COORDINATING CENTER FOR THE AHRQ CENTERS FOR EDUCATION AND RESEARCH ON 
THERAPEUTICS PROGRAM

RELEASE DATE:  May 8, 2003

RFA Number:  HS-03-007 

March 14, 2011 - This RFA has been reissued as RFA-HS-11-003.
(This RFA has been reissued, see RFA-HS-07-008)

Agency for Healthcare Research and Quality (AHRQ)(http://www.ahrq.gov)

CFDA: 93.226

LETTER OF INTENT RECEIPT DATE:  June 23, 2003 

APPLICATION RECEIPT DATE:  July 24, 2003 

THIS RFA CONTAINS THE FOLLOWING INFORMATION:

o   Purpose 
o   Research Objectives
o   Mechanism of Support
o   Funds Available 
o   Eligible Institutions
o   Special Requirements
o   Where to Send Inquiries
o   Letter of Intent
o   Submitting an Application
o   Peer Review Process
o   Review Criteria
o   Receipt and Review Schedule
o   Award Criteria
o   Required Federal Citations

PURPOSE

The Agency for Healthcare Research and Quality (AHRQ) invites applications 
from non-profit and for-profit organizations to act as the coordinating 
center for the Centers for Education and Research on Therapeutics 
(CERTs)Program.

The program consists of seven geographically dispersed research centers 
receiving multi-year funding. 

CERTs is an ongoing multi-year program that supports research demonstration 
centers.  Detailed information on the program can be obtained at 
http://www.ahrq.gov/clinic/certsovr.htm.

Congress expanded the authority of AHCPR under the Food and Drug 
Administration Modernization Act of 1997 (P.L. 105-115), to conduct a 
demonstration program to conduct research and provide objective information 
on therapeutics.  The centers (CERTs) were created under Sec. 409, which adds 
a new section (Sec. 905) to the authorizing statute for AHRQ (Public Health 
Services Act Title IX--42 U.S.C. 299 et seq.).  AHRQ administers the 
demonstration program, in close consultation with the Food and Drug 
Administration (FDA). 

The program's legislative mandate is to conduct state-of-the-art research to 
increase awareness of (1) new uses of drugs, biological products, and 
devices; (2) ways to improve the effective use of drugs, biological products, 
and devices; and (3) risks of new uses and risks of combinations of drugs and 
biological products.  Further, the legislation directs CERTs to provide 
objective clinical information to the following individuals and entities: (1) 
health care practitioners and other providers of health care goods or 
services; (2) pharmacists, pharmacy benefit managers and purchasers; (3) 
health maintenance organizations and other managed health care organizations; 
(4) health care insurers and governmental agencies; and (5) patients and 
consumers.  Additionally, the centers are to investigate various ways to 
improve the quality of health care while reducing the cost of health care 
through an increase in the appropriate use of drugs, biological products, or 
devices, and the prevention of adverse effects of drugs, biological products, 
and devices and the consequences of such effects, such as unnecessary 
hospitalizations.  Finally, the CERTs will conduct research on the 
comparative effectiveness, cost-effectiveness, and safety of drugs, 
biological products, and devices.

For the purposes of this document, therapeutics are defined as drugs, 
biologics, and devices.  A CERTs research 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 research 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.

The role of coordinating center (CC) is not to lead the program, but to 
facilitate the leadership of the CERTs Steering Committee (SC), consisting of 
the research centers , government agencies, and other members, through 
logistical support and active participation in committee.

RESEARCH OBJECTIVES

Background

The CC works with the AHRQ Program Official, Food and Drug Administration 
representative(s) and the CERTs SC to enhance synergy across the goals and 
projects of each of the research centers to fulfill the requirements of the 
program.  The CERTs SC has primary responsibility for leadership of the CERTs 
program.  The CC, through logistical, technical and intellectual support, 
acts in a consultative role to the research centers and the SC.

The Centers for Education and Research on Therapeutics (CERTs) program is a 
national initiative to increase awareness of the benefits and risks of new, 
existing, or combined uses of therapeutics through education and research. 

