Part I Overview Information

Department of Health and Human Services

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

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

Title: Centers for Education and Research on Therapeutics (CERTs)( U19)

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

Announcement Type

This is a modification and update of RFA-HS-99-004 which was released on January 27, 1999. Its subsequent Announcements were RFA-HS-05-004 released on October 26, 2004 and RFA-HS-007-004 released on September 27, 2006.

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

Request For Applications (RFA) Number: RFA HS-11-004

Catalog of Federal Domestic Assistance Number(s)

93.226

Key Dates
Release Date: March 14, 2011
Letters of Intent Receipt Date(s): April 20, 2011
Application Receipt Dates(s): May 18, 2011
Peer Review Date(s): Approximately two months after receipt date
Earliest Anticipated Start Date: Approximately two months after peer review date
Additional Information To Be Available Date: Not applicable
Expiration Date: May 19, 2011

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

While grant awards are made to institutions rather than individuals, this announcement and its instructions are written to inform individual researchers of this funding opportunity and facilitate the submission of grant applications by their organizations.

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: AHRQ and NIH are committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate multi-project programs. AHRQ and NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

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 or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
2. Technical Assistance
B. Submitting an Application to AHRQ
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. AHRQ Responsibilities
3. Collaborative Responsibilities
3. 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

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Background and Mandate of the Centers for Education and Research on Therapeutics

The Centers for Education and Research on Therapeutics (CERTs) program is a national initiative established in 1999 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 14 Research Centers (RC), a Coordinating Center (CC) and a National Steering Committee (SC). The Steering Committee meets regularly and consists of members from the RCs and representatives of consumers, the private sector, and government. Funding ends for the current Coordinating Center and Research Centers in FY2011.

The CERTs are authorized by 42 U.S.C. 299b-1(b) to conduct research to provide objective clinical information about drugs, biological products, and devices (therapeutics) to health care practitioners, pharmacy benefit managers, health maintenance or other managed care organizations, health care insurers or governmental agencies, and consumers. The CERTs are also charged with conducting 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 or of combinations of drugs and biological products.

In addition, the CERTs are charged with conducting research to improve the quality of health care while reducing its cost through: (1) the appropriate use of drugs, biological products, or devices, (2) the prevention of adverse effects and their consequences due to drugs, biological products, and devices. The CERTs mandate also includes the conduct of research on the comparative effectiveness and safety of drugs, biological products, and devices and such other activities as the Secretary determines to be appropriate.

Each CERT RC will develop research, knowledge, demonstration and educational programs responsive to the programmatic intent of this FOA and that will address the evidence gaps, educational needs, and priorities of stakeholder groups and partners poised to take action based on CERTs findings. The ultimate goal of CERTs research and education activities is to improve patient outcomes through evidence generation about therapeutics and also through research and related activities to disseminate, translate, and implement evidence into clinical practice. CERTs research may be descriptive, interventional, or methodological as long as its ultimate purpose is to be applied in practice by clinicians, patients, and other members of the health care system. CERTs education may include education, dissemination, translation, and implementation efforts that are also applied in nature, with products that may include, but are not limited, to teaching modules and materials, seminar presentations, internet-based materials, clinical decision support, social network analysis, and consultations with caregivers, policy-makers, regulators, and patients.

Definitions

CERTS Scientific Forum (CS Forum, formerly called the Coordinating Center or CC): The CS Forum, to be awarded and funded under a separate FOA (see RFA-HS-11-003) provides scientific leadership and support of the CERTs Steering Committee (SC) and workgroups and committees of the CERTs that address common issues of the CERTs RCs and SC members. The CS Forum convenes the CERTs RCs, the SC, and relevant organizations in virtual and face-to-face meetings and project activities; CS Forum scientists contribute as necessary to CERTs workgroups and committees through research, analyses, and other supportive activities. The common CERTs issues supported by the CS Forum for the CERTs may address the 5 programmatic interest areas that are described in this FOA, as well as issues which include, but are not limited to, methodologies, quality use of therapeutics, policies pertaining to research and education in therapeutics, development of meaningful partnerships with outside entities, or dissemination and implementation of CERTs findings. The CS Forum supports meetings, CERTs communications, program documents, public affairs, tracking and dissemination of CERTs products, and electronic media, such as web sites,to disseminate information about CERTs programmatic activities and promote educational tools and publications. Currently there are two 2 CERTs web sites (www.certs.hhs.gov and www.chainonline.org).

Because of the close interrelationship of the CERTs Scientific Forum and the CERTs Research Centers, applicants to each FOA are strongly encouraged to review both FOAs.

Education: Includes all efforts to increase knowledge in CERTs target audiences and includes public sharing via publications and other means of research results, tools and products developed by an individual RC or a multi-CERT collaborative working group. Dissemination and translation activities are components of education.

Dissemination: The act of sharing or transmitting research results or material by targeting different audiences using a variety of means (e.g., professional, electronic, paper, video or other avenues of communication). Outreach and building awareness about a research finding or product is a key component of dissemination.

Translation: Putting information into a context, language, format, and communication vehicle so the intended audience (s) can apply and use it. Translation is a first step in affecting behavior.

