From: David Kirstein [David.Kirstein@nbyprod.com]
Sent: Monday, July 19, 2004 2:42 PM
To: fdadocket@oc.fda.gov
Subject: Docket No. 2004N-0264

Division of Dockets Management	
(HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

July 19, 2004

To whom it may concern:

National By-Products, LLC (NBP) is one of the national's leading independent renderer with corporate office located in Des Moines, IA.  Over the past two to three years, NBP has been actively engaged informing the FDA regarding the nature of dead stock rendering and issues regarding the proper disposal of prohibited raw materials.  Most recently NBP cooperated in an industry response to the Health and Human Services press release in January 2004 announcing the FDA's intentions at that time to expand the Feed Rule (21CFR 589.2000).  We have spent an inordinate amount of time studying our economics and disposal options while preparing our company contingency plans based upon those expressed intentions.  On July 14th, the FDA and USDA published an ANPR with an entirely different focus; that being the removal of SRMs from the feed of all animals.  Consequently, we were caught off-guard by the Agency's change of focus and found ourselves ill-prepared to respond to the numerous new questions being posed.

NBP requests that the FDA extend the comment period another 60 days to permit us to collect the information and respond accordingly.

Thank you for your consideration.

Sincerely,

Mark Myers, CEO & President

David Kirstein, Director of Technical Services