The mission of the CERTs program is to provide objective, scientific 
information on the safe and effective use of therapeutics.  The research 
centers, CC, and SC  work together to achieve these goals.

The vision of the CERTs program is to become a trusted national resource for 
people seeking information about medical products.  This is being 
accomplished through research and education by first developing knowledge and 
then sharing it with people who can use it to manage risk, improve practice, 
and inform policies.  The research centers have participated in 100 projects 
to date, extending along broad spectra of research and educational efforts.

The CC, along with the SC, is at the core of the activities of the program.  
The CC provides support to the AHRQ Program Official and SC in the 
achievement of the mission and vision of the program.  The principal 
investigator, in partnership with AHRQ and the SC, provides a global 
perspective to assure that the program fulfills its goals.  The CERTs 
Principal Investigator acts as a liaison between the CERTs program, the 
academic researchers and other customers for CERTs-related research.

MECHANISM OF SUPPORT

The CERTs are funded via the Grants Mechanism as directed under Sec. 409 
under the Food and Drug Administration and Modernization Act of 1997 (P.L. 
105-115). Section 409 subpart (a) states "The Secretary, acting through the 
Administrator and in consultation with the Commissioner of Food and Drugs, 
shall establish a demonstration program for the purpose of making one or more 
grants for the establishment and operation of one or more centers to carry 
out the activities specified".  The administrative and funding instrument to 
be used for the CERTs CC will be a cooperative agreement (U18), an 
"assistance" mechanism in which substantial AHRQ and other government 
scientific and/or programmatic involvement with the CC is anticipated during 
performance of the activity.  The dominant role and prime responsibility for 
all CERTs research resides with the awardee(s) for the project as a whole, 
although specific tasks and activities in carrying out the studies will be 
shared among the awardees, the CC, the SC and the AHRQ Program Officials(s).  
Details of the responsibilities, relationships and governance of the study to 
be funded under cooperative agreement(s) are discussed later in this document 
under the section on Terms and Conditions of Award.
The total project period for applications submitted in response to the 
present request for applications may not exceed four years.  The project will 
undergo program review to determine if it meets the criteria as stated in the 
RFA.

The anticipated award date is September 29, 2003.  At this time, AHRQ has not 
determined whether or how the solicitation will be continued beyond the 
present RFA.

FUNDS AVAILABLE

AHRQ expects to award up to $300,000 in total costs in fiscal year 2003 to 
support one CC.  Of this $300,000, $100,000 in total costs should be set 
aside to fund dissemination and education activities (listed under special 
requirements) focused on cross-CERTs efforts at training and/or 
dissemination.  The CC will be responsible for coordinating training users to 
implement findings.  

Additional projects, (e.g., additional didactic and educational workshops, 
see Special Requirements) that extend the goals of the CERTs program may be 
proposed.  The total budget request to support these additional projects may 
not exceed $200,000 in total costs.  

Thus, no application submitted in response to this RFA may exceed a total 
budget of $500,000.  Applications submitted in response to this RFA with 
total budget requests that exceed $500,000 will be returned without 
undergoing peer review and will not be considered for funding.  The total 
project period may not exceed 4 years.

Applicants will not be required to match or share in project costs if an 
award is made.

ELIGIBLE INSTITUTIONS

Eligible institutions are those that have any of the following 
characteristics:

o   For-profit and non-profit organizations 
o   Public or private institutions, such as universities, colleges, 
hospitals, and laboratories
o   Non-profit firms and foundations
o   Units of State and local governments
o   Faith-based or community-based organizations
o   Domestic (foreign applications will not be accepted)
o   Tribes and tribal organizations

Under recently enacted reauthorization legislation, AHRQ is authorized to 
enter into cooperative agreements with for-profit organizations as well as 
with public and not-for-profit entities.  Thus, for-profit organizations are 
eligible to respond to this notice with research applications for cooperative 
agreements.  Such applications will be administered in accordance with 
Subpart E of 45 CFR Part 74 and 42 CFR Part 67 Subpart A.  The latter 
regulation has not yet been amended to reflect these changes in Agency name 
and authority.  (See December 6, 1999, AHRQ reauthorization at 
http://www.ahrq.gov/hrqa99a.htm). 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for AHRQ programs.

