Department of Health and Human Services December 13, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
Availability of Final Toxicological Profiles
This notice announces the availability of ten final toxicological profiles of priority hazardous substances prepared by ATSDR.
Issuance of Final Guidance Publication
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following publication: NIOSH Alert entitled ``Preventing Occupational Respiratory Disease from Exposures Caused by Dampness in Office Buildings, Schools, and Other Nonindustrial Buildings'' [2013-102].
Request for Information on Edel-Kindwall Caisson Tables for Preventing Decompression Illness in Construction Workers
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) invites comments and information on decompression tables used for protecting tunneling (caisson) workers from developing decompression illnesses. Public Comment Period: Comments must be received by March 29, 2013.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products
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Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication Errors; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication Errors.'' The draft guidance provides sponsors of investigational new drug applications, new drug applications, biologics licensing applications, abbreviated new drug applications, and nonprescription drugs marketed without an approved application (e.g., monograph) with a set of principles for developing drug products using a systems approach to minimize medication errors relating to product design. The draft guidance includes recommendations intended to improve the drug product and container closure design at the earliest stages of product development for all prescription and nonprescription drug products.
Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Design Considerations for Devices Intended for Home Use.'' This document is intended to assist manufacturers in designing and developing home use medical devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. Home use devices are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. This document identifies several factors that manufacturers should consider, especially during device design and development, and provides recommendations for reducing or minimizing these unique risks. This draft guidance is not final nor is it in effect at this time.
Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Friday, December 7, 2012 (77 FR 73034). The product name in the document was incorrect. This document corrects that error.
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