
[Federal Register: March 4, 2008 (Volume 73, Number 43)]
[Notices]               
[Page 11649-11650]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04mr08-72]                         

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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.

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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 May 5, 2008.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://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\
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                        21 CFR         No. of       Annual Frequency   Total Annual     Hours per
      Form No.          Section      Respondents      per Response       Responses       Response    Total Hours
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Form FDA 2541        108.25 and               515               1                515           .17            88
 (Registration)       108.35
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Form FDA 2541a       108.25 and             1,489               8.62          12,835           .333        4,274
 (Process Filing)     108.35
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Form FDA 2541c       108.35                    84               7.77             653           .75           490
 (Process Filing)
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Total                                                                                                      4,852
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                               No. of        Annual Frequency   Total Annual      Hours per
      21 CFR Part          Recordkeepers     of Recordkeeping      Records      Recordkeeper      Total Hours
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113 and 114                          8,950                  1           8,950             250          2,237,500
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\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
