Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers, 11649-11650 [E8-4067]
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Federal Register / Vol. 73, No. 43 / Tuesday, March 4, 2008 / Notices
collection provisions should be
extended to provide for the potential
future need of a State or local
government to petition for an exemption
from preemption under the provisions
of section 403(A) of the act.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
Dated: February 26, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–4066 Filed 3–3–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0129]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Canning
Establishment Registration, Process
Filing, and Recordkeeping for Acidified
Foods and Thermally Processed LowAcid Foods in Hermetically Sealed
Containers
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
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
reporting and recordkeeping
requirements for firms that process
acidified foods and thermally processed
low-acid foods in hermetically sealed
containers.
DATES: Submit written or electronic
comments on the collection of
information by May 5, 2008.
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
VerDate Aug<31>2005
17:57 Mar 03, 2008
Jkt 214001
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 the Chief
Information Officer (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.
Food Canning Establishment
Registration, Process Filing, and
Recordkeeping for Acidified Foods and
Thermally Processed Low-Acid Foods
in Hermetically Sealed Containers—21
CFR 108.25 and 108.35, and Parts 113
and 114 (OMB Control Number 0910–
0037)—Extension
Under the Federal Food, Drug, and
Cosmetic Act (the act), FDA is
authorized to prevent the interstate
distribution of food products that may
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Fmt 4703
Sfmt 4703
11649
be injurious to health or that are
otherwise adulterated, as defined in
section 402 of the act (21 U.S.C. 342).
Under the authority granted to FDA by
section 404 of the act (21 U.S.C. 344),
FDA regulations require registration of
food processing establishments, filing of
process or other data, and maintenance
of processing and production records for
acidified foods and thermally processed
low-acid foods in hermetically sealed
containers. These requirements are
intended to ensure safe manufacturing,
processing, and packing procedures and
to permit FDA to verify that these
procedures are being followed.
Improperly processed low-acid foods
present life-threatening hazards if
contaminated with foodborne
microorganisms, especially Clostridium
botulinum. The spores of C. botulinum
must be destroyed or inhibited to avoid
production of the deadly toxin that
causes botulism. This is accomplished
with good manufacturing procedures,
which must include the use of adequate
heat processes or other means of
preservation.
To protect the public health, FDA
regulations require that each firm that
manufactures, processes, or packs
acidified foods or thermally processed
low-acid foods in hermetically sealed
containers for introduction into
interstate commerce register the
establishment with FDA using Form
FDA 2541 (§§ 108.25(c)(1) and
108.35(c)(2) (21 CFR 108.25(c)(1) and
108.35(c)(2))). In addition to registering
the plant, each firm is required to
provide data on the processes used to
produce these foods, using Form FDA
2541a for all methods except aseptic
processing, or Form FDA 2541c for
aseptic processing of low-acid foods in
hermetically sealed containers
(§§ 108.25(c)(2) and 108.35(c)(2)). Plant
registration and process filing may be
accomplished simultaneously. Process
data must be filed prior to packing any
new product, and operating processes
and procedures must be posted near the
processing equipment or made available
to the operator (§ 113.87(a) (21 CFR
113.87(a))).
Regulations in parts 108, 113, and 114
(21 CFR parts 108, 113, and 114) require
firms to maintain records showing
adherence to the substantive
requirements of the regulations. These
records must be made available to FDA
on request. Firms are also required to
document corrective actions when
process controls and procedures do not
fall within specified limits (§§ 113.89,
114.89, and 114.100(c)); to report any
instance of potential health-endangering
spoilage, process deviation, or
contamination with microorganisms
E:\FR\FM\04MRN1.SGM
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11650
Federal Register / Vol. 73, No. 43 / Tuesday, March 4, 2008 / Notices
where any lot of the food has entered
distribution in commerce (§§ 108.25(d)
and 108.35(d) and (e)); and to develop
and keep on file plans for recalling
products that may endanger the public
health (§§ 108.25(e) and 108.35(f)). To
permit lots to be traced after
distribution, acidified foods and
thermally processed low-acid foods in
hermetically sealed containers must be
marked with an identifying code
(§§ 113.60(c) (thermally processed
foods) and 114.80(b) (acidified foods)).
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Form No.
