Department of Health and Human Services August 23, 2017 – Federal Register Recent Federal Regulation Documents
Results 1 - 15 of 15
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach To Establish an Acute Reference Dose; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GFI) #232 entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose'' (VICH GL54). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to address the nature and types of data that can be useful in determining a toxicological acute reference dose (ARfD) for residues of veterinary drugs, the studies that may generate such data, and how the ARfD may be calculated based on these data.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Peripheral and Central Nervous System 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 Peripheral and Central Nervous System Drugs Advisory 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. FDA is establishing a docket for public comment on this document.
Oncology Drugs for Companion Animals; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry #237 entitled ``Oncology Drugs for Companion Animals.'' The guidance provides recommendations for sponsors of investigational oncology drugs for use in companion animals (e.g., dogs, cats, and horses), discusses the contents of a new animal drug application for certain oncology drugs, and provides recommendations on how to address human user safety concerns.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health
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.
Draft-National Occupational Research Agenda for Manufacturing
As steward of the National Occupational Research Agenda (NORA), the National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of the draft National Occupational Research Agenda for Manufacturing for public comment. Written by the NORA Manufacturing Sector Council, the Agenda identifies the most important occupational safety and health research needs for the next decade, 2016-2026. A copy of the draft Agenda is available at https://www.regulations.gov (search Docket Number CDC-2017-0072).
Advancing the Development of Pediatric Therapeutics: Application of “Big Data” to Pediatric Safety Studies; Public Workshop
The Office of Pediatric Therapeutics, Food and Drug Administration (FDA), is announcing a public workshop entitled ``Advancing the Development of Pediatric Therapeutics (ADEPT): Application of ``Big Data'' to Pediatric Safety Studies.'' The purpose of this 2-day workshop is to understand how to access and analyze ``Big Data'' associated with safety information in the health care setting, and the utility and challenges associated with the use of ``Big Data'' to study the safety of therapeutics in children.
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