Food Allergen Labeling and Reporting

ICR 201503-0910-010

OMB: 0910-0792

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2015-05-22
Supporting Statement A
2015-05-22
ICR Details
0910-0792 201503-0910-010
Historical Active
HHS/FDA CFSAN
Food Allergen Labeling and Reporting
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 05/29/2015
Retrieve Notice of Action (NOA) 03/30/2015
Approved consistent with content of the final guidance document.
  Inventory as of this Action Requested Previously Approved
05/31/2018 36 Months From Approved
81,385 0 0
140,340 0 0
7,071,875 0 0

This information collection request supports an agency guidance document entitled, "Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications." The draft guidance is intended to help industry prepare petitions and notifications seeking exemptions from the labeling requirements for ingredients derived from major food allergens. The respondents to this collection are manufacturers and packers of packaged foods sold in the United States that declare the presence of a major food allergen on the product label. Respondents to the reporting elements are manufacturers and packers of packaged foods sold in the United States that seek an exemption from the labeling requirements of section 403(w)(1) of the FD&C Act.

PL: Pub.L. 108 - 282 203 Name of Law: Food Allergen Labeling and Consumer Protection Act of 2004
   US Code: 21 USC 343(w)(1) Name of Law: null
  
None

Not associated with rulemaking

  79 FR 47145 08/12/2014
79 FR 71107 12/01/2014
No

  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 81,385 0 0 81,385 0 0
Annual Time Burden (Hours) 140,340 0 0 140,340 0 0
Annual Cost Burden (Dollars) 7,071,875 0 0 7,071,875 0 0
Yes
Changing Regulations
No
This is a new information collection request.

$3,282,134
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.
03/30/2015


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