Part I Overview Information


Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov)
National Cancer Institute (NCI) (http://www.nci.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
National Institute of Nursing Research (NINR), (http://www.ninr.nih.gov)
National Library of Medicine (NLM) (http://www.nlm.nih.gov)
National Institute on Aging (NIA) (http://www.nia.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov)

Title:  Recovery Act Limited Competition: Methodology Development in Comparative Effectiveness Research (RC4)

Announcement Type
New

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

Request for Applications (RFA) Number: RFA-0D-10-009 

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 highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.701  

Key Dates
Release/Posted Date: December 28, 2009
Opening Date: January 26, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): N/A
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 Due Date(s):  February 26, 2010
AIDS Application Due Date(s): N/A
Peer Review Date(s): May/June 2010 
Council Review Date(s): August  2010
Earliest Anticipated Start Date(s): August 31, 2010
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: February 27, 2010

Due Dates for E.O. 12372  
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description

Section II. Award Information


Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

This FOA invites applications to enhance, develop, or evaluate methodologies to improve the efficiency, validity, and credibility of comparative effectiveness research (CER) studies.  Research to improve CER methods is seen to be necessary given the well-known limitations of commonly applied methods, ranging from technology assessments to prospective observational studies and large-scale randomized trials.  Recent advances in the capacity and uptake of information technology and statistical sciences present a unique opportunity to address a number of long-standing barriers to expansion of CER and CER findings, including assessing and limiting confounding biases in observational studies and improving efficiency and generalizability of randomized trials.  These advances, however, have not been adequately studied in the area of comparative effectiveness, leaving a substantial opportunity for improvement that could be met in part by successful applications to this FOA.

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 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;

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 is as follows:

2. Background

Comparative effectiveness research (CER) holds significant promise to improve health care quality and potentially lower costs. However, there are some limitations of commonly used research methodologies.  Observational studies suffer from confounding bias, especially from unmeasured factors (Rawlins, 2008, and Tunis, 2009), and from failure to abide by the intention to treat principle (Hernan et al, 2009).  There have been numerous instances in which treatments that appeared beneficial in observational studies turned out to be ineffective or even harmful when subjected to the rigors of randomized trials.  One well known example is hormone replacement therapy in post-menopausal women, which was thought to be effective for preventing chronic cardiovascular disease.  Large-scale observational studies seemed to show benefit, but randomized trials demonstrated otherwise (Rossouw et al, 2002).  Subsequent analyses suggested that the observational studies suffered from failure to consider certain confounders, like socioeconomic status (Humphrey et al, 2002), or failure to distinguish initiation of therapy from prevalence of therapy (Hernan et al, 2008)—an observational equivalent of “intent to treat.”  Randomized trials offer solutions for confounding bias and are based on the intention to treat principle, yet are themselves limited by poor generalizability and inefficiencies of time and place. (Duley et al, 2008, and Rawlins, 2008)  Because randomized trials often require long times to design, implement, execute, and analyze, their results may be obsolete or nearly so by the time they are known to the clinical community.  Furthermore, randomized trials that focus on effectiveness endpoints, like major morbidity and mortality, often require large sample sizes that entail considerable expense and logistical complexity.  (Califf, 2006, and Rawlins, 2008)

Meta-analyses of existing literature are complicated by a need to measure and account for heterogeneity of study populations and interventions.  Syntheses of large data sets require robust and credible methods to link patient-specific data from different sources, properly handle missing or misclassified data, account for limitations introduced by data not collected for research purposes, protect privacy and confidentiality, and engage holders of data in the research enterprise.  (Institute of Medicine (IOM) report on Initial National Priorities for Comparative Effectiveness Research (http://www.iom.edu/CMS/3809/63608/71025.aspx).

Some treatments may yield statistically significant reductions in morbidity or mortality within the carefully controlled settings of prospective studies, yet have little impact when applied in routine practice among typical patients.  (Rawlins, 2008, and Tunis, 2009)  These discrepancies may be related to the effects of multiple comorbidities, unappreciated safety hazards, and complex social, economic, and clinical environments within which health care is delivered.

