CENTERS FOR EDUCATION AND RESEARCH ON THERAPEUTICS

Release Date:  January 27, 1999

RFA: HS-99-004 

March 14, 2011 - This RFA has been reissued as RFA HS-11-004.
(Reissued as RFA-HS-07-004)

P.T.

Agency for Health Care Policy and Research

Letter of Intent Receipt Date:  February 19,1999
Application Receipt Date:  April 22, 1999

PURPOSE

The Agency for Health Care Policy and Research (AHCPR) invites applications
from nonprofit organizations to establish Centers for Education and Research
on Therapeutics (CERTs).  CERTs is a three-year program that will support
demonstration Centers.  These Centers will evaluate, develop options and
methods, and conduct and perform pilot studies.  These studies will consist of
state-of-the-art clinical, health services, or laboratory research to increase
awareness of the benefits, risks and effectiveness of new uses, existing uses,
or combined uses of therapeutics.  This demonstration program seeks new and
more effective ways to develop, translate and disseminate objective
information on therapeutics to health care providers and other decision makers
to improve practice.  In addition, CERTs may selectively develop protocols and
possibly undertake pilot studies on the comparative cost effectiveness and
safety of medical products.  This will be accomplished with data on
appropriate therapeutic usage and outcomes, and the identification and
prevention of medical errors and adverse effects.  The long term goal of the
program will be to improve the quality of care while reducing costs.

Congress expanded the authority of the AHCPR under the Food and Drug
Administration Modernization Act of 1997 (P.L. 105-115), to conduct a three-
year demonstration program to conduct research and provide objective
information on drugs, biologics, and devices.  The research centers (CERTs)
are created under Sec. 409 which adds a new section (Sec. 905) to the
authorizing statute for AHCPR (Public Health Services Act Title IX--42 U.S.C.
299 et seq.).  AHCPR will administer a demonstration program, in close
consultation with the Food and Drug Administration (FDA). Coordination with
FDA will be through the AHCPR CERTs Program Official.

For the purposes of this document, therapeutics are defined as drugs,
biologics, and devices.  A Center is defined as an organization with a core
group of investigators with either institutional or similar kinds of
professional bonds who have strong experience in the area of research in
therapeutics.  The center may be a consortium of organizations, although it is
expected that members of a consortium will provide collateral or supplemental
support to the applicant organization.

HEALTHY PEOPLE 2000

The Public Health Services (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000," a PHS-
led national activity for setting priority areas.  AHCPR encourages applicants
to submit grant applications with relevance to the specific objectives of this
initiative.  Potential applicants may obtain a copy of "Healthy People 2000"
(Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-
00473-1) through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325, telephone 202/512-1800.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by public or private non-profit organizations
including universities, clinics, units of state and local governments, non-
profit firms, and non-profit foundations.  For-profit organizations may
participate as members of consortia or subcontractors if the applicant is non-
profit.  Organizations described in section 501(c)4 of the Internal Revenue
Code that engage in lobbying are not eligible.

AHCPR encourages women, members of minority groups, and persons with
disabilities to apply as Principal Investigators.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program will be
a cooperative agreement (U18), an "assistance" mechanism, in which substantial
AHCPR scientific and/or programmatic involvement with the awardee is
anticipated during the performance of the activity.  Under the cooperative
agreement, the AHCPR purpose is to support and/or stimulate the recipient"s
activity by involvement in and otherwise working jointly with the award
recipient in a partner role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity.  Details of the
responsibilities, relationships and governance of the study to be funded under
cooperative agreements are discussed later in this document under the section
"Terms and Conditions of Award."

The anticipated award date is September 29, 1999.  At this time, AHCPR has not
determined whether or how the solicitation will be continued beyond the
present RFA.

FUNDS AVAILABLE

The AHCPR expects to award up to $2 million in Fiscal Year 1999 to support 4-6
centers.  The total project period may not exceed 3 years.  One of the Centers
will be selected to perform additional functions as a Coordinating Center.

Because the nature and scope of the research proposed in response to this RFA
may vary, it is anticipated that the sizes of awards will also vary.  Awards
and level of support depend on receipt of a sufficient number of applications
of high scientific merit.

