[Federal Register Volume 74, Number 44 (Monday, March 9, 2009)]
[Notices]
[Pages 10053-10055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4830]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Evaluation of Potential Data Sources for the Sentinel 
Initiative

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the proposed information collection through 
a survey designed to identify potential data sources and/or data 
environments that could participate in the Sentinel Initiative to 
create a national, electronic distributed system, strengthening FDA's 
ability to monitor the postmarket performance of a medical product.

DATES: Submit written or electronic comments on the collection of 
information by May 8, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information

[[Page 10054]]

Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794. To obtain a copy of the draft survey 
instrument contact Tomeka Arnett on 301-827-1512.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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.
---------------------------------------------------------------------------

    \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.)
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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) 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 follow up, 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.
    FDA estimates the burden of this collection of information as 
follows:

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


[[Page 10055]]

    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 1 
survey for a total of 6,125 hours (250 x 1 x 24.5 = 6,125).

    Dated: February 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4830 Filed 3-6-09; 8:45 am]
BILLING CODE 4160-01-S