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

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a revised draft Introduction, and a revised draft Appendix 1, within a multichapter guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food.'' This multichapter draft guidance, when finalized, will explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.'' We revised the draft Introduction and draft Appendix 1: Known or Reasonably Foreseeable Hazards (``Potential Hazards'') to address comments submitted on drafts that we made available in 2016. This draft guidance is not final nor is it in effect at this time.

Notice is hereby given for the meeting on February 27, 2024, of the Center for Substance Abuse Prevention National Advisory Council (CSAP NAC). The meeting is open to the public and can also be accessed virtually. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/ advisory-councils/meetings . The meeting will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; approval of the meeting minutes of August 29, 2023; overview of CSAP strategic planning activities; presentations on substance use prevention priorities; Council discussion and public comments.

This final rule modifies and updates certain provisions of regulations related to Opioid Treatment Program (OTP) accreditation, certification, and standards for the treatment of Opioid Use Disorder (OUD) with Medications for Opioid Use Disorder (MOUD) in OTPs. This includes making flexibilities put forth during the COVID-19 Public Health Emergency (PHE) permanent, as well as expanding access to care and evidence-based treatment for OUD. The final rule also removes all language and rules pertaining to the Drug Addiction and Treatment Act (DATA) Waiver from the regulations pursuant to the ``Consolidated Appropriations Act, 2023''.

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 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.

HRSA published a notice in the Federal Register on October 12, 2023, concerning the 2024 calendar year meetings of the Advisory Commission on Childhood Vaccines (ACCV). The meeting times have changed. The 2024 ACCV meetings will be held from 1 p.m. eastern time (ET)-4 p.m. ET instead of from 10 a.m.-4 p.m.

The Agency for Healthcare Research and Quality (AHRQ) Center for Quality Improvement and Patient Safety (CQuIPS) Division of Quality Measurement and Improvement (QMI) invites public comment in response to this Request for Information (RFI). The AHRQ Quality Indicators (QI) program maintains inpatient quality indicators (https:// qualityindicators.ahrq.gov/measures/IQI_TechSpecTechSpec) and patient safety indicators (https://qualityindicators.ahrq.gov/measures/ PSI_TechSpec), several of which are relevant to maternal health care. Specifically, the QI program maintains measures of obstetric trauma, birth trauma, and cesarean delivery calculated at the hospital level using administrative data. However, severe maternal morbidity during an inpatient stay may result from a host of complications, such as sepsis, cardiac failure, stroke, respiratory distress, and renal failure. While state-level rates of severe maternal morbidity are available from AHRQ (https://datatools.ahrq.gov/hcup-fast-stats/?tab=special- emphasis&dash=92), experts have noted some shortcomings of this measure. This RFI seeks comments on the usability, feasibility, and likely uptake of a measure of severe maternal morbidity to be validated, refined, and maintained by the QI program, with the goal of providing data for maternal health service improvements. While a measure of severe maternal morbidity is currently available from AHRQ and the Health Resources and Service Administration (HRSA), several experts have suggested that this algorithm could benefit from refinements.

The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on January 29, 2024. That Notice requires a correction in the SUPPLEMENTARY INFORMATION section.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).

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 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.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on December 21, 2023. The document announced the availability of a final guidance for industry entitled ``Development of Monoclonal Antibody Products Targeting SARS- CoV-2 for Emergency Use Authorization.'' The document was published with an incorrect docket number. This document corrects that error.

This document corrects technical errors in the final rule that appeared in the November 13, 2023 Federal Register titled ``Medicare Program; Calendar Year (CY) 2024 Home Health (HH) Prospective Payment System Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin Items and Services; Hospice Informal Dispute Resolution and Special Focus Program Requirements, Certain Requirements for Durable Medical Equipment Prosthetics and Orthotics Supplies; and Provider and Supplier Enrollment Requirements'' (referred to hereafter as the ``CY 2024 HH PPS final rule'').