The CERTs Steering Committee, CERTS Steering Committee Chair, and Executive Committee are described briefly below. Policies and practices of the current CERTs Program may be revisited and revised by future versions of the CERTs Program, that is, the RCs, Scientific Forum, and Steering Committee.

CERTs Steering Committee (SC): A committee comprised of members from the research centers, the CS Forum, AHRQ, FDA, other government agencies, and at-large representatives from consumer, health care, and medical product sectors. The CERTs SC has joint leadership responsibility along with the CS Forum for collaborative activities undertaken by the CERTs program, and along with the CS Forum, acts in a consultative role to the research centers. The SC is chaired by a national expert (see below).

CERTs Steering Committee Chair: A recognized expert in therapeutics with diverse experience working in multiple sectors. CERTs RC Principal Investigators and other scientific leaders in therapeutics will make nominations for the Chair and the future Chair (Chair-Elect), who will be selected by AHRQ in concurrence with FDA and the PIs of the CERTs RCs. By virtue of his/her expertise and contacts with the therapeutics, health care research, and health care system communities, the SC Chair promotes meaningful partnerships and collaborations of the CERTs RCs. The SC Chair contributes to the planning of the CERTs Steering Committee meetings and presides over them by leading and facilitating the meetings conduct and productivity. The SC Chair typically serves a 2 year term with a Chair-Elect serving concurrently; the Chair-Elect assumes the Chair position after the Chair’s term ends.

CERTs Executive Committee: A committee handling CERTs decision making between SC meetings and comprised of the CS Forum PI and Program Manager, the SC Chair, AHRQ Program staff, and additional SC members serving in rotating terms.

General Considerations for Applicants

AHRQ seeks applications for CERTs RCs that propose a body of work addressing at a minimum 3 of 5 programmatic interest areas which are described below and which represent overarching interests of AHRQ, FDA, CMS, and other stakeholders in therapeutics research and education. The proposed work of a CERTs RC must fall within a Center-proposed theme that unifies the 3 to 5 major projects proposed by the RC to be conducted over the 5 year period of the grant; project partnerships with individuals and/or organizations engaged in all aspects of clinical care or its financing are highly encouraged. Applicants must also propose a core infrastructure that will support not only their proposed work, but also allow the future development and conduct of additional projects and activities with other funding sources and partners.

Each applicant must also nominate 2 or more concept briefs of issues of common interest to multiple CERTs RCs and which could be pursued productively by working groups or committees made up of investigators from applicant Center and other CERTs RCs and supported by the CS Forum. The candidate issues should be described briefly (a maximum of 1 page in length) and lay out the question/issue, its significance, impact, and potential approach(es) to address the issue using a multi-CERTs working group or committee. The merits of these concepts will be separately evaluated by the Special Emphasis Panel as part of their review of RC applications. The proposed concept briefs of RC awardees will be reviewed, prioritized, and chosen as appropriate for CERTs working groups and committees by the CS Forum with input from the CERTs SC; they may also form the basis of one or more major collaborative CERTs projects or activities undertaken annually with assistance of the CERTs Scientific Forum.

Programmatic Interest Areas

Applicants to this FOA must propose a well-integrated program of research and education activities that will address at least 3 of 5 broad programmatic interest areas of AHRQ, the FDA, CMS, and other HHS agencies and partners/stakeholders. These programmatic interest areas will be used to organize collaborative and synergistic activities of the CERTs RCs with input from the CERTs National Steering Committee and the assistance of the CERTs Scientific Forum. The five programmatic interest areas specified under this FOA are not mutually exclusive, so a proposed activity may be categorized in more than one area; they are listed below and described in the following paragraphs.

  1. Comparative effectiveness
  2. Patient safety
  3. Development /enhancement and validation of tools
  4. Health care system interventions
  5. Translation into practice or policy

Comparative effectiveness research (CER) is defined as the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in real world settings. Comparative effectiveness studies can be approached with the comparison of similar treatments, such as competing drugs, or by analyzing very different approaches, such as devices, surgery, or drug therapy. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances. AHRQ operationalizes the definition of CER to include any potential medical intervention, whether prognostic, preventive, diagnostic, therapeutic, or palliative. CER includes assessments of comparative effectiveness and/or safety and the active involvement of stakeholders in the definition of which questions need to be answered, thereby establishing a ready audience poised to act upon research findings. CER can also include the development and application of methods to assess benefits or harms, or the integration of benefits, harms, or costs in therapeutic decision-making and choices. CER can include the synthesis of existing evidence, the generation of new evidence, or educational/translational or systems interventions to apply evidence to clinical practices and behaviors.

Patient safety includes the identification, assessment, or prevention of harms posed to patients from errors, quality lapses, or a lack of knowledge, including a lack of knowledge concerning the appropriate use of therapeutic products. Patient safety research encompasses the identification of risks and hazards; the design, implementation, and evaluation of patient safety practices; or maintaining vigilance to ensure that strategies to develop and sustain aspects of organizational culture that promote patient safety remain in place. Patient safety research projects may create new knowledge by identifying the risks and hazards encountered by patients as a result of health care and therapeutics. Examples of projects in this area include but are not limited to: the impact of human performance and working conditions on patient safety; the role consumers can play and how they can contribute to making care safer; health care organizational structure, leadership, communication, and teamwork; health care associated infections; diagnostic error; and the challenges inherent in transitions of care and handoffs between health care providers. Interdisciplinary research related to patient safety may include perspectives not only from the field of health care services but also from the social and behavioral sciences (such as organizational psychology), education, industrial engineering, human factors, and others. Approaches may address risks and hazards across various dimensions of patient characteristics and priority populations (e.g., the elderly, children, individuals with low health literacy, patients with multiple chronic conditions) settings of care (hospital, long-term care, ambulatory, home health care), and health-related conditions. Patient safety includes the prevention of healthcare-associated infections and medical errors, including medication errors.

