Department of Health and Human Services May 24, 2018 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management 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 Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. At least one portion of the meeting will be closed to the public. FDA is establishing a docket for public comment on this document.
Food and Drug Administration's Evaluation of Approaches To Demonstrate Effectiveness of Heartworm Preventatives for Dogs; Request for Comments
The Food and Drug Administration (FDA or we) is evaluating its current thinking regarding 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. We are specifically requesting public input on possible alternative approaches for evaluating such products or information to assist in the potential development of alternative recommended study designs.
Office of the Deputy Assistant Secretary for Administration Statement of Organization, Functions, and Delegations of Authority
The Administration for Children and Families (ACF) has realigned The Office of the Deputy Assistant Secretary for Administration (ODASA). This realignment removes the Office of the Chief Information Officer as a direct report to the Assistant Secretary for Children and Families and realigns the Office within the ODASA. It moves the National Grants Center of Excellence to the ODASA's Immediate Office. It also removes the Ethics and Facilities team from the Immediate Office of the ODASA and places the functions in the Office of Workforce Planning and Development.
Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.'' The purpose of this guidance is to assist sponsors in the development of new drugs for the prophylaxis of inhalational anthrax. This guidance finalizes the draft guidance of the same name issued on February 16, 2016.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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 information collection requirements associated with current good manufacturing practice, hazard analysis, and risk-based preventive controls for animal food.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements
The Food and Drug Administration (FDA) 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.
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