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HHS/FDA

RIN: 0910-AF85

Publication ID: Fall 2006

Title: ●Revision of the Requirements for Live Vaccine Processing
Abstract: This rulemaking is being issued to provide options to the existing requirement for processing live vaccines. FDA is amending the regulations due to advances in facility, system, and equipment design, and in sterilization technologies that will allow live vaccine processing to be performed in multiproduct manufacturing areas. We are amending this regulation to permit manufacturers greater flexibility in the use of their buildings and equipment for processing live vaccines when appropriate controls exist and have been demonstrated to be effective in preventing cross contamination of other products and areas. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations and to revise outdated regulations without diminishing public health protection.
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 600.11
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

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM--Companion to Direct Final Rule	05/00/2007
Direct Final Rule	05/00/2007

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Federalism: No
Included in the Regulatory Plan: No
Agency Contact: Nathaniel L. Geary Consumer Safety Officer Department of Health and Human Services Food and Drug Administration Suite 200N (HFM-17), Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Rockville, MD 20852-1448 Phone:301 827-6210 Fax:301 827-9434 Email: nathaniel.geary@fda.hhs.gov