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.

The Federal Register Notice(PDF 203K) seeks the public’s opinion as to whether CDC should regulate such research to ensure labs follow appropriate biosafety controls.

Those interested parties wishing to make a comment during the 60-day public comment period should visit http://www.regulations.gov/#!documentDetail;D=CDC-2012-0010-0001.

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:

APHIS/CDC Select Agent Workshop on November 16, 2012

On September 14, 2012, the Department of Health and Human Services (HHS) published a notice in the Federal Register announcing the 2012 Select Agent Workshop. The Federal Select Agent Program will broadcast the workshop via webcast-only on Friday, November 16th from 9:00a.m. to 5:00p.m (EST). The workshop will cover the following topics: changes to the select agent regulations, occupational health, information and physical security, personnel suitability, Bioterrorism Security Risk Assessment Form (FD-961 form), and changes to the Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins (APHIS/CDC Form 1). Registration for the workshop is now closed. The webcast link, agenda, and supporting information will be sent to all registered participants prior to the workshop.

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.