💊FDA Guidance on Developing Treatment for Myelodysplastic Syndromes
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment." The purpose of this guidance is to assist sponsors in the clinical development of drug and biological products for the treatment of the myelodysplastic syndromes (MDS). Specifically, this guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for the development of drug and biological products to support an indication of treatment of MDS. This guidance will focus specifically on development of drug and biological products that are considered disease-modifying and, therefore, will not cover products considered supportive only (e.g., erythropoiesis-stimulating agents). Furthermore, the guidance will not address drug development for MDS/myeloproliferative neoplasms, such as chronic myelomonocytic leukemia, which are considered a separate class of myeloid neoplasms.
Learn More💊FDA Notice on Patent Extension for REBYOTA Drug
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REBYOTA 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 biological product.
Learn More⚖️Amended Determination of Countervailing Duties on Anode Materials
The U.S. Department of Commerce (Commerce) is amending the preliminary affirmative countervailing duty (CVD) determination for active anode material from the People's Republic of China (China) to correct significant ministerial errors.
Learn More🌍Impact of Foreign Missions Act on International Organizations 2025
The Department of State's notice details the application of the Foreign Missions Act to personnel of international organizations, including those not recognized by the U.S. The determination aims to ensure efficient operations and compliance with international law, emphasizing the necessary requirements for members of these official missions.
Learn More🏠SSA Notice on Data Collection for Employment Initiatives
The Social Security Administration (SSA) is soliciting comments on information collections related to supportive housing and employment initiatives for homeless individuals. The SHIPS study aims to determine the effectiveness of combining Individual Placement and Support (IPS) services with supportive housing to improve employment outcomes, income, and self-sufficiency.
Learn More🛠️Proposed Rule to Simplify Apprenticeship Discrimination Requirements
The Department of Labor (DOL or the Department) is issuing this notice of proposed rulemaking (NPRM) to remove undue regulatory burdens on registered apprenticeship program sponsors. The Department's proposal would rescind certain regulatory provisions that it believes are unlawful. It also includes conforming, technical changes to the Department's regulation that addresses Labor Standards for the Registration of Apprenticeship Programs. This proposed rule would streamline and simplify sponsors' obligations, while maintaining broad and effective nondiscrimination protections for apprentices and those seeking entry into apprenticeship programs. A brief summer of this document may be found at regulations.gov by searching by the RIN 1205- AC21.
Learn More✈️Proposed Airworthiness Directive for Bombardier Airplanes by FAA
The FAA proposes to adopt a new airworthiness directive (AD) for all Bombardier, Inc., Model BD-100-1A10 airplanes. This proposed AD was prompted by a report that some parts of horizontal stabilizer trim actuators (HSTAs) that were meant to be replaced through a required overhaul were not replaced and were instead reinstalled on the HSTAs. This proposed AD would require verification of the HSTA serial number, and, if applicable, replacement of the HSTA. This proposed AD would also prohibit the installation of affected parts under certain conditions. The FAA is proposing this AD to address the unsafe condition on these products.
Learn More💡NSF Breakthrough Innovations Initiative
The National Science Foundation (NSF) is announcing plans to renew this collection. In accordance with the requirements of the Paperwork Reduction Act of 1995, we are providing this opportunity for public comment on this action. After obtaining and considering public comment, NSF will prepare the submission requesting Office of Management and Budget (OMB) clearance of this collection for no longer than 3 years.
Learn More💰Proposed Updates to ESRD Payment System Impacting Business
This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2026. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule proposes to update requirements for the ESRD Quality Incentive Program and to terminate and modify requirements for the ESRD Treatment Choices Model.
Learn More🏦Proposed Collection of Information on Retirement Bonds Disposition
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Application for Disposition of Retirement Plan and/or Individual Retirement Bonds Without Administration of Deceased Owner's Estate.
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