NOT-OD-10-037: NIH Announces the Availability of Recovery Act Funds for Administrative Supplements for Comparative Effectiveness Research Workforce Development

NIH Announces the Availability of Recovery Act Funds for Administrative Supplements for Comparative Effectiveness Research Workforce Development

Notice Number: NOT-OD-10-037

Catalog of Federal Domestic Assistance Numbers
93.701, 93.702

Key Dates
Release Date: January 4, 2010
Receipt Date: March 1, 2010

Issued by
National Institutes of Health (NIH) (http://www.nih.gov/)
(All NIH Institutes and Centers participate in this initiative.)

Purpose

The National Institutes of Health (NIH) announces the opportunity for investigators and United States (U.S.) institutions/organizations with active NIH research grants to request administrative supplements for the purpose of expanding the numbers of researchers qualified to oversee or conduct comparative effectiveness research (CER). Support for these supplements will come from funds provided to NIH through the American Recovery and Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5. Consistent with the intent of the Recovery Act, the purpose of this program is to promote job creation and economic development along with accelerating the pace and achievement of scientific research. This NIH Administrative Supplement Overview describes the NIH CER-specific areas of interest, process for submitting requests, and selection criteria.

Priority-Setting Process and Inputs for Use of Department of Health and Human Services (HHS) Office of the Secretary (OS) ARRA Funds

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

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

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

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

One of the 100 IOM recommendations;
One the MMA 14 Priority Conditions identified by the Agency for Healthcare Research and Quality (AHRQ) (pursuant to Section 1013 of the Medicare Prescription Drug Improvement and Modernization Act of 2003), which are not currently addressed; and/or
One of the AHRQ identified evidence gaps.

A current list of priority conditions includes:

Arthritis and non-traumatic joint disorders;
Cancer;
Cardiovascular disease, including stroke and hypertension;
Dementia, including Alzheimer’s disease;
Depression and other mental health;
Developmental delays, attention-deficit hyperactivity disorder, and autism;
Diabetes mellitus;
Functional limitations and disability;
Infectious diseases including HIV/AIDS;
Obesity;
Peptic ulcer disease and dyspepsia (digestive system conditions);
Pregnancy including preterm birth;
Pulmonary disease/asthma; and
Substance abuse disorders.

Background

The Recovery Act was signed into law on February 17, 2009, with the purpose of stimulating the United States (U.S.) economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. This administrative supplement opportunity uses funds appropriated for the purpose of CER and is one part of the overall NIH Recovery Act investment strategy, as described at www.nih.gov/recovery. For the purposes of this funding opportunity, the definition of comparative effectiveness research, which adheres to that adopted by the Federal Coordinating Council (go to http://www.hhs.gov/recovery/programs/cer/execsummary.html), is as follows:

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.

To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations and subgroups.
Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies.
This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness and actively disseminate the results.

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

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

Included within statutory limits of ARRA and the Council’s definition of comparative effectiveness research;
Potential to inform decision-making by patients, clinicians, or other stakeholders;
Responsiveness to expressed needs of patients, clinicians or other stakeholders; and
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 Federal Coordinating Council’s prioritization criteria for scientifically meritorious research and investments for all projects funded with OS ARRA funds, which are: potential impact (based on prevalence of condition, burden of disease, variability in outcomes, costs, potential for increased patient benefit or decreased harm); potential to evaluate comparative effectiveness in diverse populations and patient sub-groups and engage communities in research; addresses existing uncertainty within the clinical and public health communities regarding management decisions and variability in practice; addresses a need or is unlikely to be addressed through other organizations; and potential for multiplicative effect.

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

One of the 100 IOM recommendations;
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
Fall into one of the AHRQ identified evidence gaps.

A current list of priority conditions is as follows:

Arthritis and non-traumatic joint disorders;
Cancer;
Cardiovascular disease, including stroke and hypertension;
Dementia, including Alzheimer’s disease;
Depression and other mental health;
Developmental delays, attention-deficit hyperactivity disorder, and autism;
Diabetes mellitus;
Functional limitations and disability;
Infectious diseases including HIV/AIDS;
Obesity;
Peptic ulcer disease and dyspepsia (digestive system conditions);
Pregnancy including preterm birth;
Pulmonary disease/asthma; and
Substance abuse disorders.

