Danisco USA, Inc.; Filing of Food Additive Petition; Amendment, 24856 [E6-6370]
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24856
Federal Register / Vol. 71, No. 81 / Thursday, April 27, 2006 / Notices
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Dated: April 20, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E6–6349 Filed 4–26–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006F–0059]
Danisco USA, Inc.; Filing of Food
Additive Petition; Amendment
AGENCY:
Food and Drug Administration,
HHS.
rmajette on PROD1PC67 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
filing notice for a food additive petition
filed by Danisco USA, Inc., to indicate
that the petition proposes to amend the
food additive regulations at 21 CFR
172.841 by incorporating by reference
the specifications for polydextrose in
the 5th edition of the Food Chemicals
Codex (FCC), 2003.
ADDRESSES: Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paul
C. DeLeo, Center for Food Safety and
Applied Nutrition (HFS–265), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–3835,
301–436–1302.
SUPPLEMENTARY INFORMATION: In a notice
published in the Federal Register of
February 15, 2006 (71 FR 7975), FDA
announced that a food additive petition
(FAP 6A4763) had been filed by Danisco
USA, Inc., 440 Saw Mill River Rd.,
Ardsley, NY 10502–2605. The petition
proposed to amend the food additive
VerDate Aug<31>2005
15:13 Apr 26, 2006
Jkt 208001
regulations in § 172.841 Polydextrose
(21 CFR 172.841) to provide for the safe
use of polydextrose as a bulking agent,
formulation aid, humectant, and
texturizer in all foods, except meat and
poultry. After publication of the filing
notice, FDA learned that the petition
also proposed to update § 172.841 by
incorporating by reference the
specifications for polydextrose in the
FCC, 5th ed., 2003. Currently, § 172.841
incorporates by reference the
specifications of FCC, 4th ed., 1996.
The agency compared specifications
in the monograph for polydextrose in
the 4th and 5th editions of the FCC and
found that the 5th edition retains the
lead limit of 0.5 milligram(mg)/
kilogram(kg), but no longer lists a
specification limit of 5 mg/kg for heavy
metals as lead. The 5th edition of the
FCC eliminated the heavy metals as lead
test from most monographs in favor of
including individual specifications for
relevant heavy metals. In addition, the
5th edition added a nickel specification
of 2 mg/kg for hydrogenated
polydextrose, as well as modified the
pH specification of a 10 percent solution
of untreated polydextrose from ‘‘not less
than 2.5’’ (4th edition) to ‘‘between 2.5
and 7.0’’ (5th edition). The name of the
specification for 5–
Hydroxymethylfurfural has also
changed from ‘‘5–
Hydroxymethylfurfural’’ (4th edition) to
‘‘5–Hydroxymethylfurfural and Related
Compounds’’ (5th edition), although the
test and equation used to determine the
level have remained the same. The
agency has placed copies of the
polydextrose monograph in the 4th and
5th editions of the FCC on public
display at the Division of Dockets
Management (see ADDRESSES) for public
review.
Dated: March 30, 2006.
Laura M. Tarantino,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. E6–6370 Filed 4–26–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0202]
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00018
Fmt 4703
Sfmt 4703
Submit written or electronic
comments on agency guidances at any
time.
DATES:
Submit written requests for
single copies of this guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857; or the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your requests.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
ADDRESSES:
For
products regulated by the Center for
Drug Evaluation and Research: Valerie
L. Whipp, Center for Drug Evaluation
and Research (HFD–310), Food and
Drug Administration, 11919 Rockville
Pike, Rockville, MD 20852, 301–827–
8963. For products regulated by the
Center for Biologics Evaluation and
Research: Elizabeth Callaghan, Center
for Biologics Evaluation and Research
(HFM–370), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301–827–8963.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Background
Guidance for Industry on Bar Code
Label Requirements—Questions and
Answers; Availability
AGENCY:
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Bar Code Label
Requirements—Questions and
Answers.’’ FDA regulations require
certain human drug and biological
products to have on their labels a linear
bar code that identifies the drug’s
National Drug Code (NDC) number. We
have received several inquiries about
how the requirements apply to specific
products or circumstances. The purpose
of the guidance is to respond to the
questions.
FDA is announcing the availability of
a guidance for industry entitled ‘‘Bar
Code Label Requirements—Questions
and Answers.’’ In the Federal Register
of February 26, 2004 (69 FR 9120), FDA
issued a final rule that requires certain
human drug and biological product
E:\FR\FM\27APN1.SGM
27APN1
]]>Agencies
[Federal Register Volume 71, Number 81 (Thursday, April 27, 2006)]
[Notices]
[Page 24856]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-6370]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006F-0059]
Danisco USA, Inc.; Filing of Food Additive Petition; Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the filing
notice for a food additive petition filed by Danisco USA, Inc., to
indicate that the petition proposes to amend the food additive
regulations at 21 CFR 172.841 by incorporating by reference the
specifications for polydextrose in the 5th edition of the Food
Chemicals Codex (FCC), 2003.
ADDRESSES: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paul C. DeLeo, Center for Food Safety
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1302.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of February 15, 2006 (71 FR 7975), FDA announced that a food
additive petition (FAP 6A4763) had been filed by Danisco USA, Inc., 440
Saw Mill River Rd., Ardsley, NY 10502-2605. The petition proposed 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, formulation aid, humectant, and texturizer in all foods, except
meat and poultry. After publication of the filing notice, FDA learned
that the petition also proposed to update Sec. 172.841 by
incorporating by reference the specifications for polydextrose in the
FCC, 5th ed., 2003. Currently, Sec. 172.841 incorporates by reference
the specifications of FCC, 4th ed., 1996.
The agency compared specifications in the monograph for
polydextrose in the 4th and 5th editions of the FCC and found that the
5th edition retains the lead limit of 0.5 milligram(mg)/ kilogram(kg),
but no longer lists a specification limit of 5 mg/kg for heavy metals
as lead. The 5th edition of the FCC eliminated the heavy metals as lead
test from most monographs in favor of including individual
specifications for relevant heavy metals. In addition, the 5th edition
added a nickel specification of 2 mg/kg for hydrogenated polydextrose,
as well as modified the pH specification of a 10 percent solution of
untreated polydextrose from ``not less than 2.5'' (4th edition) to
``between 2.5 and 7.0'' (5th edition). The name of the specification
for 5-Hydroxymethylfurfural has also changed from ``5-
Hydroxymethylfurfural'' (4th edition) to ``5-Hydroxymethylfurfural and
Related Compounds'' (5th edition), although the test and equation used
to determine the level have remained the same. The agency has placed
copies of the polydextrose monograph in the 4th and 5th editions of the
FCC on public display at the Division of Dockets Management (see
ADDRESSES) for public review.
Dated: March 30, 2006.
Laura M. Tarantino,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. E6-6370 Filed 4-26-06; 8:45 am]
BILLING CODE 4160-01-S
