View Information Collection Request (ICR) Package
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View ICR - Agency Submission
OMB Control No:
0910-0495
ICR Reference No:
202512-0910-012
Status:
Received in OIRA
Previous ICR Reference No:
202403-0910-008
Agency/Subagency:
HHS/FDA
Agency Tracking No:
HFP
Title:
Food Additives; Food Contact Substances Notification System
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
Date Submitted to OIRA:
12/31/2025
Requested
Previously Approved
Expiration Date
04/30/2027
04/30/2027
Responses
472
465
Time Burden (Hours)
33,171
32,835
Cost Burden (Dollars)
0
0
Abstract:
This information collection request supports FDA rulemaking. We are revising current regulations (21 CFR part 170) relating to the procedures for determining that a premarket notification for a food contact substance (FCN) is no longer effective. The regulations provide for additional reasons that could form the basis for FDA to determine that an FCN is no longer effective. The regulations are also intended to ensure that manufacturers or suppliers have the opportunity to provide input before FDA determines that an FCN is no longer effective.
Authorizing Statute(s):
US Code:
21 USC 348(h)
Name of Law: Notification relating to food contact substance.
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AI01
Final or interim final rulemaking
89 FR 20306
03/22/2024
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
12
IC Title
Form No.
Form Name
170.39: Threshold of regulation for substances used in food-contact articles
21 CFR 170.1 Indirect Food Additives
21 CFR 170.101 (Category B)
FDA 3480
FOOD CONTACT SUBSTANCE NOTIFICATION FOR NEW USE PRE-NOTIFICATION CONSULTATION FOOD MASTER FILE
21 CFR 170.101 (Category C)
FDA 3480
Food Contact Substance Notification For New Use Pre-Notification Consultation Food Master File
21 CFR 170.101 (Category D)
FDA 3480
Food Contact Substance Notification For New Use Pre-Notification Consultation Food Master File
21 CFR 170.101 (Category E)
FDA 3480
Food Contact Substance Notification For New Use Pre-Notification Consultation Food Master File
21 CFR 170.106 (Category A)
Form FDA 3479
NOTIFICATION FOR A FOOD CONTACT
Amendment to existing notification, prenotification consultation, or Master File (concerning a food contact substance)
FDA 3480A
Amendment To An Existing Food Contact Notification Pre-Notification Consultation Food Master File
Determination that a FCN is no longer effective
Prenotification Consultation or Master File (concerning a food contact substance)
FDA 3480
Food Contact Substance Notification For New Use Pre-Notification Consultation Food Master File
Preparation for FCS in contact w/infant formula and/or human milk
Use of Recycled Plastics in Food Packaging
ICR Summary of Burden
Total Request
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
472
465
0
7
0
0
Annual Time Burden (Hours)
33,171
32,835
0
336
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
For efficiency of agency operations, we are requesting to incorporate related information collection activity currently approved in OMB control no. 0910-0298 and applicable to regulatory requirements found in 21 CFR 170.39 (threshold of regulation for substances used in food-contact articles) into this ICR. We have therefore added a new IC element corresponding with the regulation into our summary table to reflect 7 responses and 336 hours annually, burden we attribute to information collection activity under 21 CFR 170.39. Upon OMB approval, we intend to discontinue control no. 0910-0298.
Annual Cost to Federal Government:
$1,332,030
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
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?
No
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:
12/31/2025
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