federal_register: E7-18011
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
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| E7-18011 | National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Draft Performance Standards for the Murine Local Lymph Node Assay: Request for Comments | Notice | The Murine Local Lymph Node Assay (LLNA) is the first alternative test method evaluated and recommended by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). It was subsequently accepted by regulatory authorities to determine the allergic contact dermatitis potential of chemicals and products. In January 2007, the U.S. Consumer Product Safety Commission (CSPC) submitted a nomination requesting that NICEATM and ICCVAM assess the validation status of (1) The LLNA as a stand-alone assay for potency determination for hazard classification purposes; (2) modified LLNA protocols; (3) the LLNA limit test; (4) the use of LLNA to test mixtures, aqueous solutions, and metals; and (5) the applicability domain for LLNA. In order to facilitate the review of the modified LLNA protocols, ICCVAM proposed developing performance standards for the LLNA. In May 2007, a Federal Register notice was published (Vol. 72, No. 95, pages 27815-27817, May 17, 2007) requesting comments and data relevant to these nominated activities. In June 2007, the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) endorsed the nominated activities as high priorities for ICCVAM. In response to SACATM comments, along with those provided by the public in response to the previous Federal Register notice, ICCVAM also endorsed these activities as high priorities. ICCVAM subsequently prepared draft performance standards for the LLNA and now requests public comments on this draft document, which is available on the NICEATM/ICCVAM Web site at: (http://iccvam.niehs.nih.gov/methods/immunotox/immunotox.htm) or by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT below). | 2007-09-12 | 2007 | 9 | https://www.federalregister.gov/documents/2007/09/12/E7-18011/national-toxicology-program-ntp-interagency-center-for-the-evaluation-of-alternative-toxicological | https://www.govinfo.gov/content/pkg/FR-2007-09-12/pdf/E7-18011.pdf | Health and Human Services Department | 221 | The Murine Local Lymph Node Assay (LLNA) is the first alternative test method evaluated and recommended by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). It was subsequently accepted by regulatory authorities... |