[Federal Register Volume 60, Number 182 (Wednesday, September 20, 1995)]
[Notices]
[Page 48716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23246]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95F-0305]
Pfizer, Inc.; Filing of Food Additive Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Pfizer, Inc., has filed a petition proposing that the food additive
regulations be amended to provide for the safe use of polydextrose as a
bulking agent/texturizer in fruit and water ices.
DATES: Written comments on the petitioner's environmental assessment by
October 20, 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 (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food
additive petition (FAP 5A4478) has been filed by Pfizer, Inc., 235 East
42d St., New York, NY 10017-5755. The petition proposes to amend the
food additive regulations in Sec. 172.841 Polydextrose (21 CFR 172.841)
to provide for the safe use of polydextrose as a bulking agent/
texturizer in fruit and water ices.
The potential environmental impact of this action is being
reviewed. To encourage public participation consistent with regulations
promulgated under the National Environmental Policy Act (40 CFR
1501.4(b)), the agency is placing the environmental assessment
submitted with the petition that is the subject of this notice on
public display at the Dockets Management Branch (address above) for
public review and comment. Interested persons may, on or before October
20, 1995, submit to the Dockets Management Branch (address above)
written comments. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday. FDA will also place
on public display any amendments to, or comments on, the petitioner's
environmental assessment without further announcement in the Federal
Register. If, based on its review, 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).
Dated: August 28, 1995.
Alan M. Rulis,
Acting Director, Office of Premarket Approval, Center for Food Safety
and Applied Nutrition.
[FR Doc. 95-23246 Filed 9-19-95; 8:45 am]
BILLING CODE 4160-01-F
