[Federal Register: July 19, 2010 (Volume 75, Number 137)]
[Notices]
[Page 41867-41868]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jy10-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Information on Development of an Inventory of
Comparative Effectiveness Research
AGENCY: Office of the Assistant Secretary for Planning and Evaluation.
ACTION: Request for Information.
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SUMMARY: The Office of the Assistant Secretary for Planning Evaluation
(ASPE) is developing a national inventory of comparative effectiveness
research (CER) and CER-related information. This initiative is driven
by the American Recovery and Reinvestment Act of 2009 (ARRA) which
provided $1.1 billion for research and development in the area of CER.
ARRA allocated $400 million to the Office of the Secretary (OS) in the
U.S. Department of Health and Human Services (HHS), $400 million to the
National Institutes of Health (NIH), and $300 million to the Agency for
Healthcare Research and Quality. ARRA also established the Federal
Coordinating Council for CER, which, after significant public input,
developed a strategic framework and recommended high-level priorities
for OS funds. While the FCC's Report to Congress drew on an initial CER
inventory focused on federal investments, the process of cataloguing
CER activities and infrastructure will be critical to tracking ongoing
and future investments in CER. An important component of this effort is
creating an inventory of CER to ensure that patients, clinicians, and
other decision makers can identify and locate relevant CER in a timely
manner.
ASPE seeks input on approaches to developing a CER Inventory that
capture ongoing and existing CER in the United States. This inventory
will be accessible to the public, including patients, clinicians, and
policymakers, through a web-based system. Comments should focus on
appropriate resources and approaches for developing the CER Inventory,
rather than the methodology of CER or suggestions for particular CER
studies that should be included in the CER Inventory. Requested
information includes suggestions regarding sources of CER and ways to
encourage participation in the inventory; comments related to
categorizing content; and approaches to ensure the CER Inventory is
useful and sustainable over time.
DATES: Submit comments by 11:59 p.m. Eastern Time on August 9, 2010.
ADDRESSES: Written or electronic comments should be submitted to HHS as
directed below.
Comments should be identified by referring to the ``CER
Inventory'', and may be submitted to the Department of HHS by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Written comments (one original and two copies) may
be mailed to: Department of Health and Human Services, Attention: CER
Inventory, Hubert H. Humphrey Building, Room 447-D, 200 Independence
Avenue, SW., Washington, DC 20201.
Hand or courier delivery: Comments may be delivered to
Room 447-D, Department of Health and Human Services, Attention: CER
Inventory, Hubert H. Humphrey Building, Room 447-D, 200 Independence
Avenue, SW., and Washington, DC 20201. Because access to the interior
of the HHH Building is not readily available to persons without Federal
Government identification, commenters are encouraged to leave their
comments in the CER Inventory drop box located in the main lobby of the
building. A stamp-in clock is available for persons wishing to retain
proof of filing by stamping in and retaining an extra copy of the
comments being filed.
Written submissions should be brief (no more than three pages per
submission), and should be in the form of a letter. Please do not
submit duplicate comments. Please do not include any personally
identifiable information (such as name, address, or other contact
information) or confidential business information that you do not want
publicly disclosed. Consequently, comments should not include any
sensitive health information from medical records or other individually
identifiable health information, or any non-public, corporate or trade
association information, such as trade secrets or other proprietary
information. Comments may be submitted anonymously.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. All comments will be made
available publicly on the internet at http://www.regulations.gov.
Follow the search instructions on that Web site to view public
comments.
FOR FURTHER INFORMATION CONTACT: Pierre Yong, Office of the Assistant
Secretary for Planning and Evaluation, Department of Health and Human
Services, (202) 690-8384, Pierre.Yong@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The American Recovery and Reinvestment Act of 2009 (ARRA) provided
funding of $1.1 billion for CER and related activities, and established
the Federal Coordinating Council for Comparative Effectiveness
Research, which defined CER as the:
Conduct and synthesis of research comparing the benefits and
harms of different interventions and strategies to prevent,
diagnose, treat and monitor health conditions in ``real world''
settings. The purpose of CER
[[Page 41868]]
is to improve health outcomes by developing and disseminating
evidence-based information to patients, clinicians, and other
decision-makers, responding to their expressed needs, about which
interventions are most effective for which patients under specific
circumstances.