Development /enhancement and validation of tools can take many forms depending upon the nature of the tool that an applicant specifies. For purposes of this FOA, a tool is loosely defined as any instrument, intervention, or process intended to improve the appropriate or high quality use of therapeutics. Typically, tool development/enhancement and validation takes place in a limited or experimental environment with the goal of determining feasibility and/or impact. Examples include, but are not limited to, enhancement of existing data resources through linkages (such as registries allowing longitudinal follow up of patient outcomes) or the inclusion of new data elements (such as patient-reported outcomes), educational offerings such as patient videos or interactive programs designed to elicit patient treatment preferences, disease management programs intended to optimize appropriate therapeutics use, monitoring, and self-care, education or reminder techniques to enhance medication adherence and compliance, or health information technologies to support evidence-based care (such as clinical decision support to guide medication selection or PDAs to identify patient risk factors or treatment algorithms.) New or expanded research designs, methods, or analytical approaches may also be considered as tools for purposes of satisfying this programmatic interest area.

Health care system interventions focus upon local, regional, or national level interventions to improve therapeutics effectiveness, safety, quality, or efficiency in use. The goal(s) may be to determine effectiveness, benefits/harms, costs, generalizability, and/or scalability. Health care system interventions are loosely defined as interventions targeting defined populations, health care settings, providers, institutions, or specific health care processes or systems. They may represent extensions or expansions into real world settings of tools developed in the previously described programmatic interest area or of other evidence-based and beneficial interventions. It is generally expected that projects in this area will focus on multiple institutions or settings. Examples include, but are not limited to: health information technologies to guide therapeutics management (such as clinical decision support), disease management programs of various types including those focusing on patient adherence to therapy, payment or reimbursement policies, restructuring or realignment of clinical care teams and processes to integrate care across disciplines, health care reform policies and practices arising from those policies, quality improvement efforts, policy trials, Medication Therapy Management programs, and Risk Evaluation and Mitigation strategies (REMS) authorized by FDA .

Translation into practice or policy can be approached through education, communication, dissemination, or implementation/translation of evidence into clinical practice settings locally, regionally, or nationally. The evidence may be already-established or newly-developed by the RC itself through its other proposed projects. Examples include, but are not limited to: educational outreach, partnerships with professional societies or organizations in developing recommendations or guidelines, alliances with insurers such as the Medicaid Medical Directors or health plans, academic detailing, or the implementation of health information or other technology-based interventions such as clinical decision support. At a minimum, all RCs are expected to make their findings and educational products available on the CERTs educational outreach Web site, www.chainonline.org.

Center Themes

Each applicant must propose an overarching theme for its research center that unifies or represents its planned research and educational activities. Each RC will have a distinct theme, but overlapping areas may occur and result in increased program synergy. For example, an RC focused on children may propose to do work that also happens to fall within a thematic area of another RC, such as devices or infectious diseases.

Themes may be derived from the following list or by using the guidance that follows the bulleted items.

Other thematic areas that may be proposed include those 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 section in Appendix for additional information on AHRQ priority populations);

(2) Significance to Medicare, Medicaid and other Federal health programs;

(3) High costs associated with a condition, procedure, treatment, or technology, whether due to the number of people needing care, high unit cost of care, or high indirect costs;

(4) Controversy or uncertainty about the effectiveness or relative effectiveness of available clinical strategies or technologies;

(5) Potential to inform and improve patient, 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.

Proposed Research Projects

Each research center must propose 3 to 5 research or educational projects to be conducted and completed within the available funding and grant period of performance; no more than 5 projects may be proposed. Projects should be scaled with a size, duration, and sequencing that is appropriate to the question(s) being addressed and to available funding; projects may run concurrently or sequentially over the proposed term of the grant award as appropriate to the research question and their design for addressing it. Each project must be related to the Center’s theme and address at least one of the 5 programmatic interest areas stated in this FOA; a single project may address multiple programmatic interest areas. Each project should represent a substantial research or educational undertaking that, when completed, will be made publicly available; multiple products or publications are also possible within a single defined project. The proposed projects may be independent, interrelated, linked, sequential, or conducted in parallel as long as each one affords good independent feasibility and probability of completion.

A project will usually be a single large research study or other activity, but may occasionally be divided into a few smaller and interrelated components. A study typically refers to a hypothesis-driven research or evaluation project with project-specific objectives, aims, research design(s) and analytical plan(s). An activity is a goal-oriented undertaking that, in contrast to research, is not necessarily hypothesis-driven and may be hypothesis-generating or formative of future research and educational activities. Examples of activities include, but are not limited to, descriptive research, agenda-setting, methods development, expert meetings or consensus conferences, or scientific review provided to AHRQ, the CERTs SC, CS Forum, or other research centers.

