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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