[Federal Register: March 8, 2005 (Volume 70, Number 44)]
[Notices]
[Page 11245-11246]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08mr05-90]
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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: 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
[[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