Department of Health and Human Services 2024 – Federal Register Recent Federal Regulation Documents

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 is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, the Food and Drug Administration is phasing out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. This phaseout policy includes enforcement discretion policies for specific categories of IVDs manufactured by a laboratory, including currently marketed IVDs offered as LDTs and LDTs for unmet needs. This phaseout policy is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while also accounting for other important public health considerations such as patient access and reliance.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency." This draft guidance, when finalized, will describe the factors FDA intends to assess when deciding to issue an enforcement policy regarding test manufacturers' offering of certain unapproved tests and unapproved uses of approved tests during a declared emergency. This draft guidance is not final nor is it for implementation at this time.

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 Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on May 30, 2024. The topic for this meeting will be "Artificial Intelligence in Diabetes Precision Medicine: Real world data, real world opportunities and challenges". The meeting is open to the public.

Notice is hereby given of the formation of a subcommittee of the Center for Substance Abuse Prevention National Advisory Council (CSAP NAC) to be known as the Substance Use Prevention Workforce. The subcommittee reports to the CSAP NAC, and of its findings, which are further deliberated by the CSAP NAC. The expected lifespan of the subcommittee is approximately one year. It is estimated that subcommittee meetings will occur approximately on a monthly basis via web conference.

The National Advisory Committee on Seniors and Disasters (NACSD) will conduct a public meeting on Monday, May 20, 2024 (2:30 p.m.-4:30 p.m. ET). Notice of the meeting is required under Section 10(a)(2) of the Federal Advisory Committee Act (FACA). The NACSD is required by section 2811B of the Public Health Service Act (PHS) Act (42 U.S.C. 300hh-10c), as amended by the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA), Public Law 116-22, and governed by the provisions of the Federal Advisory Committee Act (FACA). The NACSD provides expert advice and guidance to the U.S. Department of Health and Human Services (HHS) regarding all-hazards public health and medical preparedness, response, and recovery activities related to meeting the unique needs of older adults. ASPR manages and convenes the NACSD on behalf of the Secretary of HHS. The NACSD will discuss and deliberate questions posed by ASPR on climate and health equity. Procedures for Public Participation: The public and expert stakeholders are invited to observe the meeting either in-person or virtually and pre-registration is required. The pre-registration link and a more detailed agenda will be available on the NACSD website. Anyone may submit questions and comments to the NACSD by email (NACSD@hhs.gov) before the meeting. American Sign Language translation and Communication Access Real-Time Translation will be provided. We would like to specifically seek input from the public on climate and health equity considerations in disaster training as well as opportunities and strategic priorities for national public health and medical preparedness, response, and recovery specific to the needs of older adults. Representatives from industry, academia, health professions, health care consumer organizations, non-federal government agencies, or community-based organizations may request up to five minutes to speak directly to the Committee. Requests to speak to the Committee will be approved in consultation with the Committee Chair and based on time available during the meeting. Requests to speak to the NACSD during the public meeting must be sent to NACSD@hhs.gov by close of business on May 15, 2024. Please provide the full name, credentials, official position(s), and relevant affiliations for the speaker and a brief description of the intended topic. Presentations that contain material with a commercial bias, advertising, marketing, or solicitations will not be allowed. A meeting summary will be available on the NACSD website post meeting.

The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the Puerto Rico Ombudsman Office for the Elderly (PROOE) for the project Puerto Rico Disaster Assistance Grant which is through the Older Americans Act, Disaster Assistance for State Units on Aging (SUAs) and Tribal Organizations in Major Disasters Declared by the President and the Consolidated Appropriations Act, 2023.

The Food and Drug Administration (FDA) is requesting nominations for a nonvoting representative of the interests of the tobacco growers to serve on the Tobacco Products Scientific Advisory Committee (TPSAC), in the Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups. A nominee may either be self-nominated or nominated by an organization. In addition, FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting representative of the interests of the tobacco growers industry to serve on the TPSAC, notify FDA in writing. Nominations will be accepted for either the representative to serve on TPSAC or for the selection group effective with this notice.

In accordance with the requirements of the Privacy Act of 1974, as amended, the U.S. Department of Health and Human Services (HHS) is establishing two new systems of records that will be maintained by the Administration for Children and Families (ACF), Office on Trafficking in Persons (OTIP): System No. 09-80-0391, Anti- Trafficking Information Management System (ATIMS) Records; and System No. 09-80-0392, National Human Trafficking Training and Technical Assistance Center (NHTTAC) Participant Records.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #187A entitled "Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach." This guidance is intended to clarify FDA's requirements and recommendations with respect to heritable intentional genomic alterations (IGAs) in animals. The guidance is being issued as one of two companion documents. This guidance, entitled "Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach," describes FDA's risk-based regulatory approach to the oversight of heritable IGAs in animals. This means that for people or companies developing certain types of IGAs in animals, FDA may not expect them to submit an application or get approval before marketing their product. For other types of IGAs in animals that do go through the approval process, the companion draft guidance document, GFI #187B entitled "Heritable Intentional Genomic Alterations in Animals: The Approval Process" describes how the approval process applies to heritable IGAs in animals.

This final notice announces our decision to approve The Joint Commission (TJC) for initial recognition as a national accrediting organization (AO) for rural health clinics (RHCs) that wish to participate in the Medicare or Medicaid programs.

This symposium is sponsored by the National Institutes of Health (NIH), Office of Research on Women's Health (ORWH), and the title of this year's symposium is "Synergy in Science: Innovations in Autoimmune Disease Research and Care." The symposium will discuss the convergence of cutting-edge insights and collaborative efforts in the realm of autoimmune diseases.

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.