Attachment 2a - Cook response

Attachment 2A-Response to Cook comments on OMB Control No. 0920-0576-1.htm

Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)

Attachment 2a - Cook response

OMB: 0920-0576

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From: Logan, Marinda D. (CDC/COTPER/OD) on behalf of COTPER OMB-PRA (CDC)
Sent: Tuesday, May 27, 2008 8:09 AM
To: OMB Clearance (CDC)
Cc: Bane, Lori (CDC/COTPER/DSAT)
Subject: FW: Comments on OMB Control No. 0920-0576

Attachments: WU Comments.pdf

I was out of the office last week.  The comments are attached.  If you need anything else, please let me know.  Thanks!

 

Marinda Logan, MPH
Health Scientist
Centers for Disease Control and Prevention
Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER)
Office of Science and Public Health Practice
1600 Clifton Road NE,  MSD44
Atlanta, GA 30333  USA
404-639-5974 Phone
404-639-7977 Facsimile


From: Bane, Lori (CDC/COTPER/DSAT)
Sent: Friday, May 23, 2008 7:38 AM
To: COTPER OMB-PRA (CDC)
Cc: Weyant, Rob (CDC/COTPER/DSAT); Blaine, James (CDC/COTPER/DSAT); Henkel, Richard (CDC/COTPER/DSAT)
Subject: FW: Comments on OMB Control No. 0920-0576

 

Please find below the response from the Program to the attached comment.

 

Thank you for your comments dated May 15, 2008 regarding the CDC 60 Day Federal Register Notice for [CDC 0920-0576], Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73).  CDC agreed with your comment about not providing the "auto-fill date" fields for the fillable forms and will not include them in the future.  The secure electronic environment to allow registered entities to conduct transactions electronically with the Select Agent Program via a single web portal is currently under development. 

 

Guidance on reporting thefts, losses, and releases of select agents and toxins is available at http://www.selectagents.gov/complianceAssistance.htm.  This document describes practices and procedures for submitting an APHIS/CDC Form 3 (Report of Theft, Loss, or Release of Select Agents or Toxins) includes definitions of various terminology related to these types of events, and presents examples of scenarios for which submission of an APHIS/CDC Form 3 may be required.  The scenarios described in the document involve bites from animals infected with select agents, sticks from needles that may have been infected with a select agent , and sharps injuries incurred during necropsy activities.  Incidents resulting in a suspected occupational exposure to a select agent would need to be reported on the Form 3 since the form is used to report a release, which by definition in the Select Agent Regulations, is an occupational exposure or a release of a select  agent or toxin outside of the primary barriers of the biocontainment area (See 42 CFR 73.19(b)). 

 

Thanks,

 

Lori J. Bane
Compliance Officer
CDC Division of Select Agents and Toxins 1600 Clifton Road MS A-46 Atlanta, GA 30333
404-718-2006
Fax: 404-718-2096
[email protected]
http://www.cdc.gov/od/sap/
 
This document is intended for the exclusive use of the recipient(s) named above.  It may contain sensitive information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information.  If you are not the intended recipient(s), any dissemination, distribution, or copying is strictly prohibited.  If you think you have received this document in error, please notify the sender immediately and destroy the original.  Thank you.

 

 


From: Logan, Marinda D. (CDC/COTPER/OD) On Behalf Of COTPER OMB-PRA (CDC)
Sent: Monday, May 19, 2008 12:47 PM
To: Bane, Lori (CDC/COTPER/DSAT)
Subject: FW: Comments on OMB Control No. 0920-0576

 

FYI - sorry

Marinda Logan, MPH
Health Scientist
Centers for Disease Control and Prevention
Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER)
Office of Science and Public Health Practice
1600 Clifton Road NE,  MSD44
Atlanta, GA 30333  USA
404-639-5974 Phone
404-639-7977 Facsimile


From: Harris, Denise (CDC/OD/OCSO) (CTR) On Behalf Of OMB-Comments (CDC)
Sent: Monday, May 19, 2008 11:10 AM
To: Logan, Marinda D. (CDC/COTPER/OD)
Cc: OMB-Comments (CDC)
Subject: FW: Comments on OMB Control No. 0920-0576

 

Hello Marinda,

 

Please see attached public comment from Susan Cook.  Let me know if the program is going to send a response or if you would like me to send our usual reply.

 

Thanks

 

Denise

 


From: Cook, Susan [mailto:[email protected]]
Sent: Thursday, May 15, 2008 5:12 PM
To: OMB-Comments (CDC)
Subject: Comments on OMB Control No. 0920-0576

Attached, please find comments on the Possession, Use, and Transfer of Select Agents and Toxins as requested in the Federal Register on March 17, 2008.

 

Respectfully,

 

Susan H. Cook, PhD, CBSP

Biological Safety Officer

Environmental Health & Safety

Campus Box 8229

Phone: 314-747-0309

Fax: 314-362-6786

Email: [email protected]

 

 


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