Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in the Production, Processing, and Handling of Food, 6075-6076 [E6-1516]
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6075
Federal Register / Vol. 71, No. 24 / Monday, February 6, 2006 / Notices
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0038]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Irradiation in the
Production, Processing, and Handling
of Food
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the reporting and recordkeeping
requirements for food irradiation
processors.
Submit written or electronic
comments on the collection of
information by April 7, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
DATES:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Irradiation in the Production,
Processing, and Handling of Food—21
CFR Part 179 (OMB Control Number
0910–0186)—Extension
Under sections 201(s) and 409 of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 321(s) and 348), food
irradiation is subject to regulation under
the food additive premarket approval
provisions of the act. The regulations
providing for uses of irradiation in the
production, processing, and handling of
food are found in part 179 (21 CFR part
179). To ensure safe use of a radiation
source, § 179.21(b)(1) requires that the
label of sources bear appropriate and
accurate information identifying the
source of radiation and the maximum
energy of radiation emitted by x ray tube
sources. Section 179.21(b)(2)(i) requires
that the label or accompanying labeling
bear adequate directions for installation
and use. Section 179.25(e) requires that
food processors who treat food with
radiation make and retain, for 1 year
past the expected shelf life of the
products up to a maximum of 3 years,
specified records relating to the
irradiation process (e.g., the food
treated, lot identification, scheduled
process, etc.). The records required by
§ 179.25(e) are used by FDA inspectors
to assess compliance with the regulation
that establishes limits within which
radiation may be safely used to treat
food. The agency cannot ensure safe use
without a method to assess compliance
with the dose limits, and there are no
practicable methods for analyzing most
foods to determine whether they have
been treated with ionizing radiation and
are within the limitations set forth in
part 179. Records inspection is the only
way to determine whether firms are
complying with the regulations for
treatment of foods with ionizing
radiation.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR
Section
179.25(e)
rmajette on PROD1PC67 with NOTICES1
1There
Annual frequency per recordkeeping
No. of recordkeepers
6
Total annual records
120
Hours per record
720
Total hours
1
720
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of firms who process
food using irradiation is extremely
limited. FDA estimates that there are
two irradiation plants whose business is
devoted primarily (i.e., approximately
100 percent) to irradiation of food and
other agricultural products. Four other
firms also irradiate small quantities of
food. FDA estimates that this irradiation
VerDate Aug<31>2005
14:55 Feb 03, 2006
Jkt 208001
accounts for no more than 10 percent of
the business for each of these firms.
Therefore, the average estimated burden
is based on: Two facilities devoting 100
percent of their business (or 600 hours
for recordkeeping annually) to food
irradiation; four facilities devoting 10
percent of their business or 120 hours (4
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
x 30 hours) for recordkeeping annually
to food irradiation.
No burden has been estimated for the
labeling requirements in
§§ 179.21(b)(2)(i) and (b)(2)(ii) and
179.26(c) because the information to be
disclosed is information that has been
supplied by FDA. Under 5 CFR
1320.3(c)(2), the public disclosure of
E:\FR\FM\06FEN1.SGM
06FEN1
6076
Federal Register / Vol. 71, No. 24 / Monday, February 6, 2006 / Notices
information originally supplied by the
Federal Government to the recipient for
the purpose of disclosure to the public
is not a collection of information.
Dated: January 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–1516 Filed 2–3–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0037]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Proposed
Experimental Study of Trans Fat
Claims on Foods
AGENCY:
Food and Drug Administration,
HHS.
rmajette on PROD1PC67 with NOTICES1
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
reinstatement of an existing collection
of information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a proposed experimental study of trans
fat claims on foods to evaluate the
effects of various possible disclosure
requirements intended to help
consumers understand and apply trans
fat claims they might see on food
products. The proposed experimental
study will estimate the communication
effectiveness of these disclosure
requirements in realistic label usage
situations for a range of products that
may bear trans fat claims.
DATES: Submit written or electronic
comments on the collection of
information by April 7, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
VerDate Aug<31>2005
14:55 Feb 03, 2006
Jkt 208001
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed reinstatement
of an existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Proposed Experimental Study of Trans
Fat Claims on Foods (OMB Control
Number 0910–0533)—Reinstatement
FDA is requesting OMB approval of a
proposed experimental study of trans fat
claims on food products intended to
help FDA’s Center for Food Safety and
Applied Nutrition formulate decisions
and policies affecting labeling
requirements for trans fat claims on
foods.
In the Federal Register of July 11,
2003 (68 FR 41507), FDA issued an
advance notice of proposed rulemaking
entitled ‘‘Food Labeling: Trans Fatty
Acids in Nutrition Labeling; Consumer
Research to Consider Nutrient Content
and Health Claims and Possible
Footnote or Disclosure Statements,’’
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
which requested comments about
possible disclosure requirements to
accompany nutrient content claims
about trans fatty acids that could help
consumers make heart-healthy food
choices. The proposed experimental
study will evaluate the ability of several
such disclosure requirements to help
consumers make heart-healthy food
choices. The results of the proposed
experimental study will provide
empirical support for possible policy
decisions about the need for such
disclosures and the appropriate form
they should take.
