📡FCC Information Collection Review
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
Learn More💊FDA Guidance on Antibacterial Therapies for Unmet Medical Needs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers." This guidance assists in the clinical development of new antibacterial drugs to treat serious bacterial diseases in patients with unmet medical needs, including patients with a serious bacterial disease for which effective antibacterial drugs are limited or lacking. This guidance finalizes the draft guidance entitled "Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers (Revision 1)" issued on May 24, 2022.
Learn More🏥PRCDA Redesignation Notice for Chippewa Cree Tribe in Montana
Notice is hereby given that the Indian Health Service (IHS) has decided to expand the geographic boundaries of the Purchased/Referred Care Delivery Area (PRCDA) for the Chippewa Cree Tribe of the Rocky Boy's Reservation ("Chippewa Cree Tribe" or "Tribe") to include the Montana County of Cascade. The final PRCDA for the Chippewa Cree Tribe now includes the Montana counties of Cascade, Choteau, Hill and Liberty. The sole purpose of this expansion is to authorize additional Chippewa Cree Tribal members and beneficiaries to receive Purchased/Referred Care (PRC) services.
Learn More🔒FDA Cybersecurity Guidance for Medical Devices
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." This guidance updates the previous version of the guidance, of the same title, issued on September 27, 2023, and finalizes the draft guidance entitled "Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act" issued on March 13, 2024. This guidance provides FDA's recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. Additionally, this guidance has been updated to identify the information FDA generally considers to be necessary for cyber devices to support obligations under the new amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) for ensuring cybersecurity of devices.
Learn More🏥Stakeholder Meetings for Medical Device User Fee Amendments
The Food and Drug Administration (FDA or the Agency) is issuing this notice to request that public stakeholders--including patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts--notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Medical Device User Fee Amendments (MDUFA). The statutory authority for MDUFA expires September 30, 2027. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
Learn More🌍Notice of Care Delivery Area Redesignation for Iowa Tribe
Notice is hereby given that the Indian Health Service (IHS) has decided to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Iowa Tribe of Kansas and Nebraska (Iowa Tribe or Tribe) to include the counties of Jackson in the State of Kansas, and Holt in the State of Missouri. The final PRCDA for the Iowa Tribe now includes the following counties: Brown, Doniphan, and Jackson in the State of Kansas; Holt in the State of Missouri; and Richardson in the State of Nebraska. The sole purpose of this expansion is to authorize additional Iowa Tribal members and beneficiaries to receive Purchased/Referred Care (PRC) services.
Learn More🚫DEA Revokes Registration of Dr. Bohdan Olesnicky
The Drug Enforcement Administration has revoked the DEA registration of Dr. Bohdan Olesnicky due to his lack of authority to practice medicine in California, following his voluntary surrender of his medical license. This action highlights the necessity for healthcare professionals to maintain state licensure to manage controlled substances legally under federal law.
Learn More📄FDA Issues Guidance on Conducting Remote Regulatory Assessments
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Conducting Remote Regulatory Assessments--Question and Answers." The final guidance describes FDA's current thinking regarding its use of remote regulatory assessments (RRAs) and provides answers to frequently asked questions. FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs, and help evaluate compliance of FDA- regulated products with applicable regulatory requirements.
Learn More🧪FDA Classifies Herpes Simplex Virus Assay as Class II Device
The Food and Drug Administration (FDA, the Agency, or we) is classifying the herpes simplex virus nucleic acid-based assay for central nervous system infections 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 classification of the herpes simplex virus nucleic acid-based assay for central nervous system infections. 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 part by reducing regulatory burdens.
Learn More🧬FDA Classifies Newborn Screening Test System Under Class II
The Food and Drug Administration (FDA, the Agency, or we) is classifying the lysosomal storage disorder newborn screening test system 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 lysosomal storage disorder newborn screening test system'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 part by reducing regulatory burdens.
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