? -Reply

[Kenneth Prendergast <KMP@nrc.gov>]

I am a little rusty in this area,  however, it appears this would fall under medical use
by an authorized user.  As far as I know this uptake type study would not need an
amendment to the license and would be covered under 35.100 or 35.200.  I am not
sure how it would fall under the FDA rules.  I would appreciate any comments that
are different than mine.

KMP@NRC.Gov. (510/975-0255)  The statement above are mine and are not meant to
be interpretations of the Agency.