Medical Devices; Immunology and Microbiology Devices; Classification of Plasmodium Species Antigen Detection Assays
The Food and Drug Administration (FDA) is classifying Plasmodium species antigen detection assays into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays.'' This guidance document describes a means by which antigen detection assays for Plasmodium species may comply with the requirement of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify these device types into class II (special controls). This guidance document is immediately in effect as the special control for antigen detection assays for Plasmodium species, but it remains subject to comment in accordance with the agency's good guidance practices.
National Toxicology Program (NTP); Report on Carcinogens (RoC); Availability of the Draft Background Document for Styrene; Request for Comments on the Draft Background Document for Styrene; Announcement of the Styrene Expert Panel Meeting
The NTP announces the availability of the draft background document for styrene on May 22, 2008, on the RoC Web site (http:// ntp.niehs.nih.gov/go/29679) or in printed text from the RoC (see ADDRESSES below). The NTP invites the submission of public comments on the draft background document for styrene. The expert panel will meet on July 21-22, 2008, at the Radisson Hotel Research Triangle Park, 150 Park Drive, Research Triangle Park, NC 27709 to peer review the draft background document for styrene and, once completed, make a recommendation regarding the listing status for styrene (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) in the 12th Edition of the RoC (12th RoC). The RoC expert panel meeting is open to the public with time scheduled for oral public comments. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the NTP will post the final version of the background document and the expert-panel peer review report on the RoC Web site.
National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the NTP Board of Scientific Counselors: Amended Notice
This notice announces the availability of a public telephone call-in line for the June 11-12, 2008 meeting of the NTP Board of Scientific Counselors. The meeting will be held at the Radisson Hotel Research Triangle Park, 150 Park Drive, Research Triangle Park, NC 27709 and videocast through the Internet at http://www.niehs.nih.gov/ news/video/live. Information regarding the meeting was announced in the Federal Register (73FR20289) published on April 15, 2008. The guidelines published in the April 15 Federal Register notice for submitting written public comments or making an oral presentation at the meeting still apply. In response to the public interest in the peer review of the Draft NTP Brief on Bisphenol A, the NTP will provide a telephone call-in line for public comments. The line will be open from 8:30 a.m. until 3 p.m. on June 11, although public comments will be received only during the formal public comment period on the draft brief. The exact time for the presentation of public comments is not set, but will follow the overview presentation on the draft brief and the talk on biomonitoring of bisphenol A exposures (the preliminary agenda is available at (http://ntp.niehs.nih.gov/go/165) or by contacting Dr. Barbara Shane, see FOR FURTHER INFORMATION CONTACT below).
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Peer Review Panel Report on the Validation Status of New Versions and Applications of the Murine Local Lymph Node Assay (LLNA): A Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals and Products: Notice of Availability and Request for Public Comments
NICEATM, in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), convened an independent international scientific peer review panel on March 4-6, 2008 to evaluate new versions and applications of the LLNA for assessing the allergic contact dermatitis potential of chemicals and products. The peer review panel (``the Panel'') report from this meeting is now available. The report contains (1) the Panel's evaluation of the validation status of the methods and (2) the Panel's comments and conclusions on draft ICCVAM test method recommendations. NICEATM invites public comment on the Panel's report. The report is available on the NICEATM-ICCVAM Web site at http:// iccvam.niehs.nih.gov/methods/immunotox/llnaPeerPanel.htm or by contacting NICEATM at the address given below.
Office of Global Health Affairs; Regulation on the Organizational Integrity of Entities Implementing Leadership Act Programs and Activities
This document corrects a technical error that appeared in the Notice of Proposed Rulemaking (NPRM) on April 17, 2008, entitled ``Organizational Integrity of Entities Implementing Leadership Act Programs and Activities.''