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

This rulemaking would revoke the required test for Mycoplasma related to vaccine products because current testing methods are outdated and more sensitive and specific methods exist and are currently being practiced.  Removal of the Mycoplasma test 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: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  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
Action Date FR Cite
Direct Final Rule  12/00/2018 
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