Department of Health and Human Services April 30, 2024 – Federal Register Recent Federal Regulation Documents
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Designated Placement Requirements Under Titles IV-E and IV-B for LGBTQI+ Children
This rule finalizes requirements under titles IV-E and IV-B for children in foster care who are LGBTQI+ (an umbrella term used in this regulation). The proposed rule was published on September 28, 2023. Federal law requires that state and tribal title IV-E and IV-B agencies ("agencies") ensure that each child in foster care receives "safe and proper" care and has a case plan that addresses the specific needs of the child while in foster care to support their health and wellbeing. To meet these and other related statutory requirements, this final rule requires agencies to ensure that placements for all children are free from harassment, mistreatment, and abuse. The final rule requires that title IV-E and IV-B agencies ensure a Designated Placement is available for all children who identify as LGBTQI+ and specifies the Designated Placement requirements.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations
The Food and Drug Administration (FDA, Agency, 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.
Medicare Program; Application by the Community Health Accreditation Partner (CHAP) for Continued CMS Approval of Its Home Infusion Therapy (HIT) Accreditation Program
This notice acknowledges the receipt of an application from the Community Health Accreditation Partner (CHAP) for continued approval by the Centers for Medicare & Medicaid Services (CMS) of CHAP's national accrediting organization program for suppliers providing home infusion therapy (HIT) services and that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, CMS will publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Removal of Outdated Regulations
The Indian Health Service (IHS) of the Department of Health and Human Services (HHS or "the Department") is issuing this final rule to remove outdated regulations that do not align with the current statutory text.
Listening Session: Optimizing the Food and Drug Administration's Use of and Processes for Advisory Committees; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled "Listening Session: Optimizing FDA's Use of and Processes for Advisory Committees." The purpose of the listening session is to solicit feedback on the Agency's use of and processes for its advisory committee system.
Unaccompanied Children Program Foundational Rule
This final rule adopts and replaces regulations relating to key aspects of the placement, care, and services provided to unaccompanied children referred to the Office of Refugee Resettlement (ORR), pursuant to ORR's responsibilities for coordinating and implementing the care and placement of unaccompanied children who are in Federal custody by reason of their immigration status under the Homeland Security Act of 2002 (HSA) and the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA). This final rule establishes a foundation for the Unaccompanied Children Program (UC Program) that is consistent with ORR's statutory duties, for the benefit of unaccompanied children and to enhance public transparency as to the policies governing the operation of the UC Program. This final rule implements the 1997 Flores Settlement Agreement (FSA). As modified in 2001, the FSA provides that it will terminate 45 days after publication of final regulations implementing the agreement. ORR anticipates that any termination of the settlement based on this final rule would only be effective for those provisions that affect ORR and would not terminate provisions of the FSA that apply to other Federal Government agencies.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Office of the Secretary, Muscular Dystrophy Coordinating Committee Call for Committee Membership Nominations
The Office of the Secretary of the Department of Health and Human Services (HHS) is seeking nominations for one individual to serve as a non-Federal public member on the Muscular Dystrophy Coordinating Committee.
Submission for Office of Management and Budget (OMB) Review; Generic Clearance for the Comprehensive Child Welfare Information System (CCWIS) Technical Assistance and Review Process (OMB #: 0970-0568)
The Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is requesting a 3-year extension of the Generic Clearance for the Comprehensive Child Welfare Information System (CCWIS) Technical Assistance (TA) and Review Process, (OMB #0970-0568, expiration 4/30/ 2024) and all approved information collections under this generic. There are no changes requested to the terms of the umbrella generic or to the currently approved information collections.
Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry." Allogeneic cells of human origin may be expanded in culture to manufacture medical products consisting of live cells, inactivated cells, cell lysates, or other cell-based materials such as cell-derived particles. The draft guidance document provides sponsors of allogeneic cell-based medical products recommendations for determining the appropriate cell safety testing to support an investigational new drug application (IND) or a biologics license application (BLA). Cell safety testing should be based on a risk analysis that considers the expansion potential of the cells, the reagents that are used to expand the cells in culture, and the number of individuals the cell-based medical product is capable of treating.
Considerations for the Use of Human-and Animal-Derived Materials and Components in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Considerations for the Use of Human- and Animal-Derived Materials and Components in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Draft Guidance for Industry." The draft guidance document provides manufacturers of cellular and gene therapy (CGT) and tissue- engineered medical products (TEMPs) with recommendations regarding assuring the safety, quality, and identity of materials of human and animal origin used in the manufacture of these products. In addition, recommendations are provided regarding the chemistry, manufacturing, and control (CMC) information submitted in an investigational new drug application (IND) relating to the use of human- and animal-derived materials.
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