RESEARCH OBJECTIVES

Background

The large, for-profit, medical product industry in the United States is unique
because of the long-standing, co-existence of the dual missions of maintaining
and improving public health and increasing profits.  For the most part this
has worked well (society has benefitted from new and better therapeutics and
the economy has prospered).  When problems have arisen in the system, the
government has stepped in to provide regulation.

Therapeutic products have contributed to improving the health and quality-of-
life of the American people and new medical products are constantly being
developed to combat and prevent major health problems.  Each year over 2
billion prescriptions are written in the U.S. and many medical devices are
used.

At the same time that medical products improve the lives of many, significant
numbers of adverse events and inappropriate product use cause serious
impairment to the health of others.  Guidance on appropriate product use,
prevention of errors and adverse effects, and cost effective use of new and
existing products is limited, thus indicating there is a need by health
professionals for more complete information about the drugs and biologics they
prescribe and the devices that they use, as well as a need to improve
practices associated with their use.

The FDA regulates most currently marketed therapeutics., In order for
marketing to occur, for most drugs and biologics, pre-marketing studies must
be completed, with final approval for marketing contingent on manufacturers
providing FDA evidence of safety and efficacy for a single indication through
adequate and well-controlled studies.  The majority of devices receive
clearance rather than approval after the manufacturer provides evidence that
the product is substantially equivalent to a device that is already on the
market.  FDA regulation continues during the post-approval phase, through post
marketing safety monitoring and through regulation of advertising.

The AHCPR activities related to therapeutics begin after product approval
through support of research on the relative effectiveness, appropriateness,
and cost effectiveness of various strategies for the prevention, diagnosis,
treatment, and management of clinical conditions.  Activities have included
development and administration of a program to study patient outcomes,
development of evidence based practice centers, and support of the development
of quality measures.

SPECIAL REQUIREMENTS

There are two types of Centers that the AHCPR intends to fund.  Research
centers will be devoted to research and dissemination activities.  One
research center will receive additional funds to act as a coordinating center.

Research Center

The overall focus of each center will be on a broad therapeutic area, such as
a particular setting or population, rather than any single disease or
condition.  A center, for the purpose of this application, should choose to
focus on a broad therapeutic area.  The chosen area should have both a strong
research and educational component.  It is expected that centers will select
areas with a high likelihood of potential impact on practice.

o  These centers will evaluate, develop options and methods, and conduct
state-of-the-art, clinical, laboratory and health services research.  The
purpose of this research and education program is to increase awareness of the
benefits, risks and effectiveness of new, existing, or combinations of
therapeutics to improve practice.

o  CERTs may selectively develop protocols and undertake pilot studies on the
comparative effectiveness and safety of medical products.

o  The program goal will be development of free-standing continuing centers
which conduct research and educate health care providers and other decision
makers.  These centers should have as their goal improved use of drugs or
medical devices with a concomitant decrease in errors and adverse events.

o  The AHCPR funds are intended to provide basic support for each center and
to allow it to function effectively.  Core funding will be provided for
administrative and staff support, and a dissemination program.  Research
projects also may be supported in their initial stages with core funds.  It is
expected that Centers will ultimately support research with funds obtained
from sources other than the CERTs demonstration program funds.  These will
include funding through other AHCPR awards, other federal agency grants,
foundations, and other funding, as appropriate.

o  As noted, review criteria include reference to the proposed Center"s plans
to attract and retain other funding sources in support of its research
projects.

o  Applications are encouraged from existing Centers receiving funds from
AHCPR, other governmental agencies, or private sources(e.g., Centers funded
through the National Center for Research Resources, General Clinical Research
Center program or the Centers for Disease Control and Prevention, Prevention
Centers).

o  Centers are expected to have access to resources that would allow study of
a wide spectrum of therapeutic issues in the chosen area.  However, specific
topic areas, in keeping with the limited availability of funds, will be
negotiated prior to funding.  These negotiated topic areas will be aimed at
having program balance and diversity in the areas covered by the CERT program.

