An application that requires the review of a new public health efficacy protocol, or a major change to an existing efficacy method (e.g. AOAC International, ASTM, AATCC, or an AD approved method described in A431). Applies to a study design that requires review by external members of an AD Efficacy Protocol Review Expert Panel. A draft label with proposed directions for use and use claims must accompany the application, along with proposed performance measures. Examples of major protocol changes would include surrogate consideration, field test component, air sanitizers, simulated or in-use testing, changes in growth conditions [e.g., shaking vs. static for TB testing] and novel protocols for products with label claims that don’t meet the recommended, conventional sterilant/disinfectant/sanitizer standards (e.g., treated materials). A pre-registration meeting is recommended prior to submission of the protocol. The Agency will make every effort during this meeting to determine if the protocol is Tier 2. Protocol review and approval must be completed before efficacy data is generated using the approved protocol and an application for registration is submitted to AD.