[Federal Register Volume 74, Number 171 (Friday, September 4, 2009)]
[Notices]
[Pages 45858-45859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21364]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0098]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Evaluation of 
Potential Data Sources for the Sentinel Initiative

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES:  Fax written comments on the collection of information by 
October 5, 2009.

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title, ``Evaluation of Potential Data Sources for the Sentinel 
Initiative.'' Also include the FDA docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794, [email protected].

SUPPLEMENTARY INFORMATION:  In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Evaluation of Potential Data Sources for the Sentinel Initiative

    In September 2005, the Secretary of Health and Human Services (the 
Secretary) asked FDA to expand its current system for monitoring 
medical product performance. The Secretary asked FDA to explore the 
possibility of working in collaboration with multiple healthcare data 
systems to augment FDA's capability of identifying and evaluating 
product safety information beyond its existing voluntary reporting 
systems. Such a step would strengthen FDA's ability, ultimately, to 
monitor the performance of a product after marketing approval. The 
Secretary recommended that FDA explore creating a public-private 
collaboration as a framework for such an effort leveraging increasingly 
available large, electronic healthcare databases and taking advantage 
of emerging technologies and building on existing systems and efforts, 
rather than creating new systems.
    In 2006, the Institute of Medicine (IOM) issued a report entitled 
``The Future of Drug Safety--Promoting and Protecting the Health of the 
Public.''\1\ Among other suggestions, this IOM report recommended FDA 
identify ways to access other health-related databases and create a 
public-private partnership to support safety and efficacy studies.
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    \1\ Institute of Medicine, ``The Future of Drug Safety--
Promoting and Protecting the Health of the Public,'' September 22, 
2006, http://www.iom.edu/. (FDA has verified the Web site address, 
but FDA is not responsible for any subsequent changes to the Web 
site after this document publishes in the Federal Register.)
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    In 2007, Congress enacted the Food and Drug Administration 
Amendments Act of 2007\2\ (FDAAA). Section 905 of FDAAA calls for the 
Secretary to develop methods to obtain access to disparate data sources 
and to establish an active postmarket risk identification and analysis 
system that links and analyzes 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. FDA views the Sentinel Initiative as a mechanism 
through which this mandate can be carried out.
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    \2\ Food and Drug Administration Amendments Act of 2007, Public 
Law 110-85, was signed into law in September 2007. See Title IX, 
Section 905.
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    Consistent with FDA's mission to protect and promote the public 
health, FDA is embarking on the Sentinel Initiative to create a 
national, electronic distributed system, strengthening FDA's ability to 
monitor the post-market performance of a product. As currently 
envisioned, the Sentinel Initiative will enable FDA to capitalize on 
the capabilities of multiple, existing data systems (e.g. electronic 
health record systems and medical claims databases)

[[Page 45859]]

to augment the agency's current surveillance capabilities. The proposed 
system will enable queries of distributed data sources quickly and 
securely for relevant product safety information. Data will continue to 
be managed by its owners, and only data of organizations who agree to 
participate in this system will be included. Operations will adhere to 
strict privacy and security safeguards.
    The success of this Initiative will depend largely on the content, 
quality, searchability, and responsiveness of participating data 
sources and/or data environments. It is essential that FDA understand 
the strengths and limitations of potential data sources that might be 
included in the Sentinel Initiative. This survey will be used to 
collect information from potentially participating data sources and/or 
environments. The data we are seeking will describe the characteristics 
of the data available, not personally identifiable information. The 
findings will help FDA plan for this proposed system and for future 
work related to the Sentinel Initiative.
    This survey will collect information on the scope, content, 
structure, quality, and timeliness of data; patient population(s), 
duration of followup, and capture of care across all settings; 
availability, experience, and interest of investigators with knowledge 
of the data in using it for post-market product safety surveillance as 
well as plans for further data source enhancements; availability, 
experience, and interest of investigators with knowledge of the data in 
participating in a distributed data system; and barriers that exist to 
including each data source in the Sentinel Initiative.
    In the Federal Register of March 9, 2009 (74 FR 10053), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions to which one comment was received but was outside 
the scope of the PRA.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                      No. of         Annual Frequency       Total Annual        Hours per
   Activity        Respondents         per Response          Responses           Response         Total Hours
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Data Source                   250                     1                250               24.5              6,125
 and/or
 Environment
 Survey
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that approximately 250 respondents will participate 
in this voluntary survey. These respondents will consist mostly of 
other Federal agencies, health plan data sources, health information 
exchanges, large multi-specialty medical groups and academic medical 
centers, large hospital systems, pharmacies, medical societies, 
consumer-oriented Web sites, commercial data sets, research networks, 
lab data, and registries.
    Each respondent will extend approximately 24.5 hours to complete 
one survey for a total of 6,125 hours (250 x 1 x 24.5 = 6,125).

    Dated: August 27, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21364 Filed 9-3-09; 8:45 am]
BILLING CODE 4160-01-S