[Federal Register Volume 61, Number 210 (Tuesday, October 29, 1996)]
[Notices]
[Pages 55805-55806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27746]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0325]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
November 29, 1996.
ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, 
Attention: Desk Officer for FDA.

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

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the 
Paperwork Reduction Act of 1995 (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--(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--Reinstatement).
    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

[[Page 55806]]

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's 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 (Secs. 108.25(c)(1) and 108.35(c)(1) (21 
CFR 108.25(c)(1) and 108.35(c)(1))). 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 (Secs. 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: (1) Document 
corrective actions when process controls and procedures do not fall 
within specified limits (Secs. 113.89, 114.89, and 114.100(c)); (2) 
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), 108.35(d), 
and (e)); and (3) 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 low-acid 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:

                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
   Form No.      21 CFR Section       No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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Form FDA 2541                                                                                                   
 (Registratio                                                                                                   
 n)             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       
Total                                                               7,300                           2,591       
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                                      Estimated Annual Recordkeeping Burden                                     
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                                                  Annual                                                        
         21 CFR Part              No. of       Frequency per   Total Annual      Hours per        Total Hours   
                               Recordkeepers   Recordkeeping      Records      Recordkeeper                     
----------------------------------------------------------------------------------------------------------------
108, 113, and 114               5,388               1           5,388             250           1,347,000       
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There are no capital costs or operating and maintenance costs associated with this collection.                  

    The reporting burden for Secs. 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 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. No burden has been 
estimated for the coding requirements in Secs. 113.60(c) and 114.80(b) 
because coding is a usual and customary practice in the foods industry 
for liability purposes, inventory control, and process control in the 
event of a problem with the product. Under 5 CFR 1320.3(b)(2), the 
time, effort, and financial resources necessary to comply with a 
collection of information are excluded from the burden estimate if the 
reporting, recordkeeping, or disclosure activities needed to comply are 
usual and customary because they would occur in the normal course of 
activities.

    Dated: October 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy.
[FR Doc. 96-27746 Filed 10-28-96; 8:45 am]
BILLING CODE 4160-01-F