Defense Contract Audit Agency September 4, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 4 of 4
Gypsy Moth Generally Infested Areas; Additions in Minnesota, Virginia, West Virginia, and Wisconsin
We are adopting as a final rule, without change, an interim rule that amended the gypsy moth regulations by adding areas in Minnesota, Virginia, West Virginia, and Wisconsin to the list of generally infested areas based on the detection of infestations of gypsy moth in those areas. As a result of the interim rule, the interstate movement of regulated articles from those areas was restricted. The interim rule was necessary to prevent the artificial spread of the gypsy moth to noninfested areas of the United States.
VSTA Records and Reports Specific to International Standards for Pharmacovigilance
We are proposing to amend the Virus-Serum-Toxin Act regulations concerning records and reports. This change would require veterinary biologics licensees and permittees to record and submit reports concerning adverse events associated with the use of biological products they produce or distribute. The information that must be included in the adverse event reports submitted to the Animal and Plant Health Inspection Service would be provided in separate guidance documents. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document.
Availability of an Environmental Assessment for Field Testing a Swine Influenza Vaccine, H1N1 & H3N2, Modified Live Virus
We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment concerning authorization to ship for the purpose of field testing, and then to field test, an unlicensed Swine Influenza Vaccine, H1N1 & H3N2, Modified Live Virus. The environmental assessment, which is based on a risk analysis prepared to assess the risks associated with the field testing of this vaccine, examines the potential effects that field testing this veterinary vaccine could have on the quality of the human environment. Based on the risk analysis and other relevant data, we have reached a preliminary determination that field testing this veterinary vaccine will not have a significant impact on the quality of the human environment, and that an environmental impact statement need not be prepared. We intend to authorize shipment of this vaccine for field testing following the close of the comment period for this notice unless new substantial issues bearing on the effects of this action are brought to our attention. We also intend to issue a U.S. Veterinary Biological Product license for this vaccine, provided the field test data support the conclusions of the environmental assessment and the issuance of a finding of no significant impact and the product meets all other requirements for licensing.
Highly Pathogenic Avian Influenza; Availability of an Environmental Assessment and Finding of No Significant Impact
We are advising the public that an environmental assessment has been prepared by the Animal and Plant Health Inspection Service relative to a national approach for the control of highly pathogenic avian influenza outbreaks within the United States. Based on our environmental assessment, we have concluded that such an approach will not have a significant impact on the quality of the human environment. We are making this environmental assessment and finding of no significant impact available to the public for review and comment.
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