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HHS/FDA | RIN: 0910-AB91 | Publication ID: Spring 2002 |
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 is required to be submitted. The proposal would require that certain labeing content described under section 201.160(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: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: Undetermined |
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 ... |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
Small Entities Affected: No | Federalism: Undetermined |
Included in the Regulatory Plan: No | |
Agency Contact: Virginia G. Beakes Regulatory Counsel, Office of Regulatory Policy Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, Rockville, MD 20852 Phone:301 594-2041 Fax:301 827-5562 Email: beakesv@cder.fda.gov |