Department of Health and Human Services May 29, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Tribal Consultation Meetings
Pursuant to the Head Start Act, notice is hereby given of one joint Tribal consultation session to be held between HHS/ACF ECD, OHS, and OCC leadership and the leadership of Tribal governments operating Tribal Maternal, Infant, and Early Childhood Home Visiting; Tribal Child Care and Development Fund; and Head Start and Early Head Start programs. The purpose of this consultation session is to discuss ways to better meet the needs of Tribal children and their families and issues affecting the delivery of early childhood services in their geographic locations. The consultation will also provide an opportunity for discussion on the review and promulgation of Head Start Program Performance Standards, as required under the Head Start Act. To meet this legislative requirement, one Tribal consultation will be held as part of HHS/ACF or ACF Tribal consultation sessions.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Platform Technology Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Platform Technology Designation Program for Drug Development." The purpose of this draft guidance is to provide details about the implementation of the Platform Technology Designation Program established by the PREVENT Pandemics Act. This draft guidance outlines eligibility factors for receiving a platform technology designation, potential benefits of receiving a designation, how to leverage data from designated platform technologies, how to discuss the planned designation request as part of a milestone meeting, the recommended content of a designation request submission, and the review timelines for a designation request. This draft guidance, when finalized, will represent the current thinking of FDA.
Maria Anzures-Camarena: Final Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Maria Anzures-Camarena from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Anzures- Camarena was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Ms. Anzures-Camarena was given notice of the proposed debarment and an opportunity to request a hearing to show why she should not be debarred. As of March 6, 2024, (30 days after receipt of the notice), Ms. Anzures-Camarena has not responded. Ms. Anzures-Camarena's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.
Notice of Award of a Single Source Cooperative Agreement To Fund Universidad del Valle de Guatemala
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $5,000,000 with an expected total funding of approximately $25,000,000 over a 5-year period, to the Universidad del Valle de Guatemala. This award will build upon previously funded Global Health Security projects, and specifically surveillance activities by CDC to collaboratively work with host countries to create sustainable systems that can inform local public health policy.
Bayer HealthCare Pharmaceuticals, Inc., et al.; Withdrawal of Approval of Three New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of three new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Agency Information Collection Activities; Proposed Collection; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation)
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions related to the De Novo Classification Process.
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