HITECH Act Breach Notification

Forms and Documents

Document Name	Status
0990-BreachPRA Supplementary Statement.doc Supplementary Document	2009-12-23
0990-BreachPRA Supplementary Statement.doc Supplementary Document	2009-12-23
0990-BreachPRA Supplementary Statement.doc Supplementary Document	2009-12-23
18737 ID_0945-0001_HITECH_Omnibus_Breach_020120131.doc Supporting Statement A	2013-09-20

IC Document Collections

IC ID	Document Title	Status
205904	Individual Notice--Substitute Notice (setting up and staffing toll-free number)	New
205902	Less than 500 Affected Individuals (investigating and documenting breach)affecting	New
205901	Individual Notice--Written and E-mail Notice (processing and sending)	New
205900	Individual Notice--Written and E-mail Notice (preparing and documenting notification)	New
190801	Individual Notice--Substitute Notice (posting or publishing)	Modified
190800	Notice to Secretary(notice for breaches affecting fewer than 500 individuals)	Modified
190799	Media Notice	Modified
190798	Individual Notice substitute Notice	Modified
190797	Less than 500 affected individuals	Modified
190796	500 or more affected Individuals	Modified
190795	Individual Notice Written and E-mail Notice	Modified

ICR Details

OMB Control No: 0945-0001	ICR Reference No: 201302-0945-002
Status: Historical Active	Previous ICR Reference No: 201211-0945-001
Agency/Subagency: HHS/OCR	Agency Tracking No: 18737
Title: HITECH Act Breach Notification
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/26/2013
	Date Received in OIRA: 02/22/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2016	36 Months From Approved	09/30/2013
Responses	7,445,930	0	514
Time Burden (Hours)	321,787	0	265,733
Cost Burden (Dollars)	2,857,160	0	1,774,068

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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.

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Authorizing Statute(s): PL: Pub.L. 111 - 5 13402 Name of Law: the Health Insurance Portability and Accountability Act of 1996
   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
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0945-AA03	Final or interim final rulemaking	78 FR 5566	01/25/2013

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 52235	10/09/2009
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Less than 500 affected individuals
Individual Notice substitute Notice
Media Notice
Notice to Secretary(notice for breaches affecting fewer than 500 individuals)
Individual Notice--Written and E-mail Notice (preparing and documenting notification)
Individual Notice--Written and E-mail Notice (processing and sending)
Less than 500 Affected Individuals (investigating and documenting breach)affecting <10 individuals
Individual Notice--Substitute Notice (posting or publishing)
Individual Notice Written and E-mail Notice
500 or more affected Individuals
Individual Notice--Substitute Notice (setting up and staffing toll-free number)

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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	7,445,930	514	0	7,445,416	0	0
Annual Time Burden (Hours)	321,787	265,733	0	56,054	0	0
Annual Cost Burden (Dollars)	2,857,160	1,774,068	0	1,083,092	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This data collection is ongoing. OCR has adjusted upward the estimated number of respondents and responses, and, as a result, adjusted the annual hour burden from 265,733 to 318,765 and the annual cost burden from $1,774,068 to $14,474,969 (including capital and other costs). The revisions to the current information collection are due to information learned about the volume and nature of breaches that occur from our actual experience in administering the breach notification requirements under the interim final rule. In addition, costs have increased due to upward adjustments in hourly wage rates since the previous information 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]? 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: 02/22/2013

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