Department of Health and Human Services April 2023 – Federal Register Recent Federal Regulation Documents

This proposed rule would update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. These proposed changes would be effective for IPF discharges occurring during the Fiscal Year (FY) beginning October 1, 2023 through September 30, 2024 (FY 2024). In addition, this proposed rule discusses proposals on quality measures and reporting requirements under the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program with proposed changes beginning with the FY 2024 payment determination through changes beginning with the FY 2028 payment determination.

The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Environmental Health and Land Reuse Certificate Training. This certification is a joint collaboration between ATSDR and the National Environmental Health Association (NEHA), and is designed to build capacity among environmental professionals.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Patient- Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making.'' This draft guidance (Guidance 4) is the fourth in a series of four methodological patient- focused drug development (PFDD) guidance documents that describe how stakeholders (patients, researchers, medical product developers, and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.

The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients (APIs)) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies one bulk drug substance that FDA has considered and is including on the list at this time: quinacrine hydrochloride (HCl) to compound drug products for oral use only. This notice also identifies 10 bulk drug substances that FDA has considered and is not including on the list at this time: hydroxyzine HCl, mannitol, methacholine chloride, metoclopramide HCl, nalbuphine HCl, potassium acetate, procainamide HCl, sodium bicarbonate, sodium nitroprusside, and verapamil HCl. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future notices.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting administrative supplements in scope of the parent award for the 11 eligible grant recipients funded in FY 2018 under the Mental Health Technology Transfer Centers (MHTTCs) Cooperative Agreements, Notice of Funding Opportunity (NOFO) SM-18-005. The MHTTC National Coordinating Center may receive up to $900,000 and the 10 MHTTC Regional Centers may receive up to $1,045,454 each. These recipients have a project end date of September 29, 2023. The supplemental funding will extend the project period by one-year and will continue to support resource development and dissemination, training and technical assistance, and workforce development to the field and provide direct technical assistance and training on the delivery of mental health services in schools and school systems to CMHS Project AWARE grantees.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting administrative supplements in scope of the parent award for the 11 eligible grant recipients funded in FY 2019 under the Prevention Technology Transfer Centers (PTTCs) Cooperative Agreements, Notice of Funding Opportunity (NOFO) SP-19-001. The PTTC National Coordinating Center may receive up to $493,966 and the 10 PTTC Regional Centers may receive up to $600,000 each for a total of $6,492,160. These recipients have a project end date of September 29, 2023. The supplemental funding will extend the project period by one-year and will continue providing training and technical assistance services and quality improvement activities to the substance abuse prevention workforce including professionals and pre-professionals, organizations, and others in the prevention community.

The Food and Drug Administration (FDA or we) is reopening the comment period for the draft guidance entitled ``Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry,'' which was announced in the Federal Register of January 25, 2023. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Office of the Assistant Secretary for Health (OASH) is seeking nominations for membership on the Advisory Committee on Blood and Tissue Safety and Availability (referred to as ACBTSA and/or the Committee). This announcement is to solicit nominations of qualified candidates to five public member positions on the ACBTSA. The ACBTSA is a federal advisory committee within the U.S. Department of Health and Human Services (HHS). Qualified individuals will be nominated to the Secretary of Health and Human Services for consideration of appointment as members of the ACBTSA. Members are invited to serve on the Committee for up to four-year terms. The Committee was established to provide advice to the Secretary on a range of policy issues related to blood, blood products, and tissues. The functions of the Committee are solely advisory in nature.

The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the proposed Laboratory Recommendations for Syphilis Testing in the United States. The proposed recommendations for syphilis testing include laboratory-based tests, point-of-care tests, processing of samples, and reporting of test results. The recommendations are intended to aid laboratorians and clinicians in the diagnosis of syphilis. These proposed recommendations are intended for use by clinical laboratory directors, laboratory staff, clinicians, and disease control personnel who must choose among the multiple available testing methods, establish standard operating procedures for collecting and processing specimens, interpret test results for laboratory reporting, and counsel and treat patients in the United States.

This quarterly notice lists the OMHA Case Processing Manual (OCPM) instructions that were published from October through December 2022. This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations, and OMHA directives, and gives OMHA staff direction for processing appeals at the OMHA level of adjudication.

The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to obtain information and comments that will assist the Agency in assessing whether in-home disposal products can be expected to meet the public health goal of mitigating the risk of nonmedical use or overdose if the Agency were to require drug manufacturers to make in-home disposal products available to patients under a risk evaluation and mitigation strategy (REMS). The Agency would like information and comments on the issues to be discussed at the public workshop convened by the National Academies of Sciences, Engineering and Medicine's (NASEM's) Forum on Drug Discovery, Development, and Translation entitled ``Defining and Evaluating In-Home Disposal Systems for Opioid Analgesics'' on June 26 and 27, 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 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 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.

The Substance Abuse and Mental Health Services Administration (SAMHSA) within the Department of Health and Human Services (HHS), is soliciting nominations from qualified organizations to be considered for non-voting liaison representative positions on a subcommittee of the Advisory Committee for Women's Services (ACWS) focused on maternal mental health. The ACWS subcommittee will consist of 5 non-voting liaison representatives who are nominated by their organizations to serve as the representatives of their organizations and selected by the ACWS DFO. The ACWS's role is to advise the Associate Administrator for Women's Services (AAWS) on appropriate activities to be undertaken by the agencies of the Administration with respect to women's substance use and mental health services, including services which require a multidisciplinary approach. These may include discussion on the development of policies and programs regarding women's issues; plans to standardize and enhance the collection of data on women's health, and other emerging issues concerning women's substance use and mental health services. In particular, this subcommittee will focus on maternal mental health issues (which includes substance use) including prevention, screening, diagnosis, treatment, equity and community-based interventions.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.'' This draft guidance demonstrates FDA's commitment to developing innovative approaches to the regulation of machine learning- enabled medical devices and describes an approach that would often be the least burdensome and would support iterative improvement through modifications to machine learning-enabled device software functions (herein referred to as ML-DSF) while continuing to ensure device safety and effectiveness. This draft guidance provides recommendations on the information to be included in a Predetermined Change Control Plan (PCCP) in a marketing submission for an ML-DSF. Such a plan describes the anticipated ML-DSF modifications and the associated methodology to implement those modifications, which would be reviewed in the marketing submission to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for each modification described in the PCCP. This draft guidance is not final nor is it for implementation at this time.

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).