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 

Title: Centers for Education and Research on Therapeutics (CERTs)(U18)

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

Announcement Type
This is a reissue of RFA-HS-99-004 which was released on January 27, 1999.  Its subsequent Announcement was RFA-HS-05-014 released on October 26, 2004.

Updates: The following updates relating to this announcement have been issued:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are strongly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Request For Applications (RFA) Number: RFA-HS-07-004 

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: September 27, 2006
Opening Date:  November 14, 2006
Letters of Intent Receipt Date(s): November 10, 2006
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Dates: December 14, 2006
Peer Review Date: March 1, 2007
Earliest Anticipated Start Date: July 15, 2007
Expiration Date: December 15, 2006

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The Centers for Education and Research on Therapeutics (CERTs) program is a merit-based, peer-reviewed program created in response to a legislative mandate to “conduct state-of-the-art research to increase awareness of:  (1) new uses of drugs, biological products, and devices; (2) ways to improve the effective use of drugs, biological products, and devices; and (3) risks of new uses and risks of combinations of drugs and biological products.”  Further, the legislation directs “CERTs to provide objective clinical information to the following individuals and entities:  (1) health care practitioners and other providers of health care goods or services; (2) pharmacists, pharmacy benefit managers and purchasers; (3) health maintenance organizations and other managed health care organizations; (4) health care insurers and governmental agencies; and (5) patients and consumers.”  Additionally the CERTs centers are to “investigate various ways to improve the quality of health care while reducing the cost of health care through an increase in the appropriate use of drugs, biological products, and devices and the prevention of adverse effects of drugs, biological products, and devices and the consequences of such effects, such as unnecessary hospitalizations.”  Finally, the CERTs will “conduct research on the comparative effectiveness, cost-effectiveness, and safety of drugs, biological products, and devices.”  The purpose of this FOA is to solicit new CERTs research centers. CERTs research centers develop and implement research and create educational strategies for translating those research findings into improved clinical practice and patient outcomes. Applicants must develop themes relevant to therapeutics that will address the CERTs legislative mandate. The application must include a proposed institutional plan for the development of a CERTs research infrastructure.

This FOA will use the Demonstration Cooperative Agreement (U18) award mechanism.  AHRQ intends to commit approximately $7 million in FY 2007 to fund up to seven cooperative agreements in response to this FOA. This mechanism  allows  AHRQ, FDA and other federal agencies to work with the recipients to address goals identified in the CERTs legislation.

The institutions housing the four CERTs research centers funded initially during FY2006 are not eligible to apply for funding under this FOA since a goal of this FOA is to maintain the geographic diversity of the CERTs program.

While grant awards are made to institutions rather than individuals, the applicants are institutions, although individual researchers assume considerable responsibility for preparation of the applications.  This announcement and its instructions are written to inform researchers of this funding opportunity and facilitate the submission of grant applications by their organizations.

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. Submission, Review and Anticipated Start Dates
      1. Letter of Intent
    B. Submitting an Application Electronically to AHRQ
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

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

The Centers for Education and Research on Therapeutics (CERTs) program is a national initiative to increase awareness of the benefits and risks of new, existing, or combined uses of therapeutics (defined as drugs, biologics and medical devices) through education and research. The program currently consists of eleven Research Centers (RC), a Coordinating Center (CC) and a Steering Committee (SC). The Steering Committee consists of members from the RCs, the private sector, and government. Funding ends for seven centers at the end of FY2006.

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

The mission of the CERTs program is to conduct research and provide education that will advance the optimal use of drugs, medical devices, and biological products. The CERTs vision is to be a trusted national resource for people seeking to improve health through the best use of medical therapies. CERTs centers accomplish the mission and vision through research, education, dissemination and knowledge development. CERTs centers leverage resources through both public and private partnerships.

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

In consultation with AHRQ, FDA and other government partners, each RC develops priorities for research and education in therapeutics, within its chosen theme. Each RC has a theme that is different from other RCs. However, some overlap exists (e.g., an RC focused on children may do some work in infectious diseases).  Thus CERTs RCs may collaborate on projects to make use of complementary foci.  Because of the limited number of CERTs RCs there are many areas where research is lacking.