AHRQ is particularly interested in projects that propose specific plans or mechanisms to engage stakeholders or involve partnerships with individuals and organizations engaged in clinical care, its oversight, or its financing. Involvement of such partners increases the likely relevance, applicability, and uptake of the planned research or education activity. Stakeholders and/or partners may represent individuals, organizations, or other entities with compelling therapeutics questions and/or a willingness to put research findings and educational activities into policy and practice; in this regard, CERTs RCs are encouraged to form close partnerships with their local and State health care systems. Others may include Federal agencies (such as AHRQ, FDA, or CMS), the Medicaid Medical Directors Learning Network, professional societies, and nonprofit and private organizations. Applicants will be reviewed for the strength of their working relationship and awareness of the needs and priorities of their proposed partners and stakeholders.

Participation in CS Forum led Workgroups and Committees

Based on guidance and input from the CERTs CS Forum and the CERTs National Steering Committee (which includes CERTs PIs, AHRQ, FDA and other government and private partners) each RC is expected to participate in workgroups or committees addressing issues of common interest or concern to the CERTs RCs and SC. Workgroups or committees will draw upon the aggregated experience and expertise of multiple CERTs RCs and be coordinated and supported by scientific investigators from the CERTs Scientific Forum as described within that FOA (RFA-HS-11-003).

Issue-oriented workgroups and committees may support activities such as, but not limited to, the following: (1) preparing presentations and discussion topics for CERTs Steering Committee meetings, (2) developing research agendas or other recommendations for future research or education needs and activities, (3) drafting white papers, perspectives, opinion pieces, or other publications for journals or electronic publications and illuminating therapeutics issues, (4) organizing all or part of special CERTs meeting(s) with government entities or other relevant partners in therapeutics. At least one major CERTs collaborative activity is planned annually, as described in the CERTs Scientific Forum FOA.

CERTs workgroup and committee activities on common CERTs issues will be chosen by the CS Forum in conjunction with the SC; the principal basis for the selections will be the concept briefs of issues proposed by each RC grantee and evaluated by peer reviewers. Each applicant must nominate two or more concept briefs of issues for a potential multiCERTs workgroup or committee; guidelines for submitting these concepts are described previously in the General Consideration for Applicants section. Evaluations of the candidate collaborative activities by the SEP will be used by the CERTs Scientific Forum and CERTs Steering Committee in prioritizing and choosing which issues should be pursued collectively by the CERTs RCs with the support of the CS Forum.

Core Infrastructure

Applicants must propose a core infrastructure that supports the Research Center and enables the conduct of their proposed 3 to 5 projects. Core infrastructure may take the form of institutional support such as shared Center personnel (e.g. a Program coordinator or research analysts), equipment, analytical packages, data systems, regular Center scientific meetings, or other investments that assist and promote the overall Center and its theme. Applicants must describe their Center’s proposed infrastructure investments and the expected benefits and accomplishments associated with their establishment. These may include the potential of the infrastructure investments to be leveraged with other funding sources to allow the conduct of related studies/activities with greater speed or reduced cost.

Applicants must prepare a separate infrastructure budget as described in the Budget Component of the PHS398 Research Components Section of this FOA.

Additional Guidance

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the AHRQ Research Program Cooperative Agreement (U19) mechanism to support a research program of multiple projects directed toward a specific major objective, basic theme or program goal, requiring a broadly based, multidisciplinary and often long-term approach. A cooperative agreement research program generally involves the organized efforts of large groups, members of which are conducting research projects designed to elucidate the various aspects of a specific objective. Substantial Federal programmatic staff involvement is intended to assist investigators during performance of the research activities, as defined in the terms and conditions of award. The Principal Investigator has primary authority and responsibility to define research objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations and conclusions of their studies. Each research project is usually under the leadership of an established investigator in an area representing his/her special interest and competencies. Each project supported through this mechanism should contribute to or be directly related to the common theme of the overall Research Center effort. The award can provide support for certain basic shared resources, including clinical components, which facilitate the total research effort. Scientifically meritorious projects must demonstrate an essential element of unity and interdependence. The individual researcher sponsored by each organizational grantee will be solely responsible for planning, directing, and executing his or her proposed projects.

AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will not be reviewed.

This funding opportunity will use an AHRQ cooperative agreement award mechanism. In the cooperative agreement mechanism, the PD/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 PD/PI, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

AHRQ intends to commit $5.1 million in FY 2011 to fund up to 6 Research Centers in response to this FOA, each ranging from $800,000 to $1,000,000 in annual total costs. Applications will be 5 years in duration with a budget supported by AHRQ not to exceed $1 million per year in total costs to the government. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. Applications with project periods that exceed 5 years or budgets that exceed $1 million total costs in any given year will not be reviewed.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total costs for a grant awarded under this FOA will not exceed $1 million annually for the entire project period. Funding beyond the first year will be contingent upon a review and acceptance by Agency staff of the non-competing continuation progress report.

