[Federal Register: August 28, 1998 (Volume 63, Number 167)]
[Notices]               
[Page 46053-46054]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28au98-109]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96F-0248]

 
Life Technologies, Inc.; Filing of Food Additive Petition; 
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is amending the filing 
notice for a food additive petition filed by Life Technologies, Inc., 
to provide for a change in the extraction requirements for sulphopropyl 
cellulose ion-exchange resin for the recovery and purification of 
proteins for food use.

FOR FURTHER INFORMATION CONTACT:  Andrew D. Laumbach, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3071.

SUPPLEMENTARY INFORMATION:  In a notice published in the Federal 
Register of July 22, 1996 (61 FR 37905), FDA announced that a food 
additive petition (FAP 6A4502) had been filed by Life Technologies, 
Inc., 8400 Helgerman Ct., Gaithersburg, MD 20874 (now, 9800 Medical 
Center Dr., Rockville, MD 20850). The petition proposed to amend the 
food additive regulations in Sec. 173.25(b)(5) Ion-exchange resins (21 
CFR 173.25(b)(5)) to provide for a

[[Page 46054]]

change in the temperature and pH limitations for sulphopropyl cellulose 
ion-exchange resin for the recovery and purification of proteins for 
food use.
    Subsequent to the publication of the filing notice, it was 
determined that the proposed amendment of the provisions in 
Sec. 173.25(b)(5) also necessitated an amendment of the provisions in 
Sec. 173.25(d)(2), the paragraph that provides extraction requirements 
for the ion-exchange resin. Accordingly, the petitioner amended the 
petition to request an amendment of Sec. 173.25(d)(2).
    Therefore, FDA is amending the filing notice of July 22, 1996, to 
indicate that the petitioner requests that the food additive 
regulations be amended to modify the extraction requirements for 
sulphopropyl cellulose resin in Sec. 173.25(d)(2).
    The agency has determined under 21 CFR 25.32(i) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

    Dated: August 3, 1998.
George H. Pauli,
Acting Director, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 98-23104 Filed 8-27-98; 8:45 am]
BILLING CODE 4160-01-F