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U.S. Department of Health and Human Services

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NPC 000010: Agency Response Letter

CFSAN/Office of Food Additive Safety

March 26, 2010

Isabelle S. Coats, Ph.D.
US Registration Manager
Bayer CropScience
2 T.W. Alexander Dr.
Research Triangle Park, NC 27709

Re: New Protein Consultation 00010; p-hydroxyphenylpyruvate dioxygenase (HPPD)

Dear Dr. Coats:

This letter is in response to Bayer CropScience’s early food safety evaluation of the protein p-hydroxyphenylpyruvate dioxygenase (HPPD) expressed in a new plant variety under development for food use, which you submitted to the Food and Drug Administration (FDA) on June 4, 2009, under FDA’s guidance to industry, “Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use” (71 FR 35688; June 21, 2006, and available via the FDA home page at http://www.fda.gov.

Based on your letter of March 9, 2010, you requested that your submission be withdrawn from consideration without prejudice to a future submission. Given your letter, we ceased to evaluate your submission on the date that we received your letter.

Sincerely yours,

Antonia Mattia, Ph.D.
Division Director
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition