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:
201911-0910-006
Status:
Historical Active
Previous ICR Reference No:
201701-0910-013
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:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
02/13/2020
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/16/2020
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2023
36 Months From Approved
02/29/2020
Responses
9,860,091
0
9,860,091
Time Burden (Hours)
1,930,264
0
1,930,264
Cost Burden (Dollars)
32,621,462
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
Other Documents for OIRA Review
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
84 FR 46544
09/04/2019
30-day Notice:
Federal Register Citation:
Citation Date:
84 FR 65820
11/29/2019
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Document Monitoring of Critical Control Points
Maintain Records of the Calibration of Process-Monitoring Instruments and the Performing of Any Periodic End-Product and In-Process Testing
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
Maintain Sanitation Control Records
Prepare New Written Verification Procedures to Verify Compliance of Imports
Reassess Hazard Analysis and HACCP Plan
Requirements for fish and fishery products
Undertake and Prepare Records of Corrective Actions
Undertake and Prepare Records of Corrective Actions Due to a Deviation From a Critical Limit
Verify Compliance of Imports and Prepare Records of Verification Activities
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)
32,621,462
0
0
0
32,621,462
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:
This information collection reflects a change. Although the burden has not changed from that shown in the current inventory, we have included guidance developed for respondents not previously included, and have uploaded cost information to appear at www.reginfo.gov.
Annual Cost to Federal Government:
$662,250
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
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:
01/16/2020
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