View Information Collection Request (ICR) Package

OMB Control No: 0910-0256	ICR Reference No: 202209-0910-009
Status: Historical Active	Previous ICR Reference No: 202104-0910-013
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Infant Formula Requirements
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Emergency	Approval Requested By: 09/28/2022
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/30/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/28/2022
Terms of Clearance: Given that the effective date of the guidance associated with this emergency request (Infant Formula Transition Plan for Exercise of Enforcement Discretion) is expected to be in effect into 2025 and emergency approval can only be granted for a maximum of 6-months, FDA will need to provide the standard notice and comment periods in order to revise this aspect of the collection beyond 6-months.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2023	6 Months From Approved	05/31/2024
Responses	8,110	0	7,995
Time Burden (Hours)	132,715	0	128,530
Cost Burden (Dollars)	0	0	0

Abstract: 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.

Emergency Justfication: FDA is submitting this request memorandum in accordance with 5 CFR 1320.13. As disruptions in the supply of infant formula continue, we are pursuing longer-term information collection pertaining to our exercise of enforcement discretion to provide certain manufacturers a pathway to market covered products that may not currently meet certain applicable requirements. Immediate implementation of the information collection is critical to providing predictability, stability, and continuity in the infant formula market, specifically with respect to products currently available to infants in the U.S. under FDA’s exercise of enforcement discretion. Because we believe that routine procedures allowing for a 60-day comment period would have prevented our ability to immediately implement the information collection, we requested a waiver from the requirement to publish notice in the Federal Register under 5 CFR 1320.13(a)(2)(iii).

Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act (FFDCA)

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking
	Other Documents for OIRA Review

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	8,110	7,995	115
Annual Time Burden (Hours)	132,715	128,530	4,185
Annual Cost Burden (Dollars)	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: FDA is temporarily exercising enforcement discretion with respect to how respondents comply with applicable requirements, including adjustments to existing ways to comply with such requirements (see 5 CFR 1320.3(b)(1)(v)) to address an immediate threat to the public health resulting from the disruption in the supply of necessary products.

Annual Cost to Federal Government: $272,773

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

View ICR - OIRA Conclusion