Department of Health and Human Services October 19, 2007 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry on the Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP).'' The draft guidance is intended to aid drug manufacturers and ancillary testing laboratories in using mechanical calibration as an alternate approach to the use of calibrator tablets in calibrating an apparatus used for dissolution testing. The guidance provides references to information on critical tolerances that should be achieved with mechanical calibration.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Data Bank
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.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Remote Medication Management System; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Remote Medication Management System.'' This guidance document describes a means by which remote medication management systems may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify remote medication management systems into class II (special controls). This guidance document is being immediately implemented as the special control for remote medication management systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Medical Devices; General Hospital and Personal Use Devices; Classification of Remote Medication Management System
The Food and Drug Administration (FDA) is classifying the remote medication management systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, ``Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Remote Medication Management System,'' which will serve as the special control for this device type. The agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and Vegetables
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and Vegetables'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the renewal of the generic information collection project: ``Questionnaire and Data Collection Testing, Evaluation, and Research for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 15, 2007 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
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