§ 5.404   Area of operation.

   Applications must specify, and the Commission will grant authorizations for,
   a  geographic area that is inclusive of an institution's real-property
   facilities where the experimentation will be conducted and that is under the
   applicant's control. Applications also may specify, and the Commission will
   grant authorizations for, defined geographic areas beyond the institution's
   real-property  facilities that will be included in clinical trials and
   monitored by the licensee. In general, operations will be permitted where
   the likelihood of harmful interference being caused to authorized services
   is minimal.

   Effective Date Note: At  78 FR 25162 , Apr. 29, 2013, § § 5.404 was added. This
   section contains information collection and recordkeeping requirements and
   will not become effective until approval has been given by the Office of
   Management and Budget.

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