Department of Health and Human Services August 20, 2018 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
National Advisory Committee on Children and Disasters Public Teleconference
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) will hold a public teleconference on September 11, 2018.
National Advisory Committee on Children and Disasters and National Biodefense Science Board Public Teleconference
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) and National Biodefense Science Board (NBSB), also known as the National Preparedness and Response Science Board (NPRSB), will hold a joint public teleconference on September 12, 2018.
Office on Trafficking in Persons; Notice of Meeting
Notice is hereby given, pursuant to the provisions of the Federal Advisory Committee Act (FACA) and the Preventing Sex Trafficking and Strengthening Families Act, that a meeting of the National Advisory Committee (NAC) on the Sex Trafficking of Children and Youth in the United States (Committee) will be held on September 13-14, 2018. The purpose of the meeting is for the Committee to discuss its duties and information for a draft report on recommended best practices for states to follow in combating the sex trafficking of children and youth based on multidisciplinary research and promising, evidence-based models and programs.
Neurological Devices Panel Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA or Agency) announces a forthcoming public Advisory Committee meeting of the Neurological Devices Panel (Committee). The general function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
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 process for formally resolving scientific and procedural disputes in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that cannot be resolved at the division level.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Samples and Protocols
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Food and Drug Administration's Evaluation of Approaches To Demonstrate Effectiveness of Heartworm Preventatives for Dogs; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the request for comments that appeared in the Federal Register of May 24, 2018. In the request for comments, FDA requested comments on the design of studies intended to generate data to support substantial evidence of effectiveness for investigational new animal drugs intended for the prevention of heartworm disease in dogs. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Pediatric 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 Pediatric Advisory Committee (PAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. FDA is establishing a docket for public comments on this document.
Questions and Answers Regarding Food Facility Registration (Seventh Edition); Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Seventh Edition).'' The guidance provides updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Supplemental Questions and Answers Regarding Food Facility Registration; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Supplemental Questions and Answers Regarding Food Facility Registration.'' This draft guidance is intended to supplement the guidance document entitled ``Questions and Answers Regarding Food Facility Registration.''
Agency Information Collection Request; 30-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of Revisions to the Provider Enrollment Moratoria Access Waiver Demonstration for Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Moratoria-Designated Geographic Locations
This document announces revisions to the Provider Enrollment Moratoria Access Waiver Demonstration (PEWD) for Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies. The demonstration was implemented in accordance with section 402(a)(1)(J) of the Social Security Amendments of 1967 and, as revised, gives CMS the authority to grant waivers to the statewide enrollment moratoria on a case-by-case basis in response to access to care issues and previously denied enrollment applications because of statewide moratoria implementation, and to subject providers and suppliers enrolling via such waivers to heightened screening, oversight, and investigations.
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