[Federal Register Volume 72, Number 44 (Wednesday, March 7, 2007)]
[Notices]
[Pages 10222-10224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3915]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0357]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Procedures for the 
Safe and Sanitary Processing and Importing of Fish and Fishery Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by April 
6, 2007.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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

Procedures for the Safe and Sanitary Processing and Importing of Fish 
and Fishery Products--21 CFR Part 123 (OMB Control Number 0910-0354)--
Extension

    FDA regulations in part 123 (21 CFR part 123) mandate the 
application of hazard analysis and critical control point (HACCP) 
principles to the processing of seafood. HACCP is a preventive system 
of hazard control designed to help ensure the safety of foods. The 
regulations were issued under FDA's statutory authority to regulate 
food safety, including section 402(a)(1) and (a)(4) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (a)(4)), and 
became effective on December 18, 1997.
    Certain provisions in part 123 require that processors and 
importers of seafood collect and record information. The HACCP records 
compiled and maintained by a seafood processor primarily consist of the 
periodic observations recorded at selected monitoring points during 
processing and packaging operations, as called for in a processor's 
HACCP plan (e.g., the

[[Page 10223]]

values for processing times, temperatures, acidity, etc., as observed 
at critical control points). The primary purpose of HACCP records is to 
permit a processor to verify that products have been produced within 
carefully established processing parameters (critical limits) that 
ensure that hazards have been avoided. HACCP records are normally 
reviewed by appropriately trained employees at the end of a production 
lot or at the end of a day or week of production to verify that control 
limits have been maintained, or that appropriate corrective actions 
were taken if the critical limits were not maintained. Such 
verification activities are essential to ensure that the HACCP system 
is working as planned. A review of these records during the conduct of 
periodic plant inspections also permits FDA to determine whether the 
products have been consistently processed in conformance with 
appropriate HACCP food safety controls.
    Section 123.12 requires that importers of seafood products take 
affirmative steps and maintain records that verify that the fish and 
fishery products they offer for import into the United States were 
processed in accordance with the HACCP and sanitation provisions set 
forth in part 123. These records are also to be made available for 
review by FDA as provided in Sec.  123.12(c).
    The time and costs of these recordkeeping activities will vary 
considerably among processors and importers of fish and fishery 
products, depending on the type and number of products involved, and on 
the nature of the equipment or instruments required to monitor critical 
control points. The burdens have been estimated using typical small 
seafood processing firms as a model because these firms represent a 
significant proportion of the industry. Costs were estimated for the 
collection of HACCP data for each type of recordkeeping activity using 
a labor cost of $15.00 per hour.
    The burden estimate in table 1 of this document includes only those 
collections of information under the seafood HACCP regulations that are 
not already required under other statutes and regulations. The estimate 
also does not include collections of information that are a usual and 
customary part of businesses' normal activities. For example, the 
tagging and labeling of molluscan shellfish (21 CFR 1240.60) is a 
customary and usual practice among seafood processors. Consequently, 
the estimates in table 1 of this document account only for information 
collection and recording requirements attributable to part 123.
    Upon reevaluation of the burden estimates for part 123, we have 
determined that PRA requirements do not apply to Sec.  123.10.
    In the Federal Register of September 26, 2006 (71 FR 56154), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                   21 CFR Section\2\                      Recordkeepers    per Recordkeeping\3\       Records           Record\4\         Total Hours
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123.6(a), (b), and (c)                                                275                     1                275              16.00              4,400
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123.6(c)(5)                                                         5,500                     4             22,000               0.30              6,600
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123.8(a)(1) and (c)                                                 5,500                     1              5,500               4.00             22,000
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123.12(a)(2)(ii)                                                    1,100                    80             88,000               0.20             17,600
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123.6(c)(7)                                                         5,500                   280          1,540,000               0.30            462,000
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123.7(d)                                                            2,200                     4              8,800               0.10                880
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123.8(d)                                                            5,500                    47            258,500               0.10             25,850
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123.11(c)                                                           5,500                   280          1,540,000               0.10            154,000
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123.12(c)                                                           1,100                    80             88,000               0.10              8,800
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123.12(a)(2)                                                           55                     1                 55               4.00                220
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TOTAL                                                                                                                                           702,350
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\These estimates include the information collection requirements in the following sections:
 Sec.   123.16--Smoked Fish--process controls (see Sec.   123.6(b))
 Sec.   123.28(a)--Source Controls--molluscan shellfish (see Sec.   123.6(b))
 Sec.   123.28(c) and (d)--Records-molluscan shellfish (see Sec.   123.6(c)(7))
\3\Based on an estimated 280 working days per year.
\4\Estimated average time per 8-hour workday unless one-time response.



[[Page 10224]]

    Dated: February 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-3915 Filed 3-6-07; 8:45 am]
BILLING CODE 4160-01-S