[Federal Register Volume 60, Number 54 (Tuesday, March 21, 1995)]
[Notices]
[Page 14950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6918]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95G-0039]


Degussa 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 
Degussa Corp. has filed a petition (GRAS 2419) proposing that 
hydrophobic silica, prepared by the hydrophobization of silicon dioxide 
with dichlorodimethyl-silane, be affirmed as generally recognized as 
safe (GRAS) as an anticaking/free-flow agent in vitamin preparations 
for animal feed.

DATES: Written comments by June 5, 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: J. D. McCurdy, Center for Veterinary 
Medicine (HFV-226), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1731.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (sec. 201(s), 409(b)(5) (21 U.S.C. 321(s) and 348(b)(5)) and the 
regulations for affirmation of GRAS status in Sec. 570.35 (21 CFR 
570.35), notice is given that Degussa Corp., c/o Counsel for 
Petitioner, Jerome H. Heckman, Keller, and Heckman, 1001 G St. NW., 
Suite 500 West, Washington, DC 20001, has filed a petition (GRASP 2419) 
proposing that hydrophobic silica, prepared by the hydrophobization of 
silicon dioxide with dichlorodimethyl-silane, be affirmed as GRAS as an 
anticaking/free-flow agent in vitamin preparations for animal feed.
    The petition has been placed on display at the Dockets Management 
Branch (address above).
    Any petition that meets the requirements outlined in Secs. 570.30 
(21 CFR 570.30) and 570.35 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 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 June 5, 1995, review the 
petition and file comments with the Dockets Management Branch (address 
above). 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. 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: March 8, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-6918 Filed 3-20-95; 8:45 am]
BILLING CODE 4160-01-F