2013-21985. Multi-Agency Informational Meeting Concerning Compliance with the Select Agent Regulations; 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) within the Department of Health and Human Services (HHS) announces a public webcast for all interested parties, including individuals and entities possessing, using, or transferring biological agents and toxins. The purpose of the webcast is to provide guidance related to the select agent regulations established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The webcast is being organized by the U.S. Department of Agriculture (USDA)'s Animal and Plant Health Inspection Service (APHIS), HHS/CDC, and the Department of Justice's Federal Bureau of Investigation (FBI), Criminal Justice Information Services. Changes to Section 11(Security) of the select agent regulations including information security, physical security, and personnel suitability will be discussed. Topics will focus on additional requirements for entities possessing select agents and toxins designated as Tier 1 agents.

DATES:

The webcast will be held on Friday, November 15, 2013 from 10 a.m. to 4 p.m. EST. All who wish to join the webcast must register by October 18, 2013. Registration instructions can be found on the Web site http://www.selectagents.gov.

ADDRESSES:

The webcast will be broadcast from the APHIS facility, 4700 River Road, Unit 2, Riverdale, MD 20737.

FOR FURTHER INFORMATION CONTACT:

APHIS: Dr. Keith Wiggins, APHIS Select Agent Program, 4700 River Road, Unit 2, Riverdale, MD 20737; 301-851-3300 option 1 (voice only); [e-mail].

CDC: Diane Martin, Division of Select Agents and Toxins, Office of Public Health Preparedness and Response, CDC, 1600 Clifton Road, NE., MS A-46, Atlanta, GA 30333; [phone]; [e-mail].

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 221), provides for the regulation of certain biological agents and toxins by HHS (subtitle A, sections 201-204) and USDA (subtitle B, sections 211-213), and provides for interagency coordination between the two departments regarding overlap agents and toxins (subtitle C, section 221). HHS/CDC regulates the possession, use or transfer biological agents and toxins that have the potential to pose a severe threat to public health and safety. The HHS/CDC select agent regulations can be found at 42 CFR part 73.

USDA/APHIS has a parallel program that regulates the possession, use or transfer biological agents that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. The USDA/APHIS select agent regulations can be found at 7 CFR part 331 and 9 CFR part 121.

The Criminal Justice Information Service (CJIS) in the Federal Bureau of Investigation (FBI) conducts security risk assessments of all individuals and nongovernmental entities that require access to select agents and toxins.

The webcast announced here 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 security issues related to the select agent regulations. Representatives from HHS/CDC, USDA/APHIS, and the FBI will be present during the webcast to address questions from and concerns of the web participants.

Changes to Section 11 (Security) of the select agent regulations including information security, physical security, and personnel suitability will be discussed. Presenters will focus on the additional requirements for entities possessing select agents and toxins designated as Tier 1 agents or toxins. A question and answer session will follow each presentation.

Registration instructions can be found on the Web site http://www.selectagents.gov. Registration must be completed by October 18, 2013. Registration is required for participation to the webcast. This is a 100% webcast; therefore, in person participation cannot be accommodated.

Participants will be able to submit questions during the webcast at [e-mail]. Closed-captioning services will be provided during the webcast.

Dated: September 4, 2013.

Tanja Popovic,

Deputy Associate Director for Science, Centers for Disease Control and Prevention.