[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