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

CERTs RC funding provides infrastructure support (a research team with adequate facilities, institutional support, and access to appropriate expertise needed to perform research, education, dissemination and translation of research into practice) such that an RC can fulfill the goals of the CERTs legislation and support the strategic needs of AHRQ, FDA, and other DHHS agencies with responsibilities for therapeutics. Each RC provides leadership in the area of its chosen theme and develops a series of research projects and related educational efforts that leads to improved use of therapeutics. The needs of the program are expected to evolve with time. For example, the RC may be asked to respond to newly identified resources, work with a variety of partners, or consider issues of national significance. Thus, a RC is expected to collaborate with AHRQ and other RCs in refining specific topics to address the overall area of focus and program goals.

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

However, other federal agencies also play a role.  For example, FDA oversees development and marketing of therapeutic products through their role as a regulator and CMS disburses payment for therapeutics through their Medicare and Medicaid programs.  Both federal agencies impact the use of therapeutics once they reach the market.  The FDA strategic plan  identifies public health issues of interest to both FDA and the CERTs.  For example, both FDA and the CERTs consider how best to minimize inappropriate use of medicines by researching and implementing risk management programs.  Both are undertaking educational initiatives to help health care providers and patients gain easier access to accurate, timely and concise therapeutic information. FDA is the sole regulator for therapeutic agents. The FDA strategic plan relates to CERTs in such areas as efficient risk management, improving health care through better information and communication about therapeutic risks and benefits, and improving patient and consumer safety. Discussion of the FDA strategic plan can be found at: http://www.fda.gov/oc/mcclellan/strategic.html.

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

Applicants are encouraged to address the impact of their proposed research on FDA , MMA  and other government activities.

DHHS is actively working to encourage the use of information technology to disseminate information and assist clinicians in the use  of  such technologies as the electronic medical record (emr) and computerized provider order entry (cpoe).  The following website provides information on these activities.  http://hhs.gov/healthinformationtechnology

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

Definitions

Education: Efforts, research results, tools and products related to the topic or research area selected by the RC.  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., personal professional, electronic, paper, video).  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

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

CERTS Coordinating Center (CC): The CC, funded through AHRQ cooperative agreement funds, facilitates the leadership of the CERTs Steering Committee (SC), consisting of the research centers, government agencies, and other members, through logistical support and active participation in committee, such that the program can fulfill the goals of the CERTs legislation and support the strategic needs of AHRQ, FDA, and other DHHS Agencies with responsibilities for therapeutics. The CC  facilitates collaborative activities, such as the quarterly SC meetings among the CERTs, AHRQ, FDA, and other stakeholders.

General Considerations for Applicants

The ultimate goal of the CERTs research center and the program is the implementation of evidence-based, safe and effective use of therapeutic products to improve patient outcomes. Each applicant must demonstrate evidence of its ability to develop research, education, dissemination and implementation plans to match the  needs and priorities that they have identified within a chosen theme, such that the CERTs program can fulfill the goals of the CERTs legislation and support the strategic needs of AHRQ, FDA, and other DHHS agencies with. Each applicant must be able provide national and local leadership and show evidence of the following capabilities.

Choice of Themes and Projects

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

Themes may be chosen from the following list or the applicant may propose an appropriate theme:

Potential Themes

Clinical conditions

Methodology

Special Populations

Therapeutic Areas

Settings of Care

Pharmacogenomics and Personalized Medicine

The overall focus of the theme should be broadly based, such as a particular setting or population, rather than any single disease or condition.  The chosen area should have both a strong research and educational component.  It is expected that centers will select and document their choice areas with a high likelihood of potential impact on practice. These themes are broadly defined therapeutic research areas. An applicant may address any aspect of the theme that is consistent with the CERTs legislation, but the proposed themes should be addressed in as comprehensive a fashion as is feasible. The themes should not duplicate continuing CERTs themes, but may be complementary with CERTs RCs funded beyond FY2006.  These four continuing CERTs focus on medical devices, mental health, consumer and patient education and adherence, and the elderly population.