SPECIAL REQUIREMENTS

o   The CERTs SC has primary responsibility for leadership of the CERTs 
program.  The CC and SC act in a consultative role to the research centers.  
Each individual research center acts independently to accomplish its research 
goals. The SC consists of members from the research centers, the CC, AHRQ and 
FDA.  It is chaired by a national expert, chosen by AHRQ, with the 
concurrence of FDA, the research centers and the CC.  Other members 
representing partnership organizations are appointed.

o   The CC convenes the SC.  The CC will organize SC meetings, to be held 
three to four times per year.  Travel will be coordinated through this CC.  
One meeting per year will be held in the Washington DC area to allow for 
participation by AHRQ, FDA and other government personnel at a "Government 
Day" Meeting.  The CC will provide facilities to convene SC meetings.  The SC 
will also meet via periodic conference calls to be held at a minimum of every 
month.

o   The Principal Investigator (PI) of the CC will work closely with the SC 
Chair and, with advice from AHRQ and FDA, help the SC develop program goals 
and to assure that the SC deliberative processes and other activities are 
adequately tracked and disseminated to appropriate audiences, such as AHRQ, 
FDA and the research community.

o   The CC will be responsible for working with the research centers and with 
AHRQ in  training users (e.g. State and Local Health Departments, clinicians, 
and other healthcare providers) to implement findings.  These activities will 
be focused on cross-CERTs efforts at training and/or dissemination.  The CC 
should develop a plan to work with AHRQ to implement wide-spread 
dissemination to audiences, such as State policy makers.  A separate plan and 
budget will need to be submitted.  The CC will investigate possible 
approaches to developing this training (e.g., convening experts to develop a 
research agenda).

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

o   The CC will identify opportunities to disseminate and implement 
information developed by the 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   The CC will work with the SC to develop a national plan for dissemination 
and educational activity for the program.  The CC and SC will develop options 
to transfer knowledge from the research centers to influential leaders in the 
health care field, and implement specific strategies to assure that the 
information is disseminated broadly and efficiently.

o   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, e.g., convene an annual meeting of potential partners.

o   The CC application should have a business plan, which has as its goal 
development of a program to carry out the various activities identified in 
the CERTs authorizing legislation on a long-term basis using both public and 
private sources.

o   The CC will develop programmatic products for the CERTs (e.g. fact 
sheets, a web site). The CC should investigate the feasibility of making 
government data more accessible to the research centers.

o   The CC will work with the SC to maintain the synergy that has developed 
across the projects of each of the research centers.  

o   The CC PI will convene and chair the public-private partnership working 
group (PPPWG) consisting of the principal investigators of the research 
centers, and others, as needed.  This subcommittee of the SC will evaluate 
potential partnerships using principles developed by the SC to assist the 
research centers in determining whether a partnership is appropriate for the 
CERTs program.  These principles can be viewed at the following web address 
http://www.certs.hhs.gov/partners/principles.html.

o   The applicant should describe experience with partnerships, both 
governmental and private.  Products of these partnerships (e.g.: program 
descriptions and publications) may be included as an appendix to the 
application.  

o   Appropriate accomplishments should be placed in the section of the 
proposal, as instructed on the application forms.  Past accomplishments 
should focus on experience related to leadership and logistical support for 
multi-disciplinary and multi-center research  (e.g., multi-center clinical 
trials or large-scale multi-center educational or dissemination programs).  
Publications, to date, should be placed in an appendix with a complete 
bibliography.

