Prevalence of Alcohol and Other Drug Use among Motor Vehicle Crash Victims Admitted to Select Trauma Centers

Forms and Documents

Document Name	Status
Form 1421 Alcohol and Drug Prevalence Form	New
Form 1422 Control Driver Questionnaire Form and Instruction	Removed
Form 1421 Control Driver Verbal Consent Form and Instruction	Removed
Data Collection Justification Appendix A July 17 2019.docx Supplementary Document	2019-07-17
Part B Supporting Statement 071619 AOD Prevelence Study - revised FINAL.docx Supporting Statement B	2019-09-05
Part A Supporting Statement - AOD Prevelence Study - revised FINAL.docx Supporting Statement A	2019-09-05

IC Document Collections

IC ID	Document Title	Status
236916	Alcohol and Drug Prevalence Form	New
233188	Control Driver Questionnaire Form and Instruction	Removed
233185	Control Driver Verbal Consent Form and Instruction	Removed

ICR Details

OMB Control No: 2127-0744	ICR Reference No: 201907-2127-001
Status: Active	Previous ICR Reference No: 201809-2127-001
Agency/Subagency: DOT/NHTSA	Agency Tracking No:
Title: Prevalence of Alcohol and Other Drug Use among Motor Vehicle Crash Victims Admitted to Select Trauma Centers
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: 09/05/2019
	Date Received in OIRA: 07/24/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2022	36 Months From Approved
Responses	7,500	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The National Highway Traffic Safety Administration (NHTSA) seeks to examine the prevalence of legal and illegal drugs in the systems of seriously- and fatally-injured drivers and other crash-involved road users (e.g., passengers, pedestrians, bicyclists, and scooter riders) presenting directly to the selected trauma centers or morgues. The participating trauma centers and medical examiners will provide the study with de-identified blood samples, when available, that were already collected during their routine clinical treatment activities. The study will then conduct independent drug toxicology testing to determine the prevalence of alcohol and other drugs in the systems of the participants. The trauma centers and medical examiners will also provide the study with other de-identified participant classification information such as patient demographics, cause of injury, and injury severity. The trauma centers and medical examiners will provide this already-collected and de-identified information to the study in accordance with all applicable Federal, State, and local regulations governing the sharing of such information and as approved by the study IRB. The trauma centers and medical examiners at the selected study sites universally draw patients’ blood for clinical treatment or autopsy purposes. The trauma centers and medical examiners also collect other information such as patient demographics, cause of injury, injury severity, and drugs administered during treatment as part of their normal operating procedures. Therefore, there is no estimated time burden on the participants as the trauma centers and medical examiners will be providing the study with de-identified blood samples already collected, but not used, during their routine clinical procedures, and other de-identified information that was already collected as part of their routine clinical documentation procedures.

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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:
	84 FR 17233	04/24/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 34045	07/16/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Control Driver Verbal Consent	1421	Control Driver Verbal Consent
Alcohol and Drug Prevalence	1421	De-identified Data Provided by Trauma Center or Medical Examiner
Control Driver Questionnaire	1422	Control Driver Questionnaire

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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	7,500	0	0	7,500	0	0
Annual Time Burden (Hours)	0	0	0	0	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $787,620

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: 07/24/2019

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