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

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

The applicant should also consider choosing a sub-theme.  A sub-theme is an area of overarching value to the whole CERTs program. Expertise within such area would allow the center to act in a consultative role. Some of the themes listed above may potentially be used as a sub-theme.  However, in choosing a sub-theme, the applicant should consider choosing an area that will be of value to the entire program.  For example, a center might choose a methodological area, such as clinical economics or information technology.

AHRQ priority topics areas or conditions 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 IV.6 for details on AHRQ priority populations); (2) significance to the Medicare, Medicaid and other Federal health programs (see research objectives); (3) high costs associated with a condition, procedure, treatment, or technology, whether due to the number of people needing care, high unit cost of care, or high indirect costs; (4) controversy or uncertainty about the effectiveness or relative effectiveness of available clinical strategies or technologies; (5) potential to inform and improve patient, provider, or purchaser decision making; (6) potential to reduce clinically significant variations in the prevention, diagnosis, treatment, or clinical management of a disease or condition, or in the use of a procedure or technology, or in the health outcomes achieved; (7) availability of scientific data to support the study or analysis of the topic; and (8) potential opportunities for rapid implementation. 

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

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

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

Each proposed project within the theme should have a limited number (no more than two) of quantifiable, desired patient outcomes. The applicant should include quantifiable methods and data sources for measuring progress toward these goals with the goals linked to a plan for implementation.  These goals may be developed as local goals, but consideration to be given to how these goals would be implemented on a larger scale

The applicant should approach the chosen theme and sub-theme in a comprehensive fashion (e.g., access to data, personnel, and partnerships).

Additional Guidance

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

Section II. Award Information


1. Mechanism(s) of Support

This FOA will use the U18 award mechanism.  The PI (Principal Investigator) sponsored by each organizational awardee will be solely responsible for planning, directing, and executing his or her proposed projects.  The earliest anticipated award date is July 2007.

AHRQ (U18) is a cooperative agreement award mechanism.  In the cooperative agreement mechanism, the Project Director/Principal Investigator (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 in Section VI. 2. A., "Cooperative Agreement Terms and Conditions of Award".

Non-competing continuation awards for subsequent years will be contingent upon satisfactory progress. The AHRQ program officer is responsible for the annual progress review. However, AHRQ, at its discretion, may convene external reviewers to supplement the program officer review. This mechanism  allows  AHRQ, FDA and other federal agencies to work with the recipients to address goals identified in the CERTs legislation.

The CERTs are funded via the Grants Mechanism as directed under Sec. 409 under the Food and Drug Administration and Modernization Act of 1997 (P.L. 105-115).  Section 409 subpart (a) states “The Secretary, acting through the Administrator and in consultation with the Commissioner of Food and Drugs, shall establish a demonstration program for the purpose of making one or more grants for the establishment and operation of one or more centers to carry out the activities specified”.  The administrative and funding instrument to be used for the CERTs Coordinating Center (CC) will be a cooperative agreement (U18), an “assistance” mechanism in which substantial AHRQ and other government scientific and/or programmatic involvement with the CC is anticipated during performance of the activity.  The dominant role and prime responsibility for all CERTs research resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees, the CC, the Steering Committee (SC) and the AHRQ Program Officials(s).  Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section on Terms and Conditions of Award.

The total project period for applications submitted in response to this funding opportunity announcement may not exceed four years.  The project will undergo program review to determine if it meets the criteria as stated in the FOA.

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

2. Funds Available

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.

AHRQ intends to commit a total of $7 million in FY07 to fund up to seven new RC cooperative agreements in response to this FOA. If additional funds become available in FY2007, AHRQ reserves the option to fund additional applications submitted in response to this FOA.

At this time, it is not known if competing renewal applications will be accepted and/or if this FOA will be reissued.

Applications must be 4 years in duration.  The total budget period may not exceed $1 million per year in total costs. Applications with project periods that are not 4 years or budgets that exceed $1 million total costs per year will be returned without review.

AHRQ grants policies as described in the PHS Grants Policy Statement (see http://grants.nih.gov/grants/policy/gps/index.html) will apply to the applications submitted and awards made in response to this FOA.

Facilities and administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation.  See NOT-OD-05-004, November 2, 2004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your domestic organization is a:

The institutions housing the four CERTs research centers funded initially during FY2006 are not eligible to apply for funding under this FOA since a goal of this FOA is to maintain the geographic diversity of the CERTs program.

