[Federal Register Volume 61, Number 91 (Thursday, May 9, 1996)]
[Notices]
[Pages 21192-21193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11515]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0115]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Extension

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, 
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 comments on the collection of information by July 
8, 1996.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Charity B. Smith, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1686.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 (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. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c). To 
comply with this requirement, FDA is publishing notice of the proposed 
collection of information listed below.
    With respect to the following collection of information, FDA 
invites comments on: (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(c)(1) and 
(c)(2), (d), (e), (g); 108.35(c)(1), (c)(2), (d), (e), (f), (h); 
113.60(c); 113.83; 113.87; 113.89; 113.100; 114.80(b); 114.89; 
114.100(a) through (d)) (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 Clostridium 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 the Food and Drug Administration using Form FDA 2541 (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 (21 CFR 108.25(c)(2), 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

[[Page 21193]]

and procedures must be posted near the processing equipment or made 
available to the operator (Sec. 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 (Secs. 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 (Secs. 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 (Secs. 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 (Secs. 113.60(c) 
(thermally processed foods), 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:

                                                                                                                
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                                        Estimated Annual Reporting Burden                                       
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                                                                Annual                                          
        Form No.               CFR Section         No. of      Frequency   Total Annual    Hours Per     Total  
                                                Respondents  per Response    Responses     Response      Hours  
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Form FDA 2541                                                                                                   
 (Registration)                 108.25(c)(1) and                                                                
                                108.35(c)(1)          300            1           300           .17         51   
Form FDA 2541a (Process                                                                                         
 Filing)                        108.25(c)(2) and                                                                
                                108.35(c)(2)        1,000            6.5       6,500           .333     2,165   
Form FDA 2541c (Process                                                                                         
 Filing)                        108.35(c)(2)        1,000             .50        500           .75        375   
                                113.60(c)               ?            ?             ?          ?             ?   
                                114.80(b)               ?            ?             ?          ?             ?   
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Where question marks appear in the burden estimates, FDA does not have current information available. Public    
  comments will be greatly appreciated.                                                                         


                                                                                                                                                        
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                                                          Estimated Annual Recordkeeping Burden                                                         
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                                                       Annual Frequency per                                                                             
   21 CFR Section        No. of Recordkeepers             Recordkeeping           Total Annual Records     Hours Per Recordkeeper        Total Hours    
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21 CFR Parts 108,     5,388                       1                              5,388                   250                         1,347,000          
 113, 114                                                                                                                                               
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There are no capital or operating and maintenance costs associated with this collection.                                                                

    The reporting burden for Secs. 108.25(d) and 108.35(d) and (e) 
isinsignificant 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 Secs. 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 1, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-11515 Filed 5-8-96; 8:45 am]
BILLING CODE 4160-01-F