-isononyl phthalate (DINP); Draft Risk Evaluation Under the Toxic Substances Control Act (TSCA); Notice of Availability, Webinar and Request for Comment
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.
Drawbridge Operation Regulation; Okeechobee Waterway, Stuart, FL; Correction
The Coast Guard is correcting a temporary interim rule with request for comments that appeared in the Federal Register on August 7, 2024. The temporary interim rule temporarily modifies the operating schedule that governs the Florida East Coast Railroad Bridge, across the Okeechobee Waterway, mile 7.41, at Stuart, FL. The temporary interim rule had a typographical error in one of the amendatory instructions. This document corrects that error.
Submission for Office of Management and Budget Review; Office of Community Services Affordable Housing and Supportive Services Demonstration Data Collection (Office of Management and Budget #: 0970-0628)
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.
Request for Comments on Significant Foreign Trade Barriers for the 2025 National Trade Estimate Report
The Office of the United States Trade Representative (USTR), through the Trade Policy Staff Committee (TPSC), publishes the National Trade Estimate Report on Foreign Trade Barriers (NTE Report) each year. USTR invites comments to assist it and the TPSC in identifying significant foreign barriers to, or distortions of, U.S. exports of goods and services, U.S. foreign direct investment, and U.S. electronic commerce for inclusion in the NTE Report. USTR also will consider responses to this notice as part of the annual review of the operation and effectiveness of all U.S. trade agreements regarding telecommunications products and services that are in force with respect to the United States.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; Federal Assistance to Individuals and Households Program
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.
Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the Commonwealth of Kentucky
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.
Monthly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations
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.
Notice of Inventory Completion: Hood Museum of Art, Dartmouth College, Hanover, NH
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Hood Museum of Art, Dartmouth College 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.
Notice of Inventory Completion: U.S. Army Corps of Engineers, Omaha District, and Hood Museum of Art, Dartmouth College, Hanover, NH
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.
Notice of Inventory Completion: Science Museum of Minnesota, Saint Paul, MN
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Science Museum of Minnesota 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.
Notice of Intended Repatriation: Wesleyan University, Middletown, CT
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.
Notice of Inventory Completion: University of Michigan, Ann Arbor, MI
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Michigan 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.
Notice of Intended Repatriation: Denver Museum of Nature & Science, Denver, CO
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.
Notice of Inventory Completion: Museum of Texas Tech University, Lubbock, TX
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Museum of Texas Tech 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.
Notice of Inventory Completion: Eastern Washington University, Cheney, WA
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.
Notice of Inventory Completion: Hartwick College, Oneonta, NY
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), Hartwick College 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 remains were recovered from Oneonta, NY, and Hyndesville, NY, respectively.
Notice of Intended Repatriation: Indiana University, Bloomington, IN
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.
Notice of Intended Disposition: U.S. Army Corps of Engineers, Walla Walla District, Walla Walla, WA
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the U.S. Army Corps of Engineers, Walla Walla District intends to carry out the disposition of human remains removed from Federal or Tribal lands to the lineal descendants, Indian Tribe, or Native Hawaiian organization with priority for disposition in this notice.
Notice of Inventory Completion: Field Museum, Chicago, IL
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.
Notice of Inventory Completion: Museum of Texas Tech University, Lubbock, TX
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Museum of Texas Tech 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.
Fine Denier Polyester Staple Fiber
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.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
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.
Federal Need Analysis Methodology for the 2025-26 Award Year-Federal Pell Grant, Federal Work-Study, Federal Supplemental Educational Opportunity Grant, William D. Ford Federal Direct Loan, and TEACH Grant Programs
The Secretary announces the annual updates to the tables used in the statutory Federal Need Analysis Methodology (Need Analysis) that determines a student's Student Aid Index (SAI) for award year (AY) 2025-26 for student financial aid programs, Assistance Listing Numbers (ALN) 84.007, 84.033, 84.063, 84.268, and 84.379. The intent of this notice is to alert the financial aid community and the broader public to these required annual updates used in the determination of student aid eligibility.
Agency Information Collection Activities; Emergency Revision of a Currently Approved Collection: Online Request To Be a Supporter and Declaration of Financial Support
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) will be submitting this collection of information to the Office of Management and Budget (OMB) with a request for review and approval in accordance with the Paperwork Reduction Act of 1995. USCIS is requesting that OMB approve this emergency revision by September 20, 2024.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
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