Infant Formula Requirements

Forms and Documents

Document	Type	Status	Availability
0256 infant formula supporting statement for GMP rule.pdf	Supporting Statement A	Uploaded 2014-09-05	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
5835	Requirements for Infant Formula		Unchanged
212810	Quality factors; PER written report		New
212809	Quality factors; PER data collection		New
212808	Quality factors; data comparisons		New
212807	Quality factors; data plotting		New
212806	Quality factors; formula intake		New
212805	Quality factors; anthropometric data		New
212804	Quality factors; written study report		New
212803	Audit plan; regular audits		New
212802	Audit plan; ongoing review and updating		New
212801	Quality control; shelf-life substantiation		New
212800	Quality control; sampling		New
212799	Quality control; nutrients		New
212798	General quality control; testing		New
212797	Controls to prevent adulteration during packaging and labeling		New
212796	Controls to prevent adulteration from microorganisms		New
212795	Controls to prevent adulteration during manufacturing		New
212794	Controls to prevent adulteration caused by ingredients, containers, and closures		New
212793	Controls to prevent adulteration due to automatic equipment (revalidation)		New
212792	Controls to prevent adulteration due to automatic equipment		New
212791	Controls to prevent adulteration by equipment or utensils (maintenance schedule)		New
212790	Controls to prevent adulteration by equipment or utensils (sanitation)		New
212789	Controls to prevent adulteration by equipment or utensils		New
212788	Controls to prevent adulteration; bacteriological contaminants in water		New
212787	Controls to prevent adulteration; testing for bacteriological contaminants		New
212786	Controls to prevent adulteration; water testing for radiological contaminants		New
212785	Controls to prevent adulteration caused by facilties; testing for radiological contaminants		New
212211	Quality Factors -- Records (first year only)		New
212208	Requirements for Quality Factors for Eligible Infant Formulas - Data Comparison (first year only)		New
212207	Requirements for Quality Factors for Eligible Formulas - Data Plotting (first year only)		New
212205	Requirements for Quality Factors for Eligible Infant Formulas - Formula Intake (first year only)		New
212202	Requirements for Quality Factors for Eligible Infant Formulas - Anthropometric Data (first year only)		New
212201	Requirements for Quality Factors for Eligible Infant Formulas -- Written Study Report (first year only)		New
212200	Controls to Prevent Adulteration due to Automatic (mechanical or electronic) Equipment (first year only)		New
212199	Production and In-process Control System (first year only)		New
212198	New Infant Formula Submission		New
212197	New Infant Formula Registration		New
212196	Requirements for Quality Factors -- PER Exemption		New
212194	Requirements for Quality Factors GMS Exemption		New
179355	Infant Formula; Labeling (3rd Party Disclosure) Requirements		Unchanged
179354	Infant Formula; Recordkeeping Requirements		Unchanged
179353	Exempt Infant Formula; Recordkeeping Requirements		Unchanged
179352	Exempt Infant Formula; Notification Requirements		Unchanged
179351	Exampt Infant Formula; Terms and Conditions		Unchanged
179350	Infant Formula; Ingredient Control		Unchanged

ICR Details

OMB Control No: 0910-0256	ICR Reference No: 201407-0910-003
Status: Historical Active	Previous ICR Reference No: 201310-0910-005
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: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/24/2014
	Date Received in OIRA: 09/12/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2017	36 Months From Approved	01/31/2016
Responses	16,901	0	218
Time Burden (Hours)	78,513	0	30,202
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 350a Name of Law: FFDCA
   US Code: 21 USC 343 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF27	Final or interim final rulemaking	79 FR 7934	02/10/2014

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 7934	02/10/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 33057	06/10/2014
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 45

IC Title	Form No.	Form Name
Controls to prevent adulteration by equipment or utensils
Requirements for Quality Factors for Eligible Formulas - Data Plotting (first year only)
Requirements for Quality Factors for Eligible Infant Formulas - Data Comparison (first year only)
Controls to prevent adulteration by equipment or utensils (sanitation)
Controls to prevent adulteration by equipment or utensils (maintenance schedule)
Controls to prevent adulteration due to automatic equipment
Controls to prevent adulteration due to automatic equipment (revalidation)
Controls to prevent adulteration caused by ingredients, containers, and closures
Controls to prevent adulteration during manufacturing
Exempt Infant Formula; Notification Requirements
Exempt Infant Formula; Recordkeeping Requirements
Infant Formula; Recordkeeping Requirements
Infant Formula; Labeling (3rd Party Disclosure) Requirements
Requirements for Quality Factors GMS Exemption
Requirements for Quality Factors -- PER Exemption
New Infant Formula Submission
Production and In-process Control System (first year only)
Controls to Prevent Adulteration due to Automatic (mechanical or electronic) Equipment (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 Infant Formulas - Formula Intake (first year only)
Quality Factors -- Records (first year only)
Controls to prevent adulteration caused by facilties; testing for radiological contaminants
Controls to prevent adulteration; water testing for radiological contaminants
Controls to prevent adulteration; testing for bacteriological contaminants
New Infant Formula Registration
Controls to prevent adulteration from microorganisms
Controls to prevent adulteration during packaging and labeling
General quality control; testing
Quality control; nutrients
Quality control; sampling
Quality control; shelf-life substantiation
Audit plan; ongoing review and updating
Audit plan; regular audits
Quality factors; written study report
Quality factors; anthropometric data
Quality factors; formula intake
Quality factors; data plotting
Quality factors; data comparisons
Quality factors; PER data collection
Quality factors; PER written report
Controls to prevent adulteration; bacteriological contaminants in water
Requirements for Infant Formula
Infant Formula; Ingredient Control
Exampt Infant Formula; Terms and Conditions

---

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	16,901	218	0	16,683	0	0
Annual Time Burden (Hours)	78,513	30,202	0	48,311	0	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: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Establishment of quality sytems and quality control requirements has resulted in an increase in burden for both hours and number of responses for this collection. A more detailed explanation of the individual requirements may be found at Q.12 of the supporting statement. A more detailed explanation of the adjustments and changes may be found at Q.15 of the supporting statement.

---

Annual Cost to Federal Government: $860,473

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 09/12/2014

---