Emergency Medical Services (EMS) Sleep Health and Fatigue Education

Forms and Documents

Document Name	Status
Form 1466 Study Subset for Additional Collection Form and Instruction	New
Form 1463 Study Form and Instruction	New
Form 1462 Consenting Process Form and Instruction	New
Form 1461 Individual Screening Form and Instruction	New
Form 1460 Agency Screening Form and Instruction	New
Appendix D ClinicianLevelStudyFlyer.docx Supplementary Document	2018-11-07
Appendix C AgencyLevelStudyFlyer.docx Supplementary Document	2018-11-07
Appendix B Graphical Summary of Study and Method.docx Supplementary Document	2018-11-07
Appendix A Question Justification.docx Supplementary Document	2018-11-07
Section B FatigueEMSExperimentalStudy 09252018.docx Supporting Statement B	2018-11-07
Section A FatigueEMSExperimentalStudy 07292019.docx Supporting Statement A	2019-08-02

IC Document Collections

IC ID	Document Title	Status
233941	Study Subset for Additional Collection Form and Instruction	New
233940	Study Form and Instruction	New
233939	Consenting Process Form and Instruction	New
233938	Individual Screening Form and Instruction	New
233937	Agency Screening Form and Instruction	New

ICR Details

OMB Control No: 2127-0742	ICR Reference No: 201811-2127-003
Status: Active	Previous ICR Reference No:
Agency/Subagency: DOT/NHTSA	Agency Tracking No:
Title: Emergency Medical Services (EMS) Sleep Health and Fatigue Education
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: 08/02/2019
	Date Received in OIRA: 12/07/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	36 Months From Approved
Responses	5,930	0	0
Time Burden (Hours)	10,141	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The National Highway Traffic Safety Administration (NHTSA) proposes to collect information from Emergency Medical Services (EMS) personnel who operate ambulances on the roadway for a onetime voluntary study to evaluate the effectiveness of a fatigue mitigation intervention that delivers education and training. Up to 200 EMS agencies across the United States will be contacted and screened in order to recruit a total of 30 agencies to participate in the study. NHTSA anticipates contacting up to 100 EMS personnel per participating agency (3,000 total) to screen and recruit 1,500 eligible participants for the study. NHTSA expects 1,200 voluntary participants to complete the sign-up process, including providing demographic information and shift schedules, and to consent to participate in the 24-week study. Participants will complete a baseline survey that includes self-reported fatigue and sleepiness and will retake the survey halfway through the study and again at the end of the study. All participants will complete the ten ten-minute training modules during the study period. Once the study is underway, participants will be asked to respond to daily text messages about sleepiness and fatigue for eight weeks of the 24-week study. Finally, NHTSA will ask 30 of the 1,200 participants to provide additional information by keeping a daily sleep diary for eight weeks and by taking a brief vigilance task test to measure fatigue at the beginning and end of each shift over eight days.

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Authorizing Statute(s): US Code: 23 USC 403 Name of Law: Highway Safety 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:
	83 FR 33306	07/17/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 49979	10/03/2018
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
Consenting Process	1462	Video Consent Slides
Agency Screening	1460	EMS Agency Telephone Screening Form
Individual Screening	1461	Individual level screening form
Study	1464, 1463, 1465	Baseline Survey ,   Follow-up Survey ,   Text Message Queries
Study Subset for Additional Collection	1467, 1466	Sleep diary ,   Psychomotor Vigilance Test

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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	5,930	0	0	5,930	0	0
Annual Time Burden (Hours)	10,141	0	0	10,141	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 information collection supporting NHTSA's behavioral safety research program and its efforts to improve Emergency Medical Services. As such, it requires a program change to add the estimated 10,141 hours for the new information collection to existing burden.

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Annual Cost to Federal Government: $159,353

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.     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: 12/07/2018

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