Regulatory Counsel

0910-AH95 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS 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would revoke the required test for Mycoplasma related to vaccine products because current testing methods are outdated and more sensitive and specific methods exist and are currently being practiced.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.

]]> Substantive, Nonsignificant First Time Published in The Unified Agenda Final Rule Stage Undetermined No Deregulatory 21 CFR 610.30 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 ... No Direct Final Rule 12/00/2018 No None No No No Tami Belouin Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-7911 tami.belouin@fda.hhs.gov Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Building 71, Silver Spring MD 20993