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| HHS/FDA | RIN: 0910-AB91 | Publication ID: Fall 2003 |
| Title: Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format | |
| Abstract: The Food and Drug Administration (FDA) is proposing to amend its regulations governing the format in which certain labeling in new drug applications, abbreviated new drug applications, certain biological license applications, supplements, and annual reports are required to be submitted. The rule would require that certain labeling content described under section 201.100(d)(3) be submitted to FDA in electronic format. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
| Major: No | Unfunded Mandates: Private Sector |
| CFR Citation: 21 CFR 314; 21 CFR 601 | |
| Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 262; ... | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: Federal |
| Small Entities Affected: Businesses | Federalism: No |
| Included in the Regulatory Plan: No | |
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Agency Contact: Nicole K. Mueller Regulatory Counsel Department of Health and Human Services Food and Drug Administration Room 3037, (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6312, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-3507 Fax:301 827-8440 Email: nicole.mueller@fda.hhs.gov |
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