Balance After Baby Intervention

Forms and Documents

Document Name	Status
Form 0920-15BEB Block Food Frequency Questionnaire Form and Instruction	New
Form 0920-15BEB BABI 24 - Month Questionnarie Form and Instruction	New
Form 0920-15BEB BABI 18 - Month Questionnaire Form and Instruction	New
Form 0920-15BEB BABI 12 - Month Questionnaire Form and Instruction	New
Form 0920-15BEB BABI 6 - Month Questionnaire Form and Instruction	New
Form 0920-15BEB BABI 6 - Week Questionnaire Form and Instruction	New
Form 0920-15BEB BABI Screener Questionnaire Form and Instruction	New
Attachment 11_InformedConsentDocumentUCH.pdf Supplementary Document	2016-01-21
Attachment 10_InformedConsentDocumentBWH.pdf Supplementary Document	2016-01-21
Attachment 8_BABI_Item-LevelCrosswalk.xlsx Supplementary Document	2016-01-21
Attachment 1_42 U.S.C. 241.docx Supplementary Document	2016-01-21
OMB_SupportingStatementB_01 12 16.docx Supporting Statement B	2016-01-21
OMB_SupportingStatementA_01 13 16_clean.docx Supporting Statement A	2016-01-21

IC Document Collections

IC ID	Document Title	Status
219655	Block Food Frequency Questionnaire Form and Instruction	New
219654	BABI 24 - Month Questionnarie Form and Instruction	New
219653	BABI 18 - Month Questionnaire Form and Instruction	New
219649	BABI 12 - Month Questionnaire Form and Instruction	New
219642	BABI 6 - Month Questionnaire Form and Instruction	New
219641	BABI 6 - Week Questionnaire Form and Instruction	New
219639	BABI Screener Questionnaire Form and Instruction	New

ICR Details

OMB Control No: 0920-1115	ICR Reference No: 201601-0920-012
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 15BEB
Title: Balance After Baby Intervention
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/09/2016
	Date Received in OIRA: 01/22/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved
Responses	698	0	0
Time Burden (Hours)	183	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Information will be collected from postpartum women with recent gestational diabetes mellitus (GDM). A randomized controlled clinical trial will be conducted to evaluate the effectiveness of a web-based lifestyle intervention program that may promote weight management and reduce risk of developing type 2 diabetes.

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Authorizing Statute(s): US Code: 24 USC 42 Name of Law: Public Health Service Act, Research and Investigations
  

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:
	80 FR 52292	08/28/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 3426	01/21/2016
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
BABI 6 - Month Questionnaire	0920-15BEB, 0920-15BEB	Att 4_BABI_6MQuestionnaire_ENG_V1 0_01122016 ,   Att 4s_BABI_6MQuestionnaire_SPAN_V1 0_01122016
BABI 12 - Month Questionnaire	0920-15BEB, 0920-15BEB	Att 5_BABI_12MQuestionnaire_ENG_ ,   Att 5s_BABI_12MQuestionnaire_SPAN
BABI 18 - Month Questionnaire	0920-15BEB, 0920-15BEB	Att 6a HIV-Neg MSM Recruitment Ads_English ,   Att 6s_BABI_18MQuestionnaire_SPAN_V1
BABI 24 - Month Questionnarie	0920-15BEB, 0920-15BEB	Att 7_BABI_24MQuestionnaire_ENG_V1 0_01122016 ,   Att 7s_BABI_24MQuestionnaire_SPAN_V1
Block Food Frequency Questionnaire	0920-15BEB, 0920-15BEB	Attachment 9_Block 2005 FFQ Screenshots_English ,   Attachment 9s_Block 2005 FFQ Screenshots_Spanish
BABI 6 - Week Questionnaire	0920-15BEB, 0920-15BEB	Att 3_BABI_6WQuestionnaire_ENG_V1 0_01122016 ,   Att 3s_BABI_6WQuestionnaire_SPAN_V1 0_01122016
BABI Screener Questionnaire	0920-15BEB, 15BEB	Attachment 2_BABI_ScreenerQuestionnaire_ENG_V1.0 ,   Attachment 2s_BABI_ScreenerQuestionnaire_SPAN_V1.0

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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	698	0	0	698	0	0
Annual Time Burden (Hours)	183	0	0	183	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: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new, one-time Information Collection.

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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: 01/22/2016

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