The Centers for Education and Research on Therapeutics (CERTs)

RFA Number: RFA-HS-05-014

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

Components of Participating Organizations
Center for Outcomes and Evidence, (http://www.ahrq.gov)

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
New

Updates: The following update relating to this announcement has been issued:

• September 29, 2006 - This RFA has been reissued as RFA-HS-07-004.

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release Date: October 26, 2004
Letters Of Intent Receipt Date(s): February 11, 2005
Application Receipt Dates(s): March 11, 2005
Peer Review Date(s): May 2005
Earliest Anticipated Start Date: July 2005
Expire: March 12, 2005

Due Dates for E.O. 12372
Not Applicable

Executive Summary

The Centers for Education and Research on Therapeutics (CERTs) program is a merit-based, peer-reviewed program created in response to a legislative mandate 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, and 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. The purpose of these awards is to expand the work of the existing CERTs program and address existing gaps to develop and implement research and create educational strategies for translating those research findings into improved clinical practices.

This RFA will use the Demonstration Cooperative Agreement (U18) award mechanism. AHRQ intends to commit approximately $3.2 million in FY 2005 to fund four new cooperative agreements in response to this RFA.

Only domestic institutions may submit applications. Both for-profit and not-for profits may apply. Institutions with funded AHRQ CERTs research centers are not eligible to apply to this RFA. 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 who are current CERTS PIs are not eligible to apply to this RFA as a PI. The application must include a proposed institutional plan for the development of a research infrastructure. Investigators must develop a center within one of the following themes: 1) mental health; 2) the elderly; 3) therapeutic devices; and 4) consumers and patients. AHRQ intends to fund one center from each of these themes.

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.

Telecommunications for the hearing impaired: TTY 301-451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Merit Review Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources

Section VI. Award Administration Information
1. Award Notices
2. Administrative Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Awardee Rights and Responsibilities
2. Federal Agency Responsibilities
3. Arbitration
3. Award Criteria
4. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

The Agency for Healthcare Research and Quality (AHRQ) announces the availability of funds for awards to new Centers for Education and Research on Therapeutics (CERTs). The purpose of these awards is to expand the number of CERTs Research Centers in order to: (a) develop and implement research and create educational strategies for translating those research findings into improved clinical practices; (b) address existing gaps within the overall CERTs program; and (c) address therapeutic themes determined to be complementary to AHRQ and Food and Drug Administration (FDA) research priorities and be responsive to the needs and goals of programs of the Department of Health and Human Services (DHHS), as discussed below.

This program began with the release of RFA: HS-99-004 on January 27, 1999, and the subsequent award of grants pursuant to the Food and Drug Administration Modernization Act of 1997 which authorized the AHCPR (now AHRQ), in coordination with FDA, to carry out a demonstration program to conduct research and provide objective information on drugs, biologics, and devices. AHRQ continues to manage this program in coordination with FDA under the Agency's reauthorizing legislation, P.L. 106-129, enacted in December 1999.

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 CERTS 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, and 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.

Research Centers (RCs) funded by this RFA would join the network of currently funded RCs. Each CERTs RC works independently to further the goals of the chosen themes (see Special Requirements). They also work with other CERTs, AHRQ, FDA, the Coordinating Center (CC) and a Steering Committee (SC) as part of a research network. The seven CERTs currently funded by AHRQ have the following themes: disorders of the heart and blood vessels; use of managed care data; disorders of joints and bones; drug interactions; children; infections and antibiotic resistance; and vulnerable populations (Medicaid and veterans benefit recipients). Detailed information on the program, CC, and SC can be found at: http://www.ahrq.gov/clinic/certsovr.htm and http://grants1.nih.gov/grants/guide/rfa-files/RFA-HS-03-007.html (Also see below under the RESEARCH OBJECTIVES section). Projects presented for consideration should also comply with the Agency's policy regarding the inclusion of priority populations (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Further information on the requirements is listed in the special requirements section of this RFA.

Authorities and regulations under which these grants will be funded are described in Section VIII.

1. Research Objectives

Background

The CERTs program is a national initiative to increase awareness of the benefits and risks of new, existing, or combined uses of therapeutics (defined as drugs, biologics and medical devices) through education and research. The program currently consists of seven Research Centers, a Coordinating Center and a Steering Committee. The Steering Committee consists of members from the RCs, the private sector, and government.

The CERTs concept grew out of recognition that physicians and providers need more information about health care interventions used in patient care. Information is available through private industry sponsored programs, continuing professional education, professional organizations, and peer-reviewed literature. However, easily accessible, impartial and usable information about the risks, benefits, therapeutic interactions, product problems, and error prevention of new and older agents, remains limited. Adequate implementation of research findings lags behind the creation of new knowledge.