If funds become available, AHRQ reserves the right to fund additional applications.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your institution/organization has any of the following characteristics:

In light of the CERTs authorizing legislation requiring them to provide objective clinical information on drugs, biological products, and devices to multiple audiences, applicant institutions are reminded that they must duly comply with 42 CFR, Part 50, Subpart F: Responsibilities of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought. AHRQ reserves the right to request and review as necessary the certification submitted by each applicant institution of their written and enforced process to identify and manage, reduce or eliminate conflicting interests with respect to the research projects in its application. If questions of conflict or bias are raised in the peer review of applications or in the selection process for awards, applicants will be required to provide timely information to AHRQ to address those questions.

Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by foreign institutions will be returned without review. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application. There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization 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 support.

The RC Principal Investigator (PI) must be an experienced senior investigator and manager who can provide strong scientific leadership. The PI will be responsible for the organization and operation of the center; mentorship of the Center investigators; 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 oversight of Center projects and activities (at a minimum 15% annually).

2. Cost Sharing or Matching

This program does not require cost sharing for applications in response to this FOA.

While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions that plan to provide support 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. This can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application to this FOA, provided each application is scientifically distinct. However, AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization. Applicants to this FOA are eligible to submit scientifically distinct applications to RFA-HS-11-003 for the CERTs Scientific Forum.

Resubmissions. Because the CERTs are competed on a periodic cycle rather than a continuous basis, resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are permitted in response to this FOA. This competition is open to all eligible institutions, including those who are former or current CERTs Research Centers or Coordinating Centers, and those who have never been a CERTs Research Center or Coordinating Center.

Section IV. Application and Submission Information

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. Applicants must use the currently approved version of the PHS 398. 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 most current PHS 398 research grant application instructions and forms. 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/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

See Section IV.3.A below for details.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): April 20, 2011
Application Receipt Date: May 18, 2011
Peer Review Date(s): Approximately two months after receipt date
Earliest Anticipated Start Date(s): Approximately two months after peer review date

3.A.1. Letter of Intent

To allow AHRQ staff to estimate the potential peer review workload and plan the review (e.g., anticipate the nature of reviewer expertise to be required), prospective applicants may submit a letter of intent that includes an acknowledgement of interest in this funding opportunity (please refer to the number and title of this funding opportunity), a few comments on the subject of the proposed research, background expertise of key personnel, and the nature and role of participating institutions. Please include the name and email address of the Principal Investigator.

This letter of intent is not required, is not binding, and is not considered in the review of a subsequent application. However, these letters are administratively very helpful, as indicated above. To be most useful, the letter of intent is to be sent by the date listed above and at the beginning of this document.

The letter of intent should be sent electronically, and should be sent to: CERTsFOA@ahrq.hhs.gov

The letter of intent is to be sent by the date listed in Section IV.3.A.

3.A.2. Technical Assistance

Potential applicants are encouraged to submit questions by email to AHRQ staff using the CERTs FOA email box address: CERTsFOA@ahrq.hhs.gov. Questions of general interest and relevance will be made available as Frequently Asked Questions on the AHRQ Web site. See Section VII, Agency Contacts, below.

3.B. Sending an Application to AHRQ/NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

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

CERTS Research Centers Application Materials
CERTS FOA Program Team
Center for Outcomes and Evidence (COE)
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850

In addition to the required hard copy submission, applicants may also submit an electronic copy of their CERTs PHS-398 application (in pdf format) to the CERTs FOA Program Team email address at: CERTsFOA@ahrq.hhs.gov. This additional electronic submission is not required, but serves to facilitate and expedite AHRQ program staff's administrative and logistic planning.

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete and/or non-responsive applications will not be reviewed.

AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit 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.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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.

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. The applicant should obtain an estimate for the costs of the requested data, if possible. 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 the confidentiality provision in the AHRQ statute, 42 USC 299c-3(c); the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule 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.

The DUA will include the requirement that the data 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 six 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 email box listed under Agency Contacts for Scientific/Research (see Section VII).

To avoid double counting, applicants should not include the cost of identifiable CMS data in the budget. In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm

Pre-award costs are allowable. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on AHRQ either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.

6. Other Submission Requirements and Information

The following section supplements the instructions found in the PHS Form 398 for preparing the multi-project grant application (U19). Additional instructions are required because the PHS Form 398 is designed primarily for individual, free-standing research grant (R01) applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme.

The supplemental instructions for multi-project applications follow below:

All applications must be submitted on Form PHS 398. The multi-project grant application should be assembled and paginated as one complete document.

1. Form Page 1 - Face Page

Items 1 - 14: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.

2. Form Page 2

Using Page 2 of Form 398, provide a succinct but accurate description (abstract) of the OVERALL multi-project application addressing the major, common theme of the program. Do not exceed the space provided.

3. Form Page 3 - Table of Contents

Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.

Bearing in mind that Research Center applications will be scientifically reviewed as to their overall theme, 3 to 5 projects, collaborative leadership, planned core infrastructure, and collaborative concepts, applicants should prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component listed below:

  1. The Center theme
  2. 3 to 5 research and/or educational projects, each addressing one or more programmatic interest area; a separate budget is to be presented for each project
  3. Core infrastructure to support proposed work and provide opportunities for other funded projects
  4. Two or more concept briefs of common interests or concerns of multiple CERTs activities to address through CS Forum-supported working groups and committees.

The detailed Table of Contents should include a page reference for the budget for each component. Further, each research project should be identified by number (e.g. Project 1), title, and responsible Project Leader. If separate Infrastructure Cores are proposed, each Core should be identified by letter (e.g. Core A), title, and responsible Core Leader. The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents." Separate budgets for proposed components are required as described under Budget Component.

