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NEW IND COVER FORM, DESIGNED TO ENCOURAGE BATCH SUBMISSIONS

Executive Summary

NEW IND COVER FORM, DESIGNED TO ENCOURAGE BATCH SUBMISSIONS, is now available at FDA. The agency announced the availability of the new cover form (FDA 1571) and a revised "statement of investigator" form (FDA 1572) in the Sept. 17 Federal Register. In addition to the batching of submissions, the new IND form calls for all submissions to be numbered sequentially for more easy tracking by the firm and FDA. FDA officials highlighted the new form at a Sept. 9 Drug Information Association (DIA) meeting in Rockville, Md. Lee Ripper, special assistant to the director, Office of Biologics Research & Review, noted at the meeting that both the batching and the sequential numbering of submissions provided for in the new form represent a change from instructions in the IND Rewrite regulations. The IND Rewrite provided for separate serial numbering of protocol amendments and information amendments. "Upon further consideration after publishing of the IND Rewrite," Ripper explained, FDA "concluded that the separate sets of serial numbers, which altogether would apply to some but not all submissions, would be confusing for both you and us to implement and maintain." In keeping with the instructions on the new forms, Ripper explained that FDA will publish a technical amendment to the IND regs providing for a single serial numbering system to be applied to all IND submissions. Under the new system, Ripper stated, "safety reports, annual reports and all kinds of correspondence should be [sequentially] numbered as well as protocol amendments and information amendments." The purpose of the numbering system, the FDAer said, "is to allow you and us some assurance that all submissions are received by FDA and properly processed." Ripper noted that the numbering system is prospective: "No attempt should be made to retrospectively number submissions already received by FDA." The FDA rep explained that, although the Rewrite "implies that each submission may contain only one type of document, for example, either a protocol or an information amendment," the new cover form is designed to encourage the batching of different types of submissions. "We strongly encourage you to batch all types of submissions whenever possible," Ripper told DIA. The new IND cover form provides boxes to be checked to identify the types of submissions that it accompanies. A revised "statement of investigator" form is also now available from FDA. In addition to information on the training of the investigator and the names of the sub-investigators, the revised form asks for the name and address of clinical lab facilities to be used and of the responsible institutional review board, and the protocol name and number of the study the investigator will be conducting.

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