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| HHS/FDA | RIN: 0910-AC57 | Publication ID: Fall 2003 |
| Title: Revision of the Requirements for Spore-Forming Microorganisms | |
| Abstract: The Food and Drug Administration (FDA) is issuing a direct final rule and a companion proposed rule to amend the biologics regulations by providing options to the existing requirement for separate, dedicated facilities and equipment for work with spore-forming microorganisms. FDA is taking this action due to advances in facility, system and equipment design, and sterilization technologies, that would allow work with spore-forming microorganisms to be performed in multi-product manufacturing areas. | |
| 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: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 600.10(c); 21 CFR 600.11(e) | |
| Legal Authority: 21 USC 321; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360i; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 300aa-25 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Federalism: No | |
| Included in the Regulatory Plan: No | |
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Agency Contact: Paul E. Levine Regulatory Counsel Department of Health and Human Services Food and Drug Administration Suite 200N (HFM-17), Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike, Rockville, MD 20852 Phone:301 827-6210 |
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