Coordinating Center

One of the funded CERTs will be designated as a coordinating center (CC).  A
research center applicant who desires to be considered to fulfil the role of
coordinating center should (a) state that intent in the application, and (b)
include a section with a budget to support these activities.  Those research
centers funded without the coordinating function would have that portion of
their application deleted for funding purposes.  The coordinating center will
have the following functions:

o  Establishment of a steering committee (SC).  The SC will consist of members
from all the Centers, AHCPR and FDA.  It will be chaired by a national expert,
chosen by FDA and AHCPR, with the concurrence of the research centers.  Other
members with appropriate expertise, will also be appointed. Organizing and
convening this committee will be the responsibility of the CC.  This SC will
act in a consultative role to all the Centers. The SC will organize and
provide funding for meetings, to be held 2-4 times per year as needed.  Travel
will be coordinated through this Center.  The steering committee will also
likely need to meet via periodic conference calls.

o  Identification and employment of an appropriate staff person who will be
hired to act as a data and information coordinator and specialist for all the
research centers. This will be a person funded and supervised through the CC,
but, will work mostly with the federal agencies involved in CERTs and other
data providers as necessary.  This person should be familiar with and be able
to facilitate the use of government data sources, such as New Drug Application
Files at the FDA, the Medical Expenditure Panel Survey at AHCPR and Medicare
data files from Health Care Financing Administration.  This person will be
shared equally by all of the centers.  This person will act as a liaison
between the Centers and the federal agencies involved.

o  The CC will work with the AHCPR Program Official, FDA representative(s) and
the SC Chair to enhance synergy across the goals and projects of each of the
research centers.

o  The CC will identify opportunities for engaging research centers in
addressing common methodologic and technical challenges.

o  The CC will identify opportunities to disseminate and implement information
developed by research centers on a large scale.  It will also identify
opportunities to coordinate with and enhance activities of other national
efforts to improve the use of therapeutics, e.g., the National Patient Safety
Foundation, quality improvement efforts of large health care systems, and the
Institute for Healthcare Improvement.

o  Identification and sharing of resources. It will be the responsibility of
the CC to determine whether other economies of scale can be identified and
developed for the CERTs program.  The CC will also coordinate efforts to
identify additional funding for the program.

o  The CC will be the major focus of national dissemination and educational
activity of the program.  The CC will develop options to transfer knowledge
from the Centers to "opinion leaders" and "change agents" in the health care
system, and implement specific strategies to assure that the information is
disseminated broadly and efficiently.  These activities would be in addition
to the existing AHCPR dissemination activities.

o  The CC will submit an annual report on the CERT implementation effort.

Qualifications

Research Centers

o  The organizational structure of each center should include a committed core
of investigators who have access to a defined population. Information on this
population should include demographics, diagnostic information and therapeutic
usage. The Center may be a consortium of organizations, although it is
expected that members of a consortium will provide collateral or supplemental
support to the applicant organization.

o  The center must have access to data that will allow for the identification
of problems associated with the use of therapeutics and also allows for the
evaluation of any planned interventions (e.g., Medicaid or managed care
administrative databases).  The Center must have experience using the data as
evidenced by publications or other products.

o  Applicants must have the scientific, technical, organizational and physical
resources, or demonstrate access to such resources, necessary to carry out the
following projects: (1) multidisciplinary research, including clinical
epidemiology, health services research, analyses of large databases, and
clinical pharmacology, as appropriate to the area of focus, (2) technical
assistance to health care providers and others, (3) professional education,
and (4) dissemination of research finding, and (5) the evaluation of
dissemination strategies.  (6) The organization should have a strong
understanding of the regulatory process as it relates to product effectiveness
and safety.

o  The center director must be an experienced senior investigator and manager
who can provide strong administrative and academic leadership.  The center
director will be responsible for the organization and operation of the center,
liaison with the research community and outside entities such as professional
societies, subcontractors, and consumer groups, and communication with the
AHCPR on scientific and operational matters.  Personnel and institutional
resources capable of developing and maintaining a substantial commitment to
patient outcomes research must be available.  The Center may consist of core
staff with significant time commitments to the Center and affiliate staff with
lesser time commitments.  Multidisciplinary collaboration among researchers
working within the Center is essential, each application must contain a plan
to assure continuing interaction an participation among the Center"s
researchers.

