[Federal Register Volume 70, Number 44 (Tuesday, March 8, 2005)]
[Notices]
[Pages 11245-11246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4444]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Limited Competition for Supplemental Grants for Centers for 
Education and Research (CERTs)

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice of availability of fund for limited competitive 
supplements.

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SUMMARY: This notice informs the research community that the Agency for 
Healthcare Research and Quality (AHRQ) is requesting applications for 
competitive supplemental grants from the seven Centers for Education 
and Research on Therapeutics (CERTs) for which it provided funding in 
fiscal year 2004.
    The purpose of the competitive supplements is to provide funds for 
existing CERTs research centers to build on and to expand their 
research work and expertise with respect to comparative effectiveness 
research specifically to carry out short term projects that will 
address research gaps in priority subject areas identified and 
published pursuant to section 1013 of the Medicare Prescription Drug, 
Improvement, and Modernization Act (MMA). Since the inception of the 
CERTs program in 1999, the CERTs research centers have gathered 
significant data regarding therapeutics, refined research 
methodologies, and developed collaborative research resources. They are 
therefore uniquely prepared and suited to efficiently carry out 
pharmaco-epidemiology and methodological studies related to comparative 
effectiveness research that is pertinent to developing therapeutic 
evidence identified as being of high interest to the Medicare, Medicaid 
or SCHIP programs. For this reason, this solicitation will be for a 
limited competition among CERTs grantees.

DATES: The receipt date for the competitive supplemental grant 
applications is April 7, 2005. AHRQ will inform the current grantees 
directly regarding application procedures and format.

ADDRESSES: Submission of the applications should be sent to: Dr. Gerald 
Calderone, Office of Extramural Research, Education, and Priority 
Populations, Agency for Healthcare Research and Quality, 540 Gaither 
Road, Rockville, MD 20850, Phone: (301) 427-1548, Fax: (301) 427-1561, 
E-mail: [email protected].

FOR FURTHER INFORMATION CONTACT: Dr. Scott R. Smith, Center for 
Outcomes and Evidence, Agency for Healthcare Research and Quality, 540 
Gaither Road, Rockville, MD 20850, Phone: (301) 427-1511, Fax: (301) 
427-1520, E-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    Section 1013 of the MMA directs the Secretary of the Department of 
health and Human Services (DHHS), acting through the Director of AHRQ, 
to support research to address priorities identified by the Medicare, 
Medicaid, and SCHIP programs and other concerned stakeholders, 
regarding improvement of health care outcomes, comparative clinical 
effectiveness, and appropriateness of health care items and services 
(including prescription drugs) either provided or possibly not 
currently covered under these programs; and strategies for improving 
program efficiency and effectiveness with attention to the ways in 
which health care items and services are organized, managed, and 
delivered under these programs.
    Pursuant to this section 1013, which may also be found at 42 U.S.C. 
229b-7, DHHS published, on December 15, 2004, an initial priority list 
of ten conditions with respect to which research mandated under this 
section is to be promptly undertaken. The ten conditions are:
     Ischemic heart disease
     Cancer
     Chronic obstructive pulmonary disease/asthma
     Stroke, including control of hypertension
     Arthritis and non-traumatic joint disorders
     Diabetes mellitus
     Dementia, including Alzheimer's disease
     Pneumonia
     Peptic ulcer/dyspepsia
     Depression and other mood disorders
    The Centers for Education and Research on Therapeutics (CERTs) 
program was first developed by AHRQ in accordance with a Congressional 
authorization in the Food and Drug Administration Modernization Act of 
1997 (Pub. L. 105-115) to carry out or support research that would 
provide objective information on drugs, biologics, and medical devices. 
Just months after the first CERTs grants were awarded, the CERTs 
program was incorporated into the AHRQ Reauthorization Act of 1999 
(Pub. L. 106-129); its objectives: to increase

[[Page 11246]]

awareness of the benefits and risks of new, existing, or combined uses 
of therapeutics through education and research and to reduce costs. The 
CERTs were to disseminate their findings to inform, among others, 
insurers and government agencies, patients and consumers. Under 42 
U.S.C. 299b-1(b), CERTs grantees were to gather, develop and provide 
evidence related to comparative effectiveness, cost effectiveness and 
safety of therapeutics. Thus, the mission and work of the CERTs is 
consistent with and addresses identified priority research requirements 
of the MMA section 1013. Accordingly, the expedite the conduct of 
priority research related to health care services and items including 
prescription drugs, as mandated by section 1013, AHRQ is seeking to 
carry out the initial work on a competitive basis with the benefit of 
the existing collaborative organizational frameworks and therapeutics 
expertise and specialization developed by CERTs with prior AHRQ 
support.

Review

    AHRQ will consider requests from current CERTs research center 
grantees to develop short term supplemental research projects 
specifically gathering, summarizing and assessing available 
therapeutics evidence with respect to subjects identified as priorities 
pursuant to MMA section 1013 or formulating and/or addressing 
methodological issues pertinent to the production of evidence that is 
needed with research to these priority subject areas. See http://www.medicare.gov/MedicareReform/researchtopics.asp. These competitive 
applications for supplemental grant awards will undergo scientific and 
technical review using regular AHRQ peer review processes. In addition 
to criteria set forth in 42 CFR part 67, subpart A, Sec.  67.15(c), the 
peer review evaluations and recommendations, in particular, will be 
based on adherence to the agenda and priorities established in 
accordance with section 1013 of the MMA.
    Each center may submit a single application for supplemental 
support of a research project that address clinical or methodological 
issues pertaining to a knowledge gap regarding the comparative 
effectiveness of therapeutics for one or more of the ten priority 
clinical areas of interest to the Medicare, Medicaid and SCHIP 
programs. Requests are to be limited to projects that can be completed 
in 12 months or less. Although each CERTs Research Center may be the 
primary applicant on any one application, AHRQ encourages partnerships 
between existing CERTs. The actual number of applications that will be 
funded is dependent on the number of high quality applications.

    Dated: February 24, 2005
Carolyn M. Clancy,
Director.
[FR Doc. 05-4444 Filed 3-7-05; 8:45 am]
BILLING CODE 4160-90-M