Qualifications

o   The CC director must be an experienced senior investigator, with 
extensive research experience and experience managing multi- disciplinary 
research.  He/she should be a manager who can provide strong administrative 
and academic leadership.  The CC director will be responsible for the 
organization and operation of the Center. The CC director should have 
experience as a leader within the research community and outside entities 
such as professional societies, subcontractors, and consumer groups.

o   The director should have extensive experience working with Federal 
agencies such that he/she is able to coordinate and communicate with AHRQ and 
other Federal Agencies on scientific and operational matters.

o   Applicants should provide evidence of personnel and institutional 
resources capable of maintaining a substantial commitment to patient outcomes 
research, patient safety, dissemination and education and program management.  
The CC should consist of core staff with significant time commitment to the 
Center, and experience working as a team.  Evidence of past collaboration 
among personnel working within the Center should be presented (e.g., 
publications or past research collaboration).

o   The CC should present evidence of appropriate staff persons with 
experience working with data and information on therapeutics, as evidenced by 
appropriate publications. 

o   The CC should be able to provide writing and editorial assistance on an 
ongoing basis for meeting minutes, written manuscripts and research 
summaries.  The CC may be expected to develop original manuscripts covering 
topics related to therapeutics research and education.

o   The CC must demonstrate expertise in dissemination and translation of 
research on therapeutics into practice, through publications and 
participation in program planning activities.

o   The CC should have demonstrable evidence of a sophisticated understanding 
of health care systems and current quality improvement strategies.

o   The CC 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   Since the CERTs program functions as a multi-center research program, 
with ongoing interactions and partnerships between the research centers, the 
CC should have experience in leading such  multi-center collaborative 
research.

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 AHRQ scientific and/or programmatic involvement with the awardee 
is anticipated during the performance of the activity.  Under the cooperative 
agreement, The AHRQ 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 CC awardee for the project as a whole, although specific tasks and 
activities in carrying out the studies will be shared among the awardees, the 
AHRQ Project Scientist, and the FDA.  Cooperative activities are intended to 
strengthen the individual CERTs activities through the facilitation of data 
sharing, data access and communications.  Through the CC and the SC joint 
decisions regarding the program can be made.

All cooperative activities that include significant government involvement 
will require prior approval by the AHRQ program officer who is expected to 
consult with the SC.

Awardee Responsibilities

The Coordinating Center will do the following:

o   The CC will organize, and work with the SC to develop themes, and provide 
funding for logistical support of SC meetings to be held 4 times per year.  
Travel will be coordinated through this Center.

o   The CC will be responsible for conference calls to be held on a monthly 
basis (or more frequently as needed).  

o   The CC will support and maintain the CERTs website.  The CC will comply 
with Federal requirements for websites and coordinate with AHRQ on website 
issues.

o   The CC convenes, monthly, as needed, a working group, which consists of 
all research center principal investigators, to review public-private 
partnerships.

o   The CC employs appropriate staff to facilitate the activities of the SC 
and monthly working group, and to provide support for dissemination and 
education.

o   The CC will work with the AHRQ Program Official, FDA representative(s) 
and the SC Chair to enhance synergy in order to achieve the goals set forth 
in the CERTs authorizing legislation.

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

o   The CC will identify opportunities to disseminate and implement 
information developed by the 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 through educational 
strategies.

o   The CC will work with the SC to develop national dissemination and 
educational activities for the program.  The CC and SC will develop options 
to transfer knowledge from the research 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.

o   The CC will work with the SC to develop criteria for successful 
achievement of goals.  These goals will be accomplished with the assistance 
of AHRQ and FDA.

o   The CC will develop an annual report and quarterly program briefs.  These 
briefs will be developed in conjunction with the SC and the research centers.  

Federal Agency Responsibilities

o   AHRQ and FDA representatives will be permanent members of the SC.  Other 
government agencies may also be invited by the SC Chair to become members of 
that committee.

o   AHRQ with assistance from FDA, the CC, and the research centers will 
identify a chair for the SC, should the current chair resign.

o   The AHRQ Program Official(s) will work in conjunction with FDA, the 
centers' principal investigators, the CC and the SC to assure that issues for 
further study receive adequate review.

o   The Federal agencies may have substantive involvement in the development 
of the education and dissemination programs (e.g., program briefs) for which 
the CC has the lead.

o   The Federal agencies involved will facilitate access to appropriate 
government resources, such as additional funding and data sources.

o   The Federal agencies involved will work with the CC staff to facilitate 
dissemination of results.

