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