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:
0910-0466
ICR Reference No:
201401-0910-009
Status:
Historical Active
Previous ICR Reference No:
201009-0910-005
Agency/Subagency:
HHS/FDA
Agency Tracking No:
21368
Title:
Hazard Analysis and Critical Control Point (HACCP) Procedures for the Safe and Sanitary Processing of Juice (21 CFR Part 120)
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:
03/07/2014
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/30/2014
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2017
36 Months From Approved
03/31/2014
Responses
21,978,653
0
21,978,653
Time Burden (Hours)
358,466
0
358,466
Cost Burden (Dollars)
0
0
0
Abstract:
FDA`s regulations in part 120(21 CFR part 120) mandate the application of HACCP procedures to fruit and vegetable juice processing. HACCP is a preventive system of hazard control that can be used by all food processors to ensure the safety of their products to consumers. A HACCP system of preventive controls is the most effective and efficient way to ensure that these food products are safe. FDAs mandate to ensure the safety of the nation`s food supply is derived principally from the Federal Food Drug and Cosmetic Act (the act)(21 U.S.C. 321, et seq.). Under the act, FDA has authority to ensure that all foods in interstate commerce, or that have been shipped in interstate commerence, are not misbranded or deceptively packaged; under section 701 (21 u.S.C. 371), the act authorizes the agency to issue regulations for its efficient enforcement. The agency also has authority under section 361 of the Public Health Service Act (42 U.S.C. 264) to issue and enforce regulations to prevent the introduction, transmission, or spread of communicable diseases from one State to another State.
Authorizing Statute(s):
US Code:
21 USC 321 et seq.
US Code:
21 USC 371.
US Code:
42 USC 264
Name of Law: PHS Act
US Code:
21 USC 342 (a)(4)
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:
78 FR 69689
11/20/2013
30-day Notice:
Federal Register Citation:
Citation Date:
70 FR 4347
01/27/2013
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
8
IC Title
Form No.
Form Name
Recordkeeping : Hazard Analysis
Recordkeeping : Review of SSOP Records
Recordkeeping: Application to Imported Products
Recordkeeping: Monitoring Critical Control Points
Recordkeeping: Sanitation Standard Operating Procedures ( SSOP`s)
Recordkeeping: Validation of the HACCP Plan
Recordkeeping: Verification and Validation of HAACP System and Hazard Analysis
Recordkeeping; Hazard Analysis Critical Control Point Plan
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
21,978,653
21,978,653
0
0
0
0
Annual Time Burden (Hours)
358,466
358,466
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:
Annual Cost to Federal Government:
$42,660
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
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:
01/30/2014
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