thefederalregister.com

Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program; Public Webcast

AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
ACTION: Notice of public webcast.
SUMMARY: The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the notice of a public webcast concerning compliance with the Federal Select Agent Program. The purpose of this notice is to notify all interested parties, including individuals and entities possessing, using, or transferring biological agents and toxins listed in 7 CFR 331.3, 9 CFR 121.3 and 121.4, or 42 CFR 73.3 and 73.4, of the webcast. The webcast is organized by the U.S. Department of Agriculture's Animal and Plant Health Inspection Service (USDA/APHIS), the Department of Health and Human Services Centers for Disease Control and Prevention (HHS/CDC), and the Department of Justice's Federal Bureau of Investigation (FBI). Issues to be discussed include 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).
DATES: The webcast will be held on Friday, November 16, 2012 from 9 a.m. to 5 p.m. EST. All who wish to join the webcast must register by October 16, 2012. Registration instructions are found on the Federal Select Agent Program Web site,http://www.selectagents.gov.
ADDRESSES: The webcast will be broadcast from the Centers for Disease Control and Prevention facility, 1600 Clifton Rd. NE., Atlanta, GA 30329.
FOR FURTHER INFORMATION CONTACT: CDC:LCDR. Jacinta Smith, Division of Select Agents and Toxins, Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS A-46, Atlanta, GA 30333;lrsat@cdc.gov.

APHIS:Dr. Lidia Carrera, APHIS Select Agent Program, APHIS, 4700 River Road, Unit 2, Riverdale, MD 20737;Lidia.Carrera@aphis.usda.gov

SUPPLEMENTARY INFORMATION:

Title II of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, “Enhancing Controls on Dangerous Biological Agents and Toxins” (sections 201 through 231), provides for the regulation of certain biological agents and toxins by the Department of Health and Human Services (subtitle A, sections 201-204) and the Department of Agriculture (subtitle B, sections 211-213). Additionally, the statute provides for interagency coordination between the two departments regarding overlap agents and toxins (subtitle C, section 221). For the Department of Health and Human Services(HHS), the Centers for Disease Control and Prevention (CDC) oversees entities that possess, use or transfer select agents and toxins that have the potential to pose a severe threat to public health and safety. The U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) has a parallel program that oversees entities that possess, use or transfer select agents that have the potential to pose a severe threat to animal or plant health, or to animal or plant products . These two programs constitute the Federal Select Agent Program. The Federal Bureau of Investigation's (FBI) Criminal Justice Information Services conducts security risk assessments of (1) all individuals and nongovernmental entities that request to possess, use, or transfer select agents and toxins, (2) all individuals who need access to select agents and toxins.

The webcast announced in this notice is an opportunity for the regulated community (i.e., registered entity responsible officials, alternate responsible officials, and entity owners) and other interested individuals to obtain specific regulatory guidance and information on standards concerning biosafety, biosecurity and incident response issues related to the Federal Select Agent Program. Representatives from HHS/CDC, USDA/APHIS, and the FBI will be present during the webcast to address questions and concerns from the web participants.

Updates on the changes to the select agent regulations; occupational health, information and physical security; personnel suitability; FD-961 form, and changes to the APHIS/CDC Form 1 are among the issues that will be discussed. A question and answer session will take place after each topic.

Registration instructions are found on the Federal Select Agent Program Web sitehttp://www.selectagents.gov. Registration ends on October 16, 2012. This is a webcast only event and there will be no on-site participation at the HHS/CDC broadcast facility. Registration is required for participation. This is a 100% webcast; therefore, in person participation cannot be accommodated.

Participants will be able to submit questions during the webcast atselectagentwkshp@cdc.gov. Closed-captioning services will be provided during the webcast.

Dated: September 10, 2012. Tanja Popovic, Deputy Associate Director for Science, Centers for Disease Control and Prevention.