recommends that such letters include the phrase “appoint AGENT NAME as the agent for DMF” rather than “authorize AGENT NAME to act as the agent for DMF,” since the latter can be confused with a “Letter of Authorization.” An “Agent Appointment Letter” may be included in an original DMF. If possible, the word “Agent” should be used for the legal entity (whether a company or an individual) who is authorized to act on behalf of the DMF holder. The word “Representative” should be used for an individual who is employed by the Agent or Holder as the contact point for FDA. If a company acting as an Agent changes its name, FDA recommends that the DMF holder issue a new Agent Appointment Letter. A different agent can be appointed for different DMFs submitted by the same holder. Agent Appointment Template HOLDER NAMES (Category 2) When the company that owns a DMF (DMF holder) changes its name, whether through sale of the company or simply a change in the company's name, the DMF holder must notify FDA. See Section VII.E. in the Guideline for DMFs for further recommendations on the procedure for transferring ownership. A change in the name of a company for registration purposes under DRLS will not change the DMF holder name. When a DMF is transferred from one company to another, the original holder should submit an administrative amendment stating that they are TRANSFERRING the DMF to the new holder. The new holder should then submit an administrative amendment stating that they are ACCEPTING the DMF from the former holder. If the DMF holder changes its name and there is no transfer of ownership, the holder may submit a single Holder Name Change amendment. A DMF holder is expected to retain a complete reference copy that is identical to, and maintained in the same chronological order as, their submissions to FDA (See Section IV.D.1 in the Guideline for DMFs). Therefore, the old owner of the DMF is expected to transfer that copy to the new owner of the DMF. If a holder name change affects multiple DMFs, all documentation must be submitted to each DMF as separate submissions. In general, the FDA expects that the manufacturer is the holder. If a manufacturer (company A) of a material wants another company (Company B) to submit the DMF, and Company B wishes to act as the holder—the DMF must include