Department of Health and Human Services August 31, 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for THEROX DOWNSTREAM SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

This is a notice of intent to award supplemental funding to the National Training and Technical Assistance Center for Certified Community Behavioral Health ClinicsExpansion Grant (TTA-CCBHC) recipient funded in FY 2021 under Funding Opportunity Announcement SM- 21-015. This is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting an administrative supplement, which is consistent with the initial award, of up to $150,000 for one-year to the TTA-CCBHC recipient, The National Council for Mental Wellbeing. This supplement will provide support to new Certified Community Behavioral Health (CCBHC) recipients that have opted to participate in the SAMHSA/NIH Evidence-Based Practices Implementation Science Pilot as noted in the Notice of Funding Opportunities (NOFOs) in FY 2022, CCBHC-Planning, Development, and Implementation (SM-22-002) and CCBHC-Improvement and Advancement (SM- 22-012). The technical assistance will provide the following: (1) support to SAMHSA and CCBHC grant recipients to develop capacity and the ability to implement and sustain effective treatment and practices; (2) support delivery of evidence-based practices with fidelity; and (3) identification and/or development of resources that can be used by CCBHC recipients to augment the implementation of effective practices in alignment with the CCBHC certification criteria. This is not a formal request for application. Assistance will only be provided to the TTA-CCBHC recipient, The National Council for Mental Wellbeing, based on the receipt of a satisfactory application and associated budget. This recipient was funded in FY 2021 under Funding Opportunity Announcement SM-21-015 with a project end date of September 29, 2026.

This is a notice of intent to award supplemental funding to the 13 Mental Health Technology Transfer Center (MHTTC) Cooperative Agreement recipients funded in FY 2018 under Funding Opportunity Announcement SM-18-015. This is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting one-year administrative supplements up to $304,081 per recipient. This supplement will provide continued direct technical assistance (TA) and training on the implementation and delivery of mental health services in schools and school systems, including training and TA provided to Project AWARE grantees. This will involve not only TA to the general field but provision of direct and tailored TA to grantees on school-based mental health services implementation. This is not a formal request for application. Assistance will only be provided to the Mental Health Technology Transfer Center Cooperative Agreement grant recipients based on receipt of a satisfactory application and associated budget. These recipients were funded in FY 2018 under the Mental Health Technology Transfer Center Cooperative Agreement Funding Opportunity Announcement SM-18-015 with a project end date of August 29, 2023.