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 Marble Therapeutics, Inc. (``Marble''), headquartered in Boston, MA.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $8,000,000, with an expected total funding of approximately $50,000,000 over a 5-year period, to the Pan-American Health Organization (PAHO). The award will support strengthening immunization systems; ensuring polio free certification status; maintaining measles, rubella, and neonatal tetanus elimination; and prevention of other vaccine-preventable diseases (VPDs) in the Americas region. This award builds upon and continues work previously supported by PAHO through a cooperative agreement under CDC-RFA-GH-1901, ``Cooperative Agreement with the Pan American Health Organization: Protecting and Strengthening Immunization Programs in the Americas.''

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award(s) of approximately $500,000, for Year 1 funding to Kisumu County GovernmentDepartment of Health Services, $8,000,000, for Year 1 funding to Servi[ccedil]os Provincial de Sa[uacute]de Gaza, $2,500,000, for Year 1 funding to Servi[ccedil]os Provincial de Saude Nampula and $800,000 for Year 1 funding to MHSA. These awards will achieve and sustain HIV/TB epidemic control through sustainable high-quality comprehensive HIV prevention and treatment services, health service delivery models, and health systems in Kenya, Mozambique and West Africa-Senegal. Funding amounts for years 2-5 will be set at continuation.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUAs) (the Authorizations) issued to Southern California Permanente Medical Group, for the Kaiser Permanente High Throughput SARS-CoV-2 Assay, that includes the Kaiser Permanente Saliva Home Collection Kit, and Drexel University College of Medicine, for the SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.

HRSA expects the availability of additional funds for the RWHAP Part C Early Intervention Services (EIS) Program due to relinquishments, reductions, closeouts, and unawarded fiscal year (FY) 2023 new service area competition funds in the estimated amount of $4.2 million and intends to distribute these supplemental funds across the current cohort of RWHAP Part C EIS recipients. The amount is subject to change depending on the availability of additional funds.

AHRQ coordinates the development of sets of standardized definitions and formats (Common Formats) that make it possible to collect, aggregate, and analyze uniformly structured information about health care quality and patient safety for local, regional, and national learning. The Common Formats include technical specifications to facilitate the collection of electronically comparable data by Patient Safety Organizations (PSOs) and other entities. Additional information about the Common Formats can be obtained through AHRQ's PSO website at https://pso.ahrq.gov/common-formats and the PSO Privacy Protection Center's website at https://www.psoppc.org/psoppc_web/ publicpages/commonFormatsOverview. The purpose of this notice is to announce a meeting to discuss implementation of the Common Formats with software developers and other interested parties. This meeting is designed as an interactive forum where software developers can provide input on use of the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ's technical specifications and implemented, or plan to implement, the Common Formats electronically.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic 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 gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Lead Exposure and Prevention Advisory Committee (LEPAC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through January 17, 2026.

The Centers for Disease Control and Prevention (CDC), 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 Capacity Building Assistance Program: Data Management, Monitoring, and Evaluation. The goal of the study is to allow CDC to evaluate the CDC cooperative agreement program entitled CDC-RFA-PS19- 1904 in order to improve the evaluation design and methods used to capture PS19-1904 outcomes, and to increase access and use of PS19-1904 data for continuous quality improvement and performance reporting.

The Centers for Disease Control and Prevention (CDC), 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 Import Permit. The goal of the information collection is to support the Public Health Service (PHS) Act and prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

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.