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

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

Arbitration
 
Any disagreement that may arise on scientific/programmatic matters (within 
the scope of the award), between award recipients and AHRQ may be brought to 
arbitration.  An arbitration panel will be composed of three members -- one 
selected by the Steering Committee (with the AHRQ members not voting) or by 
the individual awardee in the event of an individual disagreement, a second 
member selected by AHRQ, and the third member selected by the two prior 
selected members.  This special arbitration procedure in no way affects the 
awardee's right to appeal an adverse action that is otherwise appealable in 
accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS 
regulation at 45 CFR Part 16.

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the results of AHRQ-funded 
research into practice and policy, grantees and/or contractors are to inform 
the Office of Health Care Information (OHCI) when articles from their studies 
are accepted for publication in the professional literature.  Grantees and 
contractors should also discuss any ideas about other dissemination and 
marketing efforts with OHCI staff.  The goal is to ensure that efforts to 
disseminate research findings are coordinated with other Agency activities to 
maximize awareness and application of the research by potential users, 
including clinicians, patients, health care systems and purchasers and 
policymakers.  This is critical when outreach to the general and trade press 
is involved.  Contact with the media will take place in close coordination 
with OHCI and the press offices of the grantee or contractor institutions.  
In cases when products are created (such as annual or final reports, web-
based tools, CD-ROMs), grantees and contractors will be asked to submit to 
OHCI a brief plan describing how the product will be publicized.  An OHCI 
staff person will be assigned to each product and will coordinate the 
implementation of the plan, especially issues related to printing and 
electronic dissemination, and outreach to the media.

WHERE TO SEND INQUIRIES

AHRQ encourages inquiries about this announcement and welcomes the 
opportunity to answer questions from applicants.  Inquiries may fall into 
three areas: scientific/research, peer review, and financial or grants 
management issues:

o   Direct your inquiries about scientific/research issues, including 
information on the inclusion of women, minorities, and children in study 
populations to:

Lynn Bosco, MD, MPH
6010 Executive Blvd., Suite 300
Rockville, MD 20852
Phone: 301-594-2416
Email: lbosco@ahrq.gov

o   Direct your questions about peer review issues to:

Veronica M. Friel, Ph.D.
2101 East Jefferson Street, Suite 400W
Rockville, MD 20852
Phone: 301 594 6225
E-mail: vfriel@ahcq.gov

o   Direct your question about financial or grants management matters to:

Michelle Burr
2101 East Jefferson Street, Suite 600
Rockville, MD 20852
Phone: 301-594-1840
Email: mburr@ahrq.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o   Descriptive title of the proposed research
o   Name, address, and telephone number of the Principal Investigator
o   Names of other key personnel
o   Participating institutions
o   Number and title of this RFA

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows AHRQ staff to estimate the potential review workload and plan 
the review.

The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Veronica M. Friel, Ph.D.
2101 East Jefferson Street, Suite 400W
Rockville, MD 20852
Phone: 301 594 6225
E-mail: vfriel@ahcq.gov

SUBMITTING AN APPLICATION    

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone: (301) 435-
0714, Email: GrantsInfo@nih.gov.

SUPPLEMENTAL INSTRUCTIONS:

Because of the complexity of the required application, applicants are allowed 
an additional five pages beyond the usual twenty five pages allowed for a 
research plan.