The CERTs SC developed the following mission and vision statements for the program: The mission of the CERTs program is to provide objective, scientific information on the safe and effective use of therapeutics. The CERTs vision is to be a trusted national resource for people and organizations seeking information about health care products. CERTs accomplish this through research, education, dissemination and knowledge development. CERTs leverage resources through both public and private partnerships.

Each RC develops research, knowledge, demonstration and pilot educational programs to address the educational needs and priorities that they have identified. The ultimate goal of these activities is to provide access to evidence-based research and education programs in order to improve patient outcomes. Along the research spectrum, CERTs projects include descriptive, interventional, and applied research. Similarly, educational efforts generate a variety of products, including teaching modules, seminar presentations, fellowship programs, internet-based materials, and consultations with caregivers, policy-makers, regulators, and patients.

In consultation with AHRQ, each RC develops priorities for research and education in therapeutics, within its chosen theme. Each RC has a theme that is different from other RCs. However, some overlap exists (e.g., an RC focused on children may do some work in infectious diseases). In the interest of program balance, priority is given to programmatic gaps. Because there are only seven CERTs RCs there are many areas where research is lacking.

In consultation with AHRQ, each RC develops a global, comprehensive strategic plan that prioritizes a broad base of needs for education and research within the theme (e.g., priority populations, gender and age-specific issues, quality of life and economics) and includes the full-spectrum of therapeutics (drugs, devices and biologics) as appropriate. Although, the RC cannot accomplish all of the identified goals, specific projects chosen by the RC focus on a very limited number of quantifiable and generalizable outcome measures, along with strategies to achieve goals that fit within the framework of the RCs theme.

CERTs RC funding provides infrastructure support (a research team with adequate facilities, institutional support, and access to appropriate expertise needed to perform research, education, dissemination and translation of research into practice) such that an RC can fulfill the goals of the CERTs legislation and support the strategic needs of AHRQ, FDA, and other DHHS agencies with responsibilities for therapeutics. Each RC provides leadership in the area of its chosen theme and develops a series of research projects that leads to improved use of therapeutics. The needs of the program evolve with time. For example, the Medicare Modernization Act of 2003 newly authorizes Medicare coverage of prescription drugs and Section 1013 of the Act authorizes AHRQ to develop a research agenda on comparative clinical effectiveness in conjunction with the Center for Medicare and Medicaid Services [CMS]), so project flexibility is necessary. For example, the RC may be asked to respond to newly identified resources or work with newly identified partners. Thus, a RC is expected to collaborate with AHRQ in refining specific topics to address the overall area of focus and program goals.

As a legislatively mandated program, CERTs exists within the context of agencies whose therapeutics-related missions vary. AHRQ has a research and education mission which most closely aligns with the CERTs, thus the program resides within AHRQ. AHRQ's mission is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Information about AHRQ's strategic plan can be obtained at: http://www.ahrq.gov/about/strateix.htm

However, other agencies regulate and/or pay for therapeutics and thereby affect the manner in which therapeutics are used. Thus the CERTs program also addresses needs related to these agencies. The FDA strategic plan, for example, relates to CERTs in such areas as efficient risk management, improving health care through better information, and improving patient and consumer safety. Discussion of the FDA strategic plan can be found at: http://www.fda.gov/oc/mcclellan/strategic.html

On December 8, 2003 the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003 was signed into law. This legislation provides seniors and people living with disabilities with a prescription drug benefit. This legislation will have a significant impact on the use of drugs. Potential CERTs investigators should consult http://www.cms.hhs.gov/MMAUpdate/ for further information on the Act. Applicants may wish to address the impact of MMA on proposed research.

AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will be returned without review.

The U18 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator (PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with AHRQ staff being substantially involved as a partner with the PI, as described under the section VI.2. Administrative Requirements, Cooperative Agreement Terms and Conditions of Award.

Non-competing continuation awards for subsequent years will be contingent upon satisfactory progress. The AHRQ program officer is responsible for the annual progress review. However, AHRQ, at its discretion, may convene external reviewers to supplement the program officer review.

2. Funds Available

AHRQ intends to commit approximately $3.2 million in FY05 to fund four new RC cooperative agreements in response to this RFA.

Applications must be 5 years in duration with a budget supported by AHRQ not to exceed $800,000 per year in total costs to the government. Applications with project periods that are not 5 years or budgets that exceed $800,000 total costs per year will be returned without review.

