Department of Health and Human Services May 17, 2007 – Federal Register Recent Federal Regulation Documents

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) received a nomination from the U.S. Consumer Product Safety Commission (CPSC) to evaluate the validation status of: (1) The murine local lymph node assay (LLNA) as a stand- alone assay for determining potency (including severity) for the purpose of hazard classification; (2) the ``cut-down'' or ``limit dose'' LLNA approach; (3) non-radiolabeled LLNA methods; (4) the use of the LLNA for testing mixtures, aqueous solutions, and metals; and (5) the current applicability domain (i.e., the types of chemicals and substances for which the LLNA has been validated). ICCVAM reviewed the nomination, assigned it a high priority, and proposed that NICEATM and ICCVAM carry out the following activities in its evaluation: (1) Initiate a review of the current literature and available data, including the preparation of a comprehensive background review document, and (2) convene a peer review panel to review the various proposed LLNA uses and procedures for which sufficient data and information are available to adequately assess their validation status. ICCVAM also recommends development of performance standards for the LLNA. At this time, NICEATM requests: (1) Public comments on the appropriateness and relative priority of these activities, (2) nominations of expert scientists to consider as members of a possible peer review panel, and (3) submission of data for the LLNA and/or modified versions of the LLNA.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for the use of an ivermectin and clorsulon solution by subcutaneous injection in cattle for control of various internal and external parasites.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for use of a one percent ivermectin solution by subcutaneous injection in cattle, swine, reindeer, and American bison for the treatment and control of various internal and external parasites.