Infant Formula Requirements

Forms and Documents

Document Name	Status
0256 IFTRACK II Wireframes v4.pdf Supplementary Document	2017-02-13
0256 Nonsub change 2017.pdf Justification for No Material/Nonsubstantive Change	2017-02-13
0256 Supporting Statement for Selenium in Labeling of Infant Formula 2015.pdf Supporting Statement A	2015-03-03

IC Document Collections

IC ID	Document Title	Status
5835	Requirements for Infant Formula	Unchanged
212810	Quality factors; PER written report	Unchanged
212809	Quality factors; PER data collection	Unchanged
212808	Quality factors; data comparisons	Unchanged
212807	Quality factors; data plotting	Unchanged
212806	Quality factors; formula intake	Unchanged
212805	Quality factors; anthropometric data	Unchanged
212804	Quality factors; written study report	Unchanged
212803	Audit plan; regular audits	Unchanged
212802	Audit plan; ongoing review and updating	Unchanged
212801	Quality control; shelf-life substantiation	Unchanged
212800	Quality control; sampling	Unchanged
212799	Quality control; nutrients	Unchanged
212798	General quality control; testing	Unchanged
212797	Controls to prevent adulteration during packaging and labeling	Unchanged
212796	Controls to prevent adulteration from microorganisms	Unchanged
212795	Controls to prevent adulteration during manufacturing	Unchanged
212794	Controls to prevent adulteration caused by ingredients, containers, and closures	Unchanged
212793	Controls to prevent adulteration due to automatic equipment (revalidation)	Unchanged
212792	Controls to prevent adulteration due to automatic equipment	Unchanged
212791	Controls to prevent adulteration by equipment or utensils (maintenance schedule)	Unchanged
212790	Controls to prevent adulteration by equipment or utensils (sanitation)	Unchanged
212789	Controls to prevent adulteration by equipment or utensils	Unchanged
212788	Controls to prevent adulteration; bacteriological contaminants in water	Unchanged
212787	Controls to prevent adulteration; testing for bacteriological contaminants	Unchanged
212786	Controls to prevent adulteration; water testing for radiological contaminants	Unchanged
212785	Controls to prevent adulteration caused by facilties; testing for radiological contaminants	Unchanged
212211	Quality Factors -- Records (first year only)	Unchanged
212208	Requirements for Quality Factors for Eligible Infant Formulas - Data Comparison (first year only)	Unchanged
212207	Requirements for Quality Factors for Eligible Formulas - Data Plotting (first year only)	Unchanged
212205	Requirements for Quality Factors for Eligible Infant Formulas - Formula Intake (first year only)	Unchanged
212202	Requirements for Quality Factors for Eligible Infant Formulas - Anthropometric Data (first year only)	Unchanged
212201	Requirements for Quality Factors for Eligible Infant Formulas -- Written Study Report (first year only)	Unchanged
212200	Controls to Prevent Adulteration due to Automatic (mechanical or electronic) Equipment (first year only)	Unchanged
212199	Production and In-process Control System (first year only)	Unchanged
212198	New Infant Formula Submission	Unchanged
212197	New Infant Formula Registration	Unchanged
212196	Requirements for Quality Factors -- PER Exemption	Unchanged
212194	Requirements for Quality Factors GMS Exemption	Unchanged
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: 201702-0910-006
Status: Historical Active	Previous ICR Reference No: 201502-0910-012
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: 03/01/2017
	Date Received in OIRA: 02/15/2017
Terms of Clearance: Given that draft electronic Form FDA 3978 is being deployed as a pilot, if FDA decides to continue use of the electronic form the agency must report findings of the pilot to OMB as part of the renewal request.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2018	04/30/2018	04/30/2018
Responses	16,901	0	16,901
Time Burden (Hours)	78,536	0	78,536
Cost Burden (Dollars)	765,439	0	765,439

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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.

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Authorizing Statute(s): US Code: 21 USC 343 Name of Law: FFDCA
   US Code: 21 USC 350a Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF27	Final or interim final rulemaking	79 FR 7933	02/10/2014

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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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
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
Infant Formula; Ingredient Control
Exampt Infant Formula; Terms and Conditions
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
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
New Infant Formula Registration

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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	16,901	0	0	0	0
Annual Time Burden (Hours)	78,536	78,536	0	0	0	0
Annual Cost Burden (Dollars)	765,439	765,439	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: Burden increase of 23 hours reflects one-time burden for respondents to include selenium content in nutrient labeling. This is discussed in the accompanying supporting statement.

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Annual Cost to Federal Government: $696,673

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

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Common Form ICR:  No

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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: 02/15/2017

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