Notice of Limited Competition Availability of Recovery Act Funds for NCMHD Competitive Revision Applications to Support Comparative Effectiveness Research for Eliminating Disparities (CERED)

Notice Number: NOT-MD-10-002

Catalog of Federal Domestic Assistance Number(s)
93.701

Key Dates
Release Date:  February 2, 2010
Application Due Date: April 6, 2010
Earliest Anticipated Start date: July 2010

Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

Issued by
National Center on Minority Health and Health Disparities (NCMHD), (http://www.ncmhd.nih.gov)

Purpose

The National Center on Minority Health and Health Disparities (NCMHD) in partnership with the Office of Minority Health (OMH), Office of Public Health and Science, Department of Health and Human Services (HHS) announces the availability of $7.0 million in FY 2010  for institutions/organizations with active NCMHD-supported Exploratory Centers of Excellence (P20) and Comprehensive Centers of Excellence (P60) grants to submit revision applications (formerly termed competitive supplements) to support the establishment of Centers of Excellence for conducting Comparative Effectiveness Research for Eliminating Disparities (CERED).  Support for these revision applications will come from funds provided through the American Recovery and Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5 for comparative effectiveness research (CER). The Recovery Act was signed into law on February 17, 2009 with the purpose of stimulating the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. The Recovery Act appropriated $1.1 billion to support CER.  Of that total, $400 million is to be allocated at the discretion of the Secretary of HHS for a variety of comparative effectiveness research projects and related activities. This funding opportunity for revisions is one part of the overall HHS Recovery Act investment strategy, as described at www.hhs.gov/recovery and will be funded from the $400 million allocated to the Secretary.  This Notice is a collaboration between OMH, Office of Public Health and Science and NCMHD, National Institutes of Health  and will jointly evaluate the scientific progress of the participants in this initiative following standard NIH policies and procedures.

For the purposes of this funding opportunity, the definition of comparative effectiveness research will adhere to that adopted by the Federal Coordinating Council, which can be found at http://www.hhs.gov/recovery/programs/cer/execsummary.html: “Comparative effectiveness research is 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. 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.

Priority-Setting Process and Inputs for Use of ARRA OS Funds

There were four main inputs for priorities for ARRA OS comparative effectiveness research funds: public input, an internal Departmental workgroup, the Federal Coordinating Council (FCC) report, and the Institute of Medicine (IOM) report.  The FCC identified the following as minimum threshold criteria which must be met to be considered for funding:

1) Included within statutory limits of ARRA and the Council’s definition of comparative effectiveness research;
2) Potential to inform decision-making by patients, clinicians or other stakeholders;
3) Responsiveness to expressed needs of patients, clinicians or other stakeholders;
4) Feasibility of research topic (including time necessary for research).

The Comparative Effectiveness Research-Coordination and Implementation Team (CER-CIT) will require the use of the FCC’s prioritization criteria for scientifically meritorious research and investments for all projects funded with OS ARRA funds.  These criteria are:

1)  Potential impact (based on prevalence of condition, burden of disease, variability in outcomes, costs, potential for increased patient benefit or decreased harm),
2)  Potential to evaluate comparative effectiveness in diverse populations and patient sub-groups and engage communities in research,
3)  Addresses existing uncertainty within the clinical and public health communities regarding management decisions and variability in practice,
4)  Addresses a need or is unlikely to be addressed through other organizations,
5)  Potential for multiplicative effect.

Finally, investments funded from this appropriation must address at least one of the following topic areas:

1) One of the 100 IOM recommendations; http://www.iom.edu/~/media/Files/Report%20Files/2009/ComparativeEffectivenessResearchPriorities/Stand%20Alone%20List%20of%20100%20CER%20Priorities%20-%20for%20web.ashx
2) An issue within one the MMA 14 Priority Conditions identified by AHRQ (pursuant to Section 1013 of the Medicare Prescription Drug Improvement and Modernization Act of 2003) which are not currently addressed; and/or
3) Fall into one of the AHRQ identified evidence gaps.

A current list of priority conditions includes:

Background

As part of a continuing effort to improve the health and well-being of racial/ ethnic minority and other health disparity populations, the CERED Initiative is designed to: 1) conduct research and analysis of the comparative effectiveness of various health care delivery strategies within health disparities populations; 2) develop innovative research methods and designs for evaluating the impact of different treatments on reduction of healthcare disparities among priority populations and sub-populations such as observational cross-sectional studies, quasi-experimental designs, and time series analysis; 3) establish and evaluate strong and effective dissemination strategies to ensure that health disparities populations and the medical providers and health care systems that serve them are fully aware of, have access to, and are capable of utilizing the results of CER; and 4) develop strategies for enhancing participation of priority health disparities populations and sub populations in CER studies and in data registries and networks.

