View Information Collection Request (ICR) Package
Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
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:
200703-0910-009
Status:
Historical Active
Previous ICR Reference No:
200310-0910-017
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Procedures for the Safe Processing and Importing of Fish and Fishery Products; 21 CFR Part 123
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:
06/06/2007
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/21/2007
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2010
36 Months From Approved
06/30/2007
Responses
3,551,130
0
5,850
Time Burden (Hours)
702,350
0
627,075
Cost Burden (Dollars)
0
0
9,406,000
Abstract:
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.
Authorizing Statute(s):
US Code:
21 USC 342
Name of Law: FFDCA
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:
71 FR 56154
09/26/2006
30-day Notice:
Federal Register Citation:
Citation Date:
72 FR 10222
03/07/2007
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
9
IC Title
Form No.
Form Name
Procedures for the Safe Processing and Importing of Fish and Fishery Products
Procedures for the Safe Processing and Importing of Fish and Fishery Products
Procedures for the Safe Processing and Importing of Fish and Fishery Products
Procedures for the Safe Processing and Importing of Fish and Fishery Products
Procedures for the Safe Processing and Importing of Fish and Fishery Products
Procedures for the Safe Processing and Importing of Fish and Fishery Products
Procedures for the Safe Processing and Importing of Fish and Fishery Products
Procedures for the Safe Processing and Importing of Fish and Fishery Products
Procedures for the Safe Processing and Importing of Fish and Fishery Products
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
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
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The increase in burden is due to the increase in the number of processors and importers.
Annual Cost to Federal Government:
$10,634,250
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]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Uncollected
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Saleda Perryman
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:
03/21/2007
An official website of the United States government
The .gov means it's official.
The site is secure.
