Evaluation of Potential Sources for the Sentinel Initiative

Forms and Documents

Document Name	Status
sentinel ss part b 2-17-2010.doc Supporting Statement B	2010-02-17
Sentinel Survey Instructions 8-25-09.doc Supplementary Document	2009-09-01
sentinel ss part a 2-17-2010.doc Supporting Statement A	2010-02-17

IC Document Collections

IC ID	Document Title	Status
190617	Evaluation of Potential Sources for the Sentinel Initiative Other-evaluation	New

ICR Details

OMB Control No: 0910-0657	ICR Reference No: 200909-0910-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Evaluation of Potential Sources for the Sentinel Initiative
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 with change	Conclusion Date: 02/26/2010
	Date Received in OIRA: 09/10/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2013	36 Months From Approved
Responses	250	0	0
Time Burden (Hours)	6,125	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Section 905 of FDAAA calls for the Health and Human Services Secretary to develop methods to obtain access to disparate data sources and to establish a postmarket risk identification and analysis system to link and analyze healthcare data from multiple sources. The law sets a goal of access to data from 25 million patients by July 1, 2010, and 100 million patients by July 1, 2012. The law also requires FDA to work closely with partners from public, academic, and private entities.

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Authorizing Statute(s): PL: Pub.L. 110 - 85 905 Name of Law: FDAAA
  

Citations for New Statutory Requirements: PL: Pub.L. 110 - 85 905 Name of Law: FDAAA

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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:
	74 FR 10053	03/09/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 45858	09/04/2009
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Evaluation of Potential Sources for the Sentinel Initiative

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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	250	0	250	0	0	0
Annual Time Burden (Hours)	6,125	0	6,125	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: This is a one time collection of information as a result of FDAAA, which mandates FDA to establish an active surveillance system for monitoring drugs, using electronic data from healthcare information holders. The Sentinel Initiative is the FDA's response to that mandate. Its goal is to build and implement a new active surveillance system that will eventually be used to monitor all FDA-regulated products.

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Annual Cost to Federal Government: $96,532

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]? 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)? 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: 09/10/2009

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