Areas of Interest

The introduction of multiple approaches to the diagnosis, treatment, and follow-up of an increasing range of disorders creates dilemmas for health care providers and patients as they seek the most effective option(s). The discipline of CER has been increasingly emphasized as providing a rational basis for making choices, and has been the topic for recent reports (go to http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf and http://www.iom.edu/Reports/2009/ComparativeEffectivenessResearchPriorities.aspx). CER requires specialized knowledge and skills ranging from strategies for access to patients in their real world environments to economic modeling, human subject consent issues to study design, methodology, and analysis. NIH has a substantial track record of CER studies and has determined that an increase in CER will require a workforce expansion. To meet projected needs, NIH will support the training, education, and career development of researchers in CER through supplements to existing training, career development, and eligible clinical research infrastructure awards. The NIH supports the mandate of the American Recovery and Reinvestment Act by preserving and creating jobs through building research and resource capacity, partnerships, and innovative biomedical research activities. It is expected that the ARRA funds provided by the NIH to the research community will provide needed investment to stimulate the economy through spurring technological/methodological advances in science and health. The impact is expected to extend beyond the immediate applicant who receives funds.

In accordance with the Recovery Act, additional reporting requirements are expected with the conduct of research under these administrative supplements. Grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the quarterly reporting requirements of Section 1512 of the Recovery Act as specified in HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009. 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. The due date deadline for receipt of NIH Administrative Supplement requests in response to this opportunity is March 1, 2010.

Comparative Effectiveness Research Workforce Development Administrative Supplement Topics

This initiative will provide new training, education, and career development opportunities to researchers and their mentors and teachers which will develop and/or enhance skills essential to conduct CER and disseminate science information about CER. Training, education, and career development needs to be both multidisciplinary and multispecialty. Preference will be given to activities whose educational impact extend or can be disseminated beyond the awardee institution. Workforce development outcomes might include, but are not limited to:

CER skills for health care researchers who do CER such as, but not limited to physicians, dentists, allied health professionals, nurses, psychologists, and health care administration and management professionals;
CER mentoring and teaching skills for CER researchers;
CER applied research skills development for researchers, mentors, and teachers;
CER methodology skills development by and/or for economists, quality improvement professionals, and research design professionals such as statisticians and epidemiologists;
methods for analysis of observational data, e.g., case/control, cohort studies, adjusting for confounding variables, policy studies and natural experiments, health system comparison studies, multilevel analysis, etc.;
Methods and logistics for conducting rapid cycle, prospective CER trials, including methods of rapid and efficient accrual, novel Methods randomization, e.g., cluster randomization, novel endpoints and stopping rules, accounting for patient and physician preferences, etc.;
Methods of data synthesis and evaluation, e.g., retrospective studies, systematic reviews, meta-analysis, and simulation modeling; and
Methods for research analysis of large administrative databases, electronic health records, and other data resources.

If the workforce development opportunity focuses on a research topic, the research topic must address at least one of the following topic areas (as cited in the above background section on Priority Setting Process ):

1) One of the 100 IOM recommendations;
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.

Eligibility

This administrative supplement provides the opportunity for eligible grantees to develop, expand, and/or increase CER training, education, and career development program(s) within existing Domestic (U.S.) NIH-supported grants. The Principal Investigator (PI) of the Supplement Request must be the PI named on an NIH award. Funding will be restricted to the proposed project. Some types of awards from NIH (for example, S10 awards and many R and P awards) are not eligible for administrative supplements. Questions about eligibility should be addressed to the program officer and/or the grants management specialist for the award.

To be eligible, the parent grant must be active and the training, education, and career development activities proposed in the supplement must be accomplished within the current competitive segment. For example, if the parent award expires on September 30, 2011, the work proposed in the supplement must be complete by that time. The proposed supplement MUST be within the general scope of the peer-reviewed activities and aims approved within the parent grant, including projects on a no-cost extension; while supplemental funds may be awarded to grants during a no-cost extension, the period of support cannot extend beyond the award period for the additional time that was granted. Institutional awards that support the scope of training envisaged in this supplement announcement include the K12, K30, T32, T35, and T90 mechanisms, together with their KL and TL equivalents. Potential applicants unsure of their eligibility should contact their Institutional Program Officers. Note that while NIH recommends that a no-cost extension already be in place before an administrative supplement request is submitted, this is not a requirement for all administrative supplement requests. There is no limit on the number of applications a single awardee institution may submit. NIH encourages the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities and individuals from disadvantaged backgrounds. 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 U.S., applicants must be Domestic (U.S.) institutions/organizations (i.e., those that are located in the 50 States and Territories and Possessions of the U.S.). In addition, Domestic U.S. institutions planning to submit supplement requests 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 (per subcontract/subaward or in aggregate for multiple subcontracts/subawards), whichever is less. IMPORTANT: The funds requested by the NIH grantee in the supplement application must be within the general scope of the peer-reviewed activities and aims approved within the parent grant. A request to support new research objectives and aims that are outside of the scope of the approved parent grant (e.g., inclusion of new human subjects or animal studies that were not part of the parent grant) are not appropriate under an administrative supplement. The funding method being used to support this program, administrative supplements, can be used to cover cost increases that are associated with increasing the tempo of the education, training, and career development activities funded under the parent grant and/or achieving certain new research objectives as long as they are within the scope of the parent project.

