[Federal Register Volume 62, Number 40 (Friday, February 28, 1997)]
[Notices]
[Pages 9194-9195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4955]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0040]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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 and to allow 60 days 
for public comment in response to the notice. This notice solicits 
comments on a survey of the food safety practices of food processors.

DATES: Submit written comments on the collection of information by 
April 29, 1997.

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:  Margaret R. Wolff, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1223.

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. ``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.

Survey of Food Safety Practices of Food Processing Firms--New 
Collection

    FDA is evaluating the marginal costs of requiring food processors 
to use Hazard Analysis and Critical Control Point (HACCP) systems. 
HACCP is already required for seafood processors, and FDA is 
considering whether to issue regulations requiring HACCP for processors 
of other foods under the agency's jurisdiction. The analysis of 
marginal costs requires information about the prevalence of specific 
HACCP systems and practices among food manufacturers and repackers. FDA 
will collect this information through an anonymous voluntary survey of 
a random sample of food processors. Additionally, through a series of 
on-site visits to selected processors, a contractor will collect 
information on the marginal cost of various procedures required to 
operate a HACCP system. The information will help the Center for Food 
Safety and Applied Nutrition determine the baseline level of HACCP

[[Page 9195]]

use from which to estimate the economic costs to the industry of 
mandatory HACCP regulations for foods other than seafood. FDA will use 
this information in tailoring any HACCP regulations that may issue so 
that costs and benefits of such regulations are appropriately 
considered.
    FDA estimates the burden of this survey as follows:

                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
         Burden Element               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
Part 1--Computer Assisted                                                                                       
 Telephone Interview (CATI)                                                                                     
  Respond to initial recruitment                                                                                
   telephone call                   1,231               1           1,231               0.2           246.2     
  Receive and read introductory                                                                                 
   letter, key term  definitions    1,231               1           1,231               0.25          307.75    
  Obtain data to prepare for the                                                                                
   telephone interview              1,231               1           1,231               0.35          430.85    
  Respond to telephone interview    1,231               1           1,231               0.5           615.50    
Totals                                                  1                                           1,600.3     
                                                                                                                
Part 2--On-Site Cost Interview                                                                                  
  Receive initial recruitment                                                                                   
   telephone call                      17               1              17               0.2             3.4     
  Receive and read introductory                                                                                 
   letter and materials                17               1              17               0.25            4.25    
  Obtain data to prepare for the                                                                                
   site visit                          17               1              17               0.5             8.5     
  Respond to questions during                                                                                   
   site visit                          17               1              17               3.0            51.0     
  Followup questions                   17               1              17               0.25            4.25    
Total burden hours, on-site                                                                                     
 interviews                                                                                            71.4     
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There are no capital costs or operating and maintenance costs associated with this collection of information.   

    The total burden hours for Part 1--CATI and Part 2--On-Site Cost 
Interview are 1,671.7.
    The burden hour estimates are based on a pretest conducted with 
three focus groups.

    Dated: February 20, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-4955 Filed 2-27-97; 8:45 am]
BILLING CODE 4160-01-F