Under the most recently enacted reauthorization legislation, AHRQ is authorized to enter into cooperative agreements with for-profit organizations, as well as with public and not-for-profit entities. Thus, for-profit organizations are eligible to respond to this FOA with research applications for cooperative agreements.  Organizations described in sections 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

The four CERTs RC institutions that received initial funding  during FY2006 are not eligible to apply under this FOA.  The expiring CERTs are encouraged to apply and will compete with other applicants based solely on the merits of their proposals.

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

1.B. Eligible Individuals

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

The individual must be able to devote a considerable portion (at least 15%) of his/her time to the project. An individual who is currently a Principal Investigator (PI) at a RC funded beyond FY2006 may not apply as a PI for these awards. However, he or she may be an investigator or subcontractor of a new RC.

2. Cost Sharing or Matching

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

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing

 3. Other-Special Eligibility Criteria

Not applicable

Section IV. Application and Submission Information


To download a SF424 (R &R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an AHRQ peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons.  AHRQ will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the “Attachment” files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to AHRQ. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Detailed Budgets

Note: While both budget components are included in the SF424 (R&R) forms package, the AHRQ R&R uses ONLY the detailed Research & Related Budget.  Do not use the PHS 398 Modular Budget.  Applications submitted in modular budget format will be returned without review.


3. Submission Dates and Times

Applications must be received on or before the submission date set out below.   See (Section IV.3.A) for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:   November 14, 2006
Letter of Intent Receipt Date:  November 10, 2006
Application Submission Date:  December 14, 2006
Peer Review Date:  March 1, 2007
Earliest Anticipated Start Date:  July 15, 2007
 
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 are asked to 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 to this document.

The letter of intent should be sent to:

Amy Lindinha
Center for Outcomes and Evidence
540 Gaither Road, Room Number
Rockville, MD 20850
Telephone: (301) 427-1614
FAX: (301) 427-1520
Email: amy.lindinha@ahrq.hhs.gov

3.B. Submitting an Electronic Application to AHRQ

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED.

In order to expedite the review, applicants are requested to notify the AHRQ Referral Officer by email Gerald.Calderone@ahrq.hhs.gov  when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application will be returned without review.

Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation. Both the PD/PI and the SO for the organization must verify the submission via Commons within 2 business days of notification of the NIH validation.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness and responsiveness by AHRQ.  Incomplete or non-responsive applications will be returned without review.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

Institutional Review Board (IRB) approval of human subjects research 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.

Use of CMS Data

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

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

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

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

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

Questions regarding CMS data should be directed to the AHRQ program official listed under Section VII (Agency Contacts).

To avoid double counting, applicants should not include the cost of the CMS data in the budget.  Small research grant applicants should be aware that the costs of the grant, including the cost of CMS data, cannot exceed $100,000 total costs.  In the event the total costs of the project plus the cost of CMS data is greater than $100,000, 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 $100,000.

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 PHS Grants Policy Statement. The Grants Policy Statement can be found a t http://grants.nih.gov/grants/policy/gps/index.html.

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

AHRQ requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Regulation FAQs – Important Tips” -- “Electronic Submission of Grant Applications.”

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to AHRQ in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts and with the following requirements for applications:

Appendix Materials

The following materials may be included in the Appendix:

Up to ten publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant mechanisms allow the inclusion of publications.

o   Publications in press:  Include only a publication list with a link to the on-line journal article. Do not include the entire article. 

o   Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment.

o   Manuscripts published but an online journal link is not available:  The entire article may be submitted electronically as a PDF attachment.

Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the (stated) page limit of Items 2-5 of the Research Plan. No images may be included in the Appendix that are not also represented within the Research Plan.

Applicants are cautioned not to use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe the relevant policies and procedures may be delayed in the review process.

Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.

Specific Instructions for Modular Grant applications.

AHRQ is not using the Modular Grant Application and Award Process.   Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R).  Applications submitted in the Modular format will be returned without review.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the PHS 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, which include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care.  This authority is also found at 42 USC 299.  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 and Product  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 by the RC.  An OCKT staff person will be assigned to each product and will coordinate the implementation of that plan, with the AHRQ marketing 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, the AHRQ may request information essential to an assessment of the effectiveness of Agency research programs.  Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.

