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.

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: gcaldero@ahrq.gov.

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: ssmith@ahrq.gov.

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 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, § 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.