[Federal Register Volume 60, Number 134 (Thursday, July 13, 1995)]
[Notices]
[Page 36151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17233]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95G-0156]


Sandoz Nutrition Corp.; Filing of Petition for Affirmation of 
GRAS Status

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Sandoz Nutrition Corp. has filed a petition (GRASP 5G0414), proposing 
to affirm that partially hydrolyzed guar gum (PHGG) is generally 
recognized as safe (GRAS) as an ingredient in human food.

DATES: Written comments by September 26, 1995.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:  Rosalie M. Angeles, Center for Food 
Safety and Applied Nutrition (HFS-207), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3107.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (secs. 201(s) and 409(b)(5) (21 U.S.C. 321(s) and 348(b)(5)) and 
the regulations for affirmation of GRAS status in Sec. 170.35 (21 CFR 
170.35), notice is given that Sandoz Nutrition Corp., 5320 West Twenty 
Third St., P.O. Box 370, Minneapolis, MN 55440, has filed a petition 
(GRASP 5G0414), proposing that PHGG be affirmed as GRAS for use in 
human food. The petition has been placed on display at the Dockets 
Management Branch (address above).
    Any petition that meets the requirements outlined in Sec. 170.30 
(21 CFR 170.30) and Sec. 170.35 is filed by the agency. There is no 
prefiling review of the adequacy of data to support a GRAS conclusion. 
Thus, the filing of a petition for GRAS affirmation should not be 
interpreted as a preliminary indication of the suitability for GRAS 
affirmation.
    The potential environmental impact of this action is being 
reviewed. If the agency finds that an environmental impact statement is 
not required and this petition results in a regulation, the notice of 
availability of the agency's finding of no significant impact and the 
evidence supporting that finding will be published with the regulation 
in the Federal Register in accordance with 21 CFR 25.40(c).
    Interested persons may, on or before September 26, 1995, review the 
petition and/or file comments (two copies of any comments should be 
filed and should be identified with the docket number found in brackets 
in the heading of this document) with the Dockets Management Branch 
(address above). Comments should include any available information that 
would be helpful in determining whether the substance is, or is not, 
GRAS for the proposed use. In addition, consistent with the regulations 
promulgated under the National Environmental Policy Act (40 CFR 
1501.4(b), the agency encourages public participation by review of and 
comment on the environmental assessment submitted with the petition 
that is the subject of this notice. A copy of the petition (including 
the environmental assessment) and received comments may be seen in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: June 23, 1995.
 Alan M. Rulis,
 Acting Dirctor, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 95-17233 Filed 7-12-95; 8:45 am]
BILLING CODE 4160-01-F