Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing of Juice

ICR 201702-0910-003

OMB: 0910-0466

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2017-03-17
ICR Details
0910-0466 201702-0910-003
Historical Active 201401-0910-009
HHS/FDA CFSAN
Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing of Juice
Extension without change of a currently approved collection   No
Regular
Approved without change 04/25/2017
Retrieve Notice of Action (NOA) 03/21/2017
  Inventory as of this Action Requested Previously Approved
04/30/2020 36 Months From Approved 04/30/2017
21,980,369 0 21,978,653
461,426 0 358,466
0 0 0

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. FDA's mandate to ensure the safety of the nation`s food supply is derived principally from the Federal Food Drug and Cosmetic Act (the FD&C 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 commerce, 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.

US Code: 42 USC 264 Name of Law: PHS Act
   US Code: 21 USC 321 et seq. Name of Law: FFDCA
  
None

Not associated with rulemaking

  81 FR 59636 08/30/2016
82 FR 13811 03/15/2017
No

  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 21,978,653 0 0 1,716 0
Annual Time Burden (Hours) 461,426 358,466 0 0 102,960 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This collection of information has increased by 1,560 respondents, 1,716 responses, and 102,960 hours. This adjustment in burden is a result of an error that occurred with the last submission of extension. The recordkeeping burden requirement for writing an HACCP plan under sections 120.8(a), 120.8(b), and 120.12(a)(3), (b) and (c) was inadvertently left off of the burden chart in Item 12 in the supporting statement (but was included in the write up in Item 1). The adjusted total burden requested is now 461,426 recordkeeping hours (358,466 previous recordkeeping hours plus 102,960 new recordkeeping hours). The previously approved ICR submitted to OMB included eight ICs entered in ROCIS. Upon this submission, we added one IC (left out of the previous submission for extension, in error). With this submission we have also consolidated four of the ICs into two ICs. Therefore, for this submission of extension this ICR now has seven ICs. The information collection activities and the burden associated with each IC, however, remain broken down in this supporting statement and in the table in Item 12.

$44,150
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
03/21/2017


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