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HHS/FDA RIN: 0910-AH95 Publication ID: Fall 2018 
Title: Revocation of the Test for Mycoplasma 
Abstract:

This rulemaking would remove the specified test for presence of Mycoplasma for live virus vaccines and inactivated virus vaccines produced from in-vitro living cell cultures. FDA is proposing this action because the existing test for Mycoplasma is outdated and duplicative of requirements that are also specified in the biologics license application. More sensitive and specific methods exist and are currently being practiced.  Removal of the test for Mycoplasma requirements would provide manufacturers of viral vaccines flexibility for accommodating new and evolving technology and capabilities without diminishing public health protections.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 610.30   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351 to 353    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 360c    21 U.S.C. 360d    21 U.S.C. 360i    21 U.S.C. 361    21 U.S.C. 371    42 U.S.C. 216    42 U.S.C. 262    42 U.S.C. 263    42 U.S.C. 263a    42 U.S.C. 264    ...   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/00/2019 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Tami Belouin
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Building 71,
Silver Spring, MD 20993
Phone:240 402-7911
Email: tami.belouin@fda.hhs.gov