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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 ... |
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 | |
Agency Contact: Darren Eicken Regulatory Counsel Department of Health and Human Services Food and Drug Administration Room 3037, (HFD-7), Center for Drug Evaluation and Research, Building 51, Room 6206, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-0978 Fax:301 827-8440 Email: darren.eicken@fda.hhs.gov |