HITECH Act Breach Notification

Forms and Documents

Document	Type	Status	Availability
0990-BreachPRA Supplementary Statement.doc	Supplementary Document	Uploaded 2009-09-24	Available
0990-BreachAttachment A 092409	Supplementary Document	Uploaded 2009-09-24	Available
0990-BreachAttachment B 092409	Supplementary Document	Uploaded 2009-09-24	Available
0990-Breach_Supporting_Statement FINAL (6) 09 24 09.doc	Supporting Statement A	Uploaded 2009-09-24	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
190801	Individual Notice--Substitute Notice (posting or publishing)		New
190800	Notice to Secretary		New
190799	Media Notice		New
190798	Individual Notice substitute Notice		New
190797	Less than 500 affected individuals		New
190796	500 or more affected Individuals		New
190795	Individual Notice Written and E-mail Notice		New

ICR Details

OMB Control No: 0990-0346	ICR Reference No: 200909-0990-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: HITECH Act Breach Notification
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 09/25/2009
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/25/2009
	Date Received in OIRA: 09/24/2009
Terms of Clearance: This ICR is approved on an emergency basis consistent with OCR's supplementary memo on the burden estimates. OCR should promptly begin the process for obtaining full PRA clearance upon receipt of this notice of action. As agreed, OCR will publish this updated PRA burden table when publishing the 60 day Federal Register notice requesting public comment on this information collection, and will explain the discrepancies. OCR's efforts to ensure the accuracy of the burden estimates are greatly appreciated.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2010	6 Months From Approved
Responses	514	0	0
Time Burden (Hours)	265,733	0	0
Cost Burden (Dollars)	1,774,068	0	0

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Abstract: The purpose of this media notification, which must be provided in addition to individual notification, is not to alert affected individuals of the breach. The purpose of media notification is to alert the public that a covered entity has experienced a breach.

Emergency Justfication: The breach notification interim final regulation was published in the Federal Register on August 24, 2009 (74 FR 42740). This regulation goes into effect September 23, 2009. Due to the short length of time between the publication date and the effective date of the regulation, the Office for Civil Rights used an emergency process to approve the information collection associated with the regulation.

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Authorizing Statute(s): US Code: 13 USC 13402 Name of Law: Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009
   PL: Pub.L. 111 - 5 13402 Name of Law: the Health Insurance Portability and Accountability Act of 1996
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 5 13402 Name of Law: Health Insurance Portability and Accountability Act of 1996

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0991-AB56	Final or interim final rulemaking	74 FR 42740	08/24/2009

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Individual Notice Written and E-mail Notice
500 or more affected Individuals
Less than 500 affected individuals
Individual Notice--Substitute Notice (posting or publishing)
Individual Notice substitute Notice
Media Notice
Notice to Secretary

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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	514	0	514	0	0	0
Annual Time Burden (Hours)	265,733	0	265,733	0	0	0
Annual Cost Burden (Dollars)	1,774,068	0	1,774,068	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: This is a new collection.

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Annual Cost to Federal Government: $500,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 09/24/2009

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