Infant Formula Requirements

Forms and Documents

Document Name	Status
SS-0910-0256.doc Supporting Statement A	2010-06-30

IC Document Collections

IC ID	Document Title	Status
5835	Reporting -Infant Formula Requirements Other-statute	Modified
179355	Third Party disclosure - Infant Formula Requirements	Modified
179354	Recordkeeping - Infant Formula Requirements	Modified
179353	Recordkeeping - Infant Formula Requirements	Modified
179352	Reporting - Infant Formula Requirements	Modified
179351	Reporting - Infant Formula Requirements	Modified
179350	Reporting - Infant Formula Requirements	Modified

ICR Details

OMB Control No: 0910-0256	ICR Reference No: 201006-0910-008
Status: Historical Active	Previous ICR Reference No: 200703-0910-015
Agency/Subagency: HHS/FDA	Agency Tracking No:
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 without change	Conclusion Date: 10/01/2010
	Date Received in OIRA: 06/30/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2013	36 Months From Approved	09/30/2010
Responses	218	0	218
Time Burden (Hours)	30,202	0	30,202
Cost Burden (Dollars)	0	0	0

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Abstract: Statutory requirements for infant formula under the Federal Food, Drug, and Cosmetic Act (the act) are intended to protect the health of infants and include a number of reporting and recordkeeping requirements. Among other things, section 412 of the act (21 U.S.C. 350a), which was added by the Infant Formula Act of 1980 (IFA), requires manufacturers of infant formula to establish and adhere to quality control procedures, notify FDA when a batch of infant formula that has left the manufacturers' control may be adulterated or misbranded, and keep records of distribution. FDA has issued regulations to implement the act's requirements for infant formula in 21 CFR part 106 and part 107 (21 CFR parts 106 and 107). FDA also regulates the labeling of infant formula under the authority of section 403 of the act (21 U.S.C. 343). Under the labeling regulations for infant formula in part 107, the label of an infant formula must include nutrient information and directions for use. The purpose of these labeling requirements is to ensure that consumers have the information they need to prepare and use infant formula appropriately.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 23777	05/04/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 46777	06/30/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Reporting -Infant Formula Requirements
Reporting - Infant Formula Requirements
Reporting - Infant Formula Requirements
Reporting - Infant Formula Requirements
Recordkeeping - Infant Formula Requirements
Recordkeeping - Infant Formula Requirements
Third Party disclosure - Infant Formula Requirements

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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	218	218	0	0	0	0
Annual Time Burden (Hours)	30,202	30,202	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:

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Annual Cost to Federal Government: $696,674

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]? Uncollected

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: 06/30/2010

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