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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:
0910-0502
ICR Reference No:
201504-0910-003
Status:
Historical Inactive
Previous ICR Reference No:
201305-0910-006
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CFSAN
Title:
Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Comment filed on proposed rule and continue
Conclusion Date:
05/13/2015
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/09/2015
Terms of Clearance:
In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2016
36 Months From Approved
08/31/2016
Responses
380,830
0
380,830
Time Burden (Hours)
468,117
0
468,117
Cost Burden (Dollars)
0
0
0
Abstract:
This collection requires manufacturers, processors, holders, and distributers of foods to provide registration information to the agency. Information provided under the regulations enables FDA to respond to potential threats to the US food supply, to identify affected firms and products in the event of food-related emergencies, and to ensure that contaminated food producsts are quickly and efficiently removed from the marketplace.
Authorizing Statute(s):
PL:
Pub.L. 111 - 353 102 et al.
Name of Law: Food Safety Modernization Act
PL:
Pub.L. 107 - 188 305(d)
Name of Law: Public Health Security and Bioterrorism Preparedness and Response Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AG69
Proposed rulemaking
80 FR 19159
04/09/2015
Federal Register Notices & Comments
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
21 CFR 1.230-1.233 - Reporting Domestic New Facilities : Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
FDA 3537
Food Facility Registration
21 CFR 1.230-1.233 - Reporting Foreign New Facilities: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparadness and Response Act of 2002
FDA 3537
Food Facility Registration
21 CFR 1.234 Reporting: Requirement for Previously Registered Facilities to Submit Timely Updates Within 60 Days Of A Change to Any Required Item of Registration Information
FDA 3537
Food Facility Registration
21 CFR 1.235 Reporting; Requires the Registration For a Previously Registered Facility to Be Cancelled When The Facility Ceases to Operate ... .
FDA 3537a
Cancellation of Food Facility Registration
Biennial Renewal of Registration Additional Data Required by FSMA
FDA 3537
Food Facility Registration
One-time reporting burden for all facilities to comply w/new requirements
Third party registration verification procedure
US Agent Verification procedure
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:
Yes
Burden Reduction Due to:
Changing Regulations
Short Statement:
This information collection is being revised to support proposed rulemaking.
Annual Cost to Federal Government:
$8,709,000
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:
04/09/2015
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