o  Work carried out by each Center is to be multidisciplinary and must address
various health care providers, settings, and geographic areas. 
Multidisciplinary research may involve scientists in medicine, pharmacology,
epidemiology, engineering, pharmacy, nursing, human behavior, statistics,
economics, organizational behavior and related fields.  The long term goal of
the program will be to improve the quality of care while reducing costs.

o  Each CERT must have a business plan which has as its goal development of a
free standing program to carry out the various activities identified in the
statute on a long term basis beyond the three years of the AHCPR funding.

Coordinating Center

The CC will require all of the qualifications above.  Additional
qualifications will include:

o  The Center will have demonstrated expertise in dissemination and
translation of research on therapeutics into practice.

o  The Center has demonstrable evidence of a sophisticated understanding of
health care systems and current quality improvement strategies.

o  The Center should have experience in working with health system leaders to
translate research into practice, with potential for developing partnerships
between the research centers and health care systems to enhance opportunities
for broad scale implementation.

o  The Center should have experience in leading multi-center research teams.

Terms and Conditions of Award

These special Terms of Award are in addition to and not in lieu otherwise
applicable OMB administrative guidelines, HHS Grant Administration Regulations
at 45 CFR Parts 74 and 92, 42 CFR Part 67 Subpart A, and other HHS and PHS
grants administration policy statements. Applicants should be familiar with
the Agency"s grant regulations, 42 CFR Part 67 Subpart A, and particularly
sections 67.18-67.22.

The administrative and funding instrument to be used for this program will be
a cooperative agreement (U18), an "assistance" mechanism, in which substantial
AHCPR scientific and/or programmatic involvement with the awardee is
anticipated during the performance of the activity.  Under the cooperative
agreement, The AHCPR purpose is to support and/or stimulate the recipient"s
activity by involvement in and otherwise working jointly with the award
recipient in a partner role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity.  Consistent with this
concept, the dominant role and prime responsibility for the activity resides
with the awardee for the project as a whole, although specific tasks and
activities in carrying out the studies will be shared among the awardees, the
AHCPR Project Scientist, and the FDA.

Cooperative Activities are intended to strengthen the individual CERTs
activities.  Data sharing, data access and facilitate communications.  Through
the CC and the steering committee joint decisions regarding the program can be
made.
All cooperative activities will require prior approval by the steering
committee.

Awardee Responsibilities

o  The centers are  expected to work with AHCPR, the FDA and other federal
agencies, as appropriate, on analyses and studies.  Such joint activities may
involve syntheses of research findings, data analyses, or the preparation of
background information on various topics related to therapeutics.

o  The Principal Investigator will be responsible for appropriate
dissemination of study findings, including, but not limited to, publication in
peer review journals.

o  Each Principal Investigator will attend the quarterly steering committee
meetings, and other meetings as required.

o  The Principal Investigator will provide access to the various center data
sources to Coordinating Center as appropriate to the individual studies.

o  Submission of a quarterly report of progress to the responsible AHCPR
program official.

AHCPR and FDA Responsibilities

o  AHCPR and FDA representatives will be members of the steering committee.

o  AHCPR and FDA will identify a chair for the steering committee.

o  The AHCPR Program Official(s) will work in conjunction with FDA, the
centers" principal investigators, the coordinating center and the steering
committee to develop issues for further study.

o  The Federal agencies will have substantive involvement in the planning and
conduct of research, technical assistance, dissemination, and training carried
out by each center.

o  The Federal agencies involved will facilitate access to appropriate
government data sources through the CC.

o  The Federal agencies involved will work with the center employees to
facilitate dissemination of results.

o  As additional data and sources of funding are identified the Federal
agencies will work with Centers to establish appropriate agreements to
optimize use and sharing of these resources.

o  AHCPR reserves the right to terminate or curtail the study or an individual
award in the event of substantial lack of progress or lack of participation in
CERT-related activities.

