Generic Clearance to Support the Safe to Sleep Campaign at the Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD)

Forms and Documents

Document Name	Status
Form 1 Risk Reduction for Sudden Infant Death Syndrome (SIDS) and Other Sleep-Related Causes of Infant Death: Continuing Education Activity for Nurses (NICHD) Form and Instruction	New
Form 2 Risk Reduction for Sudden Infant Death Syndrome (SIDS) and Other Sleep-Related Causes of Infant Death: Continuing Education Activity for Nurses (NICHD) Form	New
Form 1 Kappa Safe Infant Sleep Community Engagement Project (NICHD) Form and Instruction	New
Form 1 Sub-Study Alabama Outreach (NICHD) Form and Instruction	New
30day FRN2017-24399.pdf Supplementary Document	2017-11-09
0925-0701_Safe to Sleep Generic_NICHD_Information Collection Instruments.pdf Supplementary Document	2017-11-01
0925-0701_NICHD_Safe to Sleep_SSA.rev 10.24.17_OMB - FINAL submission 2.2.18.docx Supporting Statement A	2018-02-02
0925-0701_NICHD_Safe to Sleep_Attach 1_Sub-study Memo Template.doc Supplementary Document	2017-10-31

IC Document Collections

IC ID	Document Title	Status
244246	Risk Reduction for Sudden Infant Death Syndrome (SIDS) and Other Sleep-Related Causes of Infant Death: Continuing Education Activity for Nurses (NICHD) Form and Instruction	New
233726	Risk Reduction for Sudden Infant Death Syndrome (SIDS) and Other Sleep-Related Causes of Infant Death: Continuing Education Activity for Nurses (NICHD) Form	New
231956	Kappa Safe Infant Sleep Community Engagement Project (NICHD) Form and Instruction	New
230667	Sub-Study Alabama Outreach (NICHD) Form and Instruction	New

ICR Details

OMB Control No: 0925-0701	ICR Reference No: 201710-0925-003
Status: Active	Previous ICR Reference No: 201403-0925-009
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Generic Clearance to Support the Safe to Sleep Campaign at the Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD)
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/26/2018
	Date Received in OIRA: 11/13/2017
Terms of Clearance: All sub-studies submitted under this Generic will include the instruments used and a justification for any incentives provided for participation..

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2021	36 Months From Approved
Responses	49,170	0	0
Time Burden (Hours)	12,920	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The campaign regularly assesses activities so feedback can be incorporated in a timely manner to better target campaign messages to audiences and improve training workshops. Frequent reporting creates opportunities for adjustments to prevent shortcomings and address concerns quickly. A Reinstatement with Change for the Generic Clearance to Support the Safe to Sleep Campaign at the Eunice Kennedy Shriver National Institute for Child Health and Human Development will allow campaign staff to: 1) gather feedback on campaign activities expeditiously and effectively; 2) be better able to monitor and improve campaign implementation; and 3) assess the utilization and practice activities of target audiences. The STS campaign generic clearance will fill a need that exists at NICHD to assess the STS campaign activities, particularly the train-the-trainer, mini-grant, and continuing education programs.

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Authorizing Statute(s): US Code: 42 USC 285 Name of Law: The Public Health Service Act
  

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:
	82 FR 40776	08/28/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 52063	11/09/2017
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Kappa Safe Infant Sleep Community Engagement Project (NICHD)	2, 3, 1	KAPPA Activity Tracker ,   KAPPA Mini-Grant Applicaiton ,   Kappa Before After Activity Knowledge Check
Sub-Study Alabama Outreach (NICHD)	1, 3, 2	Alabama Outreach Standard applicaiton ,   Alabama Outreach Activity Tracking ,   Alabama Outreach BeforeAndAfter Activity Knowledge Check
Risk Reduction for Sudden Infant Death Syndrome (SIDS) and Other Sleep-Related Causes of Infant Death: Continuing Education Activity for Nurses (NICHD)	1	Nurses CE follow up survey
Risk Reduction for Sudden Infant Death Syndrome (SIDS) and Other Sleep-Related Causes of Infant Death: Continuing Education Activity for Nurses (NICHD)	1, 3, 2, 4	Nurses CE Post Test ,   Nurses CE Pre-Test ,   Nurses CE Satisfaction Evaluation ,   Nurses CE Follow-Up survey

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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	49,170	0	0	49,170	0	0
Annual Time Burden (Hours)	12,920	0	0	12,920	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: Changes have been made to the estimated burden hours based on anticipated activities for next 3 years. Because the STS National Champions substudy is no longer active, the need for tracking/feedback forms is greatly reduced. We do not anticipate needing many focus groups or interviews, so those are reduced as well. We do anticipate more pre-/post-tests under this generic clearance due to a plan to request clearance for the STS continuing education activity.

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Annual Cost to Federal Government: $44,769

Does this IC contain surveys, censuses, or employ statistical methods? No

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.     Yes

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: 11/13/2017

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