Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice, 57962-57963 [2010-23824]
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57962
Federal Register / Vol. 75, No. 184 / Thursday, September 23, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Child Care and Development
Fund Tribal Plan Preprint—ACF–118–
A.
OMB No.: 0970–0198.
Description: The Child Care and
Development Fund (CCDF) Tribal Plan
serves as the agreement between the
applicant (Indian Tribes, Tribal
consortia and Tribal organizations) and
the Federal government that describes
how Tribal applicants will operate
CCDF Block Grant programs. The Tribal
Plan provides assurances that the CCDF
funds will be administered in
conformance with legislative
requirements, Federal regulations at 45
CFR parts 98 and 99 and other
applicable instructions or guidelines
issued by the Administration for
Children and Families ACF). Tribes
must submit a new CCDF Tribal Plan
every two years in accordance with 45
CFR 98.17.
Respondents: Tribal CCDF programs
(259 total).
ANNUAL BURDEN ESTIMATES
Number of respondents
Number of responses per
respondent
Average burden hours per
response
CCDF Tribal Plan ............................................................................................
CCDF Tribal Plan Amendments ......................................................................
Estimated Total Annual Burden Hours: ...........................................................
srobinson on DSKHWCL6B1PROD with NOTICES
Instrument
259
259
........................
1
1
........................
17.50
1.50
........................
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: September 20, 2010.
Robert Sargis,
Reports Clearance Officer.
BILLING CODE 4184–01–P
16:52 Sep 22, 2010
Food and Drug Administration
[Docket No. FDA–2010–N–0357]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Hazard Analysis
and Critical Control Point Procedures
for the Safe and Sanitary Processing
and Importing of Juice
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 October 25,
2010.
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 0910–0466. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2010–23826 Filed 9–22–10; 8:45 am]
VerDate Mar<15>2010
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 220001
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
Total burden
hours
4,532.50
388.50
4,921
Administration, 1350 Piccard Dr.,
Rockville, MD 20850, 301–796–3793.
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.
Hazard Analysis and Critical Control
Point (HACCP) Procedures for the Safe
and Sanitary Processing and Importing
of Juice—(OMB Control Number 0910–
0466)—Extension
FDA’s regulations in part 120 (21 CFR
part 120) mandate the application of
HACCP procedures to fruit and
vegetable juice processing. HACCP is a
preventative system of hazard control
that can be used by all food processors
to ensure the safety of their products to
consumers. A HACCP system of
preventive controls is the most effective
and efficient way to ensure that these
food products are safe. FDA’s mandate
to ensure the safety of the Nation’s food
supply is derived principally from the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 321, et seq.).
Under the FD&C Act, FDA has authority
to ensure that all foods in interstate
commerce, or that have been shipped in
interstate commerce, are not
contaminated or otherwise adulterated,
are produced and held under sanitary
conditions, and are not misbranded or
deceptively packaged; under section 701
(21 U.S.C. 371), the FD&C Act
authorizes the Agency to issue
regulations for its efficient enforcement.
The Agency also has authority under
section 361 of the Public Health Service
Act (42 U.S.C. 264) to issue and enforce
regulations to prevent the introduction,
transmission, or spread of
E:\FR\FM\23SEN1.SGM
23SEN1
Federal Register / Vol. 75, No. 184 / Thursday, September 23, 2010 / Notices
communicable diseases from one State
to another State. Information
development and recordkeeping are
essential parts of any HACCP system.
The information collection requirements
are narrowly tailored to focus on the
development of appropriate controls
and document those aspects of
processing that are critical to food
safety. Through these regulations, FDA
is implementing its authority under
section 402(a)(4) of the FD&C Act (21
U.S.C. 342(a)(4)).
In the Federal Register of July 14,
2010 (75 FR 40839), FDA published a
57963
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No of
Recordkeepers
Annual Frequency per
Recordkeeping
Total Annual
Records
Hours Per
Record
Total Hours
120.6(c) and 120.12(a)(1) and
(b)
1,875
120.7; 120.10(a); and
120.12(a)(2), (b), and (c)
2,300
120.8(b)(7) and 120.12(a)(4)(i)
and (b)
1,450
14,600
21,170,000
120.10(c) and 120.12(a)(4)(ii)
and (b)
1,840
12
22,080
0.1
2,208
120.11(a)(1)(iv) and (a)(2) and
120.12(a)(5)
1,840
52
95,680
0.1
9,568
120.11(b) and 120.12(a)(5) and
(b)
1,840
1
1,840
4
7,360
120.11(c) and 120.12(a)(5) and
(b)
1,840
1
1,840
4
7,360
308
1
308
4
1,232
120.14(a)(2), (c), and (d)
365
684,375
1.1
0.1
2,530
20
0.01
Total
srobinson on DSKHWCL6B1PROD with NOTICES
1 There
68,437.5
50,600
211,700
358,466
are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 of this document provides a
breakdown of the total estimated annual
recordkeeping burden. FDA bases this
hour burden estimate on its experience
with the application of HACCP
principles in food processing.
The burden estimates in table 1 of this
document are based on an estimate of
the total number of juice manufacturing
plants (i.e., 2,300) affected by the
regulations. Included in this total are
850 plants currently identified in FDA’s
official establishment inventory plus
1,220 very small apple juice
manufacturers and 230 very small
orange juice manufacturers. The total
burden hours are derived by estimating
the number of plants affected by each
portion of the final rule and multiplying
the corresponding number by the
number of records required annually
and the hours needed to complete the
record. These numbers were obtained
from the Agency’s final regulatory
impact analysis prepared for these
regulations.
