CDC Response to ABSA Comments Regarding the CDC Select Agent Program

The following summarizes the Center for Disease Control and Prevention (CDC) Select Agent Program's review and response to the April 6, 2004 letter from Stefan Wagener to Lori Bane of the CDC regarding operational concerns with this Program:

  1. To provide guidance to the public regarding Select Agent regulations, the CDC Select Agent Program provides a "FAQ" section available on the CDC web site (www.cdc.gov/od/sap). The web site is updated on an ongoing basis and notes new postings. In addition, CDC provides staff with weekly training sessions. These training sessions involve discussions regarding interpretation of the regulations, inspection findings, and other aspects related to the Program.
  2. As noted above, the "FAQ" section should provide the public with guidance regarding the Select Agent regulations and the Program. However, if the entity has specific questions, that are not addressed in this section, then the entity may contact the CDC Select Agent Program Helpline (telephone: (404) 498-2255 or e-mail: [email protected] ).
  3. The CDC Select Agent Program is working in coordination with the Animal and Plant Health Inspection Service (APHIS) Select Agent Program in the drafting of the final Select Agent Rule based on 111 comments received from the public regarding the Interim Final Rule. Based on those comments, the Final Rule should include specific examples of regulated situations in its preamble and its text.
  4. The CDC Select Agent Program is workings in coordination with the APHIS Select Agent Program, Department of Justice (DOJ) and the Federal Bureau of Investigation (FBI)'s Criminal Justice Information Services Division (CJIS) regarding security risk assessments. The "FAQ" section available on the CDC web site (www.cdc.gov/od/sap) provides guidance regarding security risk assessments.
  5. An on-line application is being developed through a secure web system so that an application could be sent electronically to APHIS or the CDC Select Agent Program.
  6. As noted above, the CDC Select Agent Program works in coordination with other agencies regarding the Select Agent regulations.


Citation:
CDC Response to ABSA Comments Regarding the CDC Select Agent Program
http://www.absa.org/0404cdcresponse.html.

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