Procedures for the Safe Processing and Importing of Fish and Fishery Products; 21 CFR Part 123

ICR 200703-0910-009

OMB: 0910-0354

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
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Supplementary Document
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Supplementary Document
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Supporting Statement A
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ICR Details
0910-0354 200703-0910-009
Historical Active 200310-0910-017
HHS/FDA
Procedures for the Safe Processing and Importing of Fish and Fishery Products; 21 CFR Part 123
Extension without change of a currently approved collection   No
Regular
Approved without change 06/06/2007
Retrieve Notice of Action (NOA) 03/21/2007
  Inventory as of this Action Requested Previously Approved
06/30/2010 36 Months From Approved 06/30/2007
3,551,130 0 5,850
702,350 0 627,075
0 0 9,406,000

FDA's regulations in 21 CFR part 12 mandate the application of hazard analysis and critical control point (HACCP) principles to the processing of seafood. HACCP procedures yeild products that are known, with a high degree of confidence, to be free of the food safety hazards controlled b a processor's plan. Part 123 mandates recordkeeping related to seafood processing, sanitation control, and corrective actions, but the regulation does not require any reporting of this data to FDA or any other government agency. The HACCP records compiled and maintained by a seafood processor or importer primarily consist of the periodic observations recorded at selected monitoring points during processing and packaging operations. All respondents are business firms that process or import fish and fishery products for the U.S. market.

US Code: 21 USC 342 Name of Law: FFDCA
  
None

Not associated with rulemaking

  71 FR 56154 09/26/2006
72 FR 10222 03/07/2007
No

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 3,551,130 5,850 0 3,545,280 0 0
Annual Time Burden (Hours) 702,350 627,075 0 75,275 0 0
Annual Cost Burden (Dollars) 0 9,406,000 0 -9,406,000 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
The increase in burden is due to the increase in the number of processors and importers.

$10,634,250
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
03/21/2007


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