View Rule
| Printer-Friendly Version Download RIN Data in XML |
| HHS/FDA | RIN: 0910-AC47 | Publication ID: Spring 2003 |
| Title: Bioavailability and Bioequivalence Requirements | |
| Abstract: The final rule revises and clarifies certain sections of parts 314 and 320 and eliminates duplication and inconsistencies. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Completed Actions |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 320 | |
| Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 371 | |
|
Legal Deadline:
None |
||||||||||||
Timetable:
|
| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Federalism: No | |
| Included in the Regulatory Plan: No | |
| Related RINs: Previously reported as 0910-AA51 | |
|
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 |
|
