Department of Health and Human Services November 20, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit comments regarding our burden estimates 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.
Findings of Research Misconduct
Findings of research misconduct have been made against Sarah Elizabeth Martin (Respondent), who was formerly a Graduate Teaching Assistant, Department of Biological Sciences, Auburn University (AU). Respondent engaged in research misconduct in research included in a grant application submitted for U.S. Public Health Service (PHS) funds, specifically R21 AI159361-01 submitted to the National Institute of Allergy and Infectious Disease (NIAID), National Institutes of Health (NIH), and in research supported by NIAID, NIH, grant R21 AI159361-01. The administrative actions, including debarment for a period of three (3) years followed by supervision for a period of two (2) years, were implemented beginning on November 3, 2023, and are detailed below.
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.
Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket; Request for Information and Comments
The Food and Drug Administration (FDA, Agency, or we) is publishing this request for information to better understand the status of trading partners' interoperable systems and processes for enhanced drug distribution security as required by the Food, Drug and Cosmetic Act (FD&C Act).
Proposed Information Collection Activity; Financing for Early Care and Education: Quality and Access for All (New Collection)
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services seeks approval to collect information to explore the role of Head Start in the early care and education (ECE) financing landscape, as well as how the use of multiple funding sources within a single Head Start program may be associated with the provision of Head Start's comprehensive services and with state-level differences in ECE funding. Survey data will be collected from Head Start program directors and state government administrators.
Supporting the Head Start Workforce and Consistent Quality Programming
We propose to add new requirements to the Head Start Program Performance Standards (HSPPS) to support and stabilize the Head Start workforce, including requirements for wages and benefits, breaks for staff, and enhanced supports for staff health and wellness. We also propose to enhance several existing requirements and add new requirements to promote consistent quality of services across Head Start programs. This includes proposed enhancements to requirements for mental health services to better integrate these services into every aspect of programs as well as elevate the role of mental health consultation to support the well-being of children, families, and staff. Enhancements are also proposed in the areas of family service, worker family assignments, identifying and meeting community needs, ensuring child safety, services for pregnant women and people, and alignment with State early childhood systems. Finally, we propose minor clarifications to existing standards to promote better transparency and clarity of understanding for grant recipients.
Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement.'' Convened by the Duke-Robert J. Margolis, MD Center for Health Policy (Duke-Margolis) in collaboration with FDA and supported by a cooperative agreement between FDA and Duke-Margolis, the workshop will focus on how best to understand patients' experiences living with a rare disease and how to incorporate those experiences, as well as patients' priorities for treatment goals, throughout the drug development process.
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
The U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a virtual meeting. The meeting will be open to the public via webcast. The committee will discuss and vote on recommendations related to surge capacity for blood and blood products.
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