5. Composite and Component Budgets

Do not use Form Page 4 of PHS Form 398 to create the composite budget. Instead, using the suggested format presented below, prepare a Composite Budget For All Proposed Years of Support. (Justification for budget elements should not be presented here, but in the individual budgets of the projects and cores.)

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Project 1. Invest.

125,000

130,000

135,200

140,608

146,232

677,040

Project 2. Study

125,000

130,000

135,200

140,608

146,232

677,040

Project 3. Develop.

100,000

104,000

108,160

112,486

116,985

541,631

Core A. Admin. Core.

50,000

52,000

54,080

56,243

58,493

270,816

Core B. DNA

25,000

50,000

52,000

54,080

56,243

237,323

Total Direct Costs

425,000

466,000

484,640

504,025

524,185

2,403,850

Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry.

Detailed budgets and budget justifications for each year of support are required within the descriptions of each project and core. The budget justifications must clearly explain and detail any budget fluctuations in future years. Please use Form Pages 4 (for each year of support for each project) and 5 of PHS Form 398 for each individual project.

6. Research Strategy

This section may not exceed 25 pages and must contain descriptions of:

(1) 3 to 5 proposed projects to be conducted during the entire grant period,

(2) 2 or more concept briefs of common CERTs issues or concerns (maximum length of one page for each) for separate SEP evaluation and ultimate consideration for CERTs working groups or committees

(3) the planned RC core infrastructure.

Each project must be separately described. For each project, the applicant must clearly state the project s:

Significance and its relationship/relevance to the Center’s proposed theme and the programmatic interest area(s) it claims to address. Applicants may include overarching or project-specific (as opposed to overall) aims and objectives as necessary to assist in the review of the project(s) and merits by the Special Emphasis Panel.

Innovation in methodologies, partnerships, or other efforts to modify or optimize therapeutics practices should be noted for each project.

Approach, including as appropriate the names and roles of any important partnerships and stakeholders that are in place or planned to be engaged as part of the proposed work. A proposed project does not have to be a hypothesis-driven research project, but instead may represent an activity with one or more proposed products or results.

For cooperative agreements, grantees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".

Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this FOA. The application will be rejected if it does not comply with these requirements.

Research Strategy Page Limitations

All application instructions outlined in the PHS398 Application Guide that are not otherwise specified within this Funding Opportunity Announcement are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Please note the specific instructions under Other Submission Requirements and Information, item 6. Research Strategy (above.)

Budget Component

Please note the specific instructions under Other Submission Requirements and Information, item 5. Composite and Component Budgets (above.)

Special 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 using the detailed budget format. Applications submitted in the Modular format will not be reviewed.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CD only. Include five identical CDs in the same package with the application. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the Public Health Service Act, 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. Priority populations 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. This authority is found at 42 USC 299(c). To implement this statutory mandate, 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 FOA should consider and discuss including priority populations in the research design as specified in this Notice.

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 are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature. Grantees 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. Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees 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.

Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs, 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 must 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.

HCUP & 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 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 includes three nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids Inpatient Database (KID), and the Nationwide Emergency Department Sample (NEDS), and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD). More information on HCUP can be found at http://www.hcup-us.ahrq.gov.

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, non-institutionalized population. MEPS is composed of 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.

Applicants use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.

Health Literacy

AHRQ encourages applicants to write Informed Consent (IC) and HIPAA Authorization documents for research to be understandable to all potential research participants, including those with low levels of literacy and limited English proficiency. AHRQ recommends that IC and Authorization documents be written in accordance with health literacy principles, and that IC and Authorization documents be available in multiple languages if potential research participants include individuals with limited English proficiency. AHRQ also recommends adopting a process to verify potential research participants understanding.

IC documents must provide information in language understandable to potential participants (45 CFR 46.116). For covered entities under the Privacy Rule, authorization documents must include core elements and required statements in 45 CFR 164.508(c) and must be written in plain language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.

Consumer Products

All consumer products produced under an AHRQ-funded grant should be appropriate for the target audience. This includes individuals from diverse cultural, language, and literacy backgrounds. Audience testing should be part of the development process. AHRQ’s Talking Quality website (http://www.talkingquality.gov/) and AHRQ’s guide and checklist for developers and purchasers of health information (IT) that is designed to be accessed and used by consumers (http://healthit.ahrq.gov and select Health IT Tools) are resources applicants can use to ensure appropriateness of consumer products.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Section V. Application Review Information

1. Criteria

Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.

Merit Review Criteria: Merit Review Criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will not be reviewed. .

As part of the initial merit review, all applications will:

The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As part of this mission, applications submitted to AHRQ under this FOA to support research and education in therapeutics are evaluated for scientific and technical merit through the AHRQ peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the proposed Research Center infrastructure, projects, and personnel to exert a sustained, powerful influence on therapeutics research and education research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Do the Center theme and projects address an important problem? If the overall and project-specific aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or health care practices that drive the appropriate use of therapeutics? Will the proposed work make an important contribution to at least 3 of the 5 stated programmatic interest areas in the FOA? What is the likelihood that the proposed leadership, contributions, and associated activities in one or more of the programmatic interest areas will advance common issues of multiple CERTs research centers and the specific area itself?

