98-23104. Life Technologies, Inc.; Filing of Food Additive Petition; Amendment  

  • [Federal Register Volume 63, Number 167 (Friday, August 28, 1998)]
    [Notices]
    [Pages 46053-46054]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-23104]
    
    
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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
    
    
    

Document Information

Published:
08/28/1998
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
98-23104
Pages:
46053-46054 (2 pages)
Docket Numbers:
Docket No. 96F-0248
PDF File:
98-23104.pdf