There have been some efforts to overcome these and other methodological limitations of CER.  Propensity scores have been proposed by some as a means to assure balance of confounders between groups and assure better estimates of treatment effects. (Rubin, 1997)  However, it is not clear that propensity scores yield properly adjusted findings or that they adequately adjust for unmeasured confounders. (Stukel et al, 2007, and Sturmer et al, 2007)  Instrumental variables, which are closely correlated with intervention exposures but not correlated with outcomes except by means of their links with exposures, may better handle missing confounders (Stukel et al, 2007); however, they are often difficult to identify or assess within common clinical contexts.  A number of innovations for clinical trials have been proposed and partially examined.  These include adaptive, Bayesian, delayed-start, pragmatic, simple, and cluster randomization designs. (D’Agostino, 2009, and Luce, 2009)  Simulations and “value-of-information” research have been proposed as approaches to prospectively assess the public health benefits of CER. (Basu and Meltzer, 2009) 

For the purposes of this FOA, the definition of comparative effectiveness research will adhere to that adopted by the Federal Coordinating Council given 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.

The term “comparative” refers to comparisons of interventions and strategies to prevent, diagnose, treat, and monitor health conditions.  The term “effectiveness” refers to applicability “to real-world needs and decisions faced by patients, clinicians, and other decision makers” within “real-world settings,” i.e. not the ideal settings created in efficacy investigations.  CER investigations compare two or more interventions and strategies that are currently available to practicing clinicians (i.e., not innovative or experimental drugs, devices, or approaches that might more typically be part of an FDA-regulated efficacy study).  These interventions and strategies can include “medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies.”  As examples, CER investigations could:

For examples of CER topics and approaches a 2009 Institute of Medicine Panel consider to be of high national priority, applicants are also encouraged to consult the Panel’s report at http://www.iom.edu/Reports/2009/ComparativeEffectivenessResearchPriorities.aspx.

Some like Rawlins (2008) have argued that widely accepted hierarchies of evidence should give way to more nuanced approaches that allow for sophisticated syntheses of multiple types of evidence and that allow for all methodologies to improve.  Note also that this FOA is dedicated to enhancing the methodology of CER research rather than to find new comparatively effective treatments.

The recent Federal Coordinating Council and IOM reports both recommend investments in research and innovation of CER methods, including better design and interpretation of observational studies and better means to make clinical trials large, simple, and pragmatic.  The increased national commitment to and interest in CER    stimulated by ARRA presents a unique opportunity to enhance and improve methods that will benefit the research enterprise and public health for years to come.

3. Scope and Specific Requirements

This FOA solicits applications for 3-year projects proposing innovative approaches to  enhance, develop, or evaluate methodologies to improve the efficiency, validity, and credibility of CER studies. (Note: this FOA does not target establishment of new CER findings, but rather research of CER methods.) As noted above, there are a wide range of valid CER study types and methods that are legitimate targets for research. Broad areas of methodology research include (but are not limited to) control for confounding and bias in observational studies, systematic combination of data from randomized and observational studies to streamline comparative assessments, linkage and use large amounts of data derived from practice-based warehouses, health economics, decision analysis, altered treatment effects in the setting of multiple comorbidities, value-of-information research and CER simulations, robust sub-group or personalized treatment interactions, rapid roll-out of observational studies and pragmatic trials within integrated health care systems or existing large-scale registries, use of Internet platforms to perform mega-randomized trials at low cost, and innovative approaches for rapid and efficient design, implementation, and completion of large-scale pragmatic trials and implementation studies, including Bayesian, adaptive, and cluster designs.

When appropriate, this FOA encourages investigators to produce publicly available CER tools, such as software, computerized trial algorithms, and web tools for study management.   

The scope of possible approaches to CER methods has also been left open. The general guideline is that the results of grants following from this RFA could set the stage for other, future studies establishing the value of the methods proposed.  Applicants should be aware of the fact that any proposed project should be feasible within a three year period and a total costs budget of $1.50 million.

References.

Basu A, Meltzer D. Modeling comparative effectiveness and the value of research. Ann Intern Med 2009;151:210-1.

Califf RM. Clinical trials bureaucracy: unintended consequences of well-intentioned policy. Clin Trials 2006;3:496-502.

D'Agostino RB, Sr. The delayed-start study design. N Engl J Med 2009;361:1304-6.

Duley L, Antman K, Arena J, et al. Specific barriers to the conduct of randomized trials. Clin Trials 2008;5:40-8.

Hernan MA, Alonso A, Logan R, et al. Observational studies analyzed like randomized experiments: an application to postmenopausal hormone therapy and coronary heart disease. Epidemiology 2008;19:766-79.

