An application that requires the review of a modified protocol where only minor changes are made to an existing efficacy method (e.g. AOAC International, ASTM, AATCC, or an AD approved method described in A431). The study design for a Tier 1 protocol will be reviewed and approved within AD. A draft label with proposed directions for use and use claims must accompany the application. Examples of minor changes include: varied test conditions (e.g., contact time, use of different hard surface carrier types [porcelain penicylinders vs. stainless steel penicylinders], modification of standard method to support additional microorganisms [e.g., Germicidal Spray Products test for spore-formers], and changes to support alternate application types [e.g., foams]. 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 1. If during further review, the Agency determines that a Tier l protocol should be elevated to Tier 2 status, the applicant will receive notification prior to this change. 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.