Although the financial plans of AHRQ provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

1. Eligible Applicants

1.A. Eligible Institutions
Applications may be submitted if the institution has any of the following characteristics:

• For-profit organizatons
• Non-profit organizations
• Domestic
• Eligible federal agencies
• Public and private non-profit institutions, such as universities, clinics, colleges, and hospitals
• Units of State government
• Units of local government
• Faith-based or community-based organizations
• Tribes and tribal organizations

Existing CERTS (either institutions or PIs) are not eligible to apply. However, current subcontractors to existing CERTS may apply. Because this RFA is principally intended to support research and provide education that advances the optimal use of therapeutics (e.g., drugs, medical devices, and biological products) in the U.S., no awards will be made to foreign institutions. Foreign organizations may participate in projects as members of consortia or as subcontractors.

Under the most 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 RFA 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). Organizations described in sections 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

Because this RFA is intended to increase the implementation of safe practice interventions in the U.S., foreign institutions are not eligible to apply for grants. No awards will be made to foreign institutions. Applications from foreign institutions will be returned without review. Foreign organizations may participate in projects as members of consortia or as subcontractors.

1.B. Eligible Individuals

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.

The individual must be able to devote a considerable portion (at least 15%) of his/her time to the project. An individual who is currently a Principal Investigator (PI) at a funded RC may not apply as a PI for these awards. However, he or she may be an investigator or subcontractor of a new RC.

2. Cost Sharing
AHRQ does not require cost sharing for applications submitted in response to this RFA.

3. Other-Special Eligibility Criteria

The ultimate goal of the CERTs program is the implementation of evidence-based research and education programs in order to improve patient outcomes. To accomplish this goal, each RC must develop research demonstration, pilot educational programs and implementation plans to match the educational needs and priorities that they have identified within a chosen theme. AHRQ funding provides for infrastructure ( a research team with adequate facilities, institutional support and access to appropriate expertise to perform required activities) such that the CERTs program can fulfill the goals of the CERTs legislation and support the strategic needs of AHRQ, FDA, and other DHHS Agencies with responsibilities for therapeutics. Each RC also provides national and local leadership.

General

o Each RC must focus on one of the broad therapeutic themes listed below. These themes are under-represented in the current CERTs. The application should speak to which aspects of the chosen theme will be included within the project. The chosen theme should have both a strong research and educational component.

o Prospective applicants should examine the themes and programmatic information for the seven currently funded CERTs RCs. Briefly, these therapeutic themes are: disorders of the heart and blood vessels; use of managed care data; disorders of joints and bones; drug interactions; children; infections and antibiotic resistance; and vulnerable populations (Medicaid and veterans benefit recipients). Applicants should consult the following websites for more detailed information on the program: (http://www.certs.hhs.gov and http://www.ahrq.gov/clinic/certsovr.htm). AHRQ is interested in complementing these RCs rather than duplicating the work ongoing under the currently awarded CERTs grants. Thus, applicants are required to develop proposals that address gaps in the current CERTs portfolio.

o An RC has as its fundamental program goal the development of a national center of excellence and therapeutics expertise.

o The applicant must provide an implementation plan including a timeline for introducing interventions into the health care delivery process. This plan should include the identification of barriers and problems to be overcome in introducing interventions. The plan should discuss the costs and benefits to the institutions of implementing the interventions. The applicant must be able to anticipate the level of adoption and acceptance of interventions. The applicant should describe potential barriers to adoption and how these barriers can be overcome. The applicant must describe the tools expected to result from these projects. The applicant should specify projected impact and generalizability of any tools developed.

Choice of Themes and Projects

Within each theme, CERTs projects include descriptive, interventional, and applied research. Similarly, educational efforts generate a variety of products, including teaching modules, seminar presentations, fellowship programs, internet-based materials, and consultations with caregivers, policy-makers, regulators, and patients. Each RC develops priorities for comprehensive education and educational research in therapeutics within its chosen theme.

Themes must be chosen from the following list. These themes are broadly defined therapeutic research areas. An applicant may address any aspect of the theme that is consistent with the CERTs legislation, but the themes should be addressed in as comprehensive a fashion as is feasible. The themes have been developed around current gaps in the funded program.

o Medical Devices (excluding diagnostics) - In 2002, Americans spent over $69 billion dollars for approximately 53 million medical devices used for therapeutic purposes (e.g., artificial joints, insulin pumps). There is limited research on the impact, use, safety, and outcomes associated with these products. Issues related to effectiveness and cost-effectiveness often need research even after a product has come on the market.

o Mental Health Therapeutics - Treatment in mental health ranges from time-limited treatment for mild impairment to complex multi-product chronic care for those with severe debilitating disorders. Of particular interest in this area is use in the elderly, in children, and for those with severe chronic illness.

o Consumer and Patient Education and Adherence - As more therapeutic options become available, those using products need to make informed decisions. Therapeutics firms invest a significant portion of their advertising budget in communicating information to consumers. What is the impact of this information? As clinicians spend less time with patients, what kinds of alternative communication methods can be used to supplement clinician interactions? How can we facilitate improved communications? In situations where adherence should not be optional, how do we ensure that patients make appropriate decisions?

o Elderly - including issues related to the unique aspects of therapeutic usage in the older population and in the very elderly. With the implementation of the Medicare Modernization Act of 2003, it is expected that the elderly will have better access to medications. Questions remain as to how to assure that this vulnerable population receives appropriate medications. With the implementation, it is expected that questions will arise regarding appropriateness, reduction of poly-pharmacy and other issues related to safety and effectiveness.