Humphrey LL, Chan BK, Sox HC. Postmenopausal hormone replacement therapy and the primary prevention of cardiovascular disease. Ann Intern Med 2002;137:273-84.

Luce BR, Kramer JM, Goodman SN, et al. Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change. Ann Intern Med 2009;151:206-9.

Rawlins M. De testimonio: on the evidence for decisions about the use of therapeutic interventions. Lancet 2008;372:2152-61

Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA 2002;288:321-33.

Rubin DB. Estimating causal effects from large data sets using propensity scores. Ann Intern Med 1997;127:757-63.

Stukel TA, Fisher ES, Wennberg DE, Alter DA, Gottlieb DJ, Vermeulen MJ. Analysis of observational studies in the presence of treatment selection bias: effects of invasive cardiac management on AMI survival using propensity score and instrumental variable methods. JAMA 2007;297:278-85.

Sturmer T, Schneeweiss S, Rothman KJ, Avorn J, Glynn RJ. Performance of propensity score calibration--a simulation study. Am J Epidemiol 2007;165:1110-8.

Tunis, S. Strategies to improve comparative effectiveness research methods and data infrastructure. In Implementing comparative effectiveness research: priorities, methods, and impact. Washington, DC: Brookings 2009.

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the ARRA-specific RC4 award mechanism.  The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).

2. Funds Available

This initiative is supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5.

This initiative is supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5. Contingent upon the submission of a sufficient number of scientifically meritorious applications, NIH intends to commit at least $10 million in response to this FOA.  We anticipate that 6-7 awards will be made in fiscal year 2010, pending the number and quality of applications and availability of funds.  Although the size of award may vary with the scope of research proposed, applications must stay within the budgetary guidelines for this FOA.  Budget proposals are limited to $500,000 total costs per year over three years and the total cannot exceed $1,500,000.

Grants that are awarded will have to use a non-modular budget. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of the IC(s) may provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

All awards are subject to the availability of funds. The estimated amount of funds available for support of projects awarded as a result of this announcement is $10,000,000 for fiscal years 2010, 2011, and 2012. Future year amounts will depend on annual appropriations.

This program is supported by funds provided to the NIH under the Recovery Act.  The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means.  Consistent with these goals, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component 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.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply. Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization. The United States institution/organization must be located in the 50 states, territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia. NIH encourages applications from all interested organizations/institutions, including those from Institutional Development Award (IDeA) states and Academic Research Enhancement Award (AREA)-eligible institutions. Foreign organizations/institutions are not permitted as the applicant organization.

The following bulleted list represents organizations that are eligible for funding:

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

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, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application.  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 with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

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

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

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

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

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.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential.  Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number.  Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the 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 NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are necessary for processing (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 “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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
PHS398 Cover Page Supplement
PHS398 Research Strategy
PHS398 Checklist
Research & Related Budget,

Optional Components:

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

SPECIAL INSTRUCTIONS  

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the Research Plan section and Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan.  In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions 

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form. 

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: January 26, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
Application Due Date(s): February 26, 2010
Peer Review Date(s): May/June 2010 
Council Review Date(s): August2010
Earliest Anticipated Start Date(s): August 31, 2010

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp  and follow Steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED.  All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used

3.C. Application Processing

3.C.1 Submitting On-Time

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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

All applications must meet the following criteria to be considered “on-time”:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons.  The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays.  All errors must be corrected to successfully complete the submission process.  Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified 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 weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and/or non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commonshttps://commons.era.nih.gov/commons/. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

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

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

4. Intergovernmental Review

This initiative is not subject to E.O. 12372 (intergovernmental review), as indicated in the NIH Grants Policy Statement.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

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

6. Other Submission Requirements

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

The NIH requires the PD(s)/PI(s) 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.

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.”

Special Instructions for PHS398 Research Strategy Component (Section 5.5 of SF424 (R&R) Application)

Research Strategy Page Limitation: The Research Strategy is limited to a total of 12 pages.

PHS398 Research Strategy Component Sections

Item Number and Title

Instructions

1. Introduction to Application

Omit (N/A: Resubmissions and Revisions not allowable)

2. Specific Aims

One page maximum. Separate PDF attachment

3. Research Strategy

Limited to 12 pages. Attach the 12- page Research Strategy as a single PDF document. Figures and illustrations may be included but must fit within the 12-page limit. Do not include links to Web sites for further information. Do not include animations.

