Department of Health and Human Services October 15, 2019 – Federal Register Recent Federal Regulation Documents

The Rural Communities Opioid Response ProgramTechnical Assistance (RCORP-TA), program supports rural consortiums and opioid recipients that provide treatment for and prevention of substance use disorder with a focus on opioid use disorder. The TA efforts will enhance the organizational and infrastructural capacity of multi-sector consortiums at the community, county, state, and/or regional levels. The overall goal is the reduction of morbidity and mortality associated with opioid overdoses in high-risk rural communities. The RCORP-TA award recipient provides resources and expertise in support of the execution of the following focus areas: (1) Preventionreducing the occurrence of opioid use disorder (OUD) among new and at-risk users as well as fatal opioid-related overdoses through community and provider education and harm reduction measures including the strategic placement of overdose reversing devices, such as naloxone; (2) treatment implementing or expanding access to evidence-based practices for opioid addiction/OUD treatment such as medication-assisted treatment, including developing strategies to eliminate or reduce treatment costs to uninsured and underinsured patients; and (3) recoveryexpanding peer recovery and treatment options to help people start and stay in recovery. The RCORP-TA initiative is part of a multi-year, opioid focused effort by HRSA that will include: Improving access to and recruitment of new substance use disorder providers; building sustainable treatment resources; increasing the use of telehealth; establishing cross-sector community partnerships; implementing new models of care, including integrated behavioral health; and providing technical assistance.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA or the Agency) is announcing the website location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in fiscal year (FY) 2020. In addition, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders. This feedback is critical to the CDRH guidance program to ensure that we meet stakeholder needs.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Potential Tobacco Product Violations Reporting Form.