[Federal Register Volume 75, Number 137 (Monday, July 19, 2010)]
[Notices]
[Pages 41867-41868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17244]


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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, [email protected].

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]
BILLING CODE 4154-05-P