Healthcare Facilities Granting State Health Departments Access to Electronic Health Record Data during a Healthcare-Associated Infection Outbreak: A Retrospective Assessment

Forms and Documents

Document Name	Status
Telephone Interview Guide for Informatics Directors Form and Instruction	New
Telephone Interview Guide for Infection Preventionist, Clinic Director, or Other as Referred Form and Instruction	New
Appendix M_60 Day FRN Comment_EHR Final 02 03 15.docx Supplementary Document	2015-02-26
Appendix H_ Healthcare Facility POC_Final.docx Supplementary Document	2015-02-26
Appendix F_CDC IRB Letter of Determination.pdf Supplementary Document	2015-02-26
Appendix C _Phase I Summary Report_Final.docx Supplementary Document	2015-02-26
Appendix B_60 day published.pdf Supplementary Document	2015-02-26
Appendix_A_Authorizing_Regulations_T42_section_241.doc Supplementary Document	2015-02-26
Supporting_Statement_B_ EHR 02 18 15.docx Supporting Statement B	2015-02-26
Supporting Statement A_EHR 25FEB2015.docx Supporting Statement A	2015-02-26

IC Document Collections

IC ID	Document Title	Status
215347	Telephone Interview Guide for Informatics Directors Form and Instruction	New
215336	Telephone Interview Guide for Infection Preventionist, Clinic Director, or Other as Referred Form and Instruction	New
215333	Request for Point of Contact at Health Care Facility Instruction	New

ICR Details

OMB Control No: 0920-1075	ICR Reference No: 201502-0920-016
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 15FY
Title: Healthcare Facilities Granting State Health Departments Access to Electronic Health Record Data during a Healthcare-Associated Infection Outbreak: A Retrospective Assessment
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 without change	Conclusion Date: 06/26/2015
	Date Received in OIRA: 03/05/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2016	12 Months From Approved
Responses	165	0	0
Time Burden (Hours)	90	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The fungal meningitis outbreak experience highlights the need to better understand the landscape of granting and using access to Electronic Health Records (EHRs) for outbreak investigations. This assessment "Healthcare Facilities Granting State Health Departments Access to EHR Data During a Healthcare-Associated Infection Outbreak: A Retrospective Assessment" examines stakeholder perspectives in granting and using access to EHRs in outbreak settings. An initial data collection (Phase I) of this assessment investigated HD experiences, and this data collection (Phase II) seeks to explore healthcare facility experiences.

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Authorizing Statute(s): US Code: 42 USC 241 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:
	79 FR 71429	12/02/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 10094	02/25/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Telephone Interview Guide for Infection Preventionist, Clinic Director, or Other as Referred	None	Telephone Interview Guide for Infection Preventionist, Clinic Director, or Other as Referred
Request for Point of Contact at Health Care Facility
Telephone Interview Guide for Informatics Directors	None	Telephone Interview Guide for Informatics Directors

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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	165	0	0	165	0	0
Annual Time Burden (Hours)	90	0	0	90	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 0920-15FY is a New ICR

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Annual Cost to Federal Government: $161,342

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: 03/05/2015

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