Procedures for the Safe Processing and Importing of Fish and Fishery Products

Forms and Documents

Document Name	Status
0354 SUPPORTING STATEMENT FINAL 1-18-2017.doc Supporting Statement A	2017-01-18

IC Document Collections

IC ID	Document Title	Status
5969	Prepare Hazard Analysis and HACCP Plan	Modified
193503	Prepare New Written Verification Procedures to Verify Compliance of Imports	Modified
179133	Maintain Records that Verify that the Fish and Fishery Products they Offer for Import in U.S. were Processed in Accordance with the HACCP and Sanitation Provisions Set Forth in Part 123	Modified
179132	Maintain Sanitation Control Records	Modified
179131	Maintain Records of the Calibration of Process-Monitoring Instruments and the Performing of Any Periodic End-Product and In-Process Testing	Modified
179130	Undertake and Prepare Records of Corrective Actions Due to a Deviation From a Critical Limit	Modified
179129	Document Monitoring of Critical Control Points	Modified
179128	Verify Compliance of Imports and Prepare Records of Verification Activities	Modified
179127	Reassess Hazard Analysis and HACCP Plan	Modified
179126	Undertake and Prepare Records of Corrective Actions	Modified

ICR Details

OMB Control No: 0910-0354	ICR Reference No: 201701-0910-013
Status: Historical Active	Previous ICR Reference No: 201311-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
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: 02/28/2017
	Date Received in OIRA: 01/23/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2020	36 Months From Approved	02/28/2017
Responses	9,860,091	0	9,860,091
Time Burden (Hours)	1,930,264	0	1,930,264
Cost Burden (Dollars)	0	0	0

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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.

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Authorizing Statute(s): US Code: 21 USC 342(a)(1) & (a)(2) Name of Law: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 48816	07/26/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 96015	12/29/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Prepare Hazard Analysis and HACCP Plan
Undertake and Prepare Records of Corrective Actions
Reassess Hazard Analysis and HACCP Plan
Verify Compliance of Imports and Prepare Records of Verification Activities
Document Monitoring of Critical Control Points
Undertake and Prepare Records of Corrective Actions Due to a Deviation From a Critical Limit
Maintain Records of the Calibration of Process-Monitoring Instruments and the Performing of Any Periodic End-Product and In-Process Testing
Maintain Sanitation Control Records
Maintain Records that Verify that the Fish and Fishery Products they Offer for Import in U.S. were Processed in Accordance with the HACCP and Sanitation Provisions Set Forth in Part 123
Prepare New Written Verification Procedures to Verify Compliance of Imports

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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:

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Annual Cost to Federal Government: $662,250

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

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Common Form ICR:  No

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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: 01/23/2017

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