Vaccines, Blood & Biologics

Letter to Manufacturers on Labeling Review Procedures

December 3, 1996

Dear Biologic Product Manufacturer:

The purpose of this letter is to notify you of revised procedures for internal labeling review number assignment to be instituted within the Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER). This change will facilitate the tracking of all non-promotional labeling submitted pursuant to Title 21 of the Code of Federal Regulations Part 201 and Subpart 610. It will not effect the submission of advertisements and/or promotional labeling material to CBER's Advertising and Promotional Labeling Staff.

Effective January 1, 1997, all labeling submitted under a Transmittal of Labels form FDA 2567 will be assigned a unique label review number which will remain with the labeling until the review is complete (approved, withdrawn or inactivated).

The first time a label is submitted, it will be assigned a unique label review number which is to be used for all subsequent drafts until the completion of the review. The label review number should be printed onto the accompanying Transmittal of Labels form 2567 for all subsequent revisions until filing of the final printed labeling. A separate form 2567 should accompany each labeling submission for each product and label type (circular, container, package, packer, etc.). With the exception of circulars, more than one label may be submitted under each form FDA 2567. For example, multiple container labels for the same product may be submitted under the same form FDA 2567 for multiple vial sizes or different vials of a kit. One form 2567 should be used for each circular.

CBER is instituting a pilot program for electronic labeling and may request but not require that an electronic version of an approved final printed label be made available to CBER. This electronic file may, for example, be submitted in Portable Document Format (PDF) or an equivalent, platform-independent format. This requirement is not an endorsement by the FDA of any proprietary document format but simply reflects the current technology available within CBER. If submitted, the disk containing the file should be submitted in duplicate as either 3.5 floppies or CD-ROMs and accompanied with duplicate hard copy cover letters indicating the contents. Disks should be clearly labeled with manufacturer and product names, label review number, label type and machine format. Additional information such as file name(s) and size(s) and the name of the program required to view the label should be included and can be put onto the disk cover if it is too large to fit onto the disk label. Please see the attachment for an example of a disk label.

If you have any questions, please call Mr. Jeff Smith in the Division of Vaccines and Related Products Applications, 301-827 3070.



--- signature ---

Kathryn C. Zoon, Ph.D.
Center for Biologics Evaluation and Research
Food and Drug Administration

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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