for the products regulated by CBER. BINDERS (Category 2) See ”FDA IND, NDA, ANDA, or Drug Master File Binders “The “binders” are actually covers. These may be ordered from the U.S. Government Printing Office (GPO) Washington, DC 20404-0001 (202) 512-1800 In addition these can be ordered online using the following links Red Binder Blue Binder One copy of the DMF should use the blue cover and one should use the red cover. Fasteners must be obtained separately. Use 2 Piece Prong Fasteners, 8 1/2" Center to Center, 3 1/2" Capacity. Binders should be used for all subsequent submissions to FDA that are more than 10 pages. FEES (Category 3) There are no fees or charges for filing a DMF or any subsequent documents. FORMS (Category 2) Certain forms are required for submission of NDAs and INDs. However, there are no forms required or available for DMFs, except for the forms discussed above under Binders. CONFIDENTIALITY OF DMFs (Category 2) The public availability of the contents of DMFs is covered in 21 CFR 314.430(e). All requests for information about DMFs beyond that provided in the tables above must be made through the CDER Freedom of Information Web site. FILING DMFs AND PATENT EXPIRATION AND EXCLUSIVITY ISSUES (Category 2) DMFs may be filed at any time. The Patent Expiration date and the Exclusivity Expiration dates listed in the Orange Book have no impact on DMF filing. The submission of Abbreviated New Drug Applications (ANDAs) that reference DMFs are subject to the regulations regarding filing of ANDAs. ENVIRONMENTAL ASSESSMENTS (Category 2) Since DMFs are neither approved nor disapproved, there is no need to file an Environmental Assessment. However the DMF should contain a commitment by the firm that its facilities will be operated in compliance with applicable environmental laws. REORGANIZATION OF A DMF (Category 1) The advice in the Guidance does not apply. It is not necessary to consult with FDA before reorganizing a DMF. REQUEST FOR CLOSURE OF A DMF BY THE HOLDER (Category 2). It is not necessary to include a statement that "the holder's obligations as detailed in Section VII have been fulfilled," as recommended in the DMF Guidance. It is sufficient to include a statement that all of the parties authorized to reference the DMF have been notified that the DMF is being closed.. LETTER TEMPLATES AND COVER LETTERS (Category 2) Note that a “Transmittal Letter” and a “Cover