Infant Formula Requirements

Forms and Documents

Document Name	Status
Form Form FDA 3978 Reports under FFDCA section 412(d) Form and Instruction	Unchanged
Form Form FDA 3978 New Infant Formula Submission Form and Instruction	Unchanged
Form Form FDA 3978 New Infant Formula Registration Form and Instruction	Unchanged
Form Form FDA 3978 Requirements for Quality Factors -- PER Exemption Form and Instruction	Unchanged
Form Form FDA 3978 Requirements for Quality Factors GMS Exemption Form and Instruction	Unchanged
Form Form FDA 3978 Exempt Infant Formula; Notification Requirements Form and Instruction	Modified
Form Form FDA 3978 Reports for exampt Infant Formula Form and Instruction	Unchanged
Form Form FDA 3978 Notifications under 106.120(b) Form and Instruction	Unchanged
0256 Nonsub 0811 Discontinue MAR 2019.pdf Justification for No Material/Nonsubstantive Change	2019-03-16
0256 Infant Formula SSA 2018 Ext rev.docx Supporting Statement A	2018-04-25

IC Document Collections

IC ID	Document Title	Status
5835	Reports under FFDCA section 412(d) Form and Instruction	Unchanged
235376	Exempt Infant Formula Production; GMP; Audits, Records & Records Other-Agency Guidance	New
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	Modified
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: 201903-0910-014
Status: Active	Previous ICR Reference No: 201804-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/19/2019
	Date Received in OIRA: 03/18/2019
Terms of Clearance: Approved with the understanding that existing collecting 0910-0811 will be discontinued.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2021	05/31/2021	05/31/2021
Responses	7,997	0	6,092
Time Burden (Hours)	128,838	0	42,940
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.

---

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:
	82 FR 52927	11/15/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 15148	04/09/2018
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 13

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

---

ICR Summary of Burden

	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

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: Consolidating recordkeeping from ICR 0910-0811.

---

Annual Cost to Federal Government: $981,052

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? Uncollected

---

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: 03/18/2019

---