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Form FDA 2541 (Registration)
108.25 and 108.35
515
1
Form FDA 2541a (Process Filing)
108.25 and 108.35
1,489
8.62
12,835
Form FDA 2541c (Process Filing)
108.35
84
7.77
Hours per
Response
515
653
.17
88
.333
.75
Total
1 There
Total Hours
4,274
490
4,852
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Part
113 and 114
1 There
8,950
Total Annual
Records
1
Hours per
Recordkeeper
8,950
250
Total Hours
2,237,500
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based its estimate on
registrations and process filings
received over the past 3 years. The
reporting burden for §§ 108.25(d) and
108.35(d) and (e) is minimal because
notification of spoilage, process
deviation or contamination of product
in distribution occurs less than once a
year. Most firms discover these
problems before the product is
distributed and, therefore, are not
required to report the occurrence. To
avoid double-counting, estimates for
§§ 108.25(g) and 108.35(h) have not
been included because they merely
cross-reference recordkeeping
requirements contained in parts 113 and
114.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
Dated: February 26, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–4067 Filed 3–3–08; 8:45 am]
BILLING CODE 4160–01–S
sroberts on PROD1PC70 with NOTICES
Annual Frequency
of Recordkeeping
VerDate Aug<31>2005
17:57 Mar 03, 2008
Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Privacy Act of 1974; Revisions to OIG’s
Privacy Act System of Records:
Criminal Investigative Files
Office of Inspector General
(OIG), HHS.
AGENCY:
Notice of proposed revisions to
existing Privacy Act systems of records.
ACTION:
SUMMARY: The Office of Inspector
General (OIG) proposes to revise and
update the existing system of records,
entitled ‘‘Criminal Investigative Files’’
(09–90–0003). This proposed notice is
in accordance with the Privacy Act
requirement that agencies publish their
amended systems of records in the
Federal Register when there is a
revision, change, or addition. This
system of records, maintained by OIG,
was last revised and updated on
December 8, 2006.
Effective Date: These revisions
will become effective without further
notice on April 18, 2008 unless
comments received on or before that
date result in a contrary determination.
Comment Date: Comments on these
revisions will be considered if we
receive them at the addresses provided
below no later than 5 p.m. on April 3,
2008. Interested parties may submit
written comments on this proposed
revision to the addresses indicated
below.
DATES:
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Frm 00040
Fmt 4703
Sfmt 4703
In commenting, please refer
to file code OIG–793-PN. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
three ways (no duplicates, please):
1. Electronically. You may submit
electronic comments on specific
recommendations and proposals
through the Federal eRulemaking Portal
at https://www.regulations.gov.
(Attachments should be in Microsoft
Word, if possible.)
2. By regular, express, or overnight
mail. You may send written comments
to the following address: Office of
Inspector General, Department of Health
and Human Services, Attention: OIG–
793–PN, Room 5246, Cohen Building,
330 Independence Avenue, SW.,
Washington, DC 20201. Please allow
sufficient time for mailed comments to
be received before the close of the
comment period.
3. By hand or courier. If you prefer,
you may deliver, by hand or courier,
your written comments before the close
period to Office of Inspector General,
Department of Health and Human
Services, Cohen Building, 330
Independence Avenue, SW.,
Washington, DC 20201. Because access
to the interior of the Cohen Building is
not readily available to persons without
Federal Government identification,
commenters are encouraged to schedule
their delivery with one of our staff
members at (202) 358–3141.
ADDRESSES:
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Agencies
[Federal Register Volume 73, Number 43 (Tuesday, March 4, 2008)]
[Notices]
[Pages 11649-11650]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-4067]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0129]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Canning Establishment Registration, Process
Filing, and Recordkeeping for Acidified Foods and Thermally Processed
Low-Acid Foods in Hermetically Sealed Containers
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 reporting and recordkeeping
requirements for firms that process acidified foods and thermally
processed low-acid foods in hermetically sealed containers.
DATES: Submit written or electronic comments on the collection of
information by May 5, 2008.
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: Jonna Capezzuto, Office of the Chief
Information Officer (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.
