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

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) reapprove the proposed information collection project ``Consumer Assessment of Healthcare Providers and Systems (CAHPS) Home and Community Based Services (HCBS) Survey Database.'' This proposed information collection was previously published in the Federal Register on August 19, 2022, and allowed 60 days for public comment. AHRQ did not receive any substantive comments during this period. The purpose of this notice is to allow an additional 30 days for public comment.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award $62,000,000 (total costs) for up to one year to Vibrant Emotional Health for the 988 National Suicide Prevention Lifeline Expansion for Behavioral Health Crisis Response (Lifeline Expansion). These funds will allow Vibrant Emotional Health to ensure effective and continuous operations of the national Lifeline backup, chat/text, Spanish and LGBTQI+ youth crisis center networks, administrative and leadership support to ensure training, evaluation, personnel, and committee oversight and implementation, and continued development of the Lifeline unified platform and information technology integration for local and national crisis centers.

In accordance with the Federal Advisory Committee Act (FACA) and the Public Health Service (PHS) Act, HHS is hereby giving notice that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has been renewed. The effective date of the charter renewal is November 10, 2022.

The Food and Drug Administration (FDA, Agency, or we) has determined the regulatory review period for PREVYMIS, new drug application (NDA) 209939, and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

This notice acknowledges the receipt of an application from a hospital that has requested a waiver of statutory requirements to enter into an agreement with an organ procurement organization (OPO) other than its designated organ procurement organization. This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled ``Referencing the Definition of `Device' in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents.'' FDA is issuing this guidance to promote clarity regarding references to the terms ``device'' and ``counterfeit device'' in guidance, regulatory documents, communications, and other public documents.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for two proposed rules that appeared in the Federal Register of September 28, 2022. In the proposed rule entitled ``Protection of Human Subjects and Institutional Review Boards,'' FDA requested comments on proposed changes to its regulations regarding obtaining and documenting informed consent from research participants, and institutional review board membership and functions, including continuing review (Docket No. FDA-2021-N-0286). In the proposed rule entitled ``Institutional Review Boards; Cooperative Research,'' FDA requested comment on a change to its regulations that would require any institution located in the United States participating in FDA-regulated cooperative research to rely on approval by a single institutional review board (IRB) for that portion of the research that is conducted in the United States, with some exceptions (Docket No. FDA-2019-N-2175). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of spirulina (Arthrospira platensis) extract as a color additive in alcoholic beverages with less than 20 percent alcohol-by-volume content, non-alcoholic beverages, condiments and sauces, dips, dairy product alternatives (identified as non-dairy yogurt alternatives, non-dairy frozen desserts, and non-dairy puddings), salad dressings, and seasoning mixes (unheated). This action is in response to a color additive petition (CAP) filed by GNT USA, Inc. (GNT).

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

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

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

The meeting of the Oncologic Drugs Advisory Committee scheduled for November 22, 2022, is canceled. This meeting was announced in the Federal Register of September 22, 2022. The meeting is no longer needed.

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.