Data Privacy

Information obtained in the course of this study that identifies an individual
or entity must be treated as confidential in accordance with section 903(c) of
the Public Health Service Act (42 U.S.C.299a-1).  Applicants must describe in
the Human Subjects section of the application procedures for ensuring the
confidentiality of identifying information.  The description of the procedures
should include a discussion of who will be permitted access to the
information, both raw data and machine readable files, and how personal
identifiers will be safeguarded.

Rights in Data

AHCPR grantees may copyright or seek patents, as appropriate, for final and
interim products and materials including, but not limited to, methodological
tools, measures, software with documentation, literature searches, and
analyses, which are developed in whole or in part with AHCPR funds.  Such
copyrights and patents are subject to a Federal Government license to use and
permit others to use these products and materials for AHCPR purposes.  In
accordance with its legislative dissemination mandate, AHCPR purposes may
include, subject to statutory confidentiality protections, making research
materials, data bases, and algorithms available for verification or
replication by other researchers, and subject to AHCPR budget constraints,
final products may be made available to the health care community and the
public by AHCPR, or its agents, if such distribution would significantly
increase access to a product and thereby produce public health benefits. 
Ordinarily, to accomplish distribution, AHCPR publicizes research findings but
relies on grantees to publish in peer-reviewed journals and to market grant-
supported products.

INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS
INVOLVING HUMAN SUBJECTS

It is the policy of AHCPR that women and members of minority groups be
included in all AHCPR-supported research projects involving human subjects,
unless a clear and compelling rationale and justification are provided that
inclusion is inappropriate with respect to the health of the subjects or the
purpose of the research.

All investigators proposing research involving human subjects should read the
"NIH Guidelines on the Inclusion of Women and Minorities as Subjects in
Clinical Research," which was published in the Federal Register of March 28,
1994 (FR 59 14508-14513), and printed in the NIH GUIDE of March 18, 1994.
AHCPR follows the NIH Guidelines, as applicable.

Investigators may obtain copies from these sources or from the AHCPR
contractor, Equals Three Communications, Inc., listed under "Inquiries."

AHCPR also encourages investigators to consider including children in study
populations, as appropriate. AHCPR announced in the NIH Guide of May 9, 1997,
that it is developing a policy and implementation plan on the inclusion of
children in health services research. This Notice is available through the
AHCPR web site http://www.ahcpr.gov (Funding Opportunities) and InstantFAX
(see instructions under INQUIRIES.

AHCPR program staff may also provide information concerning these policies
(see INQUIRIES.)

LETTER OF INTENT

Prospective applicants are asked to submit, by February 19, 1999, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, other key
personnel and other participating organizations or institutions, and the
number and title of this RFA.  Although a letter of intent is not required, is
not binding, and does not enter into the consideration of any subsequent
application, the information allows AHCPR staff to estimate the potential
review workload and avoid conflicts of interest in the review.  AHCPR will not
provide responses to letters of intent.

The letter of intent is to be sent to:

Joanne S. Book
Center for Outcomes and Effectiveness Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 605
Rockville, MD 20852-4908

APPLICATION PROCEDURES

Applicants should use the research grant application form PHS 398 (rev. 4/98)
in applying for these grants.  State and local government applicants may use
form PHS-5161-1, Application for Federal Assistance (rev. 5/96), and follow
those requirements for copy submission.

Application kits are available at most institutional offices of sponsored
research and from the Division of Extramural Outreach and Information
Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301-710-0267, e-mail: [email protected].

AHCPR applicants can also obtain application materials from the AHCPR
contractor:  Equals Three Communications, Inc. (see Inquiries)

The RFA label available in the form PHS 398 (rev. 4/98) application must be
affixed to the bottom of the face page of the original application.  Failure
to do so could result in delayed processing of the application such that it
may not reach the review committee in time for review.  In addition, the RFA
title and number must be typed on line 2 of the face page of the application
form and the YES box must be marked.

