Department of Health and Human Services May 20, 2008 – Federal Register Recent Federal Regulation Documents

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.

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 https://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 (https://ntp.niehs.nih.gov/go/165) or by contacting Dr. Barbara Shane, see FOR FURTHER INFORMATION CONTACT below).