Pediatric Shoulder Response in Frontal Loading

Forms and Documents

Document Name	Status
Form NHTSA Form 1513 Expanation of study and signature of infomred consent form Form	New
NHTSA LODC Shoulder_Data Collection Form_FINAL.docx Supplementary Document	2019-08-22
PRA_PediatricShoulder_PartASupporting Statement_FINAL_OMB_revAug22.docx Supporting Statement A	2019-08-22

IC Document Collections

IC ID	Document Title	Status
237524	Expanation of study and signature of infomred consent form Form	New
236597	Test teardown and confirmation of data collection	New
236596	Obervational Experiment	New
236595	Test Setup	New
236594	Anthropometry measurement	New

ICR Details

OMB Control No: 2127-0743	ICR Reference No: 201906-2127-002
Status: Active	Previous ICR Reference No:
Agency/Subagency: DOT/NHTSA	Agency Tracking No: NHTSA waiting on FHWA.
Title: Pediatric Shoulder Response in Frontal Loading
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 with change	Conclusion Date: 08/22/2019
	Date Received in OIRA: 07/03/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	36 Months From Approved
Responses	120	0	0
Time Burden (Hours)	24	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This is to request the Office of Management and Budget’s (OMB) review and approval of a new National Highway Traffic Safety Administration (NHTSA) information collection request (ICR) titled “Pediatric Shoulder Response in Frontal Loading.” This research is primarily observational in nature and voluntary, in which members of the public perform a light push/pull exercise activity (similar to rowing) while their shoulder movements are observed using a motion capture system. . A signature granting consent is required because the study participants will be minors (age 6 – 14). The study details of what their child will be doing and how the observational data is used will be clearly delineated on the consent form per Institutional Review Board (IRB) requirements. The parent/guardian will be on site for the testing and in view of the participant throughout the testing, which is expected to take approximately one hour, including check-in, participant measurements, and motion capture setup tasks. The participant’s name must be included on the consent form per IRB. This is the only place their name will be collected. A test ID number will be assigned and used henceforth to document the participant’s age (from birthdate), sex, and size (from anthropometry measurements made by researchers). The consent form will be a hard copy, while all other measurements will be entered electronically via computer (associated with a test ID number). The observational aspect of this research includes a fun, low-intensity activity or game where the participant’s shoulder movement is tracked with motion capture software while resisting forces generated by the test apparatus are collected using a data acquisition system. The activity, which resembles a rowing motion, will simulate the shoulder motions experienced in a crash event, but at a much lower intensity. The forces generated with respect to the movements are used to develop a “response target” that serves as design guidance for the relevant crash dummy component. The age/sex/anthropometry collection will provide contractor/NHTSA researchers with independent variables for the purpose of binning and normalizing the experimental responses to a particular child dummy size. For example, responses from males age 6 – 8 that have a shoulder breadth in a certain range may be compared with responses from males age 9 – 11 having the same shoulder breadth range to determine if there is a statistical difference between those cohorts. If there is no statistical difference between cohorts, then observational data from both cohorts may be combined to create the response target for the LODC.

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Authorizing Statute(s): US Code: 49 USC 30182 Name of Law: Motor Vehicle Safety
  

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:
	83 FR 46253	09/12/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 19153	05/03/2019
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Test teardown and confirmation of data collection
Anthropometry measurement
Test Setup
Obervational Experiment
Expanation of study and signature of infomred consent form	NHTSA Form 1513	NHTSA LODC Shoulder_Parental Permission Form

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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	120	0	0	120	0	0
Annual Time Burden (Hours)	24	0	0	24	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: There is a program change because of this new data collection whereby an additional 24 burden hours will be added to NHTSA’s overall burden total.

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Annual Cost to Federal Government: $135,469

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.     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: 07/03/2019

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