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HHS/FDA | RIN: 0910-AH95 | Publication ID: Spring 2020 |
Title: Revocation of the Test for Mycoplasma | |
Abstract:
This rulemaking will 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 FDA is taking this action because the existing test for Mycoplasma is outdated and duplicative of requirements that are also specified in the biologics license application.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 will provide manufacturers of viral vaccines flexibility for accommodating new and evolving technology and capabilities without diminishing public health protections. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final 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 |
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Timetable:
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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 |