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U.S. Department of Health and Human Services

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Agency Response Letter GRAS Notice No. GRN 000023

CFSAN/Office of Premarket Approval

August 16, 1999

Johannes Everse, Ph.D.
Gwynne Little, Ph.D.
Desanguination Products, LLC
2613 Newcomb
Lubbock, TX 79415

Re: GRAS Notice No. GRN 000023

Dear Drs. Everse and Little:

The Food and Drug Administration (FDA) is responding to your letter dated July 29, 1999, concerning the notice that you submitted in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized As Safe (GRAS)). Your notice informed FDA of the view of Desanguination Products, LLC that a protein preparation isolated from animal blood is GRAS to provide protein nutritional value in foods, including meat products. FDA received your notice on June 4, 1999, and designated it as GRAS Notice No. GRN 000023.

Your July 29, 1999, letter states that Desanguination Products, LLC requests the withdrawal of your GRAS notice, dated May 26, 1999, without prejudice to a future filing. Given your letter, and in accordance with proposed 21 CFR 170.36, FDA ceased to evaluate GRAS Notice No. GRN 000023, effective August 2, 1999, the date on which we received your letter that notified us of your intent.

In accordance with proposed 21 CFR 170.36(f), we have placed a copy of this letter, as well as a copy of the information in your notice that conforms to the information in proposed § 170.36(c)(1), in a file that is available for public review and copying on the Office of Premarket Approval's homepage on the World Wide Web.

Sincerely,
   
Linda S. Kahl, Ph.D.
Regulatory Policy Branch (HFS-206)
Division of Product Policy
Office of Premarket Approval
Center for Food Safety and Applied Nutrition