Department of Health and Human Services October 24, 2006 – Federal Register Recent Federal Regulation Documents
Results 1 - 8 of 8
Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and FDA Staff: Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems.'' This draft guidance provides FDA's recommendations concerning portable invasive blood glucose monitoring systems (BGMSs).
Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP), will hold its eleventh meeting. The meeting will be open to the public. Due to unanticipated issues during preparation for the November meeting of SACHRP, this notice will not meet the 15-day requirement for publication in the Federal Register.
Medical Devices; Exemptions From Premarket Notification; Class II Devices
The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for cranial orthosis type devices. These devices are used to improve cranial symmetry in neonates. FDA is publishing this notice in order to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Global Harmonization Task Force, Study Groups 1, 2, 4, and 5; New Proposed and Final Documents; Availability
The Food and Drug Administration (FDA) is announcing the availability of several proposed and final documents that have been prepared by Study Groups 1, 2, 4, and 5 of the Global Harmonization Task Force (GHTF). These documents represent a harmonized proposal and recommendation from the GHTF Study Groups that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. FDA is requesting comments on these documents.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Request for Samples and Protocols
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Request for Samples and Protocols'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Emergency Use Authorization of Medical Products
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry: Emergency Use Authorization of Medical Products'' 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 proposed information collection project: ``Evaluation of the Implementation and Impact of Pay-for- Quality Programs.'' 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.
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