Hartech Corporation; Denial Without Prejudice of Food Additive Petition, 15985 [2011-6624]
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Federal Register / Vol. 76, No. 55 / Tuesday, March 22, 2011 / Notices
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Dated: March 10, 2011.
James D. Seligman,
Acting Chief Operating Officer, Centers for
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[FR Doc. 2011–6515 Filed 3–21–11; 8:45 am]
BILLING CODE 4160–18–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1991–F–0203] (Formerly
Docket No. 91F–0111)
Hartech Corporation; Denial Without
Prejudice of Food Additive Petition
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is denying a food
additive petition (FAP 1M4246)
proposing that the food additive
regulations be amended to provide for
the safe use of a source of ionizing
radiation to treat shellfish, including
crustaceans.
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
This order is effective June 20,
2011; except as to any provisions that
may be stayed by the filing of proper
objections. Submit either electronic or
written objections and requests for a
hearing by April 21, 2011.
ADDRESSES: You may submit either
electronic or written objections and
DATES:
VerDate Mar<15>2010
17:11 Mar 21, 2011
Jkt 223001
requests for a hearing identified by
Docket No. FDA–1991–F–0203, by any
of the following methods:
Electronic Submissions
Submit electronic objections in the
following way:
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written objections in the
following ways:
Fax: 301–827–6870.
Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Richard E. Bonnette, Center for Food
Safety and Applied Nutrition (HFS–
255), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 301–436–1235.
SUPPLEMENTARY INFORMATION: In a notice
published in the Federal Register of
April 16, 1991 (56 FR 15373), FDA
announced that a food additive petition
(FAP 1M4246) had been filed by
Hartech Corp. (formerly United States
Harvest Technologies, Inc., One East
Chase St., suites 1112 and 1113,
Baltimore, MD). The petition proposed
to amend the food additive regulations
in § 179.26 Ionizing radiation for the
treatment of food (21 CFR 179.26) to
provide for the safe use of a source of
ionizing radiation to treat shellfish,
including crustaceans.
For any food additive petition, the
burden is on the petitioner to submit to
FDA data and information that are
adequate for the Agency to determine
that the proposed use of the additive
under the specified conditions of use is
safe (21 U.S.C. 348(c)(3)(A), 21 CFR
171.1). Hartech Corp. was notified of
significant deficiencies in the
information supporting its petition by
letters from the Agency dated May 28,
1992, February 5, 1999, December 15,
2004, March 19, 2009, and May 22,
2009. The deficiencies related primarily
to concerns about the possibility of
Clostridium botulinum outgrowth in
irradiated products, especially where
the normal growth pattern of typical
spoilage organisms could be changed by
irradiation, thus reducing perception of
spoilage. FDA had therefore requested
information on typical spoilage and
pathogenic microbial populations of
shellfish irradiated at the maximum
dose requested. FDA also requested
additional data on the efficacy of the
proposed doses of irradiation in
reducing pathogens in crustaceans
PO 00000
Frm 00052
Fmt 4703
Sfmt 9990
15985
because the petition only included data
on the efficacy of irradiation in reducing
the levels of Vibrio species in oysters.
Hartech Corp. has not provided
information to address these
deficiencies, and the Agency’s most
recent letters to Hartech Corp.’s last
known address were returned as
undeliverable. Additional efforts to
contact this petitioner have been
unsuccessful. The petitioner has not
provided sufficient data and
information for the Agency to conclude
that the proposed use of the food
additive is safe in accordance with
section 409 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 348). FDA
is therefore denying the petition without
prejudice to a future filing (21 U.S.C.
348(c)(1)(B), 21 CFR 171.100(a)).
This order is effective as shown in the
DATES section of this document; except
as to any provisions that may be stayed
by the filing of proper objections. Any
person who will be adversely affected
by this order may file with the Division
of Dockets Management (see ADDRESSES)
either electronic or written objections.
Each objection shall be separately
numbered, and each numbered
objection shall specify with particularity
the provisions of the regulation to
which objection is made and the
grounds for the objection. Each
numbered objection on which a hearing
is requested shall specifically so state.
Failure to request a hearing for any
particular objection shall constitute a
waiver of the right to a hearing on that
objection. Each numbered objection for
which a hearing is requested shall
include a detailed description and
analysis of the specific factual
information intended to be presented in
support of the objection in the event
that a hearing is held. Failure to include
such a description and analysis for any
particular objection shall constitute a
waiver of the right to a hearing on the
objection. It is only necessary to send
one set of documents. It is no longer
necessary to send three copies of all
documents. Identify documents with the
docket number found in brackets in the
heading of this document. Any
objections received in response to the
order may be seen in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
FDA will publish notice of the
objections that the Agency has received
or lack thereof in the Federal Register.
