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HHS/FDA RIN: 0910-AC12 Publication ID: Spring 2002 
Title: Revocation of Conditions for Marketing Digoxin Products for Oral Use 
Abstract: The final rule will revoke the regulation (21 CFR 310.500) that established conditions for marketing digoxin products for oral use. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 310.500 
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360b-f; 21 USC 360j; 21 USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42 USC 263b-n 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/24/2000  65 FR 70538 
Final Rule  10/00/2002   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Mary E. Catchings
Regulatory Counsel, Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
HFD-7, Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone:301 594-2041
Fax:301 827-0951

 
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