HIPAA Covered Entity and Business Associate Pre-Audit Survey

Forms and Documents

Document Name	Status
0945-0007Non-substantial change memo to OMB (2).pdf Justification for No Material/Nonsubstantive Change	2015-11-25
0945_ToSFC_050914SectionBStatMeth_OCRPreAuditSurv05072014.doc Supporting Statement B	2014-05-16
draft OMB update_03 12 2015_OCR PreAudit Survey Justification.doc Supporting Statement A	2015-03-13

IC Document Collections

IC ID	Document Title	Status
211636	Questionnaire - Business Associate Administrator Other-questionnaire	Modified
211635	Questionnaire - Covered Entity Administrator or Privacy Officer(s) Other-questionnaire	Modified

ICR Details

OMB Control No: 0945-0007	ICR Reference No: 201511-0945-001
Status: Historical Active	Previous ICR Reference No: 201405-0945-002
Agency/Subagency: HHS/OCR	Agency Tracking No:
Title: HIPAA Covered Entity and Business Associate Pre-Audit Survey
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/02/2015
	Date Received in OIRA: 11/27/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2018	03/31/2018	03/31/2018
Responses	700	0	700
Time Burden (Hours)	350	0	350
Cost Burden (Dollars)	0	0	0

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Abstract: The respondent will provide basic descriptive information about their organization. They will provide information including, but not limited to a verification of being a covered entity, the type of health care organization, the number of patients, members or transactions, their use of technology, their total revenue per fiscal year and other questions to assist OCR in determining if they are eligible candidates for HIPAA compliance audits.

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Authorizing Statute(s): PL: Pub.L. 42 - 179 13411 Name of Law: The Health Information Technology for Economic and Clinical Health 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 10158	02/24/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 26963	05/12/2014
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
Questionnaire - Covered Entity Administrator or Privacy Officer(s)
Questionnaire - Business Associate Administrator

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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	700	700	0	0	0	0
Annual Time Burden (Hours)	350	350	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: $85,000

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 11/27/2015

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