Traumatic Brain Injury (TBI) Surveillance System

Forms and Documents

Document Name	Status
Adolescent Survey - Adolescent 13-17 years of age Form and Instruction	New
Adolescent Screener - Adolescent 13-17 years of age Form and Instruction	New
Adult Proxy Survey - Adults 18 or older Form and Instruction	New
Adult Proxy Screener - Adults 18 or older Form and Instruction	New
Eligibility Screener - Adults 18 or older Form and Instruction	New
H-1 Contact Attempt Protocols.docx Supplementary Document	2018-08-10
G-1 Table Shells.docx Supplementary Document	2018-08-10
F-10 Intro Assent for Adol - Spanish.docx Supplementary Document	2018-08-10
F-8 Consent Adult Proxy-Spanish.docx Supplementary Document	2018-08-10
F-7 Consent Adult Not Proxy-Spanish.docx Supplementary Document	2018-08-10
F-6 Introduction Script-Spanish.docx Supplementary Document	2018-08-10
F-5 Intro-Assent for Adol-English.docx Supplementary Document	2018-08-10
F-4 Consent Adult for Adol-English.docx Supplementary Document	2018-08-10
F-3 Consent Adult Proxy-English.docx Supplementary Document	2018-08-10
F-2 Consent Adult Not Proxy-English.docx Supplementary Document	2018-08-10
F-1 Introduction Script-English.docx Supplementary Document	2018-08-10
D-3 ICF IRB Approval Letter.pdf Supplementary Document	2018-08-10
D-1 Privacy Impact Assessment.pdf Supplementary Document	2018-08-08
C-1 Consultants.docx Supplementary Document	2018-08-08
B-1 60 Dy FRN.pdf Supplementary Document	2018-08-08
A-2 TBI Reauthorization Act of 2014.pdf Supplementary Document	2018-08-08
A-1 Public Health Service Act.doc Supplementary Document	2018-08-08
SSB Clean - 16AOP TBI Validation 2018.7.27.docx Supporting Statement B	2018-08-07
SSA Clean - 16AOP TBI Validation 2018.7.27.docx Supporting Statement A	2018-08-07

IC Document Collections

IC ID	Document Title	Status
232649	Adolescent Survey - Adolescent 13-17 years of age Form and Instruction	New
232648	Adolescent Screener - Adolescent 13-17 years of age Form and Instruction	New
232647	Adult Proxy Survey - Adults 18 or older Form and Instruction	New
232589	Adult Proxy Screener - Adults 18 or older Form and Instruction	New
232588	Eligibility Screener - Adults 18 or older Form and Instruction	New

ICR Details

OMB Control No: 0920-1240	ICR Reference No: 201808-0920-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-16AOP
Title: Traumatic Brain Injury (TBI) Surveillance System
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: 08/15/2018
	Date Received in OIRA: 08/14/2018
Terms of Clearance: This study is approved consistent with the understanding that the data collection is designed to support exploratory research for measure development. The data collected should not be used to develop national estimates.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2021	36 Months From Approved
Responses	6,503	0	0
Time Burden (Hours)	1,396	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Traumatic Brain Injury (TBI) Surveillance System is a case definition validation study that is designed to test the validity of a three-tiered case definition which will assess whether a TBI was sustained among adults and children during the last 12 months using parent- and self-report. Data from this study will be used to understand whether the proposed case definition and its underlying hypotheses are reflective of the data collected. In addition, the analysis should illuminate the extent to which current databases over and under estimate current TBI estimates. If validated, the new case definition will be communicated to health care professionals and researchers.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: U.S. PHSA
  

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:
	81 FR 38182	06/13/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 57587	08/23/2016
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
Eligibility Screener - Adults 18 or older	NA, NA	Eligibility Screener - English ,   Eligibility Screener - Spanish
Adult Proxy Screener - Adults 18 or older	NA, NA	Adult Proxy Screener - English ,   Adult Proxy Screener - Spanish
Adult Proxy Survey - Adults 18 or older	NA, NA	Adult Proxy Survey - English ,   Adult Proxy Survey - Spanish
Adolescent Screener - Adolescent 13-17 years of age	NA, NA	Adolescent Screener - English ,   Adolescent Screener - Spanish
Adolescent Survey - Adolescent 13-17 years of age	NA, NA, NA, NA	Adolescent Survey - English ,   Adolescent Survey - Spanish ,   Adolescent Survey (Web version) - English ,   Adolescent Survey (Web version) - Spanish

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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	6,503	0	0	6,503	0	0
Annual Time Burden (Hours)	1,396	0	0	1,396	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: Submission of Traumatic Brain Injury (TBI) Surveillance System is a New ICR.

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Annual Cost to Federal Government: $1,079,683

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: 08/14/2018

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