🏥Regulatory Changes in Indian Health Service Impacting Businesses
Part G of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (HHS) is hereby amended to reflect a reorganization of the Indian Health Service (IHS). The purpose of this reorganization is to revise the current approved structure for the IHS, Office of the Director, Intergovernmental Affairs functions in Chapter GA (GAA-GAC), as provided for herein.
Learn More🚫FDA Denies Hearing; Jiao Debarred for Five Years from Drug Imports
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Yong Sheng Jiao, also known as Yongsheng Jiao and Wilson Jiao (Jiao), and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jiao for 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Jiao was convicted of a felony under Federal law for conduct relating to the importation into the United States of any drug or controlled substance under the FD&C Act. In determining the appropriateness and period of Jiao's debarment, FDA considered the relevant factors listed in the FD&C Act. Jiao submitted a request for hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.
Learn More🩺FDA Draft Guidance on Developing Drugs for Optical Imaging
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Developing Drugs for Optical Imaging." The purpose of this guidance is to provide recommendations to sponsors regarding clinical trial design features that support development and approval of optical imaging drugs that are used in conjunction with imaging devices and intended as intraoperative aids for the detection of pathology such as tumors or to enhance the conspicuity of normal anatomical structures.
Learn More📅Defense Business Board Meeting
The DoD is publishing this notice to announce that the following Federal Advisory Committee meeting of the Defense Business Board ("the Board") will take place.
Learn More🚧Study on Warning Devices for Stopped Commercial Vehicles Initiated
In accordance with the Paperwork Reduction Act of 1995, FMCSA announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for its review and approval and invites public comment. This notice invites comments on a proposed information collection titled "Study of Warning Devices for Stopped Commercial Motor Vehicles." It is an experimental study that requires data collection for evaluating whether warning devices meaningfully influence crash-relevant aspects of human performance in the presence of a parked or disabled commercial motor vehicle (PDCMV), and if so, how and to what extent. These data collection efforts are expected to require the participation of 256 drivers.
Learn More🏗️NSF Research Infrastructure Guide Updates
In accordance with the requirement of the Paperwork Reduction Act of 1995, the National Science Foundation (NSF) is providing opportunity for public comment on revisions to the NSF Research Infrastructure Guide (RIG).
Learn More🌊FEMA Notice
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
Learn More💰Treasury Announces 3% Interest Rate for Immigration Bonds (2025)
For the period beginning January 1, 2025, and ending on March 31, 2025, the U.S. Immigration and Customs Enforcement Immigration Bond interest rate is 3 per centum per annum.
Learn More✈️Regulatory Compliance Costs for Boeing 767 Airworthiness Directive
The FAA is adopting a new airworthiness directive (AD) for all The Boeing Company Model 767-200, -300, and -300F airplanes. This AD was prompted by a report of a main landing gear (MLG) collapse event following maintenance where a grinder was operating outside of its input parameters, resulting in possible heat damage to the outer cylinder of the MLG. This AD requires replacing affected outer cylinders. The FAA is issuing this AD to address the unsafe condition on these products.
Learn More⚖️EPA Civil Penalty Inflation Adjustment Effective January 2025
The Environmental Protection Agency (EPA) is promulgating this final rule to adjust the level of the maximum and minimum statutory civil monetary penalty amounts under the statutes the EPA administers. This action is mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 ("the 2015 Act"). The 2015 Act prescribes a formula for annually adjusting the statutory maximum and minimum amount of civil monetary penalties to reflect inflation, maintain the deterrent effect of statutory civil monetary penalties, and promote compliance with the law. The rule does not establish specific civil monetary penalty amounts the EPA may seek in particular cases. The EPA calculates those amounts, as appropriate, based on the facts of particular cases and applicable agency penalty policies. The EPA's civil penalty policies, which guide enforcement personnel on how to exercise the EPA's discretion within statutory penalty authorities, take into account a number of fact-specific considerations, e.g., the seriousness of the violation, the violator's good faith efforts to comply, any economic benefit gained by the violator as a result of its noncompliance, and the violator's ability to pay.
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