If the applicant is currently receiving funding to function as the CERTs 
coordinating center, the following additional information should be provided 
in the application.

o   Evidence should be presented of a continuing infrastructure capable of 
maintaining the CC.  Past or planned changes in the CC and its team should be 
described in detail and a discussion of the impact of these changes should be 
included.  

o   An appendix describing partnerships (both governmental and private) with 
products should be attached.  Activities and accomplishments of the public-
private partnerships working group should be described, with detailed 
examples of these activities (e.g., descriptions of programs funded through 
private funds).

o   Evidence should be presented that the CC serves the needs of the  CERTs 
program through support of the SC and the program  as a whole.  Provide 
evidence, such as completed reports and presentations, which support the 
goals as described in the mission, vision, and authorizing legislation. 
(e.g.,letters of support).

o   Accomplishments should be described.   Accomplishments may include 
publications, meeting abstracts, and documents which exemplify the leadership 
activities of the SC and CC (e.g., program briefs and white papers).

o   Evidence should be presented of logistical support provided by the SC and 
CC (e.g., publication tracking, web site information, proceedings of 
conferences )

o   This application may summarize past activities, such as progress and 
challenges that can be identified in the area of public-private partnerships.  
The CC will also summarize efforts to date, to identify additional external 
resources for the program.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  AHRQ is not using the 
Modular Grant Application and Award Process.  Applicants for funding from 
AHRQ should ignore application instructions concerning the Modular Grant 
Application and Award Process, and prepare applications according to 
instructions provided in form PHS 398.  Applications submitted in the Modular 
format will be returned without review.

SENDING AN APPLICATION TO THE NIH and AHRQ:  Submit a signed, typewritten 
original of the application, including the checklist, and five 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 (20817 for express/courier service)

APPLICATION PROCESSING: 

Applications must be received by the receipt date listed in the heading of 
this Request for Application.  If an application is received after that date, 
it will be returned to the applicant without review.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.
 
The Center for Scientific Review (CSR) and AHRQ will not accept any 
application in response to this RFA that is essentially the same as one 
currently pending initial review, unless the applicant withdraws the pending 
application.  However, when a previously unfunded application, originally 
submitted as an investigator-initiated application, is to be submitted in 
response to an RFA, it is to be prepared as a NEW application.  That is the 
application for the RFA must not include an Introduction describing the 
changes and improvements made, and the text must not be marked to indicate the 
changes.  While the investigator may still benefit from the previous review, 
the RFA application is not to state explicitly how.

Applicants are encouraged to read all PHS Forms 398 instructions prior to 
preparing an application in response to this announcement.  The PHS 398 type 
size requirements (p.6) will be enforced rigorously and non-compliant 
applications will be returned.

Institutional Review Board (IRB) approval of human subjects is not required 
prior to peer review of an AHRQ application.  The "AHRQ Revised Policy for IRB 
Review of Human Subjects Protocols in Grant Applications" was published in 
the NIH Guide on September 27, 2000.  
(http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

This announcement is available on AHRQ's Website, http://www.AHRQ.gov, (see 
under Funding Opportunities) and through AHRQ InstantFAX at (301) 594-2800.  
To use InstantFAX, you must call from a facsimile (FAX) machine with a 
telephone handset.  Follow the voice prompt to obtain a copy of the table of 
contents, which has the document order number (not the same as this 
announcement number).  This announcement will be sent at the end of the 
ordering process.  AHRQ InstantFAX operates 24 hours a day, 7 days a week.  
For comments or problems concerning AHRQ InstantFax, please call (301) 594-
6344.

APPLICATION PREPARATION

In carrying out its stewardship of research programs, the AHRQ, at some point 
in the future, may begin requesting information essential to an assessment of 
the effectiveness of the Agency research programs.  Accordingly, grant 
recipients are hereby notified that they may be contacted after the 
completion of awards for periodic updates on publications resulting from AHRQ 
grant awards, and other information helpful in evaluating the impact of AHRQ-
sponsored research.

AHRQ expects grant recipients to keep the Agency informed of publications as 
well as the known uses and impact of their Agency-sponsored research.  
Applicants are to agree to notify AHRQ immediately when a manuscript based on 
research supported by the grant is accepted for publication, and to provide 
the expected date of publication as soon as it is known, regardless of 
whether or not the grant award is still active.

To receive an award, applicants must agree to submit an original and 2 copies 
of an abstract, executive summary, and full report of the research results in 
the format prescribed by AHRQ no later than 90 days after the end of the 
project period.  The executive summary should be sent at the same time on a 
computer disk which specifies on the label the format used (WP5.1 or WP6.0 is 
preferable).

