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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 |
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Timetable:
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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 |