Threshold of Regulation for Substances Used in Food-Contact Articles

ICR 201911-0910-002

OMB: 0910-0298

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-11-05
IC Document Collections
ICR Details
0910-0298 201911-0910-002
Active 201610-0910-004
HHS/FDA CFSAN
Threshold of Regulation for Substances Used in Food-Contact Articles
Extension without change of a currently approved collection   No
Regular
Approved without change 12/06/2019
Retrieve Notice of Action (NOA) 11/06/2019
  Inventory as of this Action Requested Previously Approved
12/31/2022 36 Months From Approved 12/31/2019
7 0 7
336 0 336
0 0 0

This ICR collects information regarding whether a food contact substance falls within the regulatory threshold criteria provided for by FDA regulations. Respondents to this collection are individual manufacturers and suppliers of substances used in food-contact articles, such as food packaging and food processing equipment, or the articles themselves. We encourage electronic submission using our Electronic Submission Gateway (ESG).

US Code: 21 USC 348(a) Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  84 FR 29209 06/21/2019
84 FR 59831 11/06/2019
No

1
IC Title Form No. Form Name
Threshold of Regulation for Substances Used in Food-Contact Articles

  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 7 7 0 0 0 0
Annual Time Burden (Hours) 336 336 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$18,294
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
11/06/2019


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