
[Federal Register: June 3, 2008 (Volume 73, Number 107)]
[Notices]               
[Page 31694-31695]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn08-47]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0129]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 July 3, 
2008.

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: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0037. Also 
include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

[[Page 31695]]

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 where any lot of the 
food has entered distribution in commerce (Sec. Sec.  108.25(d) and 
108.35(d) and 108.35(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)).
    In the Federal Register of March 4, 2008 (73 FR 11649), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     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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Form FDA 2541 (Registration)                     108.25 and 108.35             515                     1             515             .17              88
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Form FDA 2541a (Process Filing)                  108.25 and 108.35           1,489                  8.62          12,835            .333           4,274
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Form FDA 2541c (Process Filing)                             108.35              84                  7.77             653             .75             490
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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  of      Total Annual            Hours per
                21 CFR Part                     Recordkeepers         Recordkeeping            Records            Recordkeeper           Total Hours
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113 and 114                                                7,454                     1                 7,454                   250             1,863,500
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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. FDA has changed its estimate of the 
number of recordkeepers in table 2 of this document, reducing the 
figure from 8,950 to 7,454. The agency reexamined the figure and 
excluded firms that were inactive or out of business, yet still 
registered. Thus, the lower figure is a more accurate estimate of the 
number of recordkeepers. The reporting burden for Sec. Sec.  108.25(d) 
and 108.35(d) and 108.35(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.

    Dated: May 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12337 Filed 6-2-08; 8:45 am]

BILLING CODE 4160-01-S
