Infant Formula Requirements

ICR 201903-0910-014

OMB: 0910-0256

Federal Form Document

Forms and Documents
ICR Details
0910-0256 201903-0910-014
Active 201804-0910-005
HHS/FDA CFSAN
Infant Formula Requirements
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 03/19/2019
Retrieve Notice of Action (NOA) 03/18/2019
Approved with the understanding that existing collecting 0910-0811 will be discontinued.
  Inventory as of this Action Requested Previously Approved
05/31/2021 05/31/2021 05/31/2021
7,997 0 6,092
128,838 0 42,940
0 0 0

This ICR supports the recordkeeping, reporting, and labeling requirements for the manufacture and distribution of infant formula. Respondents to this collection are infant formula manufacturers who must ensure that their products adhere to the quality control provisions and procedures found in FDA regulations, and that nutrient information and directions for use are disclosed in their product labeling.

US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act (FFDCA)
  
None

Not associated with rulemaking

  82 FR 52927 11/15/2017
83 FR 15148 04/09/2018
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 7,997 6,092 0 2 1,903 0
Annual Time Burden (Hours) 128,838 42,940 0 8 85,890 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Consolidating recordkeeping from ICR 0910-0811.

$981,052
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.
03/18/2019


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