Revocation of the Test for Mycoplasma (4 page(s), in English)

Title of document
Revocation of the Test for Mycoplasma (4 page(s), in English)

Description
The Food and Drug Administration (FDA, Agency, or we) is proposing to amend the biologics regulations by removing the specified test for the 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 restrictive in that it identifies only one test method in detail to be used even though other methods also may be appropriate. More sensitive and specific methods exist and are currently being practiced, and removal of the specific method to test for Mycoplasma provides flexibility for accommodating new and evolving technology and capabilities without diminishing public health protections. This action is part of FDA's implementation of Executive Orders 13771 and 13777. Under these Executive orders, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.

Notifying member: United States of America

Notification: G/TBT/N/USA/1462

Objective tag
Protection of human health or safety

Documents

• 19_2038_00_e.pdf

Agency responsible
Food and Drug Administration (FDA), Health and Human Services (HHS) [1490]

Timing:

• Submission: 08/04/2019
• Reception: 09/04/2019
• Distribution: 10/04/2019
• Final date for comments: 17/06/2019
• Proposed date of adoption: N/A