Department of Health and Human Services September 18, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List; Revisions to the Withdrawn or Removed List
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding 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.
Submission for Office of Management and Budget (OMB) Review; 2024 National Survey of Early Care and Education Longitudinal Follow-ups (OMB #: 0970-0391)
The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing a data collection activity to be conducted January 2025 through December 2025 as a follow-up of the 2024 National Survey of Early Care and Education (NSECE). The objectives of the 2024 NSECE Longitudinal Follow-ups are to build on the design and implementation of the 2024 NSECE to collect urgently needed information on the following two topics relevant to early care and education (ECE) policy: (1) how households learn about and make use of financial assistance in seeking and selecting ECE, with additional focus on paid individual care arrangements; and (2) patterns of retention and attrition among individuals in the center-based ECE workforce.
Medicare Program; Application by the Community Health Accreditation Partner (CHAP) for Continued CMS Approval of Its Home Infusion Therapy (HIT) Accreditation Program
This final notice announces our decision to approve the Community Health Accreditation Partner (CHAP) for continued recognition as a national accrediting organization that accredits suppliers of home infusion therapy (HIT) services that wish to participate in the Medicare or Medicaid programs.
Conducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Interested Parties Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, investigators, and other interested parties entitled "Conducting Clinical Trials With Decentralized Elements." This guidance provides recommendations regarding the implementation of decentralized elements in clinical trials for drugs, biological products, and devices. Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants (e.g., telehealth visits with investigators or visits with local healthcare providers (HCPs)). FDA's regulatory requirements are the same for trials that include decentralized elements and trials that do not include decentralized elements. To help ensure the appropriate oversight trials with decentralized elements, the integrity of trial data, and the safety of trial participants, this guidance covers the responsibilities of sponsors and investigators. This guidance finalizes the draft guidance entitled "Decentralized Clinical Trials for Drugs, Biological Products, and Devices" issued on May 3, 2023.
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice." FDA is publishing this draft guidance as part of a series of guidance documents under its Real-World Evidence (RWE) Program and to satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act to issue guidance about the use of RWE in regulatory decision-making. This draft guidance is intended to support the conduct of randomized controlled drug trials with streamlined protocols and procedures that can integrate research into routine clinical practice.
Performance Standards for Medicaid Fraud Control Units
This document sets forth OIG guidance regarding standards OIG will apply in assessing the performance of Medicaid Fraud Control Units (MFCUs or Units). Based on its experience in overseeing MFCUs, and after consultation with key stakeholders, OIG is revising the standards. These standards replace and supersede standards published on June 1, 2012.
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