View Information Collection Request (ICR) Package
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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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:
ICR Reference No:
200301-0910-003
Status:
Historical Inactive
Previous ICR Reference No:
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Registration of Food Facilities
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:
Comment filed on proposed rule
Conclusion Date:
03/26/2003
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/31/2003
Terms of Clearance:
The icr associated with Registration of Food Facilities proposed rule is not approved at this time. FDA is examining public comment in response to this NPRM. The preamble to the final rule will address how the agency has addressed comments related to minimizing the burden of this rule while maximizing its utility. OMB is particularly interested in the issues highlighted in our 3-13 memo.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
Responses
0
0
0
Time Burden (Hours)
0
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
The Bioterrorism Act requires the Secretary, through FDA to develop regulations requiring that domestic and foreign manufacturers/processors, holders, and packers of food intended for consumption in the U.S. to register with FDA by December 12, 2003. Facilties are also required to submit timely updates when any information on their registration changes.
Authorizing Statute(s):
None
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Registration of Food Facilities
FDA-3537, FDA-3537A
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:
$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]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Uncollected
Is this ICR related to the Pandemic Response?
Uncollected
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:
01/31/2003
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