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

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this Notice to McSAF Inside Oncology SAS ("McSAF Inside Oncology") located in Tours, France.

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.

This final notice announces our decision to approve The Compliance Team (TCT) for continued recognition as a national accrediting organization (AO) for Rural Health Clinics (RHCs) that wish to participate in the Medicare or Medicaid programs.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity to provide public comment on a modified risk tobacco product application (MRTPA). The application is for renewal of an existing modified risk tobacco product (MRTP) order for the IQOS 3.0 System Holder and Charger, a Heated Tobacco Product (HTP), submitted by Philip Morris Products S.A.

This rule allows title IV-E agencies to claim Federal financial participation (FFP) for the administrative costs of: legal representation in foster care proceedings provided by an attorney representing the title IV-E agency or any other public agency (including an Indian tribe) which has an agreement in effect under which the other agency has placement and care responsibility of a title IV-E eligible child; independent legal representation provided by an attorney representing a child in title IV-E foster care, a child who is a candidate for title IV-E foster care (hereafter, referred to as a child "who is eligible for title IV-E foster care"), the child's parent(s), the child's relative caregiver(s), and the child's Indian custodian(s) in foster care and other civil legal proceedings as necessary to carry out the requirements in the title IV-E agency's title IV-E foster care plan; and legal representation provided by an attorney representing an Indian child's tribe, or representation of an Indian child's tribe provided by a non-attorney, when the child's tribe participates or intervenes in any state court proceeding for the foster care placement or termination of parental rights (TPR) of an Indian child who is in title IV-E foster care or an Indian child who is a candidate for title IV-E foster care.

This final rule establishes minimum staffing standards for long-term care facilities, as part of the Biden-Harris Administration's nursing home reform initiative to ensure safe and quality care in long- term care facilities. In addition, this rule requires States to report the percent of Medicaid payments for certain Medicaid-covered institutional services that are spent on compensation for direct care workers and support staff.

The Department of Health and Human Services (HHS or the Department) is committed to protecting the civil rights of individuals with disabilities under section 504 of the Rehabilitation Act of 1973 (section 504). To implement the prohibition of discrimination on the basis of disability, the Department is making a number of revisions to update and amend its section 504 regulation.

The National Institutes of Health (NIH) announces publication of the updated significant changes that have already been made to the NIH Grants Policy Statement (GPS) in fiscal year 2023 that will be reflected in the GPS for fiscal year 2024. The NIH GPS provides both up-to-date policy guidance that serves as NIH standard terms and conditions of award for all NIH grants and cooperative agreements, and extensive guidance to those who are interested in pursuing NIH grants. This update incorporates significant changes for FY 2024, such as new and modified requirements, clarifies certain policies, and implements changes in statutes, regulations, and policies that have been implemented through appropriate legal and/or policy processes (e.g., Federal Register Notices, where appropriate) since the previous version of the NIHGPS dated December 2022.

The National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH) invites input from all interested parties (individuals or groups) on NIDCD's future research directions in Global Health defined for this RFI as international collaboration among researchers in all countries to improve health. NIDCD requests input specifically focused on the NIDCD mission of advancing the science of communication to improve lives.

The Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) in the Office of the Director, National Institutes of Health (NIH) is seeking public comment regarding its proposal to transfer the All of Us (ALL) Research Program and Environmental influences on Child Health Outcomes (ECHO) Program from the Immediate Office of the NIH Director to DPCPSI in the Office of the Director, NIH. The program offices in DPCPSI share a common mission of identifying emerging scientific opportunities, rising public health challenges, or scientific knowledge gaps that deserve special emphasis. The proposed reorganization would align the important offices with offices having similar NIH-wide functions.

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders. Interested persons may attend in person or view the meeting remotely by webcast. Time will be set aside for questions and public statements on the topics discussed. Registration is requested for attending in person and required for viewing the webcast. Registration is also required for presenting oral statements, whether in person or online. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/iccvamforum- 2024.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (the 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.

This final rule makes several clarifications and updates the definitions currently used to determine whether a consumer is eligible to enroll in a Qualified Health Plan (QHP) through an Exchange; a Basic Health Program (BHP), in States that elect to operate a BHP; and for Medicaid and Children's Health Insurance Programs (CHIPs). Specifically, Deferred Action for Childhood Arrivals (DACA) recipients and certain other noncitizens will be included in the definitions of "lawfully present" that are used to determine eligibility to enroll in a QHP through an Exchange, for Advance Payments of the Premium Tax Credit (APTC) and Cost-Sharing Reductions (CSRs), or for a BHP.

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.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the Advisory Committee to the Director (ACD). The ACD consists of up to 15 experts knowledgeable in areas pertinent to the CDC mission, such as public health, global health, health disparities, biomedical research, and other fields, as applicable.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "REMS Logic Model: A Framework to Link Program Design With Assessment." The guidance describes FDA's risk evaluation and mitigation strategy (REMS) logic model. The REMS logic model is a framework that FDA recommends, which provides applicants with a systematic, structured approach to the design, implementation, and evaluation of a REMS. The aim of applying the REMS logic model is to develop clear goals, objectives, and strategies that align with the intended outcomes and to help applicants of new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) incorporate REMS assessment planning into the design of a REMS. The principles in this guidance apply to designing a REMS, developing a REMS assessment, and modifying a REMS.