Department of Health and Human Service – Federal Register Recent Federal Regulation Documents
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Fiscal Year (FY) 2023 Notice of Supplemental Funding Opportunity
This is a notice of intent to award supplemental funding to the SPRC recipient funded in FY 2020 under Funding Opportunity Announcement SM-20-011. This is to inform the public that the SAMHSA is supporting an administrative supplement up to $5.429 million, which is consistent with the initial award for one-year to the University of Oklahoma Health Sciences Center. This recipient was funded in FY 2020 with a project end date of November 30, 2025. This supplement will provide support to the National Action Alliance for Suicide Prevention to conduct an evaluation project for populations at higher risk of suicide in support of the National Suicide Prevention Lifeline's 988 efforts. Additionally, SPRC will provide training and technical assistance to increase the capacity of existing 988 call centers to help Tribal callers and to build the capacity of Tribal crisis hotline services to qualify to join the 988 network. This is not a formal request for application. Assistance will only be provided to the Suicide Prevention Resource Center (SPRC) recipient, the University of Oklahoma Health Sciences Center, based on the receipt of a satisfactory application and associated budget that is approved by a review group.
Enforcement Policy-Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Enforcement PolicyOTC Sunscreen Drug Products Marketed Without an Approved Application.'' This guidance describes FDA's approach to enforcement for over-the-counter (OTC) sunscreen products marketed without approved applications before a final OTC sunscreen drug monograph becomes effective. This guidance finalizes the draft guidance of the same name issued June 17, 2011.
Protecting Our Infants Act Report to Congress: Summary of Public Comment and Final Strategy
The Substance Abuse and Mental Health Services Administration (SAMHSA) in the Department of Health and Human Services (HHS) announces the release of the ``Protecting Our Infants Act: Final Strategy'' in response to sections 3(a)(2) and 3(b) of the Protecting Our Infants Act of 2015 (POIA). The POIA mandated HHS to: conduct a review of planning and coordination activities related to prenatal opioid exposure and neonatal abstinence syndrome; develop recommendations for the identification, prevention, and treatment of prenatal opioid exposure and neonatal abstinence syndrome; and develop a strategy to address gaps, overlap, and duplication among Federal programs and Federal coordination efforts to address neonatal abstinence syndrome. The Protecting Our Infants Act: Report to Congress which satisfied these requirement was made available January 17, 2017, through February 21, 2017, for public comment in the following docket SAMHSA-2016-0004-0001. As a result of the public comments, summarized below, several recommendations were added to the original strategy and others expanded. The Final Strategy can be read and downloaded at https:// www.samhsa.gov/specific-populations/age-gender-based#poia.
Proposed Information Collection; 60-day Comment Request: Population Assessment of Tobacco and Health (PATH) Study
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) The approaches used to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the Office of the Secretary, Office of the National Coordinator for Health Information Technology (ONC), HHS has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).
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