View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0354
ICR Reference No:
201311-0910-011
Status:
Historical Active
Previous ICR Reference No:
201006-0910-007
Agency/Subagency:
HHS/FDA
Agency Tracking No:
20819
Title:
Procedures for the Safe Processing and Importing of Fish and Fishery Products
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
02/07/2014
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/25/2013
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2017
36 Months From Approved
02/28/2014
Responses
9,860,091
0
9,860,091
Time Burden (Hours)
1,930,264
0
1,930,264
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection request covers recordkeeping responsibilities covered in FDA regulations regarding the safe processing, handling, and packaging of seafood. Respondents are processors and importers of seafood who must record and verify various safety measures including the establishment and maintenance of procedural operations, hazard analysis, sanitation control, and product testing.
Authorizing Statute(s):
US Code:
21 USC 342(a)(1) & (a)(2)
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
78 FR 47701
08/06/2013
30-day Notice:
Federal Register Citation:
Citation Date:
78 FR 69687
11/20/2013
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
10
IC Title
Form No.
Form Name
Recodkeeping: Requirement That Processors Maintain Records of Any Corrective Action When a Deviation From A Critical Limit Occurs
Recodkeeping: Requirement for Processors to Maintain Sanitation Control Records
Recordkeeping: Verification Requirements for Processors That Their HACCP Plan Is Adequate to Control Food Safety Hazards
Recordkeeping: Maintainance of Records by Importers of Seafood Products That Fish & Fishery Products Offered For Import Were Processed in Accordance With the HACCP & Sanitation Provisions
Recordkeeping: Requirement For Processors To Incorporate A Corrective Action Plan Within Their Written HACCP Plan
Recordkeeping: Requirement That Processors Maintain Records of The Calibration of "Process-Monitoring" Instruments and The Performing of Any " Periodic End Product and In - Process Testing."
Recordkeeping: Requirement for Importers of Seafood Products to Verify Compliance of Imports and Maintain Records
Recordkeeping: Requirement for Processors to Implement a Recordkeeping System That Documents The Monitoring of The Critical Control Points
Recordkeeping: Requirement for Processors to Prepare , Implement & Maintain Records of a Written HACCP Plan If Hazard Analysis Shows Food Safety Hazzads Are Likely to Occur
Recordkeeping: Verification Procedure Requirements for Importers of Fish and Fishery Products Offered fo Import into the U.S.
ICR Summary of Burden
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
9,860,091
9,860,091
0
0
0
0
Annual Time Burden (Hours)
1,930,264
1,930,264
0
0
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$639,900
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
11/25/2013
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