View Rule

View EO 12866 Meetings

Printer-Friendly Version Download RIN Data in XML

HHS/FDA

RIN: 0910-AC57

Publication ID: Spring 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: First time 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 21 USC 352 21 USC 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

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM-Companion to Direct Final Rule	01/00/2004
Direct Final Rule	01/00/2004

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Federalism: No
Included in the Regulatory Plan: No
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