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:

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:

Previous Spotlight Information

The National Select Agents Registry Program oversees the activities of possession
of biological agents and toxins that have the potential to pose a severe threat to public, animal
or plant health, or to animal or plant products. The NSAR currently requires registration
of facilities including government agencies, universities, research institutions, and commercial
entities that possess, use or transfer biological agents and toxins. On this website
you will be able to download application packages, submit forms electronically, view current
regulations regarding Select Agents, and access additional resource information.