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:
0910-0773
ICR Reference No:
201903-0910-018
Status:
Historical Active
Previous ICR Reference No:
201604-0910-006
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CFSAN
Title:
Sanitary Transportation of Human and Animal Food
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:
07/08/2019
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/05/2019
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2022
36 Months From Approved
07/31/2019
Responses
1,502,260
0
3,280,611
Time Burden (Hours)
124,848
0
375,265
Cost Burden (Dollars)
3,845,407
0
3,929,115
Abstract:
The Food and Drug Administration is establishing requirements for shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport. This action is part of our larger effort to focus on prevention of food safety problems throughout the food chain and is part of our implementation of the Sanitary Food Transportation Act of 2005 (2005 SFTA) and the FDA Food Safety Modernization Act of 2011 (FSMA).
Authorizing Statute(s):
US Code:
21 USC 371(a) et al.
Name of Law: Food, Drug, & Cosmetic 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:
84 FR 5807
02/20/2019
30-day Notice:
Federal Register Citation:
Citation Date:
84 FR 25816
06/04/2019
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
RECORDKEEPING First Year Only; developing written procedures
RECORDKEEPING; Required record retention (1.912)
REPORTS First Year Only; Waiver Petitions
REPORTS; Waiver Petitions
THIRD PARTY DISCLOSURE First Year Only; sanitary specifications, notification of operating temperature, disclosure records
THIRD PARTY DISCLOSURE: Transportation Operations; sanitary specifications, operating temperature conditions
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
1,502,260
3,280,611
0
0
-1,778,351
0
Annual Time Burden (Hours)
124,848
375,265
0
0
-250,417
0
Annual Cost Burden (Dollars)
3,845,407
3,929,115
0
0
-83,708
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 agency adjustments. Since last OMB review we have removed one-time burdens we previously attributed to implementation of the new regulations and realization of compliance dates. Because these milestones have been met, we have removed initial burden we ascribed to associated with activities. This results in an overall decrease to the information collection by 1,778,351 responses (from 3,280,611 to 1,502,260), by 250,416 burden hours (from 375,265 to 124,849), and by $83,708 in cost adjustments.
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:
06/05/2019
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