[Federal Register Volume 70, Number 24 (Monday, February 7, 2005)]
[Notices]
[Pages 6445-6447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2297]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0032]


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.

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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 April 8, 2005.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. All comments should be identified with 
the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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,

[[Page 6446]]

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 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA 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 (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 part 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 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 complying with the information 
collection provisions of the agency's regulations for acidified foods 
and thermally processed low-acid foods in hermetically sealed 
containers as follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                             No. of        Annual Frequency       Total Annual          Hours per
             Form No.                 21 CFR Section      Respondents        per Response          Responses             Response         Total Hours
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FDA 2541                            108.25 and 108.35                585                  1                585                    .17                 99
(Registration)
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FDA 2541a                           108.25 and 108.35              1,778                  9             16,002                   .333              5,329
(Process Filing)
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FDA 2541c                                      108.35                124                 10              1,240                    .75                930
(Process Filing)
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Total                               .................  .................  .................  .....................  .................              6,358
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 6447]]


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                                  Annual Frequency per
                21 CFR Part                 No. of Recordkeepers      Recordkeeping     Total Annual Records    Hours per Record         Total Hours
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113 and 114                                                7,915                     1                 7,915                   250             1,978,750
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The reporting burden for Sec. Sec.  108.25(d) and 108.35(d) and (e) 
is insignificant 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.

    Dated: January 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2297 Filed 2-4-05; 8:45 am]
BILLING CODE 4160-01-S