Investigators. Are the PD/PI and other key personnel appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Does the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)?

Innovation. Are the theme, proposed projects, and/or infrastructure original and innovative? For example: Does the thematic focus or one or more of the proposed projects challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Do one or more projects develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area? Do the proposed project(s) employ novel partnerships, approaches, or technologies to optimize therapeutics use? Do the projects offer a novel mechanism for translating research into practice, for example, ways to penetrate difficult-to-reach audiences and populations and thereby inform clinical decision making?

Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the proposed RC theme? Are the projects feasible and do they afford a good probability of successful completion? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the research question, design, or analysis adequately informed by key partners or stakeholders who are involved in the application of the proposed studies or activities?

Environment. Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Is the proposed infrastructure reasonable and adequate in its configuration and funding to support the Center theme and proposed projects? Will the proposed infrastructure allow the conduct of other work with additional funding?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Relevance to CERTs Legislative Mandate. Reviewers also will consider the extent to which the proposed Research Center will assist the overall goals of the CERTs in therapeutics, which is to conduct research:

Concept briefs of common issues and concerns for CERTs working groups and committees. What are the scientific merits, potential impact, strengths, and limitations of each of the proposed concepts to be pursued through CS Forum-led workgroups or committees involving other CERTs RCs?

Conflicts of Interest and associated plans to address them. Are the stated conflicts of interest and management plans for them acceptable to assure the provision of objective clinical information to multiple parties using the health care system or working in association with it?

Degree of Responsiveness. How well does the application address the purpose and objectives of this FOA? How responsive is the application to the special eligibility criteria, including the project requirements and programmatic interest areas noted in the FOA?

Budget and Period of Support. Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research?

Are the proposed projects staged in relation to each other so as to assure their value and contributions should changes or new developments occur in the field during the course of the grant award? Is the proposed Center infrastructure appropriate to the proposed Center theme and projects?

Inclusion. How adequate are plans to address the needs of both genders, racial and ethnic minorities (and subgroups). How adequate is attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 Other Submission Requirements, and inclusion criteria included in section VIII of Required Federal Citations, below.)

Protection of Human Subjects from Research Risk. The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects section of the application.

Privacy and Security Protections for Patients. The resources and processes to be used to address privacy and security issues in the development and implementation of the intervention will be assessed.

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

2.B. Additional Review Considerations

Not Applicable

2.C. Resource Sharing Plan(s)

Data Confidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute 42 USC 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 this 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 FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164. 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, health care plans ordinarily will require either patient authorization for 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), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators. The DHHS 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.hhs.gov/ocr/hipaa/

The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that 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.

Sharing Research Resources:

Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ funds, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a worldwide irrevocable AHRQ 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. In addition, 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 announcements of new AHRQ-supported research results with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html).

3. Anticipated Announcement and Award Dates

Generally, applicants should anticipate six months between the application submission date and the earliest possible start date.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant. Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative issues, and certification of IRB approval of the project's proposed use of human subjects. For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

Once all administrative and programmatic issues have been resolved, a formal notification in the form of the Notice of Award (NoA) will be generated via email notification from the awarding component to the grantee business official at the applicant organization. The NoA endorsed by the AHRQ 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 NoA are at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5., Funding Restrictions.

An award issued in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm) and the terms and conditions set forth in the notice of award.

As necessary, additional Terms and Conditions will be incorporated into the notice of award.

Activities conducted under this award that involve the collection of information e.g., conducting surveys or requesting responses to uniform questions from ten or more persons, establishments or other entities, are currently required by HHS to be cleared by OMB under the Paperwork Reduction Act (PRA) (44 USC 3501-3521). Submissions for clearance under PRA are through AHRQ and HHS. Therefore, affected grantees should include the time in their proposed timelines to develop materials and receive necessary clearances. It typically takes at least six months from date of initial submission to AHRQ to receive clearances ,and sometimes much longer if submissions are incomplete or the justification for the proposed data collection plans are questioned during the clearance process. Information collection that requires PRA clearance may not begin until grantees receive written notification via e-mail from AHRQ that clearance has been obtained. Detailed information on the PRA can be found at http://www.hhs.gov/ocio/policy/collection/.

The following Terms and Conditions will be incorporated into the Notice of Award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to otherwise applicable OMB administrative guidelines: DHHS grant administration regulations at 45 CFR Parts 74 or 92 (Part 92 is applicable for State and local Governments), and other DHHS, PHS, and AHRQ grant administration policy statements. AHRQ will use these procedures in evaluating and administering the cooperative agreements under this FOA.

The administrative and funding instrument used for this program is the cooperative agreement U19, an "assistance" mechanism (rather than an "acquisition mechanism), in which substantial AHRQ programmatic involvement with the grantees is anticipated during the performance of the activities. Under the cooperative agreement, the AHRQ purpose is to support and stimulate the recipient’s activities by involvement in and otherwise working jointly with the award recipient 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 PD/PI for the project as a whole, although specific tasks and activities may be shared between a grantee and AHRQ as described in this subsection of the FOA. Cooperative activities are intended to strengthen the individual grantee activities through the facilitation of data sharing, data access and communications.

