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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:
201210-0910-003
Status:
Historical Active
Previous ICR Reference No:
201208-0910-006
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Emergency
Approval Requested By:
09/10/2012
OIRA Conclusion Action:
Approved without change
Conclusion Date:
10/19/2012
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/19/2012
Terms of Clearance:
The change is approved. In the next request for approval, the agency should ensure that the burden statement on their forms and in the system are consistent and reflect the burden accurately. We also ask that FDA submit or report on their progress in developing instructions for both the paper and electronic formats. We also will want to discuss whether the electronic pre-populates the forms for both updates and re-registration.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2013
03/31/2013
03/31/2013
Responses
542,240
0
542,240
Time Burden (Hours)
505,696
0
505,696
Cost Burden (Dollars)
0
0
0
Abstract:
Section 415 of the Federal Food, Drug, and Cosmetic Act requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to be registered with the FDA. Sections 1.230 - 1.235 (21 CFR 1.230-1.235)of FDA's regulations set forth the procedures for registration of food facilities. Information provided to FDA under these regulations will help the agency to notify quickly the facilities that might be affected by a deliberate or accidental contamination of the food supply.
Emergency Justfication:
In accordance with the 5 CFR 1320.13, FDA believes that public harm is reasonably likely to occur and the Agency will be at risk of not fulfilling its FSMA mandate, if the normal clearance procedures are followed. In the six months or more it can take to obtain a full PRA clearance, a significant number of consumers could be exposed to the risk of consuming hazardous food products. FDA believes that these circumstances can be mitigated or prevented through prompt communication with facilities that might be affected by a deliberate or accidental contamination of the food supply and through targeted import inspections.
Authorizing Statute(s):
US Code:
21 USC 350
Name of Law: FFDCA
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
Did the Agency receive public comments on this ICR?
Yes
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 Form 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 Form 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 Form 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 ... .
3537a
DHHS/FDA CANCELLATION OF FOOD FACILITY REGISTRATION FORM
Biennial Renewal of Registration Additional Data Required by FSMA
Domestic Registration Additional Data Required by FSMA
FDA Form 3537
Food Facility Registration
Foreign New Facility Registration New Data Required by FSMA
Occasional Facility Update Additional Data Required by FSMA
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
542,240
542,240
0
0
0
0
Annual Time Burden (Hours)
505,696
505,696
0
0
0
0
Annual Cost Burden (Dollars)
0
0
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:
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:
10/19/2012
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