Hazard Analysis and Critical Control Point (HACCP) Procedures for the Safe and Sanitary Processing and Importing of Juice

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0910-0466 SSA rocis.docx	Supporting Statement A	Uploaded 2023-03-02	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6161	Sanitation Standard Operating Procedures Monitoring and Correction Records		Removed
181365	Recordkeeping; Hazard Analysis and Critical Control Point (HACCP) Systems		Modified
181364	Application to Imported Products		Removed
181363	Validation of the Hazard Analysis and Critical Control Point Procedures or Hazard Analysis		Removed
181362	Corrective Actions and Vertifications		Removed
181361	Monitoring Critical Control Points		Removed
181360	Hazard Analysis		Removed

ICR Details

OMB Control No: 0910-0466	ICR Reference No: 202208-0910-013
Status: Historical Active	Previous ICR Reference No: 202002-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Hazard Analysis and Critical Control Point (HACCP) Procedures for the Safe and Sanitary Processing and Importing of Juice
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: 04/06/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/03/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2026	36 Months From Approved	04/30/2023
Responses	21,980,369	0	21,980,369
Time Burden (Hours)	461,426	0	461,426
Cost Burden (Dollars)	0	0	0

---

Abstract: This information collection supports FDA regulations in part 120 (21 CFR part 120) pertaining to sanitary procedures for fruit and vegetable juice processing. Respondents to the information collection are manufacturers of these products who must ensure hazard analysis critical control point procedures are established and implemented to prevent against insanitary, misbranded, or deceptively packaged food.

---

Authorizing Statute(s): US Code: 21 USC 321 et seq. Name of Law: FFDCA
   US Code: 42 USC 264 Name of Law: PHS Act
  

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:
	87 FR 61087	10/07/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 12939	03/01/2023
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Application to Imported Products
Corrective Actions and Vertifications
Hazard Analysis
Monitoring Critical Control Points
Recordkeeping; Hazard Analysis and Critical Control Point (HACCP) Systems
Sanitation Standard Operating Procedures Monitoring and Correction Records
Validation of the Hazard Analysis and Critical Control Point Procedures or Hazard Analysis

---

ICR Summary of Burden

table that charts list 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	21,980,369	21,980,369	0	0	0	0
Annual Time Burden (Hours)	461,426	461,426	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: Our estimate for the burden hours remains unchanged since the last review of the information collection.

---

Annual Cost to Federal Government: $53,670

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.     Yes

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? No

---

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: 03/03/2023

---