statements from both companies that Company B is responsible for all information in the DMF, and for all processes and testing performed by the manufacturer. The title of the DMF that appears on the list of DMFs is the format Material manufactured in [LOCATION OF COMPANY A] for [COMPANY B]. ANNUAL REPORTS (Category 2) According to the DMF Guideline, companies must not use annual reports to report changes in the DMF. However, as described above, companies can submit an annual report at the same time as other information. The annual report must contain (for cover letter see Templates below): 1. An administrative page that contains: Holder name Manufacturing site name if different from holder U.S. agent company name (if applicable) Name of contact person for each of the above Mailing address, phone number, fax and email address of responsible individuals AND 2. One of the following Date(s) of the amendment(s) reporting changes since the last Annual Report or the original DMF filing date, whichever is most recent. Or A statement that no amendments have been submitted since the last Annual Report or the original DMF filing date, whichever is most recent. And 3. One of the following: A complete list of all parties authorized to make reference to the DMF, identifying by name, reference number, volume, date, and page number the information that each person is authorized to incorporate Or A statement that no changes have been made to the list of authorized parties since the last annual report or the original DMF filing date, whichever is most recent. Or A statement that there are no authorized parties. And 4. List of all parties whose authorization has been withdrawn Note that the DMF Guidance uses the terms “Annual Update” and “Annual Report” interchangeably. All submissions of Annual Reports should be labeled “Annual Report.” The term “Annual Update” should not be used. Note that the annual report must list the authorized parties. If the list is long and the holder wants to list only authorized parties added since the last annual report, they should highlight this in the cover letter. There should be a statement that there have been no changes in the list of authorized parties previously submitted. BIOLOGICS MASTER FILES (Category 3) Master Files submitted in support of products regulated by the Center for Biologics Evaluation and Research (CBER) must be submitted as BB-MFs. See the CBER web site