In addition to the information contained within the Research Objectives section, the applicant should consider the following when supporting the choice of an RC theme and associated projects:

Topics areas or conditions that have: (1) high incidence or prevalence in the general population or subpopulations, including racial and ethnic minorities, women and children, and other AHRQ priority populations as appropriate (see IV.6 for details on AHRQ priority populations); (2) significance to the Medicare, Medicaid and other Federal health programs (see research objectives); (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, provider, or purchaser 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.

In addition to AHRQ's priorities, FDA's research interests include effectively educating and communicating with the clinical community. In particular, there is a crucial need for research to help understand adverse events, medication errors and health care product problems and to sensitize the clinical community towards recognition of these issues. In addition, more research needs to be conducted on the most effective means of communicating product information (whether on labeling changes, public health advisories, or alternate methods) that would be incorporated quickly into clinical practice.

The chosen theme and associated projects should have strong justification as to how this research and education will be translated into public health impact. In choosing projects, consideration should be given to the legislative mandate, as noted in the Research Objectives section.

The applicant must identify and describe relationships with several intermediary (e.g., appropriate clinical specialty organizations) and end-user groups (e.g.: consumers and patients) who the applicant will consult with as research, products, and implementation strategies are designed. These partners must be willing to help foster dissemination and translation of findings and products into practice.

Each proposed project must have a limited number (no more than two) of quantifiable, desired patient outcomes. The applicant should include quantifiable methods and data sources for measuring progress toward these goals with the goals linked to a plan for implementation.

Additional Guidance

o RCs will evaluate existing work within the chosen theme; develop options to address the identified needs; and conduct state-of-the-art, clinical, laboratory and health services research. RCs may selectively develop protocols and undertake pilot studies on the effectiveness and safety of health care products and interventions to improve use, during the period of funding. The RC will actively work with AHRQ, the CC, and other public and private organizations to foster the translation of research findings into practice at both a local and national level.

o The applicant must be able to approach the chosen theme in a comprehensive fashion (e.g., access to data, personnel, and partnerships).

o The RC Principal Investigator (PI) must be an experienced senior investigator and manager who can provide strong administrative and academic leadership. The PI 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 AHRQ on scientific and operational matters. The PI must commit substantial time to the project (at least 15%).

o The organizational structure of each center should include a committed core of investigators with experience working within the chosen theme. The application must demonstrate the availability of personnel with the necessary expertise to study a wide range of topical areas in after-market health care product research and have experience in the areas of dissemination, implementation, and evaluation of such. The Center may be a consortium of organizations, although it is expected that members of a consortium will have worked collaboratively in the past. Multidisciplinary collaboration among researchers working within the RC is essential.

o Applicants must have the necessary scientific, technical, organizational and physical resources, and must demonstrate access to such resources, necessary to carry out the following: (1) multidisciplinary research, including clinical epidemiology, health services research, clinical economics, analyses of large databases, and laboratory, as appropriate to the theme; (2) technical assistance and education for health care providers and others; (3) dissemination of research findings; (4) the evaluation of dissemination and implementation strategies and (5) a strong understanding of regulatory processes that relate to product effectiveness and safety.

o The RC personnel should have access to, and experience with, data on a defined population with adequate information to support its research theme. Information on this population should be longitudinal and include demographics, diagnostic information and therapeutic usage. Ideally this research should be widely generalizable.

o Each RC should include documentation of past and planned future contributions of partnerships for which the partner contributes substantial resources (e.g., shared publications, conferences, educational tools or other products), especially with potential collaborators and users of research findings. Collaborations may include arrangements with partners such as other governmental agencies, professional groups, consumer groups, foundations, and the private sector. 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 as appropriate; and assistance in diffusing and implementing research findings to the appropriate audiences.

o Work carried out by each RC 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.

o Each RC should incorporate measures and goals of cost effectiveness and efficiency into research and education activities.

o AHRQ funds are intended to provide basic infrastructure support for each RC to allow it to function effectively. Funds should be budgeted to provide for staff support to undertake the design, development and implementation of one or more educational studies and a dissemination program.

