Website is being revamped based on Revised Select Agent regulations. Influenza viruses containing the Hemagglutinin from the Goose/Guangdong/1/96 lineage, Request for Information and Comments On October 17, 2012, the U.S. Department of Health and Human Services (HHS) posted in the Federal Register a notice seeking public comment regarding the classification of highly pathogenic avian influenza (HPAI) variants – specifically, influenza viruses that contain an HA from the A/goose/Guangdong/1/96 lineage. These variants have been shown to be transmittable in the ferret model and have been associated with infections in humans. October 2012 Federal Register Notice(PDF 203K) and February 2013 Federal Register Notice(PDF 220K) seeks the public’s opinion as to whether CDC should regulate such research to ensure labs follow appropriate biosafety controls. PLEASE NOTE: We are reopening the comment period on February 8, 2013, to allow interested persons additional time to prepare and submit comments. Written or electronic comments must be received on or before March 11, 2013. Those interested parties wishing to make a comment during the extended public comment period should visit http://www.regulations.gov/#!docketDetail;D=CDC-2012-0010. APHIS/CDC Select Agent Regulations The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published final rules (42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121) in the Federal Register on October 05, 2012. All provisions of the final rules supersede those contained in the previous final rules. The table below describes the effective dates:
USDA Final Rule(PDF 451K) HHS Federal Register Notice(PDF 518K) Regulatory Impact Analysis(PDF 163K) List of Select Agents and Toxins(PDF 25K) Effective Date (December 4, 2012) Comparison Table of Changes in HHS Select Agent Regulations(PDF 173K) Guidance Documents for Final Rule Compliance Assistance Security Risk Assessment Tool Amended Regulations Effective December 4, 2012 7 C.F.R. Part 331(PDF 143K) 9 C.F.R. Part 121(PDF 201K) 42 C.F.R. Part 73(PDF 186K) Anonymous Reporting To provide a mechanism for you to report safety, security, or other concerns associated with select agents and toxins, Department of Health & Human Services, Office of Inspector General (OIG) maintains a hotline which offers a confidential means for reporting this vital information. When reporting these issues to OIG, please ensure that you indicate it is a "Select Agent Program" issue. OIG Hotline contact information:
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If you have questions or comments about this website, contact lrsat@cdc.gov.
To report the identification of select agent or toxin, http://www.selectagents.gov/CDForm.html. |
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Overview
The National Select Agents Registry Program oversees the activities of possession |
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