Infant Formula Requirements

Forms and Documents

Document	Type	Status	Availability
Form Form FDA 3978 Reports under FFDCA section 412(d)	Form and Instruction	Unchanged	Repair queued
Form Form FDA 3978 New Infant Formula Submission	Form and Instruction	Unchanged	Missing upstream
Form Form FDA 3978 New Infant Formula Registration	Form and Instruction	Unchanged	Repair queued
Form Form FDA 3978 Requirements for Quality Factors -- PER Exemption	Form and Instruction	Unchanged	Repair queued
Form Form FDA 3978 Requirements for Quality Factors GMS Exemption	Form and Instruction	Unchanged	Repair queued
Form Form FDA 3978 Exempt Infant Formula; Notification Requirements	Form and Instruction	Unchanged	Repair queued
Form Form FDA 3978 Reports for exampt Infant Formula	Form and Instruction	Unchanged	Repair queued
Form Form FDA 3978 Notifications under 106.120(b)	Form and Instruction	Unchanged	Repair queued
0256 IF Non Sub 2024 for MoCRA Authority.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2025-02-25	Repair queued
0256 IF to add recalls from 0188 SSA 2023.docx	Supporting Statement A	Uploaded 2023-09-29	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
5835	Reports under FFDCA section 412(d)	Form and Instruction	Unchanged
262605	Infant formula recalls		Unchanged
259321	Voluntary submission of testing results for Cronobacter spp. or Salmonella	Other-Agency Communication	Unchanged
256173	IC in support of enforcement discretion	Other-Agency Guidance	Unchanged
235376	Exempt Infant Formula Production; GMP; Audits, Records & Records	Other-Agency Guidance	Unchanged
212199	Part 106; Subpart B - CGMP Requirements (records)		Unchanged
212198	New Infant Formula Submission	Form and Instruction	Unchanged
212197	New Infant Formula Registration	Form and Instruction	Unchanged
212196	Requirements for Quality Factors -- PER Exemption	Form and Instruction	Unchanged
212194	Requirements for Quality Factors GMS Exemption	Form and Instruction	Unchanged
179355	Infant Formula; Labeling (3rd Party Disclosure) Requirements		Unchanged
179354	Recordkeeping under Part 106; Subparts C-G - quality control, audits, testing, records		Unchanged
179353	Part 107; Subpart C - Exempt Infant Formulas (records)		Unchanged
179352	Exempt Infant Formula; Notification Requirements	Form and Instruction	Unchanged
179351	Reports for exampt Infant Formula	Form and Instruction	Unchanged
179350	Notifications under 106.120(b)	Form and Instruction	Unchanged

ICR Details

OMB Control No: 0910-0256	ICR Reference No: 202412-0910-007
Status: Received in OIRA	Previous ICR Reference No: 202309-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
Title: Infant Formula Requirements
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/03/2025

	Requested	Previously Approved
Expiration Date	10/31/2026	10/31/2026
Responses	8,140	8,140
Time Burden (Hours)	145,194	145,194
Cost Burden (Dollars)	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.

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 60689	10/06/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 67303	09/29/2023
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 16

IC Title	Form No.	Form Name
Exempt Infant Formula Production; GMP; Audits, Records & Records
Exempt Infant Formula; Notification Requirements	Form FDA 3978	Infant Formula Tracking System
IC in support of enforcement discretion
Infant Formula; Labeling (3rd Party Disclosure) Requirements
Infant formula recalls
New Infant Formula Registration	Form FDA 3978	Infant Formula Tracking System
New Infant Formula Submission	Form FDA 3978	Infant Formula Tracking System
Notifications under 106.120(b)	Form FDA 3978	Infant Formula Tracking System
Part 106; Subpart B - CGMP Requirements (records)
Part 107; Subpart C - Exempt Infant Formulas (records)
Recordkeeping under Part 106; Subparts C-G - quality control, audits, testing, records
Reports for exampt Infant Formula	Form FDA 3978	Infant Formula Tracking System
Reports under FFDCA section 412(d)	Form FDA 3978	Infant Formula Tracking System
Requirements for Quality Factors -- PER Exemption	Form FDA 3978	Infant Formula Tracking System
Requirements for Quality Factors GMS Exemption	Form FDA 3978	Infant Formula Tracking System
Voluntary submission of testing results for Cronobacter spp. or Salmonella

---

ICR Summary of Burden

	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	8,140	0	0	0	0
Annual Time Burden (Hours)	145,194	145,194	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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: 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.

---

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

---

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: 06/03/2025

---