o Specific topic areas proposed in an application may be refined prior to funding the application, in keeping with the limited availability of funds and the needs of AHRQ. These negotiated topic areas will focus on program balance and diversity. RCs will expand upon topics and ultimately support larger research initiatives by combining CERTs funds with funding from other sources (e.g., government, private sector, foundation and corporate).

o Each RC should support career development of junior faculty and investigators through efforts to increase in-house expertise in the varied area of therapeutics. A program should encourage commitment to the future of therapeutics research. Partnerships that establish capacity for multidisciplinary career development programs involving multiple organizations, both public and private, are strongly encouraged. RC funds are not to be made available for training.

o Applications are encouraged from existing integrated programs, other than those already funded as CERTs. (e.g., Centers funded through the National Center for Research Resources, General Clinical Research Center(GCRC) program, the Centers for Disease Control and Prevention, Prevention Centers; AHRQ-funded Evidence-based Practice Centers [EPCs]).

o Each RC has as one of its goals the provision of leadership at the local and State level.

o Detailed research plans which allow for the review of a discrete budget for each proposed major project must be presented within the application.

o Each RC must include in its budget funds that allow for active participation of the center teams in Steering Committee, CC, and AHRQ activities. Required activities include attendance by one representative at the two-day Steering Committee meetings. The applicant should budget for four Steering Committee meetings per year. The quarterly Steering Committee meeting is usually held three times per year at the CC in Durham, North Carolina, and once per year in metropolitan Washington, DC. Additionally, each RC should budget for one trip per year to Rockville, MD for two people from the center. At the discretion of AHRQ program staff, funds may be used for investigator travel to another location. Additionally, a limited budget should be set aside, not to exceed 15% of the annual proposed total cost budget, for other collaborative activities. These activities may require rapid responses on the part of the investigator teams. Some examples of potential collaborative activities include: assisting program staff in responding to questions related to a Medicare drug benefit, participation in a workshop related to CERTs, or development of AHRQ fact sheets. This information should be clearly identified in the main budget. Lack of participation in these activities may cause termination of grant funding.

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See also Subsections III.3 and VI.2 for additional information.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Applications that do not adhere to the page number (which may be up to 30 pages for the Research Plan) and font size requirements will be returned without review.

Supplementary Instructions:

There are no cost sharing requirements included in this RFA. These grants are seen as partnerships and as facilitating opportunities for collaboration and coordinated efforts in response to new, emerging, or ongoing issues related to therapeutics. AHRQ encourages applicant institutions, including any collaborating institutions, to devote substantial amounts of their own resources to this effort. A strong indication of institutional support from the applicant and their collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include actual dollars, donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project.

Technical Assistance

AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff. The purpose of the conference call is to provide potential applicants with background information and respond to questions about the preparation of an application in response to this RFA. The conference call will take place on January 5, 2005 at 12 noon Eastern Standard Time and will last approximately 1-2 hrs.

3. Submission Dates

3.A. Receipt, Review and Anticipated Start Dates
Technical Assistance Workshop and Conference Call: January 5, 2005
Letters Of Intent Receipt Date(s): February 11, 2005
Application Receipt Dates(s): March 11, 2005
Peer Review Date(s): May 2005
Earliest Anticipated Start Date: July 2005

3.A.1. Letter of Intent

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

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

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 IC 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:

Judi Consalvo
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road, Room
Rockville, MD 20850
Telephone: (301) 427-1489
FAX: (301) 427-1520
Email: CERTSRFA@AHRQ.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional hard copies of the application and all appendix material, must also be sent to:

Judi Consalvo
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road, Room
Rockville, MD 20850
Telephone: (301) 427-1489
FAX: (301) 427-1520
Email: CERTSRFA@AHRQ.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label 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 RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review.

The NIH & AHRQ will not accept any application in response to this funding opportunity 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 a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

Applicants are encouraged to read all PHS Forms 398 instructions prior to preparing an application in response to this RFA. The PHS 398 type size requirements (p.6) will be enforced rigorously and non-compliant applications will be returned. For this RFA, the Research Plan may be up to 30 pages in length. It is very important to note that limitations on the size of the font must be observed; applications violating the font size or page limit requirements will be returned without review.

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).

The RFA is also available on AHRQ's Web site, http://www.AHRQ.gov, (see under Funding Opportunities).