FDA or its contractor will collect and
use information gathered from Internet
panel samples to evaluate how
consumers understand and respond to
possible disclosure requirements for
trans fat content claims. The distinctive
features of Internet panel and shopping
mall methodologies for the purpose of
the proposed experimental study are
that they allow for controlled visual
presentation of study materials,
experimental manipulation of study
materials, and the random assignment of
subjects to condition. Experimental
manipulation of labels and random
assignment to condition makes it
possible to estimate the effects of the
various possible disclosure
requirements while controlling for
individual differences. Random
assignment ensures that mean
differences between conditions can be
tested using well-known techniques
such as analysis of variance or
regression analysis to yield statistically
valid estimates of treatment effect size.
The proposed study will be conducted
from a sample drawn from a large,
nationally representative consumer
panel with 800,000 households. The
sample size and population pool are
adequate to ensure that results can be
generalized.
Participants will be adults, age 18 and
older, who are recruited for a study
about foods and food labels. Each
participant will be randomly assigned to
one of the 144 experimental conditions
consisting of fully crossing 8 disclosure
conditions, 3 product types, 3 fatty acid
profiles and 2 prior knowledge
conditions.
FDA will use the information from the
proposed experimental study to
evaluate regulatory policy options. The
agency often lacks empirical data about
how consumers understand and
respond to statements they might see in
product labeling. The information
gathered from this proposed
experimental study will be used by the
agency to assess likely consumer
responses to various disclosure
E:\FR\FM\06FEN1.SGM
06FEN1
]]>Agencies
[Federal Register Volume 71, Number 24 (Monday, February 6, 2006)]
[Notices]
[Pages 6075-6076]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1516]
[[Page 6075]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0038]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Irradiation in the Production, Processing, and
Handling of Food
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the reporting and
recordkeeping requirements for food irradiation processors.
DATES: Submit written or electronic comments on the collection of
information by April 7, 2006.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Irradiation in the Production, Processing, and Handling of Food--21 CFR
Part 179 (OMB Control Number 0910-0186)--Extension
Under sections 201(s) and 409 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 321(s) and 348), food irradiation is
subject to regulation under the food additive premarket approval
provisions of the act. The regulations providing for uses of
irradiation in the production, processing, and handling of food are
found in part 179 (21 CFR part 179). To ensure safe use of a radiation
source, Sec. 179.21(b)(1) requires that the label of sources bear
appropriate and accurate information identifying the source of
radiation and the maximum energy of radiation emitted by x ray tube
sources. Section 179.21(b)(2)(i) requires that the label or
accompanying labeling bear adequate directions for installation and
use. Section 179.25(e) requires that food processors who treat food
with radiation make and retain, for 1 year past the expected shelf life
of the products up to a maximum of 3 years, specified records relating
to the irradiation process (e.g., the food treated, lot identification,
scheduled process, etc.). The records required by Sec. 179.25(e) are
used by FDA inspectors to assess compliance with the regulation that
establishes limits within which radiation may be safely used to treat
food. The agency cannot ensure safe use without a method to assess
compliance with the dose limits, and there are no practicable methods
for analyzing most foods to determine whether they have been treated
with ionizing radiation and are within the limitations set forth in
part 179. Records inspection is the only way to determine whether firms
are complying with the regulations for treatment of foods with ionizing
radiation.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual frequency per
21 CFR Section No. of recordkeepers recordkeeping Total annual records Hours per record Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
179.25(e) 6 120 720 1 720
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The number of firms who process food using irradiation is extremely
limited. FDA estimates that there are two irradiation plants whose
business is devoted primarily (i.e., approximately 100 percent) to
irradiation of food and other agricultural products. Four other firms
also irradiate small quantities of food. FDA estimates that this
irradiation accounts for no more than 10 percent of the business for
each of these firms. Therefore, the average estimated burden is based
on: Two facilities devoting 100 percent of their business (or 600 hours
for recordkeeping annually) to food irradiation; four facilities
devoting 10 percent of their business or 120 hours (4 x 30 hours) for
recordkeeping annually to food irradiation.
No burden has been estimated for the labeling requirements in
Sec. Sec. 179.21(b)(2)(i) and (b)(2)(ii) and 179.26(c) because the
information to be disclosed is information that has been supplied by
FDA. Under 5 CFR 1320.3(c)(2), the public disclosure of
[[Page 6076]]
information originally supplied by the Federal Government to the
recipient for the purpose of disclosure to the public is not a
collection of information.
Dated: January 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1516 Filed 2-3-06; 8:45 am]
BILLING CODE 4160-01-S
