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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Announces Notice of Pilot Project of Electronic Margin of Safety and Submission of NonClinical Toxicology Study Data

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Cover of CVM Update on Pilot Project of Electronic Margin of Safety and Submission of NonClinical Toxicology Study Data

December 10, 2009

The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) is seeking sponsors interested in participating in a three-year pilot project to test the electronic submission of margin of safety and nonclinical toxicology study data using the Standard for Exchange of Nonclinical Data (SEND), a new electronic data standard format which is used to support review activity. 

FDA anticipates that a successful pilot will enable CVM to accept margin of safety and nonclinical toxicology study data related to investigational new animal drug (INAD) files and new animal drug applications (NADA) electronically in SEND format.

CVM currently receives margin of safety and nonclinical toxicology study data in paper, portable document format (PDF), and other electronic formats.  The lack of uniformity in the formats used by sponsors to submit data, in addition to the inconsistent use of terminology across submissions, complicates the Agency's efforts to validate, display, and evaluate the data using modern, computer-based review and analysis tools.  As part of FDA's effort to modernize its information technology systems and improve efficiency, CVM is planning to transition to a true electronic data format for submission of study data for regulatory review.

CVM considers this pilot to be the beginning of a phased implementation of SEND that will enable CVM to receive and evaluate data from toxicology studies as part of the human food safety evaluation and margin of safety studies.

CVM is seeking a limited number of sponsors (approximately five to eight, but no more than eight) to participate in this pilot.  Because a limited group of voluntary participants is needed, CVM will use its discretion in choosing volunteers, based on their experience with datasets previously submitted to CVM.

Requests to participate in the pilot and comments regarding the project should be submitted to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  Submit electronic requests and comments to http://www.regulations.gov. Please identify requests and comments with the docket number (Docket No. FDA–2009–N–0561).

 

Contact FDA

240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855