Shortcut to: http://www.ssarherps.org/pdf/IACUC-MS.pdf <http://www.ssarherps.org/pdf/IACUC-MS.pdf>
Maybe this would help?
Kathy
________________________________
From: Research Administration List on behalf of Bloomberg, Robert
Sent: Tue 12/29/2009 3:04 PM
To: xxxxxx@hrinet.org
Subject: Re: [RESADM-L] Question
Holly,
A follow up question---the article is very helpful, but applies to pre-market requirements. What if you are a non-profit and just want to release it for experimental purposes?
Thanks.
Bob
Robert P. Bloomberg
Director, Office of Grants & Contracts
Tufts Medical Center
800 Washington Street (Tupper 10)
Boston, MA 02111
Tel. 617.636.1142
Fax. 617.636.8568
________________________________
From: Research Administration List [mailto:xxxxxx@hrinet.org] On Behalf Of Holly Boykin
Sent: Tuesday, December 29, 2009 2:14 PM
To: xxxxxx@hrinet.org
Subject: Re: [RESADM-L] Question
Hi Bob-
It depends on the circumstances but believe it or not it is a combination of USDA - APHIS Division, EPA and FDA. They now provide expertise on the use of animals, importation, exportation and disposal under the view of biotechnology.
You may want to review the following article -
http://www.biotechregulationlawyer.com/lawyer-attorney-1269901.html
and also visit the APHIS site.
Please feel free to contact me if you have other questions.
Holly Boykin
Director of Contracts and Grants
Judge Baker Children's Center
53 Parker Hill Avenue
Boston, MA 02120
(617) 278-4295 (o)
(617) 232-7240 (f)
xxxxxx@jbcc.harvard.edu
________________________________
From: Research Administration List [mailto:xxxxxx@hrinet.org] On Behalf Of Bloomberg, Robert
Sent: Tuesday, December 29, 2009 1:28 PM
To: xxxxxx@hrinet.org
Subject: [RESADM-L] Question
I'm hoping that someone on our list has come across this situation before, and can offer some advice. Please reply off-line-I can give you more information, background and context if necessary.
Thank you!
Bob
We are seeking advice on which federal agency has authority over experiments involving the release of animal biologics or animal drugs into the wild or uncontrolled environment. Once identified, what is the process that must be followed to achieve approval?
Robert P. Bloomberg
Director, Office of Grants & Contracts
Tufts Medical Center
800 Washington Street (Tupper 10)
Boston, MA 02111
Tel. 617.636.1142
Fax. 617.636.8568
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