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Federal Register / Vol. 71, No.

31 / Wednesday, February 15, 2006 / Notices 7975

DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND comment. Interested persons may
HUMAN SERVICES HUMAN SERVICES submit to the Division of Dockets
Management written or electronic
Food and Drug Administration Food and Drug Administration comments by March 17, 2006. Two
[Docket No. 2006F–0059] copies of any written comments are to
[Docket No. 2006F–0058] be submitted, except that individuals
Danisco USA, Inc.; Filing of Food may submit one copy. Comments are to
ARCH Chemicals, Inc.; Filing of Food Additive Petition be identified with the docket number
Additive Petition found in brackets in the heading of this
AGENCY: Food and Drug Administration, document. Received comments may be
AGENCY: Food and Drug Administration, HHS. seen in the Division of Dockets
HHS. ACTION: Notice. Management between 9 a.m. and 4 p.m.,
ACTION: Notice. Monday through Friday. FDA will also
SUMMARY: The Food and Drug place on public display any
Administration (FDA) is announcing amendments to, or comments on, the
SUMMARY: The Food and Drug
that Danisco USA, Inc., has filed a petitioner’s environmental assessment
Administration (FDA) is announcing petition proposing that the food additive
that ARCH Chemicals, Inc., has filed a without further announcement in the
regulations be amended to provide for Federal Register. If, based on its review,
petition proposing that the food additive the safe use of polydextrose as a bulking
regulations be amended to provide for the agency finds that an environmental
agent, formulation aid, humectant and impact statement is not required and
the safe use of poly texturizer in all foods, except meat and
(iminoimidocarbonyliminoimido- this petition results in a regulation, the
poultry. notice of availability of the agency’s
carbonyliminohexamethylene) DATES: Submit written or electronic finding of no significant impact and the
hydrochloride (CAS Reg. No. 32289–58– comments on the petitioner’s evidence supporting that finding will be
0) as an antimicrobial agent in the environmental assessment by March 17, published with the regulation in the
manufacture of food-contact paper and 2006. Federal Register in accordance with 21
paperboard. CFR 25.51(b).
ADDRESSES: Submit written comments
FOR FURTHER INFORMATION CONTACT: to the Division of Dockets Management Dated: January 25, 2006.
Elizabeth R. Sanchez, Center for Food (HFA–305), Food and Drug Laura M. Tarantino,
Safety and Applied Nutrition (HFS 275), Administration, 5630 Fishers Lane, rm. Director, Office of Food Additive Safety,
Food and Drug Administration, 5100 1061, Rockville, MD 20852. Submit Center for Food Safety and Applied Nutrition.
Paint Branch Pkwy., College Park, MD electronic comments to http:// [FR Doc. E6–2130 Filed 2–14–06; 8:45 am]
20740–3835, 301–436–1239. www.fda.gov/dockets/ecomments. BILLING CODE 4160–01–S
SUPPLEMENTARY INFORMATION: Under the FOR FURTHER INFORMATION CONTACT: Paul
Federal Food, Drug, and Cosmetic Act C. DeLeo, Center for Food Safety and
(sec. 409(b)(5) (21 U.S.C. 348(b)(5))), Applied Nutrition (HFS–265), Food and DEPARTMENT OF HEALTH AND
notice is given that a food additive Drug Administration, 5100 Paint Branch HUMAN SERVICES
petition (FAP 6B4764) has been filed by Pkwy., College Park, MD 20740–3835,
ARCH Chemicals, Inc., 1955 Lake Park 301–436–1302. Food and Drug Administration
Dr., suite 100, Smyrna, GA 30080. The SUPPLEMENTARY INFORMATION: Under the [Docket No. 2005D–0505]
petition proposes to amend the food Federal Food, Drug, and Cosmetic Act
additive regulations in § 176.170 (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), Guidance for Industry and Food and
Components of paper and paperboard notice is given that a food additive Drug Administration; Class II Special
in contact with aqueous and fatty foods petition (FAP 6A4763) has been filed by Controls Guidance Document:
and § 176.180 Components of paper and Danisco USA, Inc., 440 Saw Mill River Implantable Intra-Aneurysm Pressure
paperboard in contact with dry food to Rd., Ardsley, NY 10502–2605. The Measurement System; Availability
provide for the safe use of poly petition proposes to amend the food AGENCY: Food and Drug Administration,
(iminoimidocarbonyliminoimido- additive regulations in § 172.841 HHS.
carbonyliminohexamethylene) Polydextrose (21 CFR 172.841) to ACTION: Notice.
hydrochloride (CAS Reg. No. 32289–58– provide for the safe use of polydextrose
0) as an antimicrobial agent in the as a bulking agent, formulation aid, SUMMARY: The Food and Drug
manufacture of food-contact paper and humectant, and texturizer in all foods, Administration (FDA) is announcing the
paperboard. except meat and poultry. The proposed availability of the guidance entitled
The agency has determined under 21 amendment would consolidate all ‘‘Class II Special Controls Guidance
CFR 25.32(q) that this action is of a type existing food use categories and permit Document: Implantable Intra-Aneurysm
that does not individually or additional uses not allowed by the Pressure Measurement System.’’ This
cumulatively have a significant effect on existing regulation. guidance document describes a means
the human environment. Therefore, The potential environmental impact by which the implantable intra-
neither an environmental assessment of this action is being reviewed. To aneurysm pressure measurement system
nor an environmental impact statement encourage public participation may comply with the requirement of
is required. consistent with regulations issued under special controls for class II devices.
the National Environmental Policy Act Elsewhere in this issue of the Federal
cprice-sewell on PROD1PC66 with NOTICES

Dated: January 25, 2006. (40 CFR 1501.4(b)), the agency is Register, FDA is publishing a final rule
Laura M. Tarantino, placing the environmental assessment to classify these device types into class
Director, Office of Food Safety, Center for submitted with the petition that is the II (special controls). This guidance
Food Safety and Applied Nutrition. subject of this notice on public display document is immediately in effect as the
[FR Doc. E6–2137 Filed 2–14–06; 8:45 am] at the Division of Dockets Management special control for implantable intra-
BILLING CODE 4160–01–S (see ADDRESSES) for public review and aneurysm pressure measurement

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