§  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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