View Information Collection Request (ICR) Package
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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:
0910-0816
ICR Reference No:
201605-0910-009
Status:
Historical Active
Previous ICR Reference No:
201605-0910-002
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CFSAN
Title:
Standards for the Growing, Harvesting, Packaging, and Holding of Produce for Human Consumption
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
06/08/2016
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/16/2016
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2019
36 Months From Approved
Responses
964,315
0
0
Time Burden (Hours)
1,513,079
0
0
Cost Burden (Dollars)
27,490
0
0
Abstract:
This information collection implements minimum standards for produce offered for human consumption. The rulemaking sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated because of such hazards.
Authorizing Statute(s):
PL:
Pub.L. 111 - 353 105
Name of Law: FSMA; Standards for Produce Safety
Citations for New Statutory Requirements:
PL: Pub.L. 111 - 353 105 Name of Law: Food Safety Modernization Act; Standards for Produce for Human Consumption
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AG35
Final or interim final rulemaking
80 FR 74354
11/27/2015
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
78 FR 45781
01/16/2013
30-day Notice:
Federal Register Citation:
Citation Date:
80 FR 74354
11/27/2015
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
12
IC Title
Form No.
Form Name
ANNUAL Disclosure
ANNUAL Recordkeeping related to sprouts
ANNUAL Recordkeeping; Exemptions under § 112.7
ANNUAL Recordkeeping; Records relating to agricultural water
ANNUAL Recordkeeping; Testing requirements for agricultural water under §§ 112.44 and 112.45
ANNUAL Recordkeeping; Testing requirements for sprouts
ANNUAL Recordkeeping; documentation supporting compliance w/§ 112.2
ANNUAL Recordkeeping; training under § 112.30
ONE TIME Disclosure
ONE TIME Recordkeeping; Sprouts - documentation of data and variances
ONE TIME Recordkeeping; Sprouts - establishment of environmental monitoring and sampling plans
ONE TIME Recordkeeping; agricultural water - documentation of scientific data
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
964,315
0
34,108
930,207
0
0
Annual Time Burden (Hours)
1,513,079
0
20,730
1,492,349
0
0
Annual Cost Burden (Dollars)
27,490
0
0
27,490
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This is a new information collection associated with rulemaking.
Annual Cost to Federal Government:
$0
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:
05/16/2016
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