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DOJ/DEA RIN: 1117-AB38 Publication ID: Spring 2015 
Title: ●Exemption From Registration for Persons Authorized Under U.S. Nuclear Regulatory Commission or Agreement State Medical Use Licenses or Permits and Administering the Drug Product DaTscan TM 
Abstract:

This final rule will finalize the Drug Enforcement Administration (DEA) regulations to waive the requirement of registration for persons who are authorized under U.S. Nuclear Regulatory Commission or Agreement State medical use licenses or permits and administer the radioactive drug product DaTscan TM. With this final rule, the DEA is only waiving registration requirements specifically for persons administering DaTscan TM directly to patients for diagnostic purposes. The DEA has determined that the waiver from registration of persons who administer DaTscan TM is consistent with the public health and safety.

 
Agency: Department of Justice(DOJ)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1301.29   
Legal Authority: 21 U.S.C. 822(d)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Interim Final Rule  11/25/2014  79 FR 70085   
Interim Final Rule Effective  11/25/2014 
Interim Final Rule Comment Period End  01/26/2015 
Final Action  05/00/2015 
Final Action Effective  05/00/2015 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Demetra Ashley
Associate Deputy Assistant Administrator
Department of Justice
Drug Enforcement Administration
8701 Morrissette Drive,
Springfield, VA 22152
Phone:202 307-7165