Quality Facility Attestation

ICR 201806-0910-006

OMB: 0910-0854

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
231705
New
231702
New
ICR Details
0910-0854 201806-0910-006
Active
HHS/FDA CFSAN
Quality Facility Attestation
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 07/13/2018
Retrieve Notice of Action (NOA) 06/13/2018
  Inventory as of this Action Requested Previously Approved
07/31/2021 36 Months From Approved
19,127 0 0
9,564 0 0
0 0 0

This ICR collects information from owners, operators or agents in charge of domestic or foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States asserting that a facility is a “qualified facility” and, therefore, subject to modified requirements of the Preventive Controls for Human Food and the Preventive Controls for Animal Food Rules. FDA has developed Forms FDA 3942a and 3942b for respondents to submit information attesting to their “qualified facility” status. FDA has also developed a guidance to assist respondents with the qualified facility process.

None
None

Not associated with rulemaking
Other Documents for OIRA Review

  81 FR 30219 05/16/2016
83 FR 27330 06/12/2018
Yes

2
IC Title Form No. Form Name
Attestation - Human Foods Form FDA 3942a, Form FDA 3942a
Attestation - Animal Foods Form FDA 3942b, Form FDA 3942b

  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 19,127 0 0 0 19,127 0
Annual Time Burden (Hours) 9,564 0 0 0 9,564 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new information collection. The ICR has been amended to include a revised supporting statement reflecting a more detailed discussion of changes to the agency's proposed final guidance, as well as to include comparative documents highlighting where changes may be found in the respective collection instruments since they were issued in draft.

$0
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
06/13/2018


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