Web-based Resource for Youth about Clinical Research (NHLBI)

Forms and Documents

Document Name	Status
Form 11 Pre-Post Feedback Study Questionnaire Form and Instruction	New
Form 10 One-toOne Evaluation Study Questionnaire Form and Instruction	New
Form 9 Individual Interview Questions (Comic Book) Form and Instruction	New
Form 8 Individual Interview Questions (Family Spotlights) Form and Instruction	New
Form 7 Individual Interview Questions (Feature Stories) Form and Instruction	New
Form 6 Pre-Post Feedback Study Cheld Assent Form Form and Instruction	New
Form 5 One-to-One Evaluation Study Child Assent Form Form and Instruction	New
Form 4 Individual Interview Child Assent Form Form and Instruction	New
Form 3 Pre-Post Feedback Study Parent Permission Form and Instruction	New
Form 2 One-to-One Evaluation Study Parent Permission Form and Instruction	New
Form 1 Individual Interview Parent Permission Form Form and Instruction	New
SSA_Web-based Resource about Clinical Trials_revised.doc Supporting Statement A	2015-08-04
Attachment R_IRB Approval Page with Signature.pdf Supplementary Document	2015-07-30
Attachment O_IRB Proposal.doc Supplementary Document	2015-07-30

IC Document Collections

IC ID	Document Title	Status
217719	Pre-Post Feedback Study Questionnaire Form and Instruction	New
217718	One-toOne Evaluation Study Questionnaire Form and Instruction	New
217717	Individual Interview Questions (Comic Book) Form and Instruction	New
217716	Individual Interview Questions (Family Spotlights) Form and Instruction	New
217715	Individual Interview Questions (Feature Stories) Form and Instruction	New
217714	Pre-Post Feedback Study Cheld Assent Form Form and Instruction	New
217713	One-to-One Evaluation Study Child Assent Form Form and Instruction	New
217712	Individual Interview Child Assent Form Form and Instruction	New
217711	Pre-Post Feedback Study Parent Permission Form and Instruction	New
217710	One-to-One Evaluation Study Parent Permission Form and Instruction	New
217709	Individual Interview Parent Permission Form Form and Instruction	New

ICR Details

OMB Control No: 0925-0729	ICR Reference No: 201507-0925-009
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Web-based Resource for Youth about Clinical Research (NHLBI)
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: Improperly submitted	Conclusion Date: 11/24/2015
	Date Received in OIRA: 08/28/2015
Terms of Clearance: *Re-submit with SSB and stat methods box marked.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		10/31/2016
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The benefits and necessities for this particular research on pediatric clinical trials are congruent with NHLBI's research goals and mission statement: attempting to assist in the enhancement of the health of individuals so that they can live longer and more fulfilling lives. The current lack of knowledge surrounding pediatric clinical trials can be dangerous and unhealthy towards the lives of youth, becoming a large public health need. The proposed project will involve the development of a comprehensive web-based resource for youth with chronic illnesses or diseases that will attempt to increase knowledge, self-efficacy, and positive attitudes towards participation in various clinical trials and research.

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Authorizing Statute(s): None

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 13013	03/12/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 50857	08/27/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Pre-Post Feedback Study Parent Permission	3	Attachment M Pre-Post Feedback Study Parent Permission
Individual Interview Questions (Feature Stories)	7	Attachment B Individual Interview Questions (Feature Stories)
Individual Interview Questions (Family Spotlights)	8	Attachment C Individual Interview Questions (Family Spotlights)
One-toOne Evaluation Study Questionnaire	10	Attachment H One-to One Evaluation Study Questionnaire
Pre-Post Feedback Study Questionnaire	11	Attachment L Pres-Post Feedback Study Questionnaire
Individual Interview Parent Permission Form	1	Attachment E Individual Interview Parent Permission Form
One-to-One Evaluation Study Parent Permission	2	Attachment I One-to-One Evaluation Study Parent Permission
Individual Interview Child Assent Form	4	Attachment F Individual Interview Child Assent Form
One-to-One Evaluation Study Child Assent Form	5	Attachment J One-toOne Evaluation Study Child Assent Form
Pre-Post Feedback Study Cheld Assent Form	6	Attachment N Pre-Post Feedback Study Child Assent Form
Individual Interview Questions (Comic Book)	9	Attachment D Individual Interview Questions (Comic Book)

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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 ICR.

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Annual Cost to Federal Government: $98,561

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]? 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: 08/28/2015

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