Preferences will be given to requests demonstrating multidisciplinary and/or multispecialty representation. NIH encourages a research environment which utilizes collaborative partnerships. Some examples of the types of supplements that could be appropriate include, but are not limited to: adding scholar or training slots for CER education and training through short courses, Certificate programs, and advanced degree-awarding programs; creating a course curriculum for early or midcareer researchers to develop or enhance skills in CER; creating an outreach training or course for community based research to develop or enhance skills in CER; and developing a CER training or course to include related fields such as communication and information dissemination science, medical decision-making, and outcomes and evaluation research as long as the proposal’s specific aims supports Federal Coordinating Council-defined CER.

Any cost increases need to result from making modifications to the parent project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes or to accelerate the tempo of scientific research/scientific activities. NIH will not consider requests which are solely to restore previously applied budget adjustments to a project nor to supplant institutional commitments supporting individuals and other costs previously committed to projects.

Preparing an Administrative Supplement Request

Requests submitted in response to this Notice must use the PHS 398 forms (rev. 11/2007; available at http://grants1.nih.gov/grants/funding/phs398/phs398.html) and include the following elements in the request packet. Applicants are strongly encouraged to submit applications electronically as an e-mail attachment in PDF format; however, the signature of the institutional official must be clearly visible. Applicants may also submit applications in paper format to the appropriate NIH Grants Management contact person. Font size restrictions apply as designated within the PHS398 instructions.

1) Cover Letter -- Specify a request for a Recovery Act Administrative Supplement, including the following information:

Project Director/Principal Investigator (PD/PI) name;
Parent grant number and title;
The NIH Administrative Supplement Topic Area;
Amount of the requested supplement;
Name and title of the authorized institutional official;
Phone, email, and address information for both the PD/PI and the institutional official;
If the project is a linked collaborative project between two or more grantees, list PD/PI name, grant number and title of linked applications;
The cover letter must be signed by the authorized organizational representative;

2) PHS 398 Form Page 1 (Face page) (MS Word PDF) Provide requested information as follows:

The title of the project (Box 1) should be the title of the parent award;
This Notice should be cited in Box 2, and the yes box should be checked;
The Project Director/Principal Investigator (PD/PI) must be the same as the PD/PI on the parent award -- For Multiple PD/PI parent awards, the Contact PD/PI must be the PD/PI listed on the supplement request (Administrative supplements cannot change the Multiple PD/PI team or convert a grant from a single PD/PI to a multiple PD/PI grant);
The remaining items on the face page should be filled out in accordance with the PHS 398 application instructions.

3) PHS 398 Form page 2 MS Word PDF Note: The project summary is that of the administrative supplement, not the parent grant. All other information requested on Form Page 2 should be provided.
4) A brief proposal describing the project (with parts 4a and 4b not exceeding five pages), should include:

a. An introduction that clearly states the scope of the overall project and the anticipated contribution of the requested supplement. Summarize the activities that were included in the parent grant that encompass multidisciplinary education and training that will provide the capacity to develop education, training, and mentoring in comparative effectiveness research.
b. The research project plan should discuss how the supplement will expand the workforce qualified to work on CER and/or allow for job creation and retention. This section should include a description of the supplement's plan for trainee and scholar recruitment, training, environment, career development, mentoring and/or opportunities for obtaining higher degrees. Describe the relationship of the supplement request to the parent grant. The specific aim(s) in the parent award that the proposed work falls under must be clearly stated. In order to ensure that all expenditures in support of an administrative supplement advance the objectives of the Recovery Act, all applications must address Recovery Act justifications, including how the supplement is expected to stimulate the economy by:
i. Enabling hiring of additional staff;
ii. Enabling increased hours of current part-time staff;
iii. Recruiting for additional needed skills.
c. Budget for the supplement with a justification that details the items requested, including Facilities and Administrative costs and a justification for all personnel and their role(s) in this project. Note the budget should be appropriate for the work proposed in the supplement request. Applicants are encouraged to discuss budgets with their NIH Program Officer. To meet the various transparency, accountability, and reporting requirements of 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). Modular budget pages will not be accepted even when the parent grant was funded as a modular grant. See Budget and Funding Information below for additional information.
d. Biographical Sketch for all new Senior/Key Personnel. There is no need to repeat information previously provided for other Senior/Key Personnel. MS Word PDF
e. Human Subjects/Vertebrate Animal documentation (if applicable). Include a current Human Subjects/Institutional Review Board (IRB) or Vertebrate Animals/Instutional Animal Care and Use Committee (IACUC) approval letter, if applicable. Otherwise, this letter will be required at time of funding. All appropriate IRB and IACUC approvals must be in place prior to a supplement award being made. No significant changes in the approved use of human subjects or vertebrate animals will be considered for administrative supplements.
f. PHS 398 Checklist Form MS Word PDF

