Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (VICH Topic GL24) and Data Elements for Submission of Adverse Event Reports (VICH Topic GL42)
The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed two draft guidelines titled ``Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports'' and ``Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports.'' These draft guidelines describe, respectively, standardized terminology for the identification of possible adverse events following the use of veterinary medicinal products, and the specific data elements to be used for the submission and exchange of spontaneous adverse event reports between marketing authorization holders (licensees/permittees) and regulatory authorities. Because the draft guidelines apply to pharmacovigilance and adverse event reporting on veterinary vaccines regulated by the Animal and Plant Health Inspection Service under the Virus-Serum-Toxin Act, we are requesting comments on the scope of each guideline and its provisions so that we may include any relevant public input on the drafts in the Agency's comments to the VICH Steering Committee.
Horse Protection; Public Meeting
We are advising the public that the Animal and Plant Health Inspection Service's Animal Care program will host a meeting to present current information on the enforcement of the Horse Protection Act (HPA) and provide a forum for horse industry members and other interested persons to comment on the Horse Protection Program, development of the HPA Operating Plan for 2007 and beyond, and other Horse Protection matters. This notice provides the meeting's agenda, location, and date.
Tuberculosis in Captive Cervids; Extend Interval for Conducting Reaccreditation Test
We are proposing to amend the regulations regarding tuberculosis in captive cervids by extending, from 2 years to 3, the term for which accredited herd status is valid and increasing by 12 months the interval for conducting the reaccreditation test required to maintain the accredited tuberculosis-free status of cervid herds. We are also proposing to reduce, from three tests to two, the number of consecutive negative official tuberculosis tests required of all eligible captive cervids in a herd before a herd can be eligible for recognition as an accredited herd. These actions would reduce testing costs for herd owners, lessen the potential for animal injury or death during testing, and lower administrative costs for State and Federal regulatory agencies. In addition, we are proposing to amend the regulations by removing references to the blood tuberculosis test for captive cervids, as that test is no longer used in the tuberculosis eradication program for captive cervids. This proposed change would update the regulations so that they refer only to those official tests currently in use.
Importation of Baby Corn and Baby Carrots From Zambia
We are proposing to amend the fruits and vegetables regulations to allow the importation into the continental United States of fresh, dehusked immature (baby) sweet corn and fresh baby carrots from Zambia. As a condition of entry, both commodities would be subject to inspection at the port of first arrival and would have to be accompanied by a phytosanitary certificate with an additional declaration stating that the commodity has been inspected and found free of the quarantine pest listed on the certificate. This action would allow for the importation of Zambian baby corn and baby carrots into the United States while continuing to provide protection against the introduction of quarantine pests.
University of Wisconsin-Madison; Availability of Environmental Assessment and a Finding of No Significant Impact for Field Tests of Genetically Engineered Erwinia carotovora
We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment for a field trial of genetically engineered strains of a bacterium, Erwinia carotovora, the causal agent of tuber soft rot disease in potato. The bacteria have been genetically engineered to disrupt the disease causing pathway. This field trial will allow researchers to better understand the function of each mutated gene under field conditions. The environmental assessment provides a basis for our conclusion that these field tests will not present a risk of introducing or disseminating a plant pest and will not have a significant impact on the quality of the human environment. Based on its finding of no significant impact, the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared for these field tests.
Notice of Request for Extension of Approval of an Information Collection; Requirements for Recognizing the Animal Health Status of Foreign Regions
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with requirements for recognizing the animal health status of foreign regions.
Monsanto Company; Availability of Determination of Nonregulated Status for Corn Genetically Engineered for Insect Resistance and Glyphosate Tolerance
We are advising the public of our determination that the Monsanto corn line designated as transformation event MON 88017, which has been genetically engineered for resistance to a corn rootworm complex and for tolerance to the herbicide glyphosate, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by Monsanto in their petition for a determination of nonregulated status, our analysis of other scientific data, and comments received from the public in response to a previous notice announcing the availability of the petition for nonregulated status and an environmental assessment. This notice also announces the availability of our written determination and our finding of no significant impact.
Notice of Request for Extension of Approval of an Information Collection; National Veterinary Accreditation Program
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with the National Veterinary Accreditation Program.