Balance After Baby Intervention

Forms and Documents

Document Name	Status
Form 0920-15BEB Block Food Frequency Questionnaire Form and Instruction	Modified
BABI 24 - Month Questionnaire Form and Instruction	Modified
BABI 18 - Month Questionnaire Form and Instruction	Modified
BABI 12 - Month Questionnaire Form and Instruction	Modified
BABI 6 - Month Questionnaire Form and Instruction	Unchanged
BABI 6 - Week Questionnaire Form and Instruction	Unchanged
Form 0920-15BEB BABI Screener Questionnaire Form and Instruction	Unchanged
BABI (1115) Change Request 05_08_18.docx Justification for No Material/Nonsubstantive Change	2018-05-31
BABI (1115) Change Request_10_31_17.docx Justification for No Material/Nonsubstantive Change	2017-11-02
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	Modified
219654	BABI 24 - Month Questionnaire Form and Instruction	Modified
219653	BABI 18 - Month Questionnaire Form and Instruction	Modified
219649	BABI 12 - Month Questionnaire Form and Instruction	Modified
219642	BABI 6 - Month Questionnaire Form and Instruction	Unchanged
219641	BABI 6 - Week Questionnaire Form and Instruction	Unchanged
219639	BABI Screener Questionnaire Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-1115	ICR Reference No: 201805-0920-009
Status: Historical Active	Previous ICR Reference No: 201711-0920-001
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1115-18AJY
Title: Balance After Baby Intervention
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: 06/01/2018
	Date Received in OIRA: 05/31/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	06/30/2019	06/30/2019
Responses	635	0	698
Time Burden (Hours)	169	0	187
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. Changes to the questionnaires are requested to allow for some participants to complete the final survey at 12 or 18 months, instead of 24. This will result in a slight decrease in total burden.

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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 12 - Month Questionnaire	none, none, none, none	12 month quesionnaire -Control - English ,   12 month questionnaire - Intervention - English ,   12 month questionnaire - Control - Spanish ,   12 month questionnaire - Intervention - Spanish
BABI 18 - Month Questionnaire	none, none, none, none	18 month questionnaire - Control - English ,   18 month questionnaire - Intervention - English ,   18 month questionnaire - Control - Spanish ,   18 month questionnaire - Intervention - Spanish
BABI 24 - Month Questionnaire	none, none	End of Study questionnaire - English ,   End of Study questionnaire - Spanish
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	n/a, n/a	6-week Questionnaire (Spanish) ,   6-week Questionnaire (English)
BABI Screener Questionnaire	0920-15BEB, 15BEB	Attachment 2_BABI_ScreenerQuestionnaire_ENG_V1.0 ,   Attachment 2s_BABI_ScreenerQuestionnaire_SPAN_V1.0
BABI 6 - Month Questionnaire	n/a, n/a, n/a, n/a	6-month Quesionnaire for Control Group (English) ,   6-month Questionnaire for Intervention Group (English) ,   6-month Questionnaire for Control Group (Spanish) ,   6-month Questionnaire for Intervention Group (Spanish)

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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	635	698	0	-63	0	0
Annual Time Burden (Hours)	169	187	0	-18	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Minor changes are requested to allow for some participants to complete the study at earlier points than previously anticipated. Changes decrease the total burden by 18 hours.

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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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 05/31/2018

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