Department of Health and Human Services August 23, 2022 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory 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.
Announcing the Intent To Award a Sole-Source Supplement for the Christopher and Dana Reeve Foundation
The Administration for Community Living (ACL) is announcing the award of a sole-source supplement for the National Paralysis Resource Center (PRC) as a result of the 2022 Congressional budget appropriations. The National Paralysis Resource Center is operated by the Christopher and Dana Reeve Foundation and offers important programmatic opportunities for persons with disabilities and older adults. The NPRC provides comprehensive information for people living with spinal cord injury, paralysis, and mobility-related disabilities and their families. Resources include information and referral by phone and email in multiple languages; a peer and family support mentoring program; a military and veterans' program; multicultural outreach services; multiple quality of life grants; and a national website. The administrative supplement for FY 2022 will be in the amount of $747,037, bringing the total award for FY 2022 to $9,447,037.
Charging for Investigational Drugs Under an Investigational New Drug Application: Questions and Answers; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Charging for Investigational Drugs Under an IND: Questions and Answers.'' Since issuance of the final guidance in 2016, FDA has received questions from stakeholders through the docket and in the form of communications with review divisions. These questions relate to the implementation of FDA's regulation on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use. FDA is providing this revised draft guidance in a question-and-answer format, addressing the most recently asked questions. When finalized, this revised draft guidance will replace the final guidance of the same title issued in June 2016.
Agency Information Collection Activities: Proposed Collection; 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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send 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.
Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory 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.
Publication of OIG Special Fraud Alerts
This Federal Register notice sets forth two Special Fraud Alerts previously published by OIG on its website. We are publishing these Special Fraud Alerts in the Federal Register to ensure widespread dissemination of the Special Fraud Alerts to the general public and to satisfy the Federal Register publication requirement.
Proposed Information Collection Activity; Operation Allies Welcome Survey of Resettled Afghans (New Collection)
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new Operation Allies Welcome (OAW) Survey of Resettled Afghans.
Proposed Information Collection Activity; The Role of Licensing in Early Care and Education (New Collection)
The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), is proposing to collect information for The Role of Licensing in Early Care and Education (TRLECE) project. This data collection aims to examine the child care and early education (CCEE) licensing system through surveys of child care licensing administrators, front-line child care licensing staff, and child care providers.
Proposed Information Collection Activity; Administration for Children and Families Uniform Project Description
The Administration for Children and Families (ACF) is requesting revisions to the approved ACF Uniform Project Description (UPD) (Office of Management and Budget (OMB) #0970-0139, expiration March 31, 2025).
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