National Survey on Health Information Exchange in Clinical Laboratories

Forms and Documents

Document Name	Status
OMB Supporting Statement Part B 2012-12-07.docx Supporting Statement B	2012-12-18
Attachment C - Cognitive Interviewing Report.pdf Supplementary Document	2012-12-18
Attachment E - Brochure.pdf Supplementary Document	2012-12-18
Attachment D - ACLA Comments.pdf Supplementary Document	2012-12-18
OMB Supporting Statement Part A 2012-12-07.docx Supporting Statement A	2012-12-18

IC Document Collections

IC ID	Document Title	Status
204574	Independent Laboratories Other-Evaluation	New
204573	Hospital -Based Laboratories Other-Evaluation	New

ICR Details

OMB Control No: 0955-0014	ICR Reference No: 201210-0955-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/ONC	Agency Tracking No:
Title: National Survey on Health Information Exchange in Clinical Laboratories
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: 12/20/2012
	Date Received in OIRA: 10/23/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2015	36 Months From Approved
Responses	4,692	0	0
Time Burden (Hours)	1,499	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Office of the National Coordinator for Health Information Technology's (ONC) Office of Economic Analysis, Evaluation, and Modeling in the Department of Health & Human Services (HHS) requests Office of Management and Budget (OMB) approval to conduct a national survey of clinical laboratories to assess laboratory information exchange capacity, as part of the evaluation of the State Health Information Exchange (HIE) Cooperative Agreement Program. The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 seeks to improve American health care delivery and patient care through an unprecedented investment in health information technology. ONC is the chief federal entity charged with coordinating nationwide efforts to implement a health IT infrastructure to enable the electronic use and exchange of health information.

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Authorizing Statute(s): US Code: 42 USC 3013 Name of Law: Public Health Service Act
   US Code: 13 USC 111-5 Name of Law: The American Recovery and Reinvestment Act of 2009
  

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:
	77 FR 37047	06/20/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 64340	10/19/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Hospital -Based Laboratories
Independent Laboratories

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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	4,692	0	0	4,692	0	0
Annual Time Burden (Hours)	1,499	0	0	1,499	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: New collection

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Annual Cost to Federal Government: $675,000

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)? Yes

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: 10/23/2012

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