Department of Health and Human Services August 12, 2024 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Transitional Coverage for Emerging Technologies
This final notice finalizes the process and procedures for the Transitional Coverage for Emerging Technologies (TCET) pathway and provides our responses to the public comments received.
Agency Information Collection Activities; Proposed Collection; Risk/Safety Considerations and Motivations for Purchase and Use of Kratom and Psychedelics Alone and in Combination With Other Substances; Withdrawal of Notice
The Food and Drug Administration (FDA) is announcing the withdrawal of a notice that was published in the Federal Register of August 2, 2024.
Development of an Enhanced Systematic Process for the Food and Drug Administration's Post-Market Assessment of Chemicals in Food; Public Meeting; Request for Comments
The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled "Development of an Enhanced Systematic Process for FDA's Post-Market Assessment of Chemicals in Food." This public meeting will assist in developing the post-market chemicals assessment program we will establish under the new FDA Human Foods Program. The purpose of the public meeting is to hear from interested parties about approaches to systematic post-market assessment of chemicals in food.
Notice of Supplemental Funding for Regional Pediatric Pandemic Network Award Recipients
Per Congressional Report language accompanying the Further Consolidated Appropriations Act, 2024, HRSA is awarding supplemental funds in FY 2024 to two Regional Pediatric Pandemic Network (RPPN) Program recipients to increase activities to coordinate among the Nation's pediatric hospitals and their communities to prepare for and coordinate research-informed responses to future pandemics. The current RPPN program period of performance ends on August 31, 2026.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve a revision of the currently approved information collection project: "Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats." In accordance with the Paperwork Reduction Act of 1995, AHRQ invites the public to comment on this proposed information collection.
Notice of Extension and Supplemental Award for Living Organ Donation Reimbursement Program
HRSA is providing supplemental award funds to the award recipient under the Living Organ Donation Reimbursement Program. This action will extend the current period of performance for the recipient by 12 months to ensure continued access to lifesaving living organ transplants via the National Living Donor Assistance Center.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; COVID-19 Provider Relief Programs Single and Commercial Audits and Delinquent Audit Reporting Submission Activities-Revision
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Common Formats for Patient Safety Data Collection
As authorized by the Secretary of HHS, AHRQ coordinates the development of common definitions and reporting formats (Common Formats or formats) for reporting on health care quality and patient safety. The purpose of this notice is to announce the availability of Common Formats for SurveillanceHospital (CFS-H) Version 1.0.
Gastrointestinal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental New Drug Application 207999 S-011 for OCALIVA (obeticholic acid) Oral Tablets
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Gastrointestinal Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Advancing Rare Disease Therapies Through a Food and Drug Administration Rare Disease Innovation Hub; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting, entitled "Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub." The purpose of the public meeting is to discuss the establishment of a Rare Disease Innovation Hub, which will enhance collaboration and cooperation across the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), as well as other centers and offices across FDA, to advance rare disease therapies. In particular, this meeting will be an opportunity for those in the rare disease community, including patients and caregiver groups, industry organizations, and scientific/academic organizations, to provide input on the priorities of the Rare Disease Innovation Hub and how the Hub can best engage with members of the rare disease community. The public meeting will be facilitated by the Reagan-Udall Foundation for the FDA.
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