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

HCUPS & MEPS

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

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

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

Plan for Sharing Research Data

Not Applicable

Sharing Research Resources

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 their own auspices by mailing a disk or posting data on their institutional or personal website, 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.

In addition to sharing data, the applicant may also share analytical coding or algorithms for observational data and/or educational resources.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.  All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

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 are described in section V.2 below.

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 unresponsive applications or applications not following instructions given in this FOA will be returned to the applicant without review.

AHRQ uses these procedures in evaluating and administering the cooperative agreement under this FOA.

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

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:

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

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

General review criteria for AHRQ grant applications relevant to this application include: adequacy of the plan for organizing and carrying out the project; qualification and experience of the Principal Investigator and proposed staff; reasonableness of the proposed budget; adequacy of the proposed facilities and resources available to the applicant.  For CERTs, the latter is of particular importance.

Significance: Does this study address an important problem? If the 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 preventative interventions that drive this field? What specific outcomes will be achieved if the aims are realized? Do the component projects chosen by the applicant address important problems? If the aims of the application are achieved, how will scientific knowledge and healthcare be advanced? Will the RC affect the concepts or methods that drive this field? Does this proposed center assist AHRQ in meeting the goals of the overall CERTs program? How does the proposed RC address the current gaps in knowledge surrounding the selected theme?

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

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Is consideration given to current activities within HHS to disseminate and assist clinicians in the use  of  such technologies as the electronic medical record (emr) and computerized provider order entry (cpoe)? The folowing website provides information on these activities.  http://hhs.gov/healthinformationtechnology/

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

Environment: Does the scientific environment 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, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?  Do the proposed projects employ useful collaborative arrangements?

Budget: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Does the application include detailed budgets for individual projects? Does the applicant present evidence of both past and future partnerships and institutional support that supplement the resources of the RC to fulfill the requirements of the program for implementation?

2.A. Additional Review Criteria:

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

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, noted in the FOA?

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 item 7 of the Research Plan component of the SF 424 (R&R)).

Inclusion: The adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups).  Adequacy of attention to AHRQ priority populations (see discussion on Priority Populations in the section on Other Submission Requirements IV.6 above, and Inclusion Criteria included in the section on Required Federal Citations in Section VIII below.)

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

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

Translation: Programs developed for this application should show plans for how the research will be translated into specific, measurable outcomes. It should include a plan that describes the steps required to progress from developmental pilot programs to national programs that measurably affect outcomes. This plan should identify how this goal will be achieved.

Resubmission Applications (formerly “revised/amended” applications): In addition to the above criteria, the following criteria will be applied to resubmission applications: 

Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

2.B. Additional Review Considerations

Not Applicable

2.C. Sharing Research Data

Data Confidentiality

Pursuant to 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are now civil monetary penalties for violation of this confidentiality statute [42 U.S.C.299c-3(d)). In the Human Subjects section of the application, there must be a description of 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 42 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  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 of disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) 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.aspe.hhs.gov/admnsimp/ or http://www.hhs.gov/ocr/hipaa/.

The PI 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 websites 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.

2.D. Sharing Research Resources

Rights in Data

AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a worldwide irrevocable 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; and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents, if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits.  Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products.  AHRQ'’s Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted when a manuscript is accepted for publication and during the early stages of product development 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 the AHRQ'’s grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO'’s website http://www.gpoaccess.gov/cfr/index.html).

3. Anticipated Announcement and Award Dates

Generally, applicants should anticipate 7 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 and certification of Institutional Review Board (IRB) approval of the project'’s proposed use of human subjects.  For details, applicants may refer to the "AHRQ Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications"(http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

Once an application has been selected for funding, AHRQ program and grants management staff will work with the applicant to resolve any programmatic and administrative issues.  A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization once all issues are resolved. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance.  Any costs incurred before receipt of the NGA are at the recipient'’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions. “

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, and beyond that the terms and conditions of the Public Health Service (PHS) Grants Policy Statement as part of the NGA, found at http://grants.nih.gov/grants/policy/gps/index.html. For terms of the award, see http://grants.nih.gov/grants/policy/gps/5award.htm#terms, and see http://grants.nih.gov/grants/policy/gps/5award.htm#fund for the award and funding process.

