[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Notices]
[Page 54505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26357]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95G-0321]
Amoco Bioproducts 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
Amoco Bioproducts Corp. has filed a petition (GRAS 2449) proposing that
25-hydroxyvitamin D3 be affirmed as generally recognized as safe
(GRAS) as a source of vitamin D3 activity in broiler chicken feed.
DATES: Written comments by January 8, 1996.
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: Sharon A. Benz, Center for Veterinary
Medicine (HFV-226), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1724.
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. 570.35 (21 CFR
570.35), notice is given that Amoco Bioproducts Corp., Amoco Research
Center, P.O. Box 3011, Naperville, IL 60566-7011, has filed a petition
(GRAS 2449) proposing that 25-hydroxyvitamin D3 be affirmed as
GRAS as a source of vitamin D3 activity in broiler chicken 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 January 8, 1996, 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: October 17, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-26357 Filed 10-23-95; 8:45 am]
BILLING CODE 4160-01-F
