Department of Health and Human Services September 24, 2021 – Federal Register Recent Federal Regulation Documents

This notice announces a Town Hall Meeting in accordance with the Social Security Act (the Act) to discuss fiscal year (FY) 2023 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). The United States is responding to an outbreak of respiratory disease caused by the virus ``SARS-CoV-2'' and the disease it causes ``coronavirus disease 2019'' (abbreviated ``COVID-19''). Due to the COVID-19 pandemic, the Town Hall Meeting will be held virtually rather than as an in-person meeting. Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2023 new medical services and technologies applications meet the substantial clinical improvement criterion.

The Administration for Children and Families (ACF), in partnership with the Health Resources and Services Administration (HRSA), both of the U.S. Department of Health and Human Services (HHS), is proposing to extend data collection activity as part of the kindergarten phase of the Mother and Infant Home Visiting Program Evaluation Long-Term Follow-Up project (MIHOPE-K). The purpose of MIHOPE-K is to conduct a follow-up study that assesses the long-term impact of the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program when the participating children are in kindergarten. This Federal Register notice is seeking to extend data collection for the kindergarten follow-up. The original Federal Register notices for the MIHOPE-K data collection were titled under MIHOPE-Long-Term Follow-Up (MIHOPE-LT).

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Gravity Diagnostics, LLC (Gravity) for the Gravity Diagnostics COVID-19 Assay, Materials and Machines Corporation of America (DBA MatmaCorp, Inc.) (Matmacorp) for the MatMaCorp COVID-19 2SF Test, and Guardant Health Inc. (Guardant) for the Guardant-19. FDA revoked Gravity's Authorization on July 21, 2021, Matmacorp's Authorization on August 3, 2021, and Guardant's Authorization on August 6, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

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.

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.

In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC) has scheduled a public meeting. Information about CHAC and the agenda for this meeting can be found on the CHAC website at https://www.cdc.gov/maso/facm/facmCHACHSPT.html and the meeting website at https://www.chacfall2021.org/.