Comparative Effectiveness Research (CER)

CER is 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. It is a way to identify what works for which patients and under what circumstances.  CER can involve the conduct of new research or meta-analysis of existing research and literature on CER.  Clinicians and patients frequently face important health care decisions that are made in the absence of reliable information.  Such decisions can range from what pain medication to take to whether to start an exercise program instead of a particular diet regimen.  Many of these patients do so without clear, scientifically sound information.  Additionally, there is limited information since many of the studies that are conducted do not sufficiently include health disparities populations. CER provides an extraordinary opportunity to develop and conduct research that will address the specific needs of these populations.

The purpose of CER is to provide information that helps clinicians and patients choose which option best fits an individual patient's needs and preferences.  Clinicians and patients need to know not only that a treatment works on average but also which interventions work best for specific types of patients (e.g. elderly, racial and ethnic minorities).  This information is essential to translating new discoveries into better health outcomes for Americans, accelerating the application of beneficial innovations, and delivering the right treatment to the right patient at the right time.

The proposed CERED Initiative will not only compare certain medical options for health disparities populations, but will utilize expertise and community networks to promote awareness and acceptance of CER, encourage health disparity population participation, track results, and ensure that the results of CER are understood and used by health disparity population consumers and the health care systems that treat large proportions of health disparity populations.   Under this initiative, CERED CER funding will support the following investments and activities.

Types of CER investments and activities:

The CERED Initiative will focus on the CER categories recommended in the Congressional Report by the Federal Coordinating Council for CER (http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf ):

1. Research:

Proposed research funded under this initiative should be consistent with the Strategic Framework described in the FCC Report to Congress and should also relate to or complement a CER research subproject listed below.  Such research may cut across one or more categories within the framework. 

Applicants are expected to propose a single research subproject from the list below.   Proposed research projects must also address one of the 100 IOM research topics or the 14 AHRQ priority conditions.   Applications with more than one research subproject will be considered non-responsive to this FOA and may not be referred for scientific review.

Applicants are expected to include strategies and activities that address each of the other components of the FCC Strategic Framework, e.g., human capital, data infrastructure and networks, and dissemination and translation of CER.  Applications that do not propose activities under these areas will be considered non-responsive to this FOA and may not be referred for scientific review.

2. Human Capital:

Enhance skills, and help build the supply and diversity of researchers from health disparity populations in the workforce, and contributes to greater researcher capability to conduct CER by the integration of activities within the Research Training/Education Core of the existing NCMHD Center of Excellence in Health Disparities Research.

3. Data Infrastructure and Networks:

Propose strategies and activities to promote linkages to patient data registries that enroll health disparity patients (e.g., promote participation of priority population and subpopulation in EHR, registries, and other data networks) to enhance capacity to conduct CER.

4. Dissemination and Translation of CER:

Propose strategies and activities that help in the dissemination of CER findings and translation into interventions, programs, and policies for priority populations, providers, and researchers from health disparity populations.

Applicants are also strongly encouraged to explain how the proposed CER project relates to the ongoing CER activities of the Center.

Eligibility

Due to the limited nature of Recovery Act funds, the ability to accomplish the stated goals and objectives of the initiative in an expeditious manner is paramount.  Therefore, building upon an existing research infrastructure and utilizing the inherent economies of scale is an effective means to that end.  Consequently, eligibility for this announcement is restricted to active NCMHD-supported Exploratory Centers of Excellence (P20) or Comprehensive Centers of Excellence (P60) grantees and support for revision applications is contingent on availability of funds.

To be eligible, the parent grant must be active at the time the revision application is submitted, and the research proposed in the revision must be accomplished within the current competitive segment. That is, the period of support requested for the revision cannot exceed the current project period end date of the parent grant, including projects on a no-cost extension.  If needed, a no-cost extension must be in place before the revision application is submitted.

Applications from foreign institutions are not permitted. Consistent with the goals of the Recovery Act to preserve and create jobs and promote economic recovery in the United States, applicants must be domestic (United States) institutions/organizations (i.e., located in the 50 states, territories and possessions of the United States, Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia).

IMPORTANT: Revision applications should be for costs to support new research objectives or training that are outside of the scope of the approved parent grant.

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

For all revision applications, the Project Director/Principal Investigator (PD/PI) should be the same as the PD/PI on the parent award. For Multiple PD/PI parent awards, the Contact PD/PI should be the PD/PI listed on the revision request. Revisions allow a change in the Multiple PD/PI team as well as a conversion from a single PD/PI to multiple PD/PI. However, applicants must include a multiple PD/PI Leadership Plan with the revision application.