4. Intergovernmental Review

This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement. The Grants Policy Statement can be found at http://grants1.nih.gov/grants/policy/gps/index.html (See also Section VI.3. Award Criteria)

6. Other Submission Requirements

o Priority Populations

The Healthcare Research and Quality Act of 1999 (See http://www.ahrq.gov/hrqa99a.htm) reauthorized the Agency and directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas); and health care for priority populations, which include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. To implement this directive, AHRQ published a notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this RFA should address the requirements of including priority populations as specified in the Notice.

o 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 AHRQ Office of Communications and Knowledge Transfer (OCKT) 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 OCKT 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 OCKT and the press offices of the grantee's or contractor's 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 OCKT a brief plan describing how the product will be publicized. An OCKT 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.

o HCUPS & MEPS

Applicants are encouraged to make use of AHRQ'S Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS). HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership. HCUP inpatient databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data. HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place. HCUP databases include: the Nationwide Inpatient Sample (NIS) with inpatient data from a national sample of over 1,000 hospitals, the Kids' Inpatient Database (KID) with a nationwide sample of pediatric inpatient discharges, the State Inpatient Databases (SID) with the universe of inpatient discharge abstracts from participating states, the State Ambulatory Surgery Databases (SASD) with data from ambulatory care encounters from hospital-affiliated and sometimes freestanding ambulatory surgery sites from participating states, and the State Emergency Department Databases (SEDD) with data from emergency department encounters from hospital-affiliated emergency departments from participating states. More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, noninstitutionalized population. MEPS comprises three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample. The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees. More information on the MEPS is available at http://www.meps.ahrq.gov.

This does not preclude the use of secondary data sources or primary data collection.

o Use of CMS Data

Purchase of Centers for Medicare and Medicaid Services (CMS) public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the Research Design and Methods section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research. In consultation with CMS, previously called Health Care Financing Administration (HCFA), AHRQ will use this information to develop a cost estimate for obtaining the data. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.

Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with AHRQ's confidentiality statue, 42 USC 299c-3(c), the Privacy rules at 45 CFR Parts 160 and 164, if applicable, and standards set out in OMB Circular A-130, Appendix III Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed.

Unless AHRQ is able to negotiate exceptional arrangements included in the DUA is the requirement that the User agrees to submit to CMS, a copy of all findings within 30 days of making such findings, for the sole purpose of assuring CMS that data confidentiality is maintained. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS's approval to do so.

In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take 6 months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff.

CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats.

Questions regarding CMS data should be directed to the AHRQ program official listed under INQUIRIES.

o Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs, the AHRQ may request information essential to an assessment of the effectiveness of 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 two 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 (Word Perfect, or Word, or ASCII format).

The past cooperation of applicants with regard to the submissions described in this section may be considered in the application review to assess applicants' potential for responsible stewardship of awarded funds.

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. Applications submitted in the Modular format will be returned without review.

Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness. Merit Review Criteria are described in section V.3 below.

2 . Review and Selection Process

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 standard AHRQ peer review procedures. Incomplete and/or non-responsive applications or applications not following instructions given in this RFA will be returned to the applicant without further consideration.

3. Merit Review Criteria

As part of the merit review, all applications will:

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

In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application.

• Significance
• Approach
• Innovation
• Investigator
• Environment
• Budget

The application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Approach: Are the conceptual framework, design, methods, and analyses of the component projects adequately developed, well integrated, and appropriate to the aims of the chosen theme? Are the project choices and outcomes appropriately justified? Are the aims important, quantifiable and achievable? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

Investigators: Is this person a senior level individual with experience in both research and implementation of change within the healthcare setting? Is the investigator appropriately trained and well suited to carry out this work? Is the experience level of the principal investigator and other team members proposed appropriate to the requirements of a RC? Does the PI devote an adequate amount of time to this application (at least 15%). Does the investigator and the research team have an advanced level of knowledge, and research, education, and dissemination experience related to the chosen theme? Is there flexibility within the team?

Environment: Is this a supportive environment that provides appropriate resources (personnel and structural) for the accomplishment of the aims of the project? Does the scientific environment in which work will be done contribute to the probability of success? Do the proposed projects take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support (both financial and other)?

Budget: Is the proposed project budget and the requested period of support for individual projects in relation to the proposed research reasonable? Does the application include detailed budgets for individual projects? Does the applicant present evidence of both past and future partnerships and institutional support that supplement the resources of the RC to fulfill the requirements of the program for implementation?

3.A. Additional Review Criteria:

Protection: The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application.

Inclusion: The adequacy of plans to address the needs of both genders, racial and ethnic groups (and subgroups), children as appropriate for the aims of the project, and other AHRQ priority populations (see discussion on Priority Populations in IV.6 and in Required Federal Citations below) .

