Department of Health and Human Services April 2, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Electronic Submission of Expedited Safety Reports From Investigational New Drug-Exempt Bioavailability/Bioequivalence Studies; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies." This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies to the FDA Adverse Event Reporting System (FAERS). This guidance finalizes the draft guidance entitled "Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies" issued on August 3, 2022.
Medicaid Program; Streamlining the Medicaid, Children's Health Insurance Program, and Basic Health Program Application, Eligibility Determination, Enrollment, and Renewal Processes
This is the second part of a two-part final rule that simplifies the eligibility and enrollment processes for Medicaid, the Children's Health Insurance Program (CHIP), and the Basic Health Program (BHP). This rule aligns enrollment and renewal requirements for most individuals in Medicaid; establishes beneficiary protections related to returned mail; creates timeliness requirements for redeterminations of eligibility; makes transitions between programs easier; eliminates access barriers for children enrolled in CHIP by prohibiting premium lock-out periods, benefit limitations, and waiting periods; and modernizes recordkeeping requirements to ensure proper documentation of eligibility determinations.
Solicitation of Nominations for Appointment to the Communications and Public Engagement Workgroup of the Advisory Committee to the Director, CDC; Notice of Extension
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Communications and Public Engagement Workgroup (CPEW) of the Advisory Committee to the Director, CDC. The CPEW consists of approximately 15 members who are experts in fields associated with communications, including public relations, health communication, risk communication, communication research, and marketing; community and partner engagement; public health science and practice, including implementation; and behavioral science/behavior change campaigns.
Notice of Update to the Purchased/Referred Care Delivery Area for the Mississippi Band of Choctaw Indians
Notice is hereby given that the Indian Health Service (IHS) has updated the geographic boundaries of the purchased/referred care delivery area (PRCDA) for the Mississippi Band of Choctaw Indians to include the counties of Carroll and Jackson in the State of Mississippi and the county of Lauderdale in the State of Tennessee. The PRCDA for the Mississippi Band of Choctaw Indians now comprises the Mississippi counties of Attala, Carroll, Jackson, Jasper, Jones, Kemper, Leake, Neshoba, Newton, Noxubee, Scott, and Winston, and the Tennessee county of Lauderdale. The sole purpose of this expansion is to authorize additional Mississippi Band of Choctaw Indians members and beneficiaries to receive purchased/referred care (PRC) services.
Notice of Purchased/Referred Care Delivery Area Redesignation for the Mashantucket Pequot Tribal Nation in the State of Connecticut
Notice is hereby given that the Indian Health Service (IHS) has decided to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Mashantucket Pequot Tribal Nation to include the counties of Fairfield, Hartford, Litchfield, Middlesex, New Haven, Tolland, and Windham in the State of Connecticut. The final PRCDA for the Mashantucket Pequot Tribal Nation now includes the Connecticut counties of Fairfield, Hartford, Litchfield, Middlesex, New Haven, New London, Tolland, and Windham. The sole purpose of this expansion is to authorize additional Mashantucket Pequot Tribal Nation members and eligible IHS beneficiaries to receive purchased/referred care (PRC) services.
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a webcast on April 18, 2024. This virtual meeting will be open to the public. Registration is required for the public to attend the meeting, provide comment, and/or distribute material(s) to ACMH members. Any individual who wishes to participate in the virtual meeting should register using the Zoom registration link provided below by 5:00 p.m. EDT on April 12, 2024. Instructions regarding participating in the call and providing written or verbal public comments will be provided after meeting registration occurs. Information about the meeting will be posted on the HHS Office of Minority Health (OMH) website: www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH website under the heading About OMH, Committees and Working Groups.
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