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Re: Question Katherine Tragos 29 Dec 2009 17:07 EST

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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====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================

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 Instructions on how to use the RESADM-L Mailing List, including
 subscription information and a web-searchable archive, are available
 via our web site at http://www.hrinet.org (click on "Listserv Lists")
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