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Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Million Hearts[supreg] Hospital & Health System Recognition Program. This program recognizes institutions working systematically to improve the cardiovascular health of the population and communities they serve.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Program of Cancer Registries Program Evaluation Instrument (NPCR-PEI). The NPCR-PEI is a web-based survey instrument designed to evaluate NPCR-funded registries' operational attributes and their progress towards meeting program standards.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled 2024 Marburg Traveler Monitoring Assessment. This information collection is intended to determine the number of travelers coming to the United States from Rwanda, where a Marburg outbreak is occurring, that are enrolled by jurisdictions into monitoring, if recommended, and the proportion of travelers that completed monitoring.
Product Change-Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail and USPS Ground Advantage® Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail and USPS Ground Advantage® Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail and USPS Ground Advantage® Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail and USPS Ground Advantage® Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Arms Sales Notification
The DoD is publishing the unclassified text of an arms sales notification.
Privacy Act of 1974; Matching Program
This is an 18-month re-establishment computer matching agreement (CMA) with the Defense Manpower Data Center (DMDC), Department of Defense (DoD) and the Department of Veterans Affairs (VA), Veterans Benefits Administration (VBA), regarding Veterans who are in drilling status and also in receipt of compensation or pension benefits. The purpose of this CMA is to re-establish the agreement between VA, Veterans Benefits Administration (VBA) and the DoD, Defense Manpower Data Center (DMDC). DoD will disclose information about individuals who are in drill pay status. VBA will use this information as a match for recipients of Compensation and Pension benefits for adjustments of awards.
Arms Sales Notification
The DoD is publishing the unclassified text of an arms sales notification.
Arms Sales Notification
The DoD is publishing the unclassified text of an arms sales notification.
Arms Sales Notification
The DoD is publishing the unclassified text of an arms sales notification.
Privacy Act of 1974; System of Records
Pursuant to the Privacy Act of 1974, notice is hereby given that the Department of Veterans Affairs (VA) is modifying the system of records titled, "VA Child Care Subsidy Program Records-VA" (165VA05CCSP). This system contains the records used by the Child Care Records Management System (CCRMS) which provides a mechanism for online application processing; subsidy benefit requests; and the tracking, filing, retrieving, and storing of documents.
Safety Advisory 2024-01; Roadway Maintenance Machines-Importance of Communications and Compliance With Red Zone Procedures
FRA is issuing Safety Advisory 2024-01 to emphasize the importance of rules and procedures regarding the safety of roadway workers who operate or work near roadway maintenance machines (RMMs). This safety advisory recommends that railroads and contractors review and update their rules regarding communication between roadway workers who work near RMMs and the operators of those RMMs, and increase monitoring of their employees for compliance with existing rules and procedures (including through operational testing). This safety advisory also recommends that railroads review and update their rules regarding work/red zones and evaluate the work/red zone distances for each type of RMM. In addition, this safety advisory recommends that railroads and contractors conduct additional safety briefings to raise worker awareness of the hazards associated with operating and working around RMMs.
Application for Renewal of Authorization to Export Electric Energy; Macquarie Energy LLC
Macquarie Energy LLC (Macquarie Energy or Applicant) has applied for renewed authorization to transmit electric energy from the United States to Canada pursuant to the Federal Power Act.
30-Day Notice of Proposed Information Collection: Request for Overseas U.S. Citizen Vital Records Services
The Department of State has submitted the information collections described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on these collections from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Depository Library Council Meeting
The Depository Library Council (DLC) will meet virtually in conjunction with the Federal Depository Library Conference from Monday, October 21, 2024, through Wednesday, October 23, 2024. The meetings will take place online, and anyone may register to attend at https:// www.fdlp.gov/2024-fdl-conference. Closed captioning will also be provided. The purpose is to discuss matters affecting the Federal Depository Library Program. All sessions are open to the public.
Core Patient-Reported Outcomes in Cancer Clinical Trials; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Core Patient-Reported Outcomes in Cancer Clinical Trials." This final guidance provides recommendations to sponsors regarding the collection of a core set of patient-reported clinical outcomes (herein referred to as core patient-reported outcomes) in cancer clinical trials and related considerations for instrument selection and trial design. This final guidance focuses on patient-reported outcome (PRO) measures and is specific to registration trials for anti-cancer therapies intended to demonstrate an effect on survival, tumor response, or delay in the progression of a malignancy.
Determination of Regulatory Review Period for Purposes of Patent Extension; EXXUA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EXXUA 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.
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Guidance for Industry." This guidance is intended to provide a framework for considering whether and what type of long-term neurologic, sensory, and developmental evaluations could be useful in supporting a determination of safety of an FDA-regulated "medical product" (i.e., drug, biological product, or medical device) for use in neonates. Although short-term safety evaluations may be appropriate for adults or other populations, such evaluations may not identify important adverse events in the neonatal population, as medical treatment during the neonatal period coincides with a time of critical growth and physiologic development and latent effects may not be evident until later in life following early-life exposures. Consideration of the potential for long-term neurologic, sensory, and developmental effects in the neonatal population early in a development program is important for establishing safety of a medical product intended for use in neonates. This guidance finalizes the draft guidance of the same title issued on February 13, 2023.
Postoperative Nausea and Vomiting: Developing Drugs for Prevention; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Postoperative Nausea and Vomiting: Developing Drugs for Prevention." This guidance provides recommendations regarding the design of clinical trials for the prevention of postoperative nausea and vomiting in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.