Excluded from the 12-page Research Strategy limitation are the following items:

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).  Also see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Do not use the Appendix to circumvent the page limitations.  An application that does not comply with the required page limitations may be delayed in the review process.  

No supplemental/update information will be accepted.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Regardless of the amount requested, applicants under this FOA are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)

Section V. Application Review Information


1. Criteria 

The review criteria described below will be considered in the review process along with the review criteria listed in the “Priority-Setting Process and Inputs for Use of ARRA OS Funds” section above.

2. Review and Selection Process

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 and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review groups convened by Center for Scientific Review and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

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

The NIH RC4 grant is a mechanism for supporting research under ARRA. 

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 following five core review criteria, and additional review criteria (as applicable for the project proposed). 

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

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technological advances, technical capability, clinical practice, and/or health be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Would this project help enhance the efficiency, validity, and credibility of future CER projects and initiatives?  How would this project build upon the advancement in infrastructure development made possible with other ARRA CER funds and capitalize on these investments (e.g., methods for registries, linked claims data, and data networks)?  How well does this project complement other Federally funded CER methods efforts (e.g. issuance of competitive task orders against Indefinite Delivery Indefinite Quantity Contracts for the Evidence-based Practice Centers where the purpose of the task orders is to have Evidence-based Practice Centers lead specific research activities for advancing evidence synthesis methods and serve as a resource to the Evidence-based Practice Center Program and http://www.effectivehealthcare.ahrq.gov/ehc/index.cfm/search-for-guides-reviews-and-reports/?category=&search=&methodCategory=0&language=1)?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the research team include sufficient expertise in the areas of CER methodology to allow adequate progress in the accelerated time line required by this FOA?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, technological developments, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Will the applicants be able to obtain access to either provider populations or the appropriate data sources to complete the proposed work in the time allowed for by this FOA?

For additional information regarding the Review process, please refer to the following:  NOT-OD-09-054, “Recovery Act of 2009:  NIH Review Criteria, Scoring System, and Suspension of Appeals Process” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-054.html); and NOT-OD-09-024, “Enhancing Peer Review:  The NIH Announces New Scoring Procedures for Evaluation of Research Applications Received for Potential FY2010 Funding” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-024.html).

2.A. 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.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

2.B. 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.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession, use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

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

Appeals will not be permitted.  See NOT-OD-09-054, Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of Appeals Process.

3. Anticipated Announcement and Award Dates

Not applicable.

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, 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. In addition, as part of “just-in-time” information for those Recovery Act awards, for any modular budget application, a detailed budget will be required prior to award.

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.

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.”  

Applicants should plan to attend an AHRQ CER conference of awardees supported under this FOA for dissemination purposes.  For budgetary purposes, applicants should plan for two representatives to travel to the Washington, DC, area for conference presentations as arranged by AHRQ and NIA. To this end, applicants should present a relevant plan, to include involved personnel, budget justifications, and timetables appropriate to participating in such a conference.

In addition, applicants should plan to attend an annual investigator’s meeting including grantees from this FOA and the companion Clinical Trials FOA.

2. Administrative and National Policy Requirements

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.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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 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.

Section VII. Agency Contacts


This funding announcement 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 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.

_____________________________

[1] Formal application includes the preliminary application and letter of intent phases of the program.

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

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

1. Scientific/Research Contact(s):

Michael S. Lauer, MD
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8128
Bethesda, MD 20892
Telephone: (301) 435-0422
Fax: (301) 480-7971
Email: lauerm@nhlbi.nih.gov


2. Peer Review Contact(s):

Kate Bent, PhD
Healthcare Delivery and Methodologies IRG
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 3160
Bethesda, MD 20892
Telephone: (301) 435-0695
Email: bentkn@csr.nih.gov

3. Financial/Grants Management Contact(s):

Robert Tarwater
National Heart, Lung, and Blood Institute
RKL2 – Two Rockledge Center, 7150
6701 Rockledge Dr.
Bethesda, MD  20892
Telephone: (301)402-6090
Fax:  (301)451-5462
Email: tarwater@nhlbi.nih.gov

Section VIII. Other Information


Required Federal Citations

The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf

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: http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated 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).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. 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 on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 priority areas. This FOA is related to one or more of the priority areas. 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. Awards are made under Sections 301 and 405 of the PHS Act, as amended (42 USC 241 and 284) and are subject to 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


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