Infant Formula Enforcement Discretion Policy

ICR 202205-0910-003

OMB: 0910-0903

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
202205-0910-003
Received in OIRA
HHS/FDA CFSAN
Infant Formula Enforcement Discretion Policy
New collection (Request for a new OMB Control Number)   No
Emergency 05/20/2022
05/20/2022
  Requested Previously Approved
6 Months From Approved
30 0
720 0
0 0

This information collection supports recommendations discussed in Food and Drug Administration (FDA, us or we) guidance. FDA has issued the guidance document, “Infant Formula Enforcement Discretion Policy,” to communicate its intention to temporarily exercise enforcement discretion with respect to certain requirements for infant formulas that may not comply with certain statutory and regulatory requirements, and is seeking information from manufacturers regarding the safety and nutritional adequacy of their products
FDA intends to exercise enforcement discretion to last only until adequate supplies of infant formula which meet all statutory and regulatory requirements become readily available. We seek to address a given public health harm and, pursuant to direction from the President, to work urgently to ensure that infant formula is safe and available for families across the country (see FACT SHEET: President Biden Announces Additional Steps to Address Infant Formula Shortage | The White House). We are therefore issuing the document "Infant Formula Enforcement Discretion Policy: Guidance for Industry" in this regard.

US Code: 21 USC 342; 343 Name of Law: Federal Food, Drug, & Cosmetic Act: Adulterated and Misbranded Food
  
None

Not associated with rulemaking
Other Documents for OIRA Review

No

1
IC Title Form No. Form Name
Provide information to FDA related to enforcement discretion request

  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 30 0 0 0 30 0
Annual Time Burden (Hours) 720 0 0 0 720 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new information collection.

$0
No
    Yes
    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.
05/20/2022


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