Department of Health and Human Services September 21, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 20 of 20
Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on November 16, 2023. The topic for this meeting will be ``The Application of Digital Health Technology to Type 2 Diabetes Management: Current Status, Research Gaps, and Opportunities''. The meeting is open to the public.
Streamlining Medicaid; Medicare Savings Program Eligibility Determination and Enrollment
This final rule simplifies processes for eligible individuals to enroll and retain eligibility in the Medicare Savings Programs (MSPs). This final rule better aligns enrollment into the MSPs with requirements and processes for other public programs. Finally, this final rule reduces the complexity of applications and reenrollment for eligible individuals.
Fiscal Year (FY) 2023 Notice of Supplemental Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is proposing to provide one-year supplemental funding in FY 2023 to three Hawaii grant programs to support Maui residents in the aftermath of the Maui wildfires. The Hawaii State Department of Health, the recipient for Certified Community Behavioral Health Clinics Planning, Development, and Implementation (CCBHC-PDI), Grants for Expansion and Sustainability of the Comprehensive Community Mental Health Services for Children with Serious Emotional Disturbances Program (CMHI), and Community Mental Health Services Block Grant (MHBG) will be offered a total of $2,765,556 in supplemental funding since they are the only recipient providing or able to provide services to Maui residents.
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Engineered T Cell Therapies for the Treatment of HPV-Positive Cancer(s)
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 Scarlet TCR, Inc. (``Scarlet''), presently headquartered in Kingston, New Jersey.
Government-Owned Inventions; Availability for Licensing and Collaboration
The invention described below presents an advancement concerning osteoclast fusion; osteoclasts are responsible for human skeletal remodeling and their dysfunction is a key factor for both rare and common bone diseases. The invention covers methods for modulating osteoclast fusion and bone resorption through the Lupus autoantigen (La) protein. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, has conducted conceptual in-vitro studies and is now seeking potential licensees and collaborators for further development and advancement.
Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies; Guidance for Industry, Investigators, and Institutional Review Boards; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.'' This guidance recommends approaches that sponsors of clinical trials of medical products can consider when there is a major disruption to clinical trial conduct and operations due to disasters or public health emergencies, which can include but are not limited to hurricanes, earthquakes, military conflicts, infectious disease outbreaks, or bioterrorist attacks. The appendix to this guidance further explains those approaches by providing answers to questions that the Agency has received about conducting clinical trials during major disruptions.
Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research; Public Workshop
The Food and Drug Administration (FDA) Office of Women's Health and Office of Clinical Pharmacology is announcing the following public workshop: ``Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research.'' The purpose of the public workshop is to discuss the current understanding of the impact of menopause on the pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response relationships of FDA-regulated drugs and biologics used by menopausal women for non-menopause-related indications. Researchers, educators, clinicians, and patients may benefit from attending this scientific workshop. Presentations will discuss whether changes in drug absorption, distribution, metabolism, and elimination, if any, could be affected by hormonal changes of menopause (independent of age), or other non-hormonal influences (including age-related renal and hepatic changes). The discussion is further intended to identify the research and data gaps regarding the potential impact of menopause on PK/PD. Speakers will highlight areas with the greatest need for further research and exploration.
Scientific Challenges and Opportunities To Advance the Development of Individualized Cellular and Gene Therapies; Request for Information
The Food and Drug Administration (FDA or Agency), Center for Biologics Evaluation and Research (CBER) is requesting information from stakeholders regarding critical scientific challenges and opportunities to advance the development of individualized cellular and gene therapies (CGTs). FDA intends to gather information and comments submitted in response to this request for information (RFI) to inform potential planning of future town halls, workshops, or discussion papers which could ultimately facilitate the development of additional regulatory science tools, standards, or guidance.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503
The Food and Drug Administration (FDA) 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.
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