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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:
0910-0495
ICR Reference No:
202301-0910-004
Status:
Historical Inactive
Previous ICR Reference No:
202201-0910-011
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CFSAN
Title:
Food Additives; Food Contact Substances Notification System
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Comment filed on proposed rule and continue
Conclusion Date:
02/06/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/05/2023
Terms of Clearance:
In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2025
36 Months From Approved
03/31/2025
Responses
458
0
458
Time Burden (Hours)
32,675
0
32,675
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection request supports agency rulemaking as required under 5 CFR 1320.11.
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
Proposed rulemaking
87 FR 3949
01/26/2022
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
11
IC Title
Form No.
Form Name
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
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
RIN 0910-AI01: Food Additives; Food Contact Substance Notification That Is No Longer Effective,
Use of Recycled Plastics in Food Packaging
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:
This information collection reflects program changes resulting from rulemaking. As a result, we have adjusted our estimate adding 160 hours and 7 responses annually to reflect information collection associated with new regulatory requirements.
Annual Cost to Federal Government:
$6,360,000
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:
01/05/2023
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