Archival copying

NUMBER OF VOLUMES SUBMITTED Please enter the number of volumes, including and identifying electronic media, contained in the archival copy of this submission. 

Archival Copy. This is a complete copy of the entire submission and serves as a reference for information not included in specific review copies and also as a repository for case report tabulations and case report forms. This copy is maintained on file at FDA after the review of the submission is completed. In accordance with recent guidances, certain sections (Sections 11 and 12) of a marketing application archival copy maybe submitted in electronic format. 

Large submissions should be packed in boxes measuring 14" x 12" x 9 j". All electronic media and any reviewer desk copies should be clearly marked and included in the first box of the shipment. The shipping containers should be identified with application number, product name, volume numbers, review copy or archival copy, and applicant name and address. Specific instructions for marking the mailing package (e.g., safety reports) should be followed. 

The applicant shall submit the following in the archival copy of the application ... 

The archival copy is a complete copy of an application and is intended to serve as the official reference source for the Agency. After an application is approved, the archival copy is retained by the Agency and serves as the sole file copy of the approved application. The review copy is destroyed. If there is a requirement for a BE study, then the review copy is divided into two parts containing the scientific information needed for FDA review of the application by different scientific reviewers. One part should contain information about CMC, and one part should contain information about BA and BE. 

An applicant may submit all or portions of the archival copy of the application in any form that the applicant and the FDA agree is acceptable. Submission of electronic versions of the application are welcome but should be discussed with the Office of Generic Drugs prior to actual submission. 

Sections contained in the review copy should be identical to those of the archival copy, including use of the same page numbers. For the typical ANDA... 

Field Copy—Additional Guidance. In addition to the archival copy, domestic applicants must submit a certihcation (21CFR 314.94) that a true third/ field copy of the technical sections (CMC) of the application has been submitted to the appropriate FDA District Office. Foreign applicants should submit the field copy to the Office of Generic Drugs (see Appendix A for mailing address and specifications). 

Archival Copy Enclosed or Review Copy Enclosed (or both)... 

The NDA regulations (21 CFR 314.50) require the submission of an archival copy and a review copy. 

After approval, the archival copy is retained by the FDA and serves as the sole file copy of the approved application. Certain parts of the archival copy will be accepted on microfiche, another suitable microform system, or by electronic (computer) means. 

Because of the procedures used at the FDA to file and retrieve material from the document rooms where applications are kept, it is necessary that applicants use the colored folders (or jackets ) to bind the archival copy and each technical section. The folder colors and form numbers are listed below. 

If the archival copy is submitted on microfiche, the page numbers on the microfiche page image should correspond to the page numbers in the review copy. 

Numbering of the volumes for the technical sections of the review copy should be the same as that used for the volumes of the archival copy. 

Microfiche corresponding to more than one volume of the paper (hard copy) application may be bound together if a clear physical separation is made between each volume of microfiche. This can be accomplished if one or more empty slots is left between the last microfiche sheet of one volume and the first microfiche sheet of the next. New drug application numbers for applications submitted in microfiche will be preassigned. For more information and details on the use of microfiche, the FDA has prepared a guideline for the submission in microfiche of the archival copy of the application. Contact the Office of Management (HFN-42) at the FDA for this information. 

The box size of 14" x 12" x 9 /2" is recommended for shipment of applications to FDA. Because ANDAs are handled and stored separately, smaller boxes may be appropriate for them. An exterior label should indicate the contents by applicant s name, drug name, and volume numbers it is also important to identify which cartons contain the archival copy and which the review copy. 

The submission format for amendments to pending applications and supplements to approved applications will be the same as an original application. Each submission will consist of two copies a complete archival copy and an appropriately segmented review copy. 

The archival copy should include a cover letter that confirms agreements or understandings between the FDA and the applicant. The letter should cite any relevant correspondence or meetings by date and topic, and identify one or more persons the FDA may contact regarding the application. The letter may include any other important information the applicant wishes to convey to the FDA about the application. 

The archival copy of an application is required to contain copies of the label and all labeling proposed for the drug product. 

The archival copy of an ANDA may include a cover letter and is required to contain the following data and information ... 

Guideline for the submission in microfiche of the archival copy of an application... 

Verify backups and archive copies are being made and can be restored. 

Whereever possible employ standard data formats for archive copies to assist in any recovery process when original equipment to read speciahst data formats may not be available. Industry standards are not widely used at present, with products often specifically implementing new functions and standards as a means of retaining existing customers and attracting new ones. Portability seems a long way off. 

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