[Federal Register Volume 62, Number 152 (Thursday, August 7, 1997)]
[Notices]
[Pages 42559-42560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20754]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0040]


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 (the PRA).

DATES: Submit written comments on the collection of information by 
September 8, 1997.

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, Attn: 
Desk Officer for FDA.

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: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

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 
onsite 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 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.
    In the Federal Register of February 28, 1997 (62 FR 9194), the 
agency requested comments on the proposed collection of information. 
FDA received one comment that supported the implementation of HACCP but 
questioned several aspects associated with the proposed survey. First, 
the comment questioned whether the survey would yield ``reliable'' or 
``practical'' data because it was difficult to interpret what 
``critical control point'' means and what the term ``hazards'' 
includes. The comment stated ``it is difficult to identify costs 
attributable only to HACCP in facilities where the system has been 
implemented.'' This comment is not relevant to the survey because the 
survey does not ask processors about critical control points, hazards, 
or costs of HACCP but, instead, seeks information on the processes and 
controls currently in place.
    The comment also stated that FDA should use other sources of data. 
In fact, FDA is already planning to used multiple sources of 
information to estimate the marginal costs of requiring HACCP. These 
sources include interviews with food processing firms and information 
taken from pilot plants that are already using HACCP, and comments 
received during other HACCP rulemakings.

[[Page 42560]]

    Finally, the comment stated that FDA's reporting burden estimate is 
too low because successful telephone contact typically requires 
multiple attempts. FDA disagrees with this comment for two reasons: 
First, the burden of making multiple attempts to contact a potential 
survey respondent will fall on FDA, not on the potential respondent. 
Second, the burden estimate already includes time to be spent by 
respondents to set up a subsequent interview.
    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                   
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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--Onsite 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, onsite                                                                                      
 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--Onsite Cost 
Interview are 1,671.7.
    The burden hour estimates are based on a pretest conducted with 
three focus groups.

    Dated: July 30, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-20754 Filed 8-6-97; 8:45 am]
BILLING CODE 4160-01-F