Department of Health and Human Services December 15, 2022 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Office of Laboratory Animal Welfare (OLAW) in the Office of Extramural Research will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA or we) 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pulmonary Tuberculosis: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of new antibacterial drugs for the treatment of pulmonary tuberculosis (TB). This draft guidance does not address the development of drugs for latent TB infection or for extrapulmonary TB. This draft guidance revises and replaces the draft guidance for industry of the same name published on November 6, 2013.

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.

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 Substance Abuse and Mental Health Services Administration published a correction document in the Federal Register on December 7, 2022 concerning request for comments on Confidentiality of Substance Use Disorder Patient Records published November 22, 2022. The November 22, 2022 publication only listed the Department of Health and Human Services in the headings and contained an incorrect Document Identifier and contact for further information or submission of public comments. The December 7, 2022 document corrected those errors but contained an incorrect contact email address. This document corrects the contact email address. Comments on the information collect request must be received on or before January 23, 2023.

The Food and Drug Administration (FDA, Agency, or we) received objections and requests for a hearing from the International Dairy Foods Association (IDFA) and Chobani, Inc. (Chobani) on the final rule titled ``Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt,'' which published on June 11, 2021. The final rule revoked the standards of identity for lowfat yogurt and nonfat yogurt and amended the standard of identity for yogurt in numerous respects. We are denying the requests for a public hearing and modifying the final rule in response to certain objections. Therefore, the stay of the effectiveness for the final regulation is now lifted.