[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