All cooperative activities that include significant government involvement will require prior approval by AHRQ.

2. A.1. Principal Investigator Rights and Responsibilities

The PD/PI will have the primary responsibility for providing strong scientific leadership, for the organization and operation of the center; mentorship of CERTs investigators; 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 oversight of Center projects and activities (at a minimum 15% annually).

Grantees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and AHRQ policies.

2. A.2. AHRQ Responsibilities

AHRQ program staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

As non-majority members of the CERTs Steering Committee, AHRQ program staff will contribute input and vote as necessary on all planned activities of the CS Forum, including but not limited to nomination and selection of at-large Steering Committee members and Chairpersons, planning of meeting agendas, prioritization and participation in CERTs working groups and committees that address common CERTs issues, and selection of relevant outside organizations for partnerships.

Additionally, AHRQ program staff will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

Based on guidance and input from the CERTs CS Forum and the CERTs National Steering Committee (which includes AHRQ, FDA and other government and private partners) each RC is expected to participate as appropriate in working groups or committees responsive to common issues and priorities pertaining to research and education on therapeutics. These efforts will draw upon the aggregated experience and expertise of multiple CERTs RCs and be coordinated and supported by scientific investigators from the CERTs Scientific Forum.

CERTs working groups and committees that will be chosen by the CS Forum in conjunction with the SC; the principal basis for the selections will be the concept briefs of common issues proposed by all RC grantees and evaluated by the Special Emphasis Panel. Evaluations of the concept briefs by the SEP will be used by the CERTs Scientific Forum and CERTs Steering Committee in prioritizing and choosing which issues or concerns should be pursued collectively by the CERTs RCs with the support of the CS Forum.

Each RC must include in its budget funds that allow for active participation of the center teams in Steering Committee, CS Forum, and AHRQ activities. Required activities include:

The RC and CS Forum will work with OCKT and the AHRQ program official in product dissemination, including the development of marketing plans, launch and press release activities, and media outreach and partnership development, with a focus on the first 30 days following publication or product release. OCKT staff and the AHRQ program official will work in consultation with the parent institution of the RC to determine the extent of outreach and target audiences for each publication or product. As part of this effort, OCKT will translate key messages for the intended audience. A summary of these outreach efforts will be provided to the RC and CS Forum on an ongoing basis as determined by the characteristics of the specific research result or product. OCKT also will work with the RC and CS Forum to track the impact of publications and products. Other Federal Agencies (e.g., FDA, CMS) and private or public stakeholders involved in therapeutics may also participate in dissemination and translation activities for specific publications or products.

3. Reporting

When multiple years are involved, grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.

The annual progress reports must include Sections 2.2.6 A through F as described in the general PHS form 2590 instructions. For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future. At a minimum, the reports will include descriptive comments on: progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities. AHRQ will provide the timetable for these progress reports.

Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). This report must be submitted for each budget period no later than 90 days after the close of the budget period. A hard copy of the report should be submitted to the assigned grants management specialist.

A final Progress Report, Financial Status Report, and Invention Statement are required when an award ends. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.FSRS.gov on all subawards over $25,000. See the AHRQ Grants Process web site at http://www.ahrq.gov/fund/postawrd.htm#terms for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may be written or by telephone, and fall into three areas: scientific/research (program), peer review, and financial or grants management issues.

1. Scientific/Research Contacts:

Direct your questions about general FOA issues, including information on the inclusion of priority populations to: CERTsFOA@ahrq.hhs.gov

As appropriate, replies will be developed into anonymous Frequently Asked Questions and shared on the AHRQ Web site.

2. Peer Review Contacts:

Direct your questions about peer review issues of grant applications made in response to this FOA to:

Andrew Louden, Ph.D.
Scientific Review Officer
Department of Health and Human Services
Agency for Healthcare Research and Quality
Office of Extramural Research, Education and Priority Populations
540 Gaither Road
Room 2238
Rockville, MD 20850
Tel: (301) 427-1183
Fax: (301) 427-1562
Andrew.Louden@AHRQ.hhs.gov

3. Financial or Grants Management Contacts:

Direct inquiries regarding fiscal matters to:

Galen Gregor
Grants Management Specialist
Office of Performance Accountability, Resources and Technology
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1457
E-mail address: Galen.Gregor@ahrq.hhs.gov

Section VIII. Other Information

Required Federal Citations

Inclusion of Women and Minorities in Research Study Populations:

Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate, e.g., because of the lack of connection between the study and the health of women or particular minorities.

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 NIH Guide Web site at http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see Section VII, Agency Contacts).

Human Subjects Protection:

Federal regulations at 45 CFR Part 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Standards for Privacy of Individually Identifiable Health Information:

The HIPAA Privacy Rule, 45 CFR Parts 160 and 164, governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). 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 member of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory. Decisions about applicability and implementation of the Privacy Rule reside with covered entities. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain 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 or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data, disclosure of such data is limited in accordance with the AHRQ Confidentiality Statute, 42 USC 299c-3(c). 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 FOA in a public archive, which can provide protections for the data (e.g., as required by confidentiality provisions of the statute applicable to AHRQ-supported projects, 42 USC 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.

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/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authority of 42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and other referenced applicable statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

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 Public Health Service mission to protect and advance the physical and mental health of the American people.

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