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:
0910-0816
ICR Reference No:
201903-0910-020
Status:
Historical Active
Previous ICR Reference No:
201605-0910-009
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:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
07/12/2019
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/11/2019
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2022
36 Months From Approved
07/31/2019
Responses
871,993
0
964,315
Time Burden (Hours)
1,521,594
0
1,513,079
Cost Burden (Dollars)
27,490
0
27,490
Abstract:
This information collection supports FDA regulations that implement minimum standards for produce offered for human consumption. The regulations set 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:
Not associated with rulemaking
Other Documents for OIRA Review
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
84 FR 6793
02/28/2019
30-day Notice:
Federal Register Citation:
Citation Date:
84 FR 26878
06/10/2019
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
9
IC Title
Form No.
Form Name
3rd Party-Disclosure
ANNUAL Recordkeeping related to sprouts
ANNUAL Recordkeeping; Exemptions under § 112.7
ANNUAL Recordkeeping; Records relating to agricultural water
ANNUAL Recordkeeping; Testing requirements for sprouts
ANNUAL Recordkeeping; Testing requirements produce
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
Recommendations in GFI (Sprouts Guidance)
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
871,993
964,315
0
0
-92,322
0
Annual Time Burden (Hours)
1,521,594
1,513,079
0
0
8,515
0
Annual Cost Burden (Dollars)
27,490
27,490
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:
The information collection reflects program changes and adjustments. Although we have removed one-time burden and costs associated with implementation of the new regulations, we have added burden for recommendations included in agency guidance regarding testing for sprouts. This results in an overall reduction in responses of 92,322, but an increase in burden hours by 8,515. We also note a nominal cost increase of $104, which we attribute to calculation adjustments in rounding to whole numbers.
Annual Cost to Federal Government:
$0
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.
No
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?
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:
06/11/2019
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