Infant Formula Requirements

ICR 202309-0910-014

OMB: 0910-0256

Federal Form Document

ICR Details
0910-0256 202309-0910-014
Received in OIRA 202303-0910-019
HHS/FDA CFSAN
Infant Formula Requirements
Revision of a currently approved collection   No
Regular 09/29/2023
  Requested Previously Approved
36 Months From Approved 05/31/2026
8,140 8,130
145,194 132,340
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

  87 FR 60689 10/06/2022
88 FR 67303 09/29/2023
No

  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 8,140 8,130 0 0 10 0
Annual Time Burden (Hours) 145,194 132,340 0 0 12,854 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We have revised the information collection to include activities applicable to regulations in 21 CFR part 107, subpart E (21 CFR 107.200 through 107.280) pertaining to infant formula recalls, currently approved in OMB control no. 0910-0188. Upon OMB approval of this request we intend on discontinuing 0910-0188.

$272,773
No
    No
    No
No
No
No
No
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.
09/29/2023


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