Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in the Production, Processing, and Handling of Food, 29352-29353 [2012-11933]
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29352
Federal Register / Vol. 77, No. 96 / Thursday, May 17, 2012 / Notices
Children, SIP12–055, and Innovative
Message Framing to Increase Support
for Evidence-based Tobacco Control,
SIP12–060, Panel A, initial review.’’
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M. Chris Langub, Ph.D., Scientific
Review Officer, CDC, 4770 Buford
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Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: May 10, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2012–11952 Filed 5–16–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0473]
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.
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 information collection provisions of
FDA’s requirements for food irradiation
processors.
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SUMMARY:
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Submit either electronic or
written comments on the collection of
information by July 16, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. 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:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850, 301–796–
5733, domini.bean@fda.hhs.gov.
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,
DATES:
PO 00000
Frm 00040
Fmt 4703
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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 FD&C Act) (21 U.S.C. 321(s) and
348), food irradiation is subject to
regulation under the food additive
premarket approval provisions of the
FD&C 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 (or
minimum and maximum) energy of
radiation emitted by X-ray tube sources.
Section 179.21(b)(2) requires that the
label or accompanying labeling bear
adequate directions for installation and
use and a statement supplied by FDA
that indicates maximum dose of
radiation allowed. Section 179.26(c)
requires that the label or accompanying
labeling bear a logo and a radiation
disclosure statement. 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.
Description of respondents:
Respondents are businesses engaged in
the irradiation of food.
FDA estimates the burden of this
collection of information as follows:
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29353
Federal Register / Vol. 77, No. 96 / Thursday, May 17, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
179.25(e), Large processors ................................................
179.25(e), Small processors ................................................
3
4
300
30
900
120
1
1
900
120
Total ..............................................................................
........................
........................
........................
........................
1,020
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate of burden for
the recordkeeping provisions of
§ 179.25(e) on the Agency’s experience
regulating the safe use of radiation as a
direct food additive. The number of
firms who process food using irradiation
is extremely limited. FDA estimates that
there are three 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
three facilities devoting 100 percent of
their business to food irradiation (3 ×
300 hours = 900 hours for recordkeeping
annually), and four facilities devoting
10 percent of their business to food
irradiation (4 × 30 hours = 120 hours for
recordkeeping annually).
No burden has been estimated for the
labeling requirements in §§ 179.21(b)(1),
179.21(b)(2), 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 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: May 11, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–11933 Filed 5–16–12; 8:45 am]
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BILLING CODE 4160–01–P
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Food and Drug Administration
Experimental Study on Comparing Data
Obtained From Landline Telephone
and Cell Phone Surveys—(OMB Control
Number 0910–NEW)
[Docket No. FDA–2011–N–0858]
I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study on Comparing Data Obtained
From Landline Telephone and Cell
Phone Surveys
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 18,
2012.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–New and
title ‘‘Experimental Study on Comparing
Data Obtained From Landline
Telephone and Cell Phone Surveys.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850, 301–796–
5733, domini.bean@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
ADDRESSES:
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Since the early 1980s, the Center for
Food Safety and Applied Nutrition at
FDA has been commissioning several
waves of two national consumer
surveys, the Food Safety Survey (FSS)
and the Health and Diet Survey (HDS),
to gather data on consumer knowledge,
perceptions, and behaviors regarding
food safety and nutrition. The purposes
of the surveys are threefold: (1) To
generate nationally representative
estimates of knowledge, perceptions,
and practices of interest at a given point
in time; (2) to track trends of the
estimates over time; and (3) to
understand the relationships among
knowledge, perceptions, and practices
regarding food safety and nutrition, and
how these relate to demographic
characteristics.
Traditionally, all waves of the surveys
have been administered via landline
telephones and have used the random
digit dialing (RDD) technique to recruit
national samples of adults (18 years old
or above) from households with
landline telephone numbers. A
noticeable phenomenon that has
appeared in our recent surveys is a
precipitous decline of younger
respondents in completed interviews.
For example, the proportion of
respondents in the 18 to 29 age group
for the FSS has dropped from 17 percent
in 2001, to 11 percent in 2006, to only
4 percent in 2010; the corresponding
proportion for the HDS has gone from
14 percent in 2002, to 15 percent in
2004, to only 6 percent in 2008.
One possible reason for the decline is
the rapid adoption of cell phones in
recent years. During the second half of
2010, 28 percent of American adults
lived in households with only wireless
service (‘‘wireless-only households’’ or
‘‘cell-phone only households’’),
compared to 15 percent in the second
half of 2007 and 5 percent in the second
half of 2004 (Ref. 1). During the second
half of 2010, 17 percent of adults lived
E:\FR\FM\17MYN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 96 (Thursday, May 17, 2012)]
[Notices]
[Pages 29352-29353]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11933]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0473]
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 information collection
provisions of FDA's requirements for food irradiation processors.
DATES: Submit either electronic or written comments on the collection
of information by July 16, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. 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: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, 301-796-5733, domini.bean@fda.hhs.gov.
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 FD&C Act) (21 U.S.C. 321(s) and 348), food
irradiation is subject to regulation under the food additive premarket
approval provisions of the FD&C 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 (or minimum and maximum) energy of radiation
emitted by X-ray tube sources. Section 179.21(b)(2) requires that the
label or accompanying labeling bear adequate directions for
installation and use and a statement supplied by FDA that indicates
maximum dose of radiation allowed. Section 179.26(c) requires that the
label or accompanying labeling bear a logo and a radiation disclosure
statement. 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.
Description of respondents: Respondents are businesses engaged in
the irradiation of food.
FDA estimates the burden of this collection of information as
follows:
[[Page 29353]]
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
179.25(e), Large processors..... 3 300 900 1 900
179.25(e), Small processors..... 4 30 120 1 120
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,020
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA bases its estimate of burden for the recordkeeping provisions
of Sec. 179.25(e) on the Agency's experience regulating the safe use
of radiation as a direct food additive. The number of firms who process
food using irradiation is extremely limited. FDA estimates that there
are three 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 three facilities devoting 100
percent of their business to food irradiation (3 x 300 hours = 900
hours for recordkeeping annually), and four facilities devoting 10
percent of their business to food irradiation (4 x 30 hours = 120 hours
for recordkeeping annually).
No burden has been estimated for the labeling requirements in
Sec. Sec. 179.21(b)(1), 179.21(b)(2), 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 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: May 11, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-11933 Filed 5-16-12; 8:45 am]
BILLING CODE 4160-01-P