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness and 
responsiveness to the RFA.  Incomplete and/or non-responsive applications or 
applications not following instructions given in this RFA will be returned to 
the applicant without further consideration.  An appropriate peer review 
group convened by AHRQ in accordance with standard AHRQ peer review 
procedures will evaluate applications that are complete and responsive to the 
RFA for scientific and technical merit.  

As part of the merit review, all applications will:

o   Receive a written critique
o   Undergo a process in which only those applications deemed to have the 
highest scientific merit will be discussed and assigned a priority score. 

REVIEW CRITERIA

General review criteria for AHRQ grant applications relevant to this 
application include:  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; adequacy of the 
proposed facilities and resources available to the applicant.  For a 
coordinating center, the latter is of particular importance.

o   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 academically diverse research centers, and the 
capability for accessing and interfacing with the health care delivery 
systems.

o   The applicant institution should have a broad base of skills with 
demonstrated experience in multi disciplinary research in therapeutics, 
including clinical epidemiology, health services research, analyses of large 
databases and clinical pharmacology.  The CC will need to be able to work 
closely with the research centers in the translational and evaluation 
activities, thus a strong background in therapeutics research should be 
demonstrated

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   The CC director must be an experienced senior investigator and manager 
who can provide strong administrative and academic leadership.  The director 
should be appropriately trained and well suited to carry out this work.  The 
investigator should demonstrate appropriate experience level, through 
publications and leadership activities. The director will need to have 
training such that he/she is able to interact with senior members of the 
academic and health care communities.

o   Evidence of past successes in developing partnerships, including reports 
on funds obtained through leverage of public-private partnerships for a 
program should be included with this application.

o   The applicant for the CC will need to have a history of involvement in 
multi-center research or similar programs, as the CERTs research centers work 
cooperatively with a variety of partners from government and the private 
sector.

o   The CC should demonstrate 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 CC applicant will need to demonstrate experience with dissemination 
and translational research.

o   The CC personnel should have experience working together as a team, as 
evidenced by previously funded grants or publications.

ADDITIONAL REVIEW CRITERIA: Reviewers will also consider the responsiveness 
of the proposal to the goal of the Centers for Education and Research on 
Therapeutics legislative mandate.  The purpose of the center is to facilitate 
leadership of the SC through logistical and programmatic support.

DATA SHARING:

Data Confidentiality
 
Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c- 
3(c)), information obtained in the course of any AHRQ supported-study that 
identifies an individual or entity must be treated as confidential in 
accordance with any explicit or implicit promises made regarding the possible 
uses and disclosures of such data. There are now civil monetary penalties for 
violation of this confidentiality statute. (42 U.S.C.299c-3(d))  In the Human 
Subjects section of the application, applicants must describe procedures for 
ensuring the confidentiality of the identifying information to be collected. 
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 and other identifying or identifiable 
data will be restricted and safeguarded. Identifiable patient health 
information collected by grantees under this RFA will also be managed in 
accordance with 42 CFR Parts 160 and 164, federal regulations pertaining to 
the privacy of patient-related health information.  These privacy 
regulations, developed by the Department of Health and Human Services 
pursuant to the Health Insurance Portability and Accountability Act of 1996 
(HIPAA), are scheduled to be effective and enforceable in April 2003. These 
regulations serve to limit the disclosure of personally identifiable patient 
information and define when and how such information can be disclosed. Thus, 
for example, health care plans and providers will require either patient 
authorization of disclosures of identifiable information to be made to 
researchers who are not their health care providers or waivers of such 
authorizations obtained from an IRB or Privacy Board (defined in the 
regulations) upon being satisfied that any identifiable health information 
will be appropriately safeguarded by the investigators. Additional 
information about the regulations and their implementation can be obtained 
from: http://www.aspe.hhs.gov/admnsimp/.  

