Infant Formula Requirements

Forms and Documents

Document Name	Status
Form Form FDA 3978 Reports under FFDCA section 412(d) Form and Instruction	Modified
Form Form FDA 3978 New Infant Formula Submission Form and Instruction	Modified
Form Form FDA 3978 New Infant Formula Registration Form and Instruction	Modified
Form Form FDA 3978 Requirements for Quality Factors -- PER Exemption Form and Instruction	Modified
Form Form FDA 3978 Requirements for Quality Factors GMS Exemption Form and Instruction	Modified
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	Modified
Form Form FDA 3978 Notifications under 106.120(b) Form and Instruction	Modified
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	Modified
212810	Quality factors; PER written report	Removed
212809	Quality factors; PER data collection	Removed
212808	Quality factors; data comparisons	Removed
212807	Quality factors; data plotting	Removed
212806	Quality factors; formula intake	Removed
212805	Quality factors; anthropometric data	Removed
212804	Quality factors; written study report	Removed
212803	Audit plan; regular audits	Removed
212802	Audit plan; ongoing review and updating	Removed
212801	Quality control; shelf-life substantiation	Removed
212800	Quality control; sampling	Removed
212799	Quality control; nutrients	Removed
212798	General quality control; testing	Removed
212797	Controls to prevent adulteration during packaging and labeling	Removed
212796	Controls to prevent adulteration from microorganisms	Removed
212795	Controls to prevent adulteration during manufacturing	Removed
212794	Controls to prevent adulteration caused by ingredients, containers, and closures	Removed
212793	Controls to prevent adulteration due to automatic equipment (revalidation)	Removed
212792	Controls to prevent adulteration due to automatic equipment	Removed
212791	Controls to prevent adulteration by equipment or utensils (maintenance schedule)	Removed
212790	Controls to prevent adulteration by equipment or utensils (sanitation)	Removed
212789	Controls to prevent adulteration by equipment or utensils	Removed
212788	Controls to prevent adulteration; bacteriological contaminants in water	Removed
212787	Controls to prevent adulteration; testing for bacteriological contaminants	Removed
212786	Controls to prevent adulteration; water testing for radiological contaminants	Removed
212785	Controls to prevent adulteration caused by facilties; testing for radiological contaminants	Removed
212211	Quality Factors -- Records (first year only)	Removed
212208	Requirements for Quality Factors for Eligible Infant Formulas - Data Comparison (first year only)	Removed
212207	Requirements for Quality Factors for Eligible Formulas - Data Plotting (first year only)	Removed
212205	Requirements for Quality Factors for Eligible Infant Formulas - Formula Intake (first year only)	Removed
212202	Requirements for Quality Factors for Eligible Infant Formulas - Anthropometric Data (first year only)	Removed
212201	Requirements for Quality Factors for Eligible Infant Formulas -- Written Study Report (first year only)	Removed
212200	Controls to Prevent Adulteration due to Automatic (mechanical or electronic) Equipment (first year only)	Removed
212199	Part 106; Subpart B - CGMP Requirements (records)	Modified
212198	New Infant Formula Submission Form and Instruction	Modified
212197	New Infant Formula Registration Form and Instruction	Modified
212196	Requirements for Quality Factors -- PER Exemption Form and Instruction	Modified
212194	Requirements for Quality Factors GMS Exemption Form and Instruction	Modified
179355	Infant Formula; Labeling (3rd Party Disclosure) Requirements	Modified
179354	Recordkeeping under Part 106; Subparts C-G - quality control, audits, testing, records	Modified
179353	Part 107; Subpart C - Exempt Infant Formulas (records)	Modified
179352	Exempt Infant Formula; Notification Requirements Form and Instruction	Modified
179351	Reports for exampt Infant Formula Form and Instruction	Modified
179350	Notifications under 106.120(b) Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0256	ICR Reference No: 201804-0910-005
Status: Historical Active	Previous ICR Reference No: 201702-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Infant Formula Requirements
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/16/2018
	Date Received in OIRA: 04/11/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2021	36 Months From Approved	05/31/2018
Responses	6,092	0	16,901
Time Burden (Hours)	42,940	0	78,536
Cost Burden (Dollars)	0	0	765,439

---

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: 12

IC Title	Form No.	Form Name
Quality control; nutrients
Controls to prevent adulteration caused by ingredients, containers, and closures
Controls to prevent adulteration during packaging and labeling
Quality factors; formula intake
Quality factors; written study report
Quality factors; PER written report
Quality factors; PER data collection
Quality factors; data comparisons
Quality Factors -- Records (first year only)
Quality factors; data plotting
Controls to prevent adulteration due to automatic equipment (revalidation)
General quality control; testing
Controls to prevent adulteration from microorganisms
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
Quality factors; anthropometric data
Requirements for Quality Factors for Eligible Infant Formulas - Formula Intake (first year only)
Controls to prevent adulteration caused by facilties; testing for radiological contaminants
Audit plan; regular audits
Controls to Prevent Adulteration due to Automatic (mechanical or electronic) Equipment (first year only)
Requirements for Quality Factors for Eligible Infant Formulas - Data Comparison (first year only)
Requirements for Quality Factors for Eligible Infant Formulas -- Written Study Report (first year only)
Requirements for Quality Factors for Eligible Infant Formulas - Anthropometric Data (first year only)
Requirements for Quality Factors for Eligible Formulas - Data Plotting (first year only)
Controls to prevent adulteration; water testing for radiological contaminants
Controls to prevent adulteration; testing for bacteriological contaminants
Controls to prevent adulteration; bacteriological contaminants in water
Controls to prevent adulteration during manufacturing
Controls to prevent adulteration by equipment or utensils
Controls to prevent adulteration by equipment or utensils (sanitation)
Controls to prevent adulteration by equipment or utensils (maintenance schedule)
Audit plan; ongoing review and updating
Quality control; shelf-life substantiation
Controls to prevent adulteration due to automatic equipment
Quality control; sampling

---

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	6,092	16,901	0	0	-10,809	0
Annual Time Burden (Hours)	42,940	78,536	0	0	-35,596	0
Annual Cost Burden (Dollars)	0	765,439	0	0	-765,439	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 consolidated individual ICs as appropriate. This is discussed more fully at Q15. of the supporting statement.

---

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: 04/11/2018

---