Health Breach Notification Rule

Forms and Documents

Document Name	Status
HIT SS for Final rule_mtd.pdf Supporting Statement A	2009-09-22

IC Document Collections

IC ID	Document Title	Status
188849	Creating a toll-free line & related non-labor costs	Modified
188848	Identifying breach, affected customers, notifying customers, etc.	Modified

ICR Details

OMB Control No: 3084-0150	ICR Reference No: 200909-3084-002
Status: Historical Active	Previous ICR Reference No: 200904-3084-002
Agency/Subagency: FTC	Agency Tracking No:
Title: Health Breach Notification Rule
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: 09/23/2009
	Date Received in OIRA: 09/22/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2012	36 Months From Approved
Responses	22	0	0
Time Burden (Hours)	34,837	0	0
Cost Burden (Dollars)	260,657	0	0

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Abstract: The American Recovery and Reinvestment Act of 2009 ("Recovery Act") requires the Department of Health and Human Services to study, in consultation with the FTC, potential privacy, security, and breach notification requirements and submit a report to Congress containing recommendations within one year of enactment of the Recovery Act. Until Congress enacts new legislation implementing any recommendations contained in the HHS/FTC report, the Recovery Act contains temporary requirements, to be enforced by the FTC, that such entities notify customers in the event of a security breach. The proposed rule implements these requirements.

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Authorizing Statute(s): PL: Pub.L. 111 - 5 13407 Name of Law: American Recovery and Reinvestment Act of 2009
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 5 13407 Name of Law: American Recovery and Reinvestment Act of 2009

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
3084-AB17	Final or interim final rulemaking	74 FR 42962	08/25/2009

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Federal Register Notices & Comments

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
Creating a toll-free line & related non-labor costs
Identifying breach, affected customers, notifying customers, etc.

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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	22	0	22	0	0	0
Annual Time Burden (Hours)	34,837	0	34,837	0	0	0
Annual Cost Burden (Dollars)	260,657	0	260,657	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 rule having provisions requiring notification to consumers and to the Commission; thus, there are "collection(s) of information" subject to the PRA.

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Annual Cost to Federal Government: $300,000

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: 09/22/2009

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