As necessary, additional Terms and Conditions will be incorporated into the award statement and will be provided to the appropriate institutional official at the time of award.

Activities conducted under this award that involve the collection of information e.g. conducting surveys or requesting responses to uniform questions from nine or more persons, establishments or other entities, are currently required by HHS to be cleared by OMB under the Paperwork Reduction Act (PRA).  Submissions for clearance under the PRA are through AHRQ and HHS. Therefore, impacted awardees should include the time in their proposed timelines to develop materials and receive necessary clearances.  It typically takes at least 6 months from date of initial submission to AHRQ 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 awardees receive written notification via e-mail from AHRQ that clearance has been obtained. Detailed information on the PRA can be found here http://www.hhs.gov/ocio/infocollect/.

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

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to 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 will be the cooperative agreement U18, an "assistance" mechanism (rather than an "acquisition” mechanism), in which substantial AHRQ programmatic involvement with the awardees is anticipated during the performance of the activities.  Under the cooperative agreement, the purpose is to support and stimulate the recipients'’ activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.  Consistent with this concept, the dominant role and prime responsibility resides with the PD/PI for the project as a whole, although specific tasks and activities may be shared between an awardee and AHRQ as described in this subsection of the FOA. Cooperative activities are intended to strengthen the individual CERTs activities through the facilitation of data sharing, data access and communications.

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

2.A.1. Research Centers Rights and Responsibilities

2.A.2. Federal Agency Responsibilities

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

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

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

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

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

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

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

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the AHRQ may be brought to arbitration.  An Arbitration Panel composed of three members will be convened.  It will have three members: a designee of AHRQ’s CERTS Steering Committee, one AHRQ designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee.  This special arbitration procedure is not intended to deny the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and DHHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the Public Health Service (PHS) Grants Policy Statement, found at http://grants.nih.gov/grants/policy/gps/index.html.

The Progress Report must include Sections a through f as described on pages 10-14 in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the 2590 instructions.

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.  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 and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.

PD/PI must refer to the Funding Opportunities/Grants Process section of the AHRQ website (www.AHRQ.gov) for additional information and instructions regarding the submission of progress and financial reports.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential PIs or applicant organizations. Inquiries may fall into three areas: scientific/research, 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 Women, Minorities and Children, and other priority populations to:

Anne Trontell, M.D., MPH.
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville , MD 20850
Telephone: (301) 427-1607
FAX: 301-427-1640
Email: Anne.Trontell@ahrq.hhs.gov

2. Peer Review Contacts:

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

Carl Ohata
Office of Extramural Research, Education, and Priority Populations
540 Gaither Road, Room Number
Rockville, MD 20850
Telephone: (301) 427-1549
FAX: (301)-427-1562

3. Financial or Grants Management Contacts:

Direct your questions about financial or grant management matters to:

Michelle Burr
Office  of Performance, Accountability, Resources and Technology (OPART)
Grants Management
540 Gaither Road,  
Rockville, MD 20850
Telephone: (301) 427-1451
FAX: (301) 427-1462
Email: Michelle.Burr@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 conducted and 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 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 45 CFR 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 Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff of a covered entity. 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:

The OMB Circular A-110 has been revised to provide access to research data developed with Federal support through the Freedom of Information Act (FOIA) 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) 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 under FOIA, 5 USC 552(b), disclosure of confidential identifiable data from such study, statutorily protected under 42 U.S.C. Section 299c-3(c), is exempted from disclosure under "the (b)(3) exemption” in FOIA.  It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support.  Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", for example, if they constitute trade secrets or commercial information.  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 the confidentiality statute applicable to AHRQ supported projects, 42 U.S.C. 299c-3(c)) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.

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 authorization of 42 USC 299 et seq, and under Federal Regulations 42 CFR 67 and 45 CFR Parts 74 and 92 and applicable authorizing statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement. The PHS Grants Policy Statement and the above authorizing statutes and applicable regulations.  The PHS Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/gps/index.html.

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


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