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The National Institutes of Health (NIH), part of the Department of Health and Human Services, is seeking public comments as part of their routine process under the Paperwork Reduction Act of 1995. They aim to gather qualitative feedback on agency service delivery to improve performance. This initiative is not intended to generate statistical data but to gather insights and opinions that help enhance the quality of NIH's services. Stakeholders or customers who have interacted with NIH services are encouraged to provide their feedback within 60 days of the notice's publication date.

The Office of Inspector General under the Health and Human Services Department announced a delay in the effective date of certain changes to the regulations that protect against kickbacks in the pharmaceutical industry. These changes, initially set to take effect on January 1, 2022, involve the removal of safe harbor protection for certain rebates on prescription drugs, and the creation of new protections for reductions in prices at the point of sale and for fixed fees paid to pharmacy benefit managers. The new effective date for these amendments is now January 1, 2023, following a court order. This action was taken without public comment due to a court-ordered mandate.

The Centers for Medicare & Medicaid Services (CMS), part of the Department of Health and Human Services (HHS), issued a notice about a new information collection related to PACE Medicaid Capitation Rate Setting. The notice is looking for public comments on the proposed collection methods, which aim to assist states in setting PACE rates for elderly care programs integrating Medicare and Medicaid services. This process involves obtaining feedback on minimizing the burden of information collection and improving the clarity and utility of the collected data. Comments must be submitted by December 20, 2024, through options like electronic submission at regulations.gov or via mail.

The National Institute on Aging has announced a closed meeting for the Career Development for Early Career Investigators Study Section, scheduled for February 12-13, 2025, from 9:00 a.m. to 5:00 p.m. This virtual meeting will involve reviewing and evaluating grant applications. The meeting is closed to the public because it might involve discussion of confidential trade secrets or personal information. Dario Dieguez, Ph.D., is the contact person for this meeting, and he can be reached at dario.dieguez@nih.gov.

The National Institute on Minority Health and Health Disparities announced a closed meeting scheduled for April 29, 2025. The meeting will run from 10:00 a.m. to 6:00 p.m. and is set to be held virtually. It is closed to the public because discussions will involve confidential information, like trade secrets and private details from grant applications. For more information, Xinli Nan, the Scientific Review Officer, can be contacted via email or phone.

The Food and Drug Administration (FDA) has released a draft guidance document titled "Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." This document provides general advice on evaluating donor eligibility, including screening and testing procedures. It also updates existing guidelines and plans to introduce additional guidance to help minimize communicable disease risks from donors. Public feedback on these recommendations can be submitted electronically or in writing until February 6, 2025.

The Department of Health and Human Services has issued a notice clarifying that businesses that started producing hand sanitizers during the COVID-19 pandemic are not required to pay certain facility fees under the Food, Drug, and Cosmetic Act. These businesses, many of which normally produce alcoholic beverages, were allowed to make hand sanitizers due to a temporary policy by the FDA to address shortages. The Department emphasizes that imposing such fees would be inconsistent with the intent of the CARES Act and clarifies that these businesses are not considered drug manufacturing facilities under the law, unless they also engage in producing other over-the-counter drugs.

The National Institute on Aging has announced a change to the date of an upcoming meeting. Originally scheduled for March 1, 2021, the meeting will now be held on March 15, 2021. This meeting will take place at the Gateway Building in Bethesda, Maryland and is not open to the general public. This change was officially noted in the Federal Register on February 4, 2021.

The Department of Health and Human Services (HHS), via the National Institutes of Health (NIH), has amended a regulation regarding clinical trials. This change updates the web address in the regulation concerning where to find information about submitting trial data to ClinicalTrials.gov. The new rule removes the old URL https://prsinfo.clinicaltrials.gov and replaces it with https://clinicaltrials.gov or a future site, modernizing and centralizing information access. This amendment is technical and does not add new requirements for affected parties.

The National Institutes of Health has announced a change in the contact person for an upcoming meeting of the HIV/AIDS Intra- and Inter-personal Determinants and Behavioral Interventions Study Section. This meeting, originally detailed in the Federal Register on March 12, 2025, will take place from April 24 to April 25, 2025. The new contact is Joann Wu Shortt, Ph.D., replacing Mark Rubert, Ph.D. The meeting will be held in Bethesda, MD, and it is closed to the public.