Department of Health and Human Services June 21, 2023 – Federal Register Recent Federal Regulation Documents
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Fiscal Year (FY) 2023 Notice of Supplemental Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting one administrative supplement in scope of the parent award to the State Opioid Response (SOR)/Tribal Opioid Response (TOR) Technical Assistance Grant recipient, the American Academy of Addiction Psychiatry (AAAP) funded in FY 2022 under Notice of Funding Opportunity (NOFO) TI-22-007 to provide training and technical assistance to federally-recognized Tribes and Tribal organizations.
Fiscal Year (FY) 2023 Notice of Supplemental Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting administrative supplements (in the scope of the parent award) for the 60 eligible grant recipients funded in FY 2023 under the Substance Use Prevention, Treatment, and Recovery Services Block Grant (SUBG). Recipients may receive an amount of between $25,000 and $2,089,193 for a total of $15,400,000. If all eligible SUBG recipients do not apply, remaining funds will be redistributed to applicants. These recipients have a project end date of September 30, 2024. The supplemental funding will be used for providing and/or obtaining training and technical assistance, or workforce development meetings and activities.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
National Institute of Biomedical Imaging and Bioengineering; Notice of Proposed Reorganization
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) will host a public online forum to enable public discussion of the Institute's proposal to establish the Section on Mechanics and Tissue Remodeling Integrating Computational & Experimental Systems (MATRICES). The proposed reorganization will more accurately reflect the current structure by which the Intramural Research Program is functioning and improve the coordination of the scientific activities within the Institute. The online forum will allow members of the public to review the reorganization proposal and submit comments.
PHM Brands; Filing of Food Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by PHM Brands, proposing that the food additive regulation for chlorine dioxide be amended to provide for an additional method for producing the additive.
National Institute of Biomedical Imaging and Bioengineering Notice of Proposed Reorganization
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) will host a public online forum to enable public discussion of the Institute's proposal to establish the Section on Mechanics and Tissue Remodeling Integrating Computational & Experimental Systems (MATRICES). The proposed reorganization will more accurately reflect the current structure by which the Intramural Research Program is functioning and improve the coordination of the scientific activities within the Institute. The online forum will allow members of the public to review the reorganization proposal and submit comments.
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Daylen Diaz: Final Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Daylen Diaz from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Daylen Diaz was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. Daylen Diaz was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of February 26, 2023 (30 days after receipt of the notice), Ms. Diaz had not responded. Ms. Diaz' failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of her right to a hearing concerning this action.
Oncology Drug Products Used With Certain In Vitro Diagnostic Tests: Pilot Program; Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, clinical laboratories, and FDA staff entitled ``Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program.'' FDA is issuing this guidance to announce and describe FDA's voluntary pilot program for certain oncology drug products regulated by FDA's Center for Drug Evaluation and Research (CDER) used with certain in vitro diagnostic tests. FDA intends to pilot a new approach to provide greater transparency regarding performance characteristics that certain tests for oncology biomarkers should meet. Through this transparency FDA seeks to support better and more consistent performance of certain laboratory-developed tests (LDTs) used to identify patients for treatment with certain oncology drug products, resulting in better drug selection and improved care for patients with cancer. The guidance has been implemented without prior comment, but remains subject to comment in accordance with the Agency's good guidance practices.
Agency Information Collection Request; 30-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
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