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U.S. Department of Health and Human Services

Food

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Agency Response Letter GRAS Notice No. GRN 000169

CFSAN/Office of Food Additive Safety

November 15, 2005

Ms. Bonnie Humm
Proliant Health Ingredients
2425 SE Oak Tree Court
Ankeny, Iowa 50021

Re: GRAS Notice No. GRN 000169

Dear Ms. Humm:

The Food and Drug Administration (FDA) is responding to the notice, dated May 16, 2005, that Proliant Health Ingredients submitted in accordance with the agency's proposed regulation, 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS)). FDA received the notice on May 23, 2005, filed it on May 24, 2005, and designated it as GRN No. 000169.

The subject of the notice is bovine globulin. The notice informs FDA of the view of Proliant Health Ingredients that bovine globulin is GRAS, through scientific procedures.

In a letter dated July 19, 2005, you asked that FDA cease evaluating Proliant Health Ingredients' notice in light of the technical requirements discussed during our July 13, 2005, telephone conversation with the understanding that Proliant Health Ingredients may, in the future, submit another GRAS notification on bovine globulin. Accordingly, we ceased our evaluation of GRN No. 000169 effective, July 19, 2005, the date that we received your letter.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter, as well as a copy of the information in your notice that conforms to the information in proposed 21 CFR 170.36 (c)(1), are available for public review and copying on the homepage of the Office of Food Additive Safety (on the Internet at http://www/cfsan.fda.gov/~lrd/foodadd.html).

Sincerely,

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