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

Forms and Documents

Document	Type	Status	Availability
0354 cover memo 3-6-2007.doc	Supplementary Document	Uploaded 0000-00-00	Available
0354 21cfr123.12.pdf	Supplementary Document	Uploaded 0000-00-00	Available
0354 21cfr123.11.pdf	Supplementary Document	Uploaded 0000-00-00	Available
0354 21cfr123.8.pdf	Supplementary Document	Uploaded 0000-00-00	Available
0354 21cfr123.7.pdf	Supplementary Document	Uploaded 0000-00-00	Available
0354 21cfr123.6.pdf	Supplementary Document	Uploaded 0000-00-00	Available
0354 ss 3-5-2007.doc	Supporting Statement A	Uploaded 0000-00-00	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
5969	Procedures for the Safe Processing and Importing of Fish and Fishery Products		Modified
179133	Procedures for the Safe Processing and Importing of Fish and Fishery Products		New
179132	Procedures for the Safe Processing and Importing of Fish and Fishery Products		New
179131	Procedures for the Safe Processing and Importing of Fish and Fishery Products		New
179130	Procedures for the Safe Processing and Importing of Fish and Fishery Products		New
179129	Procedures for the Safe Processing and Importing of Fish and Fishery Products		New
179128	Procedures for the Safe Processing and Importing of Fish and Fishery Products		New
179127	Procedures for the Safe Processing and Importing of Fish and Fishery Products		New
179126	Procedures for the Safe Processing and Importing of Fish and Fishery Products		New

ICR Details

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
	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

---

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

---