Moreover, these estimates assume that
every processor will prepare sanitary
standard operating procedures and a
HACCP plan and maintain the
associated monitoring records and that
VerDate Mar<15>2010
16:52 Sep 22, 2010
Jkt 220001
every importer will require product
safety specifications. In fact, there are
likely to be some small number of juice
processors that, based upon their hazard
analysis, determine that they are not
required to have a HACCP plan under
the regulations.
Dated: September 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–23824 Filed 9–22–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0459]
Draft Guidance for Industry and Food
and Drug Administration Staff;
Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for the Detection of
Helicobacter pylori; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00077
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for the Detection of
Helicobacter pylori.’’ This draft guidance
document provides industry and agency
staff with updated recommendations
concerning 510(k) submissions for
various types of in vitro diagnostic
devices (IVDs) intended to be used for
detecting Helicobacter pylori (H. pylori).
This draft guidance is not final nor is it
in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by December 22,
2010.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Establishing the
Performance Characteristics of In Vitro
Diagnostic Devices for the Detection of
Helicobacter pylori’’ to the Division of
SUMMARY:
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 75, Number 184 (Thursday, September 23, 2010)]
[Notices]
[Pages 57962-57963]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23824]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0357]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Hazard Analysis and
Critical Control Point Procedures for the Safe and Sanitary Processing
and Importing of Juice
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 October
25, 2010.
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 0910-0466.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-796-3793.
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.
Hazard Analysis and Critical Control Point (HACCP) Procedures for the
Safe and Sanitary Processing and Importing of Juice--(OMB Control
Number 0910-0466)--Extension
FDA's regulations in part 120 (21 CFR part 120) mandate the
application of HACCP procedures to fruit and vegetable juice
processing. HACCP is a preventative system of hazard control that can
be used by all food processors to ensure the safety of their products
to consumers. A HACCP system of preventive controls is the most
effective and efficient way to ensure that these food products are
safe. FDA's mandate to ensure the safety of the Nation's food supply is
derived principally from the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 321, et seq.). Under the FD&C Act, FDA has
authority to ensure that all foods in interstate commerce, or that have
been shipped in interstate commerce, are not contaminated or otherwise
adulterated, are produced and held under sanitary conditions, and are
not misbranded or deceptively packaged; under section 701 (21 U.S.C.
371), the FD&C Act authorizes the Agency to issue regulations for its
efficient enforcement. The Agency also has authority under section 361
of the Public Health Service Act (42 U.S.C. 264) to issue and enforce
regulations to prevent the introduction, transmission, or spread of
[[Page 57963]]
communicable diseases from one State to another State. Information
development and recordkeeping are essential parts of any HACCP system.
The information collection requirements are narrowly tailored to focus
on the development of appropriate controls and document those aspects
of processing that are critical to food safety. Through these
regulations, FDA is implementing its authority under section 402(a)(4)
of the FD&C Act (21 U.S.C. 342(a)(4)).
In the Federal Register of July 14, 2010 (75 FR 40839), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No of Annual Frequency per Total Annual
21 CFR Section Recordkeepers Recordkeeping Records Hours Per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.6(c) and 120.12(a)(1) and (b) 1,875 365 684,375 0.1 68,437.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.7; 120.10(a); and 120.12(a)(2), (b), and (c) 2,300 1.1 2,530 20 50,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.8(b)(7) and 120.12(a)(4)(i) and (b) 1,450 14,600 21,170,000 0.01 211,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.10(c) and 120.12(a)(4)(ii) and (b) 1,840 12 22,080 0.1 2,208
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.11(a)(1)(iv) and (a)(2) and 120.12(a)(5) 1,840 52 95,680 0.1 9,568
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.11(b) and 120.12(a)(5) and (b) 1,840 1 1,840 4 7,360
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.11(c) and 120.12(a)(5) and (b) 1,840 1 1,840 4 7,360
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.14(a)(2), (c), and (d) 308 1 308 4 1,232
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 358,466
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 of this document provides a breakdown of the total
estimated annual recordkeeping burden. FDA bases this hour burden
estimate on its experience with the application of HACCP principles in
food processing.
The burden estimates in table 1 of this document are based on an
estimate of the total number of juice manufacturing plants (i.e.,
2,300) affected by the regulations. Included in this total are 850
plants currently identified in FDA's official establishment inventory
plus 1,220 very small apple juice manufacturers and 230 very small
orange juice manufacturers. The total burden hours are derived by
estimating the number of plants affected by each portion of the final
rule and multiplying the corresponding number by the number of records
required annually and the hours needed to complete the record. These
numbers were obtained from the Agency's final regulatory impact
analysis prepared for these regulations.
Moreover, these estimates assume that every processor will prepare
sanitary standard operating procedures and a HACCP plan and maintain
the associated monitoring records and that every importer will require
product safety specifications. In fact, there are likely to be some
small number of juice processors that, based upon their hazard
analysis, determine that they are not required to have a HACCP plan
under the regulations.
Dated: September 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23824 Filed 9-22-10; 8:45 am]
BILLING CODE 4160-01-S