The awardee should ensure that computer systems containing confidential data 
have a level and scope of security that equals or exceeds those established 
by the Office of Management and Budget (OMB) in OMB Circular No. A-130, 
Appendix III - Security of Federal Automated Information Systems. The 
National Institute of Standards and Technology (NIST) has published several 
implementation guides for this circular. They are: An Introduction to 
Computer Security: The NIST Handbook; Generally Accepted Principals and 
Practices for Securing Information Technology Systems; and Guide for 
Developing Security Plans for Information Technology Systems. The circular 
and guides are available on the web at 
http://csrc.nist.gov/publications/nistpubs/800-12/.  The applicability and 
intended means of applying these confidentiality and security standards to 
subcontractors and vendors, if any, should be addressed in the application. 

Rights in Data 

AHRQ grantees may copyright unless otherwise provided in grant awards, 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 AHRQ funds.  Such copyrights and patents are subject to 
a worldwide irrevocable Federal government license to use and permit others 
to use these products and materials for government purposes.  In accordance 
with its legislative dissemination mandate, AHRQ purposes may include, 
subject to statutory confidentiality protections, making project materials, 
data bases, results, and algorithms available for verification or replication 
by other researchers; and subject to AHRQ budget constraints, final products 
may be made available to the health care community and the public by AHRQ or 
its agents, if such distribution would significantly increase access to a 
product and thereby produce public health benefits.  Ordinarily, to 
accomplish distribution, AHRQ publicizes research findings but relies on 
grantees to publish research results in peer-reviewed journals and to market 
grant-supported products.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  June 23, 2003
Application Receipt Date:  July 24, 2003
Peer Review Date:  August 2003
Earliest Anticipated Award Date:  September 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  quality of the proposed project as determined by peer review
o  program balance
o  availability of funds
o  potential impact of proposed research  

AHRQ reserves the right to fund all or part of any application.

REQUIRED FEDERAL CITATIONS

INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS:  
It is the policy of AHRQ that women and members of minority groups be 
included in all AHRQ-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 
UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects 
in Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-
048.html).  A complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.
To the extent possible, AHRQ requires adherence to these NIH Guidelines.
Investigators may obtain copies from the above sources or from the AHRQ 
Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web 
site http://grants.nih.gov/grants/guide/index.html.  AHRQ Program staff may 
also provide additional information concerning these policies (see 
INQUIRIES).

AHRQ also encourages investigators to consider including children in study 
populations, as appropriate.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  If no Federal act is taken, having the force and effect of 
law, in reliance upon an AHRQ-supported research project, the underlying data 
is not subject to this disclosure requirement.  Also, disclosure of 
identifiable data from any AHRQ-supported-study is exempted from FOIA 
disclosures under "the (b)(3) exemption.", unless the identifiable subjects 
or provider(s) of data consent to such disclosures.  It is important for 
applicants to understand the scope of this requirement and its limited 
potential impact on data collected with AHRQ support. Proprietary data might 
also be exempted from FOIA disclosure requirements under "the (b)(4) 
exemption", for example, if it constituted trade secrets or commercial 
information.  However, courts have generally not regarded a researcher's 
interest in "his" data as proprietary.  NIH has provided guidance for 
researchers on the requirements of A-110.36 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. 

Should applicants wish to place data collected under this RFA in a public 
archive, which can provide protections for the data (e.g., as required by the 
confidentiality statute applicable to AHRQ supported projects, 42 U.S.C. 
299c-3(c)) and manage the distribution of non-identifiable data for an 
indefinite period of time, they may.  The application should include a 
description of any archiving plan in the study design and include information 
about this in the budget justification section of the application.  In 
addition, applicants should consider how to structure informed consent 
statements or other human subjects protection procedures to permit or 
restrict disclosures of identifiable data, as warranted. 

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting health improvement 
priorities for the United States.  AHRQ encourages applicants to submit grant 
applications with relevance to the specific objectives of this initiative.  
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance, Number 93.226.  Awards are made under Title IX 
of the Public Health Service Act (42 USC 299-299c-7) as amended by P.L. 106-
129 (1999).  Awards are administered under the PHS Grants Policy Statement 
and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 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 
childhood 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.


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