Followup Study for Infant Feeding Practices Study II

Forms and Documents

Document Name	Status
FUS IFPS II Revised SS Part B - 02-03-12.doc Supporting Statement B	2012-02-16
Justification Memo - Non Material - Non Substantive Change - 0910-0696.doc Justification for No Material/Nonsubstantive Change	2012-02-16
FUS IFPS II Revised Appendices- 02-03-12.doc Supplementary Document	2012-02-16
FUS Main Study Questionnaire- 02-03-12.doc Supplementary Document	2012-02-16
FUS IFPS II Revised SS Part A-02-03-12.doc Supporting Statement A	2012-02-16

IC Document Collections

IC ID	Document Title	Status
198723	Reporting : Demographic Questionnaire Other-questionnaire	Modified
198722	Reporting: Main Study Telephone Interview Other-questionnaire	Modified
198721	Reporting : Main Study Mailed Questionnaire Other-Questionnaire	Modified
198720	Reporting: Pilot Study Telephone Interview Other-Questionnaire	Modified
198719	Reporting : Pilot Study Mailed Questionnaire Other-Questionnaire	Modified

ICR Details

OMB Control No: 0910-0696	ICR Reference No: 201202-0910-005
Status: Historical Active	Previous ICR Reference No: 201108-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Followup Study for Infant Feeding Practices Study II
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: 04/17/2012
	Date Received in OIRA: 02/17/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2014	11/30/2014	11/30/2014
Responses	3,540	0	3,540
Time Burden (Hours)	832	0	832
Cost Burden (Dollars)	0	0	0

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Abstract: FDA is planning to conduct a survey of the mothers who participated in the Infant Feeding Practices Study II (IFPS II ) The purpose of the study is to enhance FDA`s understanding of the associations between infant feeding practices and diet quality, food allergy, overweight and obesity, and other health and development outcomes in young children. The study results will be used to help the Agency understand the possible role of infant feeding practices in the development and progression of food allergy and childhood overweight and obesity, in addition to resistance to infection and other health and development outcomes. The results of the study will not be used to develop population estimates.

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Authorizing Statute(s): US Code: 21 USC 393 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

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Reporting: Pilot Study Telephone Interview
Reporting : Pilot Study Mailed Questionnaire
Reporting : Main Study Mailed Questionnaire
Reporting: Main Study Telephone Interview
Reporting : Demographic Questionnaire

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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	3,540	3,540	0	0	0	0
Annual Time Burden (Hours)	832	832	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: $500,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 02/17/2012

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