Relevance to Legislative Mandate: Reviewers will also consider the extent to which the projects outlined in the proposal will assist AHRQ in achieving the overall goals of the CERTs; potential of the proposed activity to foster and sustain innovation opportunities for the partner organizations; and the degree to which the participation of the institutions that serve groups currently underrepresented in the scientific workforce are involved in the proposed activity.

o Evidence should be presented of an infrastructure capable of maintaining the CERTs RC.

o The applicant should describe in detail an approach to the proposed theme, including the priorities and criteria for the choice of topics within the theme of the RC. Each application should outline how it expects to help AHRQ meet the overall goals of CERTs. In addition, each center should articulate specific outcomes it expects to achieve as a result of the program of work being undertaken.

o Programs developed for this application should show plans for how the research will be translated into specific, measurable outcomes. It should include a plan that describes the steps required to progress from developmental pilot programs to national programs that measurably affect outcomes. This plan should identify how this goal will be achieved. The RCs, the CERTs program, DHHS, and other partners will ultimately use results from these small pilot and developmental projects to translate this developmental work into educational programs. A high priority should be given to translational activity that results in education and outreach. The goal of this activity is measurable improvement in health outcomes, as measured by commonly accepted indicators, such as mortality, hospitalization rates, quality of life, or reduced resource utilization.

o Each proposed project should have a limited number (no more than two) of quantifiable, desired patient outcomes. The applicant should include quantifiable methods and data sources for measuring progress toward these goals with the goals linked to a plan for implementation.

o The applicant should summarize plans in the application for additional funding through private partnerships, institutional support and additional government funding (e.g.: training awards) to be used to assist in completing projects. For those projects where a non-governmental partner has been identified, the applicant should include in the application a description of the steps that have been taken to assure adherence to the principles set forth in the CERTs Principles for Public-private Partnerships. These principles can be viewed at the following web address http://www.certs.hhs.gov/partners/principles.html.

o Detailed research plans which allow for the review of a discrete budget for each proposed major project proposed should be presented within the application.

o When proposed projects involve surveys that are not research center initiated or collection of survey data from individuals is required by AHRQ, plans should consider the applicability of the Paperwork Reduction Act 44 USC 3501ff and related regulations, 5 CFR 1320 [1320.3(h)(5) exempts collections of data from patients e.g., in clinical trials] and seek technical assistance from the agency, as needed, (e.g., as to the impact of these requirements on timing of these projects).

3.B. Additional Review Considerations
Not Applicable

3.C. Sharing Research Data

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 protected 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) became mandatory for covered entities on April 14, 2003. These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers. Thus, for example, health care plans, will require either patient authorization of disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) satisfied that any identifiable health information will be appropriately safeguarded by the investigators. The HHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.aspe.hhs.gov/admnsimp/ or http://www.hhs.gov/ocr/hipaa/

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.

3.D. Sharing Research Resources

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, databases, 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 substantial or valuable 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. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate these issuances with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO's website http://www.gpoaccess.gov/cfr/index.html).

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will receive a written critique called a summary statement.

A formal notification in the form of a Notice of award will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Notification will be made electronically to the designated administrative/institutional official.

2. Administrative Requirements

All AHRQ grant and cooperative agreement awards are subject to the terms and conditions of the Public Health Service (PHS) Grants Policy Statement as part of the notice of grant award, found at http://grants1.nih.gov/grants/policy/gps/index.html. For terms of the award, see http://grants1.nih.gov/grants/policy/gps/5award.htm#terms, and see http://grants1.nih.gov/grants/policy/gps/5award.htm#fund for the award and funding process.

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator, as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement ( U18 ), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial AHRQ programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the AHRQ purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the AHRQ as defined above.

All cooperative activities that potentially include significant government involvement will require prior approval by the AHRQ program official who is expected to consult with the Steering Committee (SC).

2.A.1. Awardee Rights and Responsibilities

o The Research Centers (RCs) are expected to work with AHRQ, the FDA and other Federal Agencies, as appropriate, on analyses, studies and other joint activities. Such joint activities may involve syntheses of research findings, data analyses, or the preparation of background information on various topics related to therapeutics. Active participation with such programs as the AHRQ-funded Evidence-based Practice Centers is expected.

o The PI will work with the Coordinating Center (CC), as appropriate, to disseminate study findings and participate in program implementation

o The RC will give appropriate attribution to AHRQ on all publications and other products resulting from AHRQ funded activities. Attribution in situations where there are multiple sources of funding requires consultation with the AHRQ Program official.

o Each PI is a member of the CERTs Steering Committee (SC) and will attend the quarterly SC meetings, and bi-monthly conference calls convened by the CC. Costs associated with SC participation will be the responsibility of the RC. The RC will update the SC on program progress at each meeting. One co-investigator from the RC will be designated in the application to act and make decisions related to SC business or attend SC meetings, in the absence of the PI.

o The PI will provide access to RC data sources to the CC and to AHRQ as appropriate to the individual studies, consistent with statutorily based promises of confidentiality.

o Publications and other pertinent information, such as educational modules, web sites, and training tools, should be submitted to the CC as soon as they are available via both direct transmittal and hard copy.

o Dissemination of findings is a shared responsibility between the RC, CC, SC, AHRQ and FDA; the RC should utilize its relationship with end users and partners to foster rapid translation into practice of findings and tools.

o The RC will contribute to the Annual Report and the Program Updates. These documents are developed by the CC in conjunction with AHRQ.