Linde, Inc.; Withdrawal of Approval of a New Drug Application and New Animal Drug Application for Helium, USP
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) 205851 and the new animal drug application (NADA) 141-389 for the designated medical gas Helium, USP held by Linde, Inc., 175 East Park Dr., Tonawanda, NY 14150-7844. Linde, Inc. notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
Review of Drug Master Files in Advance of Certain Abbreviated New Drug Application Submissions Under Generic Drug User Fee Amendments; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA." This guidance provides information and recommendations on the Generic Drug User Fee Amendments (GDUFA) III program enhancements agreed upon by the Agency and industry in "GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027" (GDUFA III commitment letter), related to the early assessment of certain Type II drug master files (DMFs) 6 months prior to the submission of certain abbreviated new drug applications (ANDAs) or prior approval supplements (PASs). This guidance describes the process outlined in the GDUFA III commitment letter in greater detail and provides recommendations to DMF holders on how to provide the relevant information to FDA. This guidance finalizes the draft guidance of the same title issued on October 6, 2022.
Determination That TAVIST (Clemastine Fumarate) Tablet, 2.68 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that TAVIST (clemastine fumarate) tablet, 2.68 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Parts and Accessories Necessary for Safe Operation; Application for Renewal of Exemption; Vision Systems North America, Inc.
FMCSA announces that it has received an application from Vision Systems North America, Inc. (VSNA) for a renewal of its exemption allowing motor carriers to operate commercial motor vehicles (CMVs) with the company's Smart-Vision high-definition camera monitoring system (Smart-Vision) installed as an alternative to the two rear-vision mirrors required by the Federal Motor Carrier Safety Regulations (FMCSRs). VSNA currently holds an exemption for the period January 15, 2020, through January 15, 2025, and requests a five-year renewal of the exemption. FMCSA requests public comment on VSNA's request for exemption.
Safety Zone; NAS Jax Air Show; St. John's River, Jacksonville, FL
The Coast Guard is establishing a temporary safety zone for certain navigable waters within St. John's River in Jacksonville, FL. This action is necessary to provide for the safety of life on these navigable waters during the Naval Air Station Jacksonville Air Show. Entry of vessels or persons into this safety zone is prohibited unless specifically authorize by the Captain of the Port Sector Jacksonville or a designated representative.
Implementation of Employment Authorization for Individuals Covered by Deferred Enforced Departure for Lebanon
On July 26, 2024, President Joseph Biden issued a memorandum to the Secretary of State and the Secretary of Homeland Security (Secretary) determining that it was in the foreign policy interest of the United States to defer for 18 months through January 25, 2026, the removal of certain Lebanese nationals present in the United States and to provide them with employment authorization documentation. The memorandum directed the Secretary to make provision for immediate allowance of employment authorization for such individuals. This notice provides information about Deferred Enforced Departure (DED) for Lebanese nationals and provides information on how eligible individuals may apply for DED-based Employment Authorization Documents (EADs) with USCIS, as well as for travel authorization.
Employment Authorization for Certain Lebanese F-1 Nonimmigrant Students Experiencing Severe Economic Hardship as a Direct Result of the Current Humanitarian Crisis in Lebanon
The Department of Homeland Security (DHS) is suspending certain regulatory requirements for certain Lebanese F-1 nonimmigrant students who are experiencing severe economic hardship as a direct result of the current humanitarian crisis in Lebanon. The Secretary is providing relief to these students who are in lawful F-1 nonimmigrant status, so the students may request employment authorization, work an increased number of hours while school is in session, and reduce their course load while continuing to maintain their F-1 nonimmigrant status.
Clean Air Act Operating Permit Program; Order on Petition for Objection to State Operating Permit for HighPoint Operating Corporation's Anschutz Equus Farms 4-62-28 NWNW Oil and Gas Production Facility
The Environmental Protection Agency (EPA) Administrator signed an order dated July 31, 2024, granting in part and denying in part a petition dated April 1, 2024, from the Center for Biological Diversity. The petition requested that the EPA object to a Clean Air Act (CAA) operating permit issued by the Colorado Department of Public Health and Environment's Air Pollution Control Division (Division) to HighPoint Operating Corporation for its Anschutz Equus Farms 4-62-28 NWNW oil and gas production facility located in Weld County, Colorado.
Presidential Declaration Amendment of a Major Disaster for the State of Vermont
This is an amendment of the Presidential declaration of a major disaster for the State of Vermont (FEMA-4810-DR), dated 08/20/ 2024. Incident: Severe Storm, Flooding, Landslides, and Mudslides. Incident Period: 07/09/2024 through 07/11/2024.
Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of Georgia
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Georgia (FEMA-4830-DR), dated 10/09/2024. Incident: Hurricane Helene. Incident Period: 09/24/2024 and continuing.
Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of Georgia
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Georgia (FEMA-4830-DR), dated 10/09/2024. Incident: Hurricane Helene. Incident Period: 09/24/2024 and continuing.
Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of Florida
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Florida (FEMA-4828-DR), dated 10/05/2024. Incident: Hurricane Helene. Incident Period: 09/23/2024 and continuing.
Presidential Declaration Amendment of a Major Disaster for the State of Georgia
This is an amendment of the Presidential declaration of a major disaster for the State of Georgia (FEMA-4830-DR), dated 09/30/2024. Incident: Hurricane Helene. Incident Period: 09/24/2024 and continuing.
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