Examining Traumatic Brain Injury in Youth

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
TBI Records Data Tool	Form	New	Repair queued
Supporting Statement B.docx	Supporting Statement B	Uploaded 2014-02-06	Repair queued
Attachment D - IRB Approval Letter.pdf	Supplementary Document	Uploaded 2014-02-06	Repair queued
Attachment B - Published 60-FRN.pdf	Supplementary Document	Uploaded 2014-02-05	Repair queued
Attachment A - Authorizing Legislation.docx	Supplementary Document	Uploaded 2014-02-05	Repair queued
Supporting Statement A - 2-11-2014.docx	Supporting Statement A	Uploaded 2014-02-11	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
210349	TBI Records Data Tool	Form	New

ICR Details

OMB Control No:	ICR Reference No: 201402-0920-010
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 21401
Title: Examining Traumatic Brain Injury in Youth
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: Not subject to PRA	Conclusion Date: 04/04/2014
	Date Received in OIRA: 02/12/2014
Terms of Clearance: While data abstraction of the type described in the package (medical records abstraction) is subject to the PRA (see for instance, the NCHS Hospital Care Survey), this particular collection does not trigger the PRA because it is only gathering data from 2 facilities. Although 50+ patient records are being examined, the “respondent” in this collection is the facility – not the patient – so the number of respondents does not exceed 9 and does not trigger the PRA.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		12 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: In 1996, Congress passed Public Law 104-166, the Traumatic Brain Injury Act, which charged CDC with implementing projects to reduce the incidence of traumatic brain injury. The CDC definition of TBI uses selected codes of the International Classification of Diseases, 9th Clinical Modification (ICD-9 CM) to identify cases of TBI from hospital and non-hospital databases containing billing records for services rendered to patients. It is thought, however, that the ICD-9 CM codes currently used in CDC's surveillance system to capture cases of TBI are not sufficiently sensitive to capture diagnosed TBI. CDC, therefore, would like to collect de-identified medical information of a representative sample of pediatric patients, from two clinical settings, who received a confirmed diagnosis of mild to severe TBI and link these patients to their administrative medical claims forms.

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Authorizing Statute(s): US Code: 42 USC 301 Name of Law: Public Health Service 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:
	78 FR 53764	08/30/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 7457	02/07/2014
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
TBI Records Data Tool	none	Data Extraction Tool

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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 data collection request.

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Annual Cost to Federal Government: $39,876

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 02/12/2014

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