All revision applications must be submitted by the PD/PI (or Contact PD/PI for multi-PI grants) listed on the parent grant.

NIH encourages individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities and individuals from disadvantaged backgrounds to apply.

Budget and Funding Information

Funding for revisions to existing grants will be available from Recovery Act funds in FY 2010. Due to the limited nature of Recovery Act funds, FY 2010 revision applications may only be requested for up to a two year project period.  Therefore the scope and budget of the requested revision must reflect aims and goals that can be accomplished within that limited timeframe and awardees should accelerate work wherever possible.   For the purposes of this announcement, it is anticipated that five awards will be made with total costs not to exceed $1,400,000. 

Applicants must submit a budget using non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

In addition, domestic U.S. institutions planning to submit applications that include foreign components should be aware that requested funding for any foreign components should not exceed 10% of the total requested direct costs or $25,000 per year (aggregate total for a subcontract or multiple subcontracts), whichever is less.

Application Review Process

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Applications that are complete will be evaluated for scientific and technical merit by appropriate scientific review group(s) convened by NCMHD in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below. Applicants will be notified regarding the review outcome.

As part of the scientific peer review, all applications will:

When reviewing a Revision application, the committee will consider the scientific merit of the new work proposed and the appropriateness of the proposed expansion of the scope of the project.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the standard review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria.  Reviewers will consider each of the standard review criteria of Significance, Investigator(s), Innovation, Approach, and Environment (NOT-0D-09-025) 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.

Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items: Protections for Human Subjects; Inclusion of Women, Minorities, and Children; Vertebrate Animals; and Biohazards.  In addition, the review criteria specified in the “Priority-Setting Process and Inputs for Use of ARRA OS Funds” will also be used.

Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score: Budget and Period Support; Select Agent Research; and Resource Sharing Plans.

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.

Selection Process

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

Award Notices

While geographic variation will be considered in awarding Recovery Act funding, a proposal’s scientific merit will always be the prevailing criterion. If the application is considered for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General. To meet the various transparency, accountability, and reporting requirements of the Recovery Act, all applications under this notice that are selected for Recovery Act funding and that used a modular budget format at the time of submission will be required to submit a detailed budget as part of the Just-In-Time information.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Terms of Award

The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard NIH terms of award, all awards will be subject to the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

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 Section IV.5., “Funding Restrictions.”

The resource sharing plan will become part of the terms and conditions of the award.

A Program Official from the NCMHD will be assigned to each funded application and will assume responsibility for normal stewardship of the awards.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

None of the funds appropriated or otherwise made available in ARRA may be used by any state or local government, or any private entity, for any casino or other gambling establishment, aquarium, zoo, golf course, or swimming pool.  (ARRA Sec. 1604)

In addition, recipients of Recovery Act funds are reminded that such funds must be separately tracked and monitored independently of any non-Recovery Act funding.

Reporting

Awardees will be required to submit separate financial statements as required in the NIH Grants Policy Statement. This will be in addition to any financial reporting required for the parent grant. In addition, separate information for the ARRA competitive revision will be required to be included as part of any annual progress report for the parent grant.  The funded Recovery Act revision application will also require separate closeout reports.

In addition, grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the reporting requirements described in Section 1512 of the Act, as well as applicable OMB guidance regarding the use of Recovery Act funds. As noted above, grantees must also comply with the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for ARRA Awards.

Recovery Act-related reporting requirements will be incorporated as a special term of award.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated. Until such time as HHS has migrated to the SF 425 FFR, award recipients will utilize the SF 269 FSR.

Preparing a Revision Application

Requests under this notice should use the most current PHS 398 forms available at: http://grants1.nih.gov/grants/funding/phs398/phs398.html) and include the following elements in the request packet. Font size restrictions apply as designated within the PHS398 instructions.

1) Cover Letter - Citing this Notice (NOT-MD-10-002), specify a request for a Recovery Act Competitive Revision, including the following information:

The cover letter must be signed by the authorized organizational representative.

2) PHS 398 Form Page 1 (Face page) MS Word  PDF

3) PHS 398 Form page 2 MS Word  PDF

Note: The project “summary” is that of the competitive revision, not the parent grant.  All other information requested on Form Page 2 should be provided.