To provide this information, comparative effectiveness
research must assess a comprehensive array of health-related outcomes
for diverse patient populations and sub-groups.
Defined interventions compared may include medications,
procedures, medical and assistive devices and technologies, diagnostic
testing, behavioral change, and delivery system strategies.
This research necessitates the development, expansion, and
use of a variety of data sources and methods to assess comparative
effectiveness and actively disseminate the results.\1\
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\1\ U.S. Department of Health and Human Services. Federal
Coordinating Council for Comparative Effectiveness Research. Report
to the President and the Congress. June 30, 2009. http://
www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf.
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The FCC Report to Congress additionally described the criteria for
prioritization of potential CER investments, a strategic framework for
CER activity, and high-level priority recommendations for OS funds
(http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf). Because
CER is inherently multi-disciplinary, the Department recognizes the
importance of highlighting research that informs CER, including
relevant published literature as well as ongoing research activity. To
fulfill this goal the CER Inventory is intended to be a living document
that will both facilitate access to CER for interested stakeholders;
and assist in identifying priorities and gaps for future research. The
goal is to routinize the inventory process, allow for easy updating and
identifying gaps, and create a system that is sustainable. Connecting
users to CER information via a publicly available, searchable online
tool is an efficient approach to disseminating this breadth of
information.
II. Request for Information
The Department of HHS is inviting public comment to aid in the
development of the content and structure of the CER Inventory. This
notice specifically requests suggestions for potential sources of
information on ongoing and completed CER; ways to encourage
participation in the Inventory; approaches to categorizing information;
and ways to ensure that the CER Inventory is useful and sustainable.
ASPE is developing a system to catalog CER activities including
ongoing and completed CER. The CER Inventory will be publicly
available, and will be designed for a diverse community of stakeholders
including researchers, policy makers, decision-makers, health care
providers, patients, and consumers. The CER Inventory will include
records (e.g., abstracts and other summary descriptive information) of
CER and information related to CER, including research and resources on
methods and training for CER, data infrastructure and databases to
support CER, and methods and approaches for translation and
dissemination of CER to help inform healthcare decisions and policies.
The information provided in response to this notice will be used to
plan and develop the CER Inventory in order to ensure that it meets the
needs of such users as researchers, policy makers, decision-makers,
health care providers, patients, and consumers. We are seeking public
comment on the following issues:
1. Sources for CER. The CER Inventory will draw electronically on
existing sites (e.g., PubMed, HSRProj, and Clinicaltrials.gov) and will
also permit direct entry of information. Please identify any sources of
information, such as relevant sources of gray literature or research
databases from private foundations, that would help meet the goals of
the CER Inventory.
2. Encouraging participation/submission. What incentives would
encourage the contribution of CER research abstracts and other relevant
documents into the CER Inventory?
3. Categorization. CER projects and resources should be categorized
in a manner that ensures that individuals from diverse backgrounds with
varying levels of technical expertise (e.g., researchers, policy
makers, clinicians, and patients and consumers) can access relevant
information. How might such a categorization scheme and approach be
designed? Please comment on the rationale behind suggested
categorization schemes.
4. Data elements. Are there specific types of data or information
regarding records or descriptions of CER entered into the CER Inventory
that should be captured and available to users? Please identify key
data and information, if any.
5. Features. Are there features of a web-based CER Inventory that
would promote long-term use among the intended audiences?
6. Sustainability. What approaches or business models would provide
for a sustainable inventory over time?
7. Additional considerations. Are there potential drawbacks,
unintended consequences, or other specific issues that may limit
participation in the CER Inventory?
The information submitted in response to this RFI will inform the
planning and development of the CER Inventory to ensure that the
resource meets the needs of the intended users, is accessible, and is
easy to use.
Dated: July 9, 2010.
Sherry A. Glied,
Assistant Secretary for Planning and Evaluation.
[FR Doc. 2010-17244 Filed 7-16-10; 8:45 am]
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