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HHS/FDA RIN: 0910-AB78 Publication ID: Spring 2002 
Title: Antibiotic Resistance Labeling 
Abstract: The final rule would require the inclusion of certain statements about the use of antibiotics in the prescription drug labeling of these products. These statements will emphasize the proper use of these products in an effort to reduce the development of drug-resistant bacterial strains. 
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: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 201.24 
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; ... 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/19/2000  65 FR 56511 
Final Rule  12/00/2002   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Christine F. Rogers
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 3059 (HFD-7), Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, Room 6316,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440
Email: christine.rogers@fda.hhs.gov

 
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