other materials used in product preparation. Examples of materials that would use a Type IV DMF include bases, waxes, and edible inks. See relevant section in the Guideline for Drug Master Files. Toxicology studies may be submitted in the same DMF as the CMC information but they should be in a separate volume or volumes. It is preferable for holders to submit such information as a separate Type V DMF. See also the “Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients Type V DMFs (Category 3) The following types of DMFs may be filed as Type V DMFs without requesting prior clearance from FDA. Manufacturing Site, Facilities, Operating Procedures, and Personnel for sterile manufacturing plants. See Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. Contract Facilities for the manufacture of biotech products. See Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research For other submissions as Type V DMFs the holder must request permission from FDA before filing a Type V DMF. (21 CFR 314.420(a)(5)). Prospective Type V DMF holders may send their request to dmfquestion@cder.fda.gov, explaining the necessity for filing the information in a Type V DMF. Examples of sites and procedures that would require Type V DMFs include clinical studies, sterilization facilities, and toxicological information. Administrative Information in a DMF (Category 3) The only elements of the administrative information that should be in a DMF are: The name and address of the holder The name and address of manufacturing facility For the contact person: Name Mailing Address Telephone number Fax number E-mail address Statement of Commitment The name and address of the agent (if applicable) For the contact person at the agent (if applicable): Name Mailing Address Telephone number Fax number E-mail address The appointment of an Agent is optional. See discussion below under “Agents” Submission of Amendments, Annual Reports, and Letters of Authorization(Category 3) To facilitate processing of documents that are submitted to an existing DMF, please list the Submission Type and the Category/Subcategory of the Amendment (Supporting Document) in bold type in the header on the transmittal letter. See list below. More than one Submission Type/Category/Subcategory can be used but all must be listed. Example: If updated stability data is submitted at the same time as an Annual Report, the heading of