[Federal Register: November 24, 2004 (Volume 69, Number 226)]
[Notices]              
[Page 68381-68383]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no04-95]                        

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0369]

Draft guidance for industry: Recommendations for the early food safety evaluation of new non-pesticidal proteins produced by new plant varieties intended for food use; availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use.'' The draft guidance, when finalized, is intended to provide
recommendations to developers of new plant varieties, in particular bioengineered plants, on the early food safety evaluation of new non-pesticidal proteins. The draft guidance describes procedures for submitting an early food safety evaluation of such proteins to the agency.

Complete document in PDF format:   
http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-26049.pdf