The Food and Drug Administration (FDA) proposes to amend the biologics regulations under 21 CFR 610.30 by removing a specified test for Mycoplasma in the production of live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. This regulation is restrictive in that it identifies only one test method to be used even though other methods may be appropriate. Removal of the required test for Mycoplasma would provide flexibility for accommodating new and evolving technology and capabilities without diminishing public health protections.

This Preliminary Regulatory Impact Analysis discusses the economic impacts of the proposed rule, including potential costs, cost savings, and benefits. Because manufacturers already have the ability to pursue alternative Mycoplasma testing procedures, FDA anticipates no measurable change in behavior from this proposed rulemaking. While the proposed rule may produce some unquantifiable efficiencies by increasing flexibility, it would produce no quantifiable costs, cost savings, or benefits.

Regulatory Impact Analysis

Elimination of 21 CFR 610.30 Test for Mycoplasma (Proposed Rule) Regulatory Impact Analysis (PDF - 105KB)

Federal Register: 84 FR 12534, April 2, 2019

Docket: FDA-2018-N-4757