Food Canning Establishment Registration, Process Filing, and
Recordkeeping for Acidified Foods and Thermally Processed Low-Acid
Foods in Hermetically Sealed Containers--21 CFR 108.25 and 108.35, and
Parts 113 and 114 (OMB Control Number 0910-0037)--Extension
Under the Federal Food, Drug, and Cosmetic Act (the act), FDA is
authorized to prevent the interstate distribution of food products that
may be injurious to health or that are otherwise adulterated, as
defined in section 402 of the act (21 U.S.C. 342). Under the authority
granted to FDA by section 404 of the act (21 U.S.C. 344), FDA
regulations require registration of food processing establishments,
filing of process or other data, and maintenance of processing and
production records for acidified foods and thermally processed low-acid
foods in hermetically sealed containers. These requirements are
intended to ensure safe manufacturing, processing, and packing
procedures and to permit FDA to verify that these procedures are being
followed. Improperly processed low-acid foods present life-threatening
hazards if contaminated with foodborne microorganisms, especially
Clostridium botulinum. The spores of C. botulinum must be destroyed or
inhibited to avoid production of the deadly toxin that causes botulism.
This is accomplished with good manufacturing procedures, which must
include the use of adequate heat processes or other means of
preservation.
To protect the public health, FDA regulations require that each
firm that manufactures, processes, or packs acidified foods or
thermally processed low-acid foods in hermetically sealed containers
for introduction into interstate commerce register the establishment
with FDA using Form FDA 2541 (Sec. Sec. 108.25(c)(1) and 108.35(c)(2)
(21 CFR 108.25(c)(1) and 108.35(c)(2))). In addition to registering the
plant, each firm is required to provide data on the processes used to
produce these foods, using Form FDA 2541a for all methods except
aseptic processing, or Form FDA 2541c for aseptic processing of low-
acid foods in hermetically sealed containers (Sec. Sec. 108.25(c)(2)
and 108.35(c)(2)). Plant registration and process filing may be
accomplished simultaneously. Process data must be filed prior to
packing any new product, and operating processes and procedures must be
posted near the processing equipment or made available to the operator
(Sec. 113.87(a) (21 CFR 113.87(a))).
Regulations in parts 108, 113, and 114 (21 CFR parts 108, 113, and
114) require firms to maintain records showing adherence to the
substantive requirements of the regulations. These records must be made
available to FDA on request. Firms are also required to document
corrective actions when process controls and procedures do not fall
within specified limits (Sec. Sec. 113.89, 114.89, and 114.100(c)); to
report any instance of potential health-endangering spoilage, process
deviation, or contamination with microorganisms
[[Page 11650]]
where any lot of the food has entered distribution in commerce
(Sec. Sec. 108.25(d) and 108.35(d) and (e)); and to develop and keep
on file plans for recalling products that may endanger the public
health (Sec. Sec. 108.25(e) and 108.35(f)). To permit lots to be
traced after distribution, acidified foods and thermally processed low-
acid foods in hermetically sealed containers must be marked with an
identifying code (Sec. Sec. 113.60(c) (thermally processed foods) and
114.80(b) (acidified foods)).
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR No. of Annual Frequency Total Annual Hours per
Form No. Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Form FDA 2541 108.25 and 515 1 515 .17 88
(Registration) 108.35
----------------------------------------------------------------------------------------------------------------
Form FDA 2541a 108.25 and 1,489 8.62 12,835 .333 4,274
(Process Filing) 108.35
----------------------------------------------------------------------------------------------------------------
Form FDA 2541c 108.35 84 7.77 653 .75 490
(Process Filing)
----------------------------------------------------------------------------------------------------------------
Total 4,852
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Part Recordkeepers of Recordkeeping Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
113 and 114 8,950 1 8,950 250 2,237,500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA based its estimate on registrations and process filings
received over the past 3 years. The reporting burden for Sec. Sec.
108.25(d) and 108.35(d) and (e) is minimal because notification of
spoilage, process deviation or contamination of product in distribution
occurs less than once a year. Most firms discover these problems before
the product is distributed and, therefore, are not required to report
the occurrence. To avoid double-counting, estimates for Sec. Sec.
108.25(g) and 108.35(h) have not been included because they merely
cross-reference recordkeeping requirements contained in parts 113 and
114.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
Dated: February 26, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4067 Filed 3-3-08; 8:45 am]
BILLING CODE 4160-01-S