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HHS/FDA | RIN: 0910-AC35 | Publication ID: Spring 2002 |
Title: ●Section 17 Best Pharmaceuticals for Children Act | |
Abstract: To require drug product labeling to include a toll-free number for reports of adverse events regarding drug products, and a statement that the number is to be used for reporting purposes only and not to receive medical advice. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.) | |
Legal Authority: 21 USC 355a |
Legal Deadline:
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
Agency Contact: Ann L. Simoneau Regulatory Counsel Department of Health and Human Services Food and Drug Administration Suite 3037, HFD-7, 1451 Rockville Pike, Rockville, MD 20852 Phone:301 594-2041 Fax:301 827-5562 |