Department of Health and Human Services July 11, 2006 – Federal Register Recent Federal Regulation Documents
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Determination of Regulatory Review Period for Purposes of Patent Extension; MULTIHANCE
The Food and Drug Administration (FDA) has determined the regulatory review period for MULTIHANCE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.
National Toxicology Program (NTP), Liaison and Scientific Review Office; Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a teleconference meeting of the SACATM on August 3, 2006. The teleconference is scheduled from 1 p.m. to 4 p.m. and is open to the public. At the teleconference, SACATM will discuss the conclusions of a peer review panel that met on May 23, 2006 to evaluate the validation status of the in vitro 3T3 and normal human keratinocyte (NHK) neutral red uptake (NRU) basal cytotoxicity test methods (see ``Background'' for more detail). The public is invited to participate in the teleconference and will be provided with an opportunity to make oral comments during the public comment period. Participation is limited only by the number of phone lines available.
National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of Peer Review Panel Report on the Use of In Vitro
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), organized an independent, scientific peer review meeting on May 23, 2006, to evaluate the validation status of the in vitro 3T3 and normal human keratinocyte (NHK) neutral red uptake (NRU) basal cytotoxicity test methods. These two in vitro cytotoxicity test methods are proposed as adjuncts (for the purpose of determining the starting dose) to in vivo acute oral toxicity tests. The peer review report from this meeting, entitled Peer Review Panel Evaluation of the Use of In Vitro Basal Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Testing, is now available. The report contains (1) a summary of the peer review evaluation and (2) the peer review panel's (Panel) conclusions on the draft ICCVAM test method recommendations regarding the proposed usefulness, limitations, and validation status of the 3T3 and NHK cytotoxicity test methods. The NICEATM invites public comment on the Panel's conclusions on the draft ICCVAM test method recommendations. Copies of the Panel report may be obtained on the ICCVAM/NICEATM Web site at https://iccvam.niehs.nih.gov, or by contacting NICEATM at the address given below.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Office of the National Coordinator; American Health Information Community Biosurveillance Data Steering Group Meeting
This notice announces the first meeting of the American Health Information Community Biosurveillance Data Steering Group in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
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