The PHS 398 type size requirements will be enforced rigorously and non-
compliant applications returned.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies, labeled "Advanced Copies"
must also be sent to:

Joanne Book
Center for Outcomes and Effectiveness Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 605
Rockville, MD 20852-4908

Applications submitted under this RFA must be received in the Center for
Scientific Review, NIH, by April 22, 1999.  If an application is received
after that date, it will be returned to the applicant without review.

REVIEW CONSIDERATIONS

Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened in
accordance with AHCPR peer review procedures. If the application is not
responsive to the RFA, it will be returned to the applicant without review. 
As part of the merit review, all applications will receive a written critique,
and also may undergo a process in which only those applications deemed to have
the highest scientific merit will be discussed and assigned a priority score.

General Review Criteria

Review criteria for AHCPR grant applications are:  significance and
originality from a scientific and technical viewpoint, adequacy of the
method(s), availability of data or proposed plans to collect data required for
the project, adequacy of the plan for organizing and carrying out the project,
qualification and experience of the Principal Investigator and proposed staff,
reasonableness of the proposed budget and duration, adequacy of the proposed
facilities and resources available to the applicant, the extent to which
women, minorities and children (as appropriate), are adequately represented in
study population, and when applicable, the adequacy of the proposed means for
protecting human subjects.

Special Review Criteria

Research Centers

Of all the criteria set forth, the infrastructure and capacity of the
applicant are the most important criteria.  Capacity should include evidence
of the ability to provide rapid production of information, the ability to link
geographically and demographically diverse sites of care, the ability to
access a longitudinal and large database, and the capability for accessing and
interfacing with the delivery systems.

o  The applicant institution will have a broad base of skills with
demonstrated experience in multidisciplinary research, including clinical
epidemiology and  health services research and analyses of large databases. 
Additional strengths would include schools of public health, medicine, nursing
and pharmacy, a bioengineering program, a clinical pharmacology program, or a
pharmacoeconomics program, from which to draw appropriate personnel.

o  Successful applicants must have the necessary expertise, to study a wide
range of topical areas in after-market medical product research and have
experience in the areas of dissemination and evaluation of such.  Preference
will be given to primary applicants who currently devote a major portion of
their resources to working on drug, biologics or medical device research and
dissemination.

o  Applicants will have an appropriate administrative structure in place that
will enable it to complete projects in a timely fashion, with full
accountability for funds.

o  Applicants will need to develop additional funding prior to submitting the
application.  The documentation of such collaborative arrangements will be a
part of the review criteria.  Collaborators may include arrangements with
partners such as other governmental agencies, professional groups, consumer
groups, foundations, and pharmaceutical companies. Contributions of outside
entities may include significant donation of investigator time, free access to
computerized databases or computer time and personnel, free pharmaceuticals or
other therapeutics, or others as appropriate.

o  The Center director must be an experienced senior investigator and manager
who can provide strong administrative and academic leadership.

o  The Center must have access and demonstrated experience with appropriate
data.

Therapeutic areas chosen by applicant centers will be evaluated using the
criteria listed below.

o  A Center, for the purpose of demonstrating expertise, capacity, and
existence of infrastructure, should choose a broad therapeutic issue.  The
chosen area should have both a strong research and educational component.  The
applicant will define how to best approach the issues of improving treatment
in that particular area.  In choosing an area, consideration should be given
to the priorities of AHCPR and FDA.  The therapeutics field is vast, but some
examples of areas that exemplify the nature and scope of focus include:
pediatric drug usage and safety, assessment and prevention of overuse of
antibiotics, vaccine usage and safety, development and dissemination of cost-
effective strategies for reduction of medication errors, or evaluation of
patterns of use and education on the safety of implantable medical devices. 
These are merely a few examples and applicants should not limit their choices
to these examples.

o  Other useful guidance that may be helpful for choosing topics chosen
include: (1)high incidence or prevalence in the general population or in
subpopulations, including racial and ethnic minorities, women and children,
(2) significance to the Medicare, Medicaid and other Federal health programs,
(3) high costs associated with a condition, procedure, treatment, or
technology, whether due to the number of people needing care, high unit cost
of care, or high indirect costs, (4) controversy or uncertainty about the
effectiveness or relative effectiveness of available clinical strategies or
technologies, (5)potential to inform and improve patient or provider decision
making, (6)potential to reduce clinically significant variations in the
prevention, diagnosis, treatment, or clinical management of a disease or
condition, or in the use of a procedure or technology, or in the health
outcomes achieved, (7) availability of scientific data to support the study or
analysis of the topic, and (8) potential opportunities for rapid
implementation.