4) A brief proposal describing the project, including:

a) Introduction (not to exceed one page).  Describes the nature of the revision and how it will expand the scope of the specific aims, research design, and methods of the parent grant. Use Item 1, Introduction to Application, of the PHS 398 Research Plan component to provide this information

b) Specific Aims (not to exceed one page).   Summarize the activities that were included in the parent grant that encompass those proposed in the revision request. This section should include a description of the revision’s specific aims, including research design and methods and data analysis.   Describe the relationship of the revision request to the parent grant and the impact that the proposed work will have on the research field. 

c) Research Strategy (not to exceed 12 pages).  For this section address the following points:

                        1) enabling hiring of additional staff;
                        2) enabling increased hours of current part-time staff;
                        3) procuring additional needed equipment (costing under $100,000); and/or
                        4) contracting for additional needed skills.

d) Budget for the revision with a justification that details the items requested, including Facilities and Administrative costs and a justification for all personnel and their role in this project.  The budget should be appropriate for the work proposed in the revision request. To meet the various transparency, accountability, and reporting requirements of the Recovery Act, all applications under this Notice must include detailed budgets on the PHS 398 Form Pages 4 (MS Word PDF) and 5 (MS Word PDF). Any budgetary changes for the remainder of the project period of the current grant must be discussed in the Budget Justification.

e) Biographical Sketch for PD/PI and all new Senior/Key Personnel (those who are additions on the revision project). You should include an updated biographical sketch for the PD/PI and new Senior/Key Personnel, using the forms, which are available as MS Word (http://grants.nih.gov/grants/funding/phs398/biosketch.doc) or PDF (http://grants.nih.gov/grants/funding/phs398/biosketch.pdf). There is no need to repeat information previously provided for other Senior/Key Personnel.

f) Human Subjects/ Vertebrate Animal documentation (if applicable). Include a current Human Subjects/IRB or Vertebrate Animals/IACUC approval letter, if available. Otherwise, this will be required at the time of funding. All appropriate IRB and IACUC approvals must be in place prior to a revision award being made. Any differences in the involvement or use of human subjects or specimens, or use of vertebrate animals, between the administrative revision activity and the parent grant should be noted. When appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities. Additional guidance on Human Subjects Research and Vertebrate Animals is provided under Part II of the PHS 398 instructions (http://grants1.nih.gov/grants/funding/phs398/phs398.html).

g) PHS 398 Checklist Form MS Word  PDF

h) Appendices. Include documentation and other supporting information in this section, including MOUs, IAs, letters of support, and other relevant information.  All applications submitted must provide appendix material on CDs only.  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 Strategy component.  An application that does not observe the required page limitations may be delayed in the review process.

How to Apply

The due date for revision applications is April 6, 2010.   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 five copies of the appendix material should be sent to:

Prabha Atreya, PhD
Chief, Office of Scientific Review
National Center on Minority Health and Health Disparities
Suite 800, MSC 5465
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 594-8676
FAX: (301) 480-4049
Email: atreyapr@mail.nih.gov

Inquiries

This Notice is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application [1] by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist1. This restriction applies unless:

(i) the communication is purely logistical;
(ii) the communication is made at a widely attended gathering;
(iii) the communication is to or from a Federal agency official and another Federal Government employee;
(iv) the communication is to or from a Federal agency official and an elected chief executive of a state, local or tribal government, or to or from a Federal agency official and the Presiding Officer or Majority Leader in each chamber of a state legislature; or
(v) the communication is initiated by the Federal agency official.

For scientific or technical questions relating to research that would be supported by this solicitation, contact the Program Officer assigned to the parent grant.  For administrative questions related to this solicitation, contact the Grants Management Specialist noted on the Notice of Award for the parent grant. Inquiries and discussion of plans for responding to this Notice are strongly encouraged.

For additional information see
http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf

 1Formal application includes the preliminary application phase of the program.

Inquiries and discussion of plans for responding to this Notice are strongly encouraged.

1. Scientific/Research Contacts:

Nathan Stinson, Jr., PhD, MD, MPH
Chief, Office of Scientific Programs
National Center on Minority Health and Health Disparities
Suite 800, MSC 5465
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 401-1366
FAX: (310) 480-4049
Email: stinsonni@mail.nih.gov

2. Peer Review Contacts:

Prabha Atreya, PhD
Chief, Office of Scientific Review
National Center on Minority Health and Health Disparities
Suite 800, MSC 5465
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 594-8676
FAX: (301) 480-4049
Email: atreyapr@mail.nih.gov

3. Financial or Grants Management Contacts:

Priscilla Grant, JD, CRA
Chief, Grants Management Officer
National Center on Minority Health and Health Disparities
Suite 800, MSC 5465
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 594-8412
FAX: (310) 480-4049
Email: grantp@mail.nih.gov


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