[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