2.A.2. Federal Agency Responsibilities

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

o AHRQ with assistance from FDA, the CC, and the RCs will identify a chairperson for the SC, should the current chairperson need to be replaced.

o The AHRQ Program Official(s) and staff will work in conjunction with FDA, the RCs PI, the CC and the SC to assure that issues for further study (e.g., money becomes available through partnerships or supplementary funds) receive adequate review and reflect the mission and goals of AHRQ and FDA. Government representatives will also meet periodically to provide input and advice to the SC.

o The Federal agencies may have substantive involvement in the planning and conduct of research, technical assistance, dissemination, and career development carried out by each center. Such involvement will require the approval of the AHRQ Program Official and such research may require further approval by OMB.

o The Federal agencies involved will provide information on appropriate government resources, such as additional funding and data sources. Of particular importance will be the incorporation of information generated through other AHRQ programs, such as the Evidence-based Practice Centers (EPCs). This information will be posted at the CERTs website, once it is publicly available. More information about the EPCs can be found at http://www.ahrq.gov/clinic/epcix.htm.

o As additional data and sources of funding are identified, the Federal agencies will work with RCs, through a Public-Private Partnership Working Group (PPWG) to establish appropriate agreements to optimize use and sharing of these resources. The PPWG, chaired by the PI of the CC, consists of representatives from each RC, the DHHS Office of General Council, AHRQ, and FDA. The PPWG will review all proposed non-governmental partnerships to ensure they do not constitute a conflict of interest in the study design, performance, or reporting of results.

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.

2.A.3 Arbitration

Any disagreement that may arise regarding 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 SC (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.

3. Award Criteria

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

• Scientific merit (as determined by peer review)
• Availability of funds
• Programmatic priorities

It is AHRQ's intention to fund one RC from each of the four themes (see Special Requirements), subject to the receipt of quality applications. Awards will take into consideration program and geographic balance.

4. Reporting

Each RC should expect to actively participate in the following activities: Steering Committee Meetings (four times per year), bimonthly conference calls, monthly conference calls of the public-private partnership working group and monthly progress updates to the CC. Participation in these activities requires that each PI share with the SC, CC, AHRQ and FDA activities of interest, progress, and preliminary findings. Each RC may also be required to participate in ad-hoc collaborative activities. These activities may require rapid responses on the part of the investigator teams. Some examples of potential collaborative activities include assisting program staff in responding to questions related to a Medicare drug benefit, participation in a workshop related to CERTs, or development of AHRQ fact sheets. The purpose of these activities is enhancement of communication between the RC, CC and SC and development and achievement of strategic program goals. Assistance for developing a budget for these activities is below. Lack of participation in these activities may cause termination of grant funding.

Direct your questions about financial or grants management matters to:

Lynn Bosco
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road, Room
Rockville, MD 20850
Telephone: (301) 427-1490
FAX: (301) 427-1520
e-mail: CERTSRFA@ahrq.gov

2. Peer Review Contacts:

Direct your questions about peer review issues to:

Michele Hindi Alexander
OEREP/Division of Scientific Review
Agency for Healthcare Research and Quality
540 Gaither Road, Room
Rockville, MD 20850
Telephone: (301) 427-1547
FAX: (301) 427-1437
Email: mhindi@ahrq.gov

3. Financial or Grants Management Contacts:

Direct your questions about financial or grant management matters to:

Michelle Burr
OPART/Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road, Room
Rockville, MD 20850
Telephone: (301) 427-1451
FAX: (301) 427-1462
Email: mburr@AHRQ.gov

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. Furthermore, even if a Federal regulation action is taken in reliance on AHRQ-supported data under FOIA, 5 USC 552(b), disclosure of statutorily protected confidential identifiable data from such study is exempted from disclosure under "the (b)(3) exemption." 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 collected. NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

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 subject 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 the last modification the "Standards for Privacy of Individually Identifiable Health Information", was mandated by the "Privacy Rule," on August 14, 2002. This regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). Mandatory compliance with the Privacy Rule (for those 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 covered entities. 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 that may be used to determine whether a researcher is a staff of a covered entity. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

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 at http://www.cfda.gov/, 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.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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			Department of Health and Human Services (HHS)
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