Selection Factors

Administrative supplement requests will be reviewed administratively by NIH Program and Grants Management staff persons with expertise relevant to the supplement request. Awards will be determined on the basis of the merit of the supplement request, its applicability to the goals of the Recovery Act, and the availability of funds. Selection factors will include the following:

Relevance of the proposed activities to the parent grant and determination that the proposed activities are within the existing peer-reviewed and approved scope of the project;

Adequate progress of the parent grant appropriate to the current stage of the project;

Appropriate and well-described plan to accomplish the goals within the timeframe proposed;

Access of the applicants to a pipeline of eligible trainees and scholars;

Expertise of the research/scientific team proposed to enroll and train the conduct and achieve the goals of the supplemental study or accelerate the tempo of scientific research;

Appropriateness of the request to achieve Recovery Act goals in promoting job creation, economic development, and accelerating the pace and achievement of scientific research, as well as the future sustainability of the proposed project;

The relevance to the aims of the ARRA goals, the Administrative Supplement defined areas, and the NIH Mission; and

Geographical, programmatic, and strategic balance of awards.

While geographic variation will be considered in awarding Recovery Act funding, the scientific merit of each request will always be the prevailing criterion.

Budget and Funding Information

The maximum sum that may be requested is $500,000, as total costs. Funding for administrative supplements to existing grants will be available from Recovery Act funds in FY2010 only. Up to 16 awards may be made. It is anticipated that successful applications will be awarded by September 2010 and, where possible, shortly after their approval. Requests selected for funding in FY2010 will be limited to one year for the budget and project period. In addition, Domestic (U.S.) institutions planning to submit supplement requests 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 (per subcontract/subaward or in aggregate for multiple subcontracts/subawards), whichever is less.

How to Apply

To be considered for an administrative supplement, submit a request to the respective NIH Institute and Center (IC) of the parent grant, not to the Division of Receipt and Referral, NIH Center for Scientific Review. Applications must be signed by the authorized institutional official and submitted to the appropriate IC Grants Management Specialist noted on the Notice of Award (NoA) for the parent grant (referenced in the Inquiries section below). Applicants are strongly encouraged to submit applications electronically as an e-mail attachment in PDF format to the appropriate IC Grants Management contact; however, the signature of the institutional official must be clearly visible. Applicants may submit applications in paper format, although paper applications are strongly discouraged. Do NOT send both an electronic and a paper version of the same administrative supplement.

Terms of Award

A formal notification in the form of a Notice of Award (NoA) will be provided to the grantee 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. The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard NIH terms of award, all funding provided under the Recovery Act will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (Recovery Act or ARRA). The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for ARRA 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.

Administrative and National Policy Requirements

A Program Official from one or more of the participating NIH Institutes and Centers 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 NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. 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

Awarded administrative supplements that include a commitment for funding in FY2010 will be required to submit a separate Non-Competing Continuation Grant Progress Report (PHS 2590) and financial statement as required in the NIH Grants Policy Statement. This will be in addition to any annual progress report required for the parent grant. The funded Recovery Act administrative supplement 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 quarterly reporting requirements of Section 1512 of the Recovery Act as specified in HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009. The full text of these terms approved for NIH awards can be found at the following document: Standard Terms and Conditions for AARA 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.

Inquiries

This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application, which includes the preliminary application and letter of intent phases of the program, 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 lobbyist. 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 additional information, go to http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf.

For scientific or technical questions relating to research that would be supported by this solicitation, contact the Program Administrator 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.