Dated: March 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–6624 Filed 3–21–11; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\22MRN1.SGM
22MRN1
]]>Agencies
[Federal Register Volume 76, Number 55 (Tuesday, March 22, 2011)]
[Notices]
[Page 15985]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6624]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1991-F-0203] (Formerly Docket No. 91F-0111)
Hartech Corporation; Denial Without Prejudice of Food Additive
Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is denying a food
additive petition (FAP 1M4246) proposing that the food additive
regulations be amended to provide for the safe use of a source of
ionizing radiation to treat shellfish, including crustaceans.
DATES: This order is effective June 20, 2011; except as to any
provisions that may be stayed by the filing of proper objections.
Submit either electronic or written objections and requests for a
hearing by April 21, 2011.
ADDRESSES: You may submit either electronic or written objections and
requests for a hearing identified by Docket No. FDA-1991-F-0203, by any
of the following methods:
Electronic Submissions
Submit electronic objections in the following way:
Federal eRulemaking Portal: https://www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written objections in the following ways:
Fax: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Richard E. Bonnette, Center for Food
Safety and Applied Nutrition (HFS-255), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1235.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of April 16, 1991 (56 FR 15373), FDA announced that a food
additive petition (FAP 1M4246) had been filed by Hartech Corp.
(formerly United States Harvest Technologies, Inc., One East Chase St.,
suites 1112 and 1113, Baltimore, MD). The petition proposed to amend
the food additive regulations in Sec. 179.26 Ionizing radiation for
the treatment of food (21 CFR 179.26) to provide for the safe use of a
source of ionizing radiation to treat shellfish, including crustaceans.
For any food additive petition, the burden is on the petitioner to
submit to FDA data and information that are adequate for the Agency to
determine that the proposed use of the additive under the specified
conditions of use is safe (21 U.S.C. 348(c)(3)(A), 21 CFR 171.1).
Hartech Corp. was notified of significant deficiencies in the
information supporting its petition by letters from the Agency dated
May 28, 1992, February 5, 1999, December 15, 2004, March 19, 2009, and
May 22, 2009. The deficiencies related primarily to concerns about the
possibility of Clostridium botulinum outgrowth in irradiated products,
especially where the normal growth pattern of typical spoilage
organisms could be changed by irradiation, thus reducing perception of
spoilage. FDA had therefore requested information on typical spoilage
and pathogenic microbial populations of shellfish irradiated at the
maximum dose requested. FDA also requested additional data on the
efficacy of the proposed doses of irradiation in reducing pathogens in
crustaceans because the petition only included data on the efficacy of
irradiation in reducing the levels of Vibrio species in oysters.
Hartech Corp. has not provided information to address these
deficiencies, and the Agency's most recent letters to Hartech Corp.'s
last known address were returned as undeliverable. Additional efforts
to contact this petitioner have been unsuccessful. The petitioner has
not provided sufficient data and information for the Agency to conclude
that the proposed use of the food additive is safe in accordance with
section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
348). FDA is therefore denying the petition without prejudice to a
future filing (21 U.S.C. 348(c)(1)(B), 21 CFR 171.100(a)).
This order is effective as shown in the DATES section of this
document; except as to any provisions that may be stayed by the filing
of proper objections. Any person who will be adversely affected by this
order may file with the Division of Dockets Management (see ADDRESSES)
either electronic or written objections. Each objection shall be
separately numbered, and each numbered objection shall specify with
particularity the provisions of the regulation to which objection is
made and the grounds for the objection. Each numbered objection on
which a hearing is requested shall specifically so state. Failure to
request a hearing for any particular objection shall constitute a
waiver of the right to a hearing on that objection. Each numbered
objection for which a hearing is requested shall include a detailed
description and analysis of the specific factual information intended
to be presented in support of the objection in the event that a hearing
is held. Failure to include such a description and analysis for any
particular objection shall constitute a waiver of the right to a
hearing on the objection. It is only necessary to send one set of
documents. It is no longer necessary to send three copies of all
documents. Identify documents with the docket number found in brackets
in the heading of this document. Any objections received in response to
the order may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday. FDA will publish notice of the
objections that the Agency has received or lack thereof in the Federal
Register.
Dated: March 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6624 Filed 3-21-11; 8:45 am]
BILLING CODE 4160-01-P