Consideration of topic areas will be evaluated based on FDA priorities. 
Essentially  FDA"s needs relate to research into areas of more effective
education of and communication with the clinical community.  In particular,
there is a crucial need for research to understand the keys to recognition of
adverse events and use error problems with medical products and to sensitize
the clinical community toward this recognition.  In addition, more research
needs to be conducted on the most effective means of communicating product
information (whether it be information on labeling changes or public health
advisories) that would be incorporated quickly into clinical practice.

Additional Criteria for Coordinating Center

o  The applicant for the coordinating center will need to have a history of
involvement in multi-center research or similar programs.

o  The CC applicant will need to have strong skills in program evaluation, and
strong experience in a wide variety of data, including cost data and other
sources of information related to therapeutics.

o  Thee CC will need to have identified personnel with expertise in the unique
aspects of data available through the various government agencies (FDA, AHCPR,
etc.).

o  The center should have experience in working with health system leaders to
translate research into practice, with potential for developing partnerships
between the research centers and health care systems to enhance opportunities
for broad scale implementation.

AWARD CRITERIA

Applications will compete for available funds with all other applications
under this RFA.  The following will be considered in making funding decisions: 
1) quality of the proposed project as determined by peer review, 2) program
balance, and 3) availability of funds.

INQUIRIES

Applicants are encouraged to use AHCPR"s Web site (http://www.ahcpr.gov) and
FDA"s Web site (http://www.fda.gov) to learn about pertinent major initiatives
in this area.  This will help assure that new applications build on existing
research, as appropriate, and are not unnecessarily redundant with currently
supported research.

Copies of this RFA are available from:

Equals Three Communications, Inc.
7910 Woodmont Avenue, Suite 200
Bethesda, MD  20814-3015
Telephone:  (301) 656-3100
FAX:  (301) 652-5264

The RFA is available on AHCPR"s Web site http://www.ahcpr.gov (Funding
Opportunities) and through AHCPR Instant FAX at 301/594-2800.  To use Instant
FAX, you must call from a facsimile (FAX) machine with a telephone handset. 
Follow the voice prompt to obtain a copy of the Instant FAX table of contents,
which has the document order number (not the same as the PA number).  The RFA
will be sent at the end of the ordering process.  AHCPR Instant FAX operates
24 hours a day, 7 days a week.  For questions about this service, call Judy
Wilcox, Office of Health Care Information, at 301/594-6344.

AHCPR welcomes the opportunity to clarify any issues or questions from
potential applicants.  Written and telephone inquiries are encouraged.  Direct
inquiries regarding programmatic issues, including information on the
inclusion of women, minorities, and children in study populations, to:

Lynn Bosco
Center for Outcomes and Effectiveness Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 605
Rockville, MD  20852-4908
Telephone:  (301) 594-2416
FAX:  (301) 594-3211
Email: l[email protected]

Direct inquiries regarding fiscal matters to:

Joan Metcalfe
Grants Management Specialist
Agency for Health Care Policy and Research
2101 East Jefferson, Suite 601
Rockville, MD 20852-4908
Telephone: (301) 594-1841
FAX (301) 594-3210
Email: [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Number
93.226.  Awards are made under authorization of Title IX of the Public Health
Service Act (42 U.S.C. 299-299c-6) and Section 1142 of the Social Security Act
(42 U.S.C. 1320b-12) as applicable.  Awards are administered under the PHS
Grants Policy Statement and Federal regulations 42 CFR 67, Subpart A, and 45
CFR Parts 74 and 92.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products.  In
addition, Public Law 103-227, The Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early child
development services are provided to children.  This is consistent with the
PHS mission to protect and advance the physical and mental health of the
American people.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Department of Health and Human Services

National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892