Department of Health and Human Services June 29, 2010 – Federal Register Recent Federal Regulation Documents
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National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of Interagency Coordinating Committee on the Validation of Alternative Methods Test Method Evaluation Reports on Two Nonradioactive Versions of the Murine Local Lymph Node Assay for Assessing Allergic Contact Dermatitis Hazard Potential of Chemicals and Products, and Expanded Uses of the Local Lymph Node Assay for Pesticide Formulations and Other Products; Notice of Transmittal to Federal Agencies
NICEATM announces availability of Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Test Method Evaluation Reports (TMERs) recommending two nonradioactive versions of the Local Lymph Node Assay (LLNA) for assessing allergic contact dermatitis (ACD) hazard potential of chemicals and products and expanded uses of the LLNA for pesticide formulations and other products. Related ICCVAM Test Method Recommendations in each report have also been transmitted to Federal agencies for their review and response to ICCVAM in accordance with the provisions of the ICCVAM Authorization Act of 2000. The LLNA: 5-Bromo-2'-deoxyuridine-Enzyme- Linked Immunosorbent Assay (BrdU-ELISA) and LLNA: Daicel Adenosine Triphosphate (DA) do not use radioactive reagents and therefore provide advantages in terms of reduced hazardous waste disposal and broader availability for use by laboratories that cannot use radioactive reagents. ICCVAM concludes that the accuracy and reliability of the LLNA: BrdU-ELISA and LLNA: DA support use of these test methods to identify substances as potential skin sensitizers or nonsensitizers. Based on an updated evaluation, ICCVAM is also recommending expanded use of the LLNA to evaluate the ACD hazard potential of pesticide formulations and other products.
Change of Address; Abbreviated New Drug Applications; Technical Amendment
The Food and Drug Administration (FDA) is amending its
Draft Guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance (209) entitled ``The Judicious Use of Medically Important Antimicrobial Drugs in Food- Producing Animals.'' This draft guidance is intended to inform the public of FDA's current thinking on the use of medically important antimicrobial drugs in food-producing animals.
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