Evaluation of Potential Sources for the Sentinel Initiative

ICR 200909-0910-004

OMB: 0910-0657

Federal Form Document

Forms and Documents
Supporting Statement B
Supplementary Document
Supporting Statement A
IC Document Collections
ICR Details
0910-0657 200909-0910-004
Historical Active
Evaluation of Potential Sources for the Sentinel Initiative
New collection (Request for a new OMB Control Number)   No
Approved with change 02/26/2010
Retrieve Notice of Action (NOA) 09/10/2009
  Inventory as of this Action Requested Previously Approved
02/28/2013 36 Months From Approved
250 0 0
6,125 0 0
0 0 0

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.

PL: Pub.L. 110 - 85 905 Name of Law: FDAAA
PL: Pub.L. 110 - 85 905 Name of Law: FDAAA

Not associated with rulemaking

  74 FR 10053 03/09/2009
74 FR 45858 09/04/2009

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

  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
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.

Yes Part B of Supporting Statement
Jonnalynn Capezzuto 3018274659


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:
    (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;
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.

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