Agency Information Collection Activities; Submission for Office of Management and Budget Review; Irradiation in the Production, Processing, and Handling of Food, 43842-43843 [2012-18234]
Download as PDF
<![CDATA[
43842
Federal Register / Vol. 77, No. 144 / Thursday, July 26, 2012 / Notices
Description of Respondents:
Respondents to this collection of
information are manufacturers, packers,
and distributors whose name (under
section 502(b)(1) of the FD&C Act)
appears on the label of a
nonprescription drug product marketed
in the United States without an
approved application.
Burden Estimate: FDA is requesting
public comment on the estimated onetime reporting burden from these
respondents, as required by 502(x) of
the FD&C Act and described in the
guidance ‘‘Questions and Answers
Regarding the Labeling of
Nonprescription Human Drug Products
Marketed Without an Approved
Application as Required by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act.’’ The
estimates for one-time reporting are
based on FDA’s knowledge of
nonprescription drug product labeling
in the United States, whether or not
marketed under an approved
application.
In the Federal Register of May 15,
2012 (77 FR 28604), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received on the information collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ONE-TIME REPORTING BURDEN 1
Number of
respondents
Number of
responses
per
respondent
Total
responses
Average
burden per
response
Total hours
200
500
100,000
4
400,000
Domestic address or phone number labeling requirement
(21 U.S.C. 502(x)) and recommendation to clarify its
purpose .............................................................................
1 There
are no capital costs or maintenance and operating costs associated with this collection of information.
TKELLEY on DSK3SPTVN1PROD with NOTICES
As indicated in table 1 of this
document, FDA estimates that
approximately 200 manufacturers will
revise approximately 100,000 labels to
add a full domestic address and a
domestic telephone number, and should
they choose to adopt the guidance’s
recommendation, to add a statement
identifying the purpose of the domestic
address or telephone number. FDA
believes that designing the label change
should not take longer than 4 hours per
label. Automated printing of the labels
should only require a few seconds per
label. This estimate accounts for the
possibility that every manufacturer will
make label revision, which is unlikely.
Because the majority of over-the-counter
drug product labels currently have a
domestic telephone number that
satisfies the requirement, we believe
many manufacturers will opt not to
adopt the guidance’s recommendation
to add a statement identifying the
purpose of the address or telephone
number, significantly reducing the
number of total responses. However,
assuming that all labels are revised, we
estimate a one-time reporting burden for
this information collection of 400,000
hours.
Dated: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18233 Filed 7–25–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0473]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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
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 August 27,
2012.
ADDRESSES: 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 0910–0186. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
VerDate Mar<15>2010
16:42 Jul 25, 2012
Jkt 226001
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
400T, Rockville, MD 20850, 301–796–
5733, domini.bean@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
E:\FR\FM\26JYN1.SGM
26JYN1
43843
Federal Register / Vol. 77, No. 144 / Thursday, July 26, 2012 / Notices
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
comment on the proposed collection of
information. One comment was received
outside the scope of the four collection
of information topics solicited by the
notice.
Description of respondents:
Respondents are businesses engaged in
the irradiation of food.
FDA estimates the burden of this
collection of information as follows:
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.
In the Federal Register of May 17,
2012 (77 FR 29352), FDA published a
60-day notice requesting public
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
TKELLEY on DSK3SPTVN1PROD with NOTICES
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 3 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 3
facilities devoting 100 percent of their
business to food irradiation (3 × 300
hours = 900 hours for recordkeeping
annually), and 4 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0280]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Financial
Disclosure by Clinical Investigators
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Dated: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
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 August 27,
2012.
ADDRESSES: 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 0910–0396. Also
include the FDA docket number found
in brackets in the heading of this
document.
[FR Doc. 2012–18234 Filed 7–25–12; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
BILLING CODE 4160–01–P
VerDate Mar<15>2010
16:42 Jul 25, 2012
SUMMARY:
Jkt 226001
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@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.
Financial Disclosure by Clinical
Investigators—(OMB Control Number
0910–0396)—Extension
Respondents to this collection are
sponsors of marketing applications that
contain clinical data from studies
covered by the regulations. These
sponsors represent pharmaceutical,
biologic, and medical device firms.
Respondents are also clinical
investigators who provide financial
information to the sponsors of
marketing applications.
Under § 54.4(a) (21 CFR 54.4(a)),
applicants submitting an application
that relies on clinical studies must
submit a complete list of clinical
investigators who participated in a
covered clinical study, and must either
certify to the absence of certain financial
arrangements with clinical investigators
(Form FDA 3454) or, under § 54.4(a)(3),
disclose to FDA the nature of those
arrangements and the steps taken by the
applicant or sponsor to minimize the
potential for bias (Form FDA 3455).
Under § 54.6, the sponsors of covered
studies must maintain complete records
of compensation agreements with any
compensation paid to nonemployee
clinical investigators, including
information showing any financial
interests held by the clinical
investigator, for a time period of 2 years
after the date of approval of the
applications. Sponsors of covered
studies maintain many records with
E:\FR\FM\26JYN1.SGM
26JYN1
]]>Agencies
[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Notices]
[Pages 43842-43843]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18234]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0473]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 August
27, 2012.
ADDRESSES: 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 0910-0186.
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.
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
[[Page 43843]]
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.
In the Federal Register of May 17, 2012 (77 FR 29352), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received outside the scope
of the four collection of information topics solicited by the notice.
Description of respondents: Respondents are businesses engaged in
the irradiation of food.
FDA estimates the burden of this collection of information as
follows:
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 3 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 3 facilities devoting 100 percent
of their business to food irradiation (3 x 300 hours = 900 hours for
recordkeeping annually), and 4 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: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18234 Filed 7-25-12; 8:45 am]
BILLING CODE 4160-01-P
