[Federal Register: March 9, 2009 (Volume 74, Number 44)]
[Notices]
[Page 10053-10055]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09mr09-60]
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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.
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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.
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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) 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\
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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.
[[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