Part I Overview Information


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

Components of Participating Organizations
National Cancer Institute (NCI), (http://www.cancer.gov/)
National Institute on Aging (NIA), (http://www.nia.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID), (http://www3.niaid.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)

Title: Recovery Act Limited Competition:  Comparative Effectiveness Research on Upper Endoscopy in Gastroesophageal Reflux Disease (GERD), Eradication Methods for Methicillin Resistant Staphylococcus aureus (MRSA), and Dementia Detection and Management Strategies (RC4)

Announcement Type
New

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

Request for Applications (RFA) Number: RFA-OD-10-008

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): Not Applicable
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): NA
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 conduct initial or preliminary comparative effectiveness research (CER) projects in targeted, high-priority areas in which such efforts have been lacking.  CER encompasses a wide array of methodologies, including technology assessment, meta-analysis, systematic reviews, observational studies, and experimental trials.  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.

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 includes:

2. Background

Both clinicians and patients are faced with increasingly complex information about the effects, risks and costs of various health care options.  To assist them with this challenge, comparative effectiveness research (CER) attempts to provide systematic, well-founded information that will enable them to engage in informed clinical decision-making.  CER holds significant promise to improve health care quality and potentially lower costs.  

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.). 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:

This FOA solicits applications on three topics identified in the recent Institute of Medicine (IOM) report on Initial National Priorities for Comparative Effectiveness Research (http://www.iom.edu/CMS/3809/63608/71025.aspx) as being in the top quartile of national priorities for CER, but regarding which there is a paucity of NIH supported CER:  upper endoscopy in Gastroesophageal Reflux Disease (GERD), eradication methods for methicillin resistant Staphylococcus aureus (MRSA), and strategies for detection and management of dementia.  Applications responsive to this FOA must address the IOM recommendation pertaining to one of these three areas, but are not limited to the specific research examples discussed below.

CER on Upper Endoscopy in Gastroesophageal Reflux Disease (GERD)

Among digestive diseases, GERD is by far the most common diagnosis at outpatient visits.  Stricture, ulceration, and bleeding are significant non-malignant complications of GERD.  Extraesophageal reflux syndromes of asthma, laryngitis, and cough commonly co-occur with GERD.  The symptoms and diagnosis of GERD are common among children as well as adults.  GERD is strongly associated with Barrett’s esophagus (intestinal metaplasia in the lower esophagus), but is poor at predicting who has Barrett’s.  As many as half of persons with Barrett’s have mild or no reflux symptoms and go undiagnosed, and most persons with GERD do not have Barrett’s.  Barrett’s esophagus is the major risk factor found on endoscopy for adenocarcinoma of the esophagus, although the incidence of cancer is not high even in the presence of Barrett’s. A finding of dysplasia among persons with Barrett’s does markedly increase the rate of progression to cancer.  Risk of adenocarcinoma of the esophagus is greatest among middle-age and older white males.  Other factors that define a subset at increased risk are poorly defined.

Adenocarcinoma of the esophagus is one of the few malignancies whose incidence is rapidly increasing. The 5-year survival of patients with esophageal adenocarcinoma is poor, but it is greatly improved by early endoscopic detection followed by either resection of the esophagus or endoscopic mucosal ablation. Anti-reflux therapy with surgery or proton pump inhibitors has not been demonstrated to reduce the risk of cancer.  Some experimental evidence suggests a potential chemoprotective effect of non-steroidal anti-inflammatory drugs (NSAIDs).

The IOM report has recommended research to “compare the effectiveness of upper endoscopy utilization and frequency for patients with gastroesophageal reflux disease on morbidity, quality of life, and diagnosis of esophageal adenocarcinoma.” 

Studies are needed to address the comparative effectiveness of medications, anti-reflux surgery, and endoscopic therapies for GERD patients at all ages.  Such research could use existing databases or conduct pilot studies needed to plan definitive prospective studies. 

Minimally invasive techniques are now available for endoscopic diagnosis and monitoring.  CER pilot and planning studies are needed to determine the relative effectiveness of trans-nasal and capsule endoscopy in monitoring Barrett’s esophagus.

CER studies are needed to determine which uses of diagnostic upper endoscopy and which patient characteristics among patients with GERD and other indications for endoscopy are most effective in identifying those with Barrett’s esophagus, increasing diagnostic yield and reducing the costs of endoscopy.  These issues can be addressed through analyses of existing databases supplemented by limited additional data collection.

Therapeutic endoscopic radio-frequency ablation of high-grade dysplasia has been shown to reduce the incidence of adenocarcinoma of the esophagus. Through existing data or new pilot data collection, CER studies are needed to compare the outcomes of ablative therapy with esophageal resection or no therapy for patients with dysplasia.

CER on Eradication Methods for Methicillin Resistant Staphylococcus aureus (MRSA)

Methicillin resistant Staphylococcus aureus (MRSA) is evolving and emerging both in the healthcare (hospital and institutions) and in the community setting.  The distinction between strains from these two broadly different compartments is beginning to blur.  Given the public health significance of this species, it is important to understand the comparative effectiveness of currently available measures for the prevention and treatment of disease that can result from encounter with this protean pathogen that also can exist in harmony with the human host.

The IOM report has recommended research to “compare the effectiveness of various screening, prophylaxis, and treatment interventions in eradicating methicillin resistant Staphylococcus aureus (MRSA) in communities, institutions, and hospitals.” 

Particularly with respect to decolonization of the host, results differ according to geographical location, location of the patients within the hospital, and institutional and practice norms.  Any assessment of these topics should carefully consider the relevant variables and represent advance of knowledge beyond the point of individual primary or comparative (review articles) literature sources.  Applicants are encouraged to review the following links with information that may be of interest or helpful in preparing applications:

This solicitation targets proposals that evaluate either pre-existing databases or the diverse literature to assess any of the following in reducing the incidence of infection with MRSA in healthcare or community settings:

Studies submitted in response to this FOA must comprise a rigorous evaluation of the impact of different options that are available for screening, prophylaxis or treatment of patients for the purpose of eradication of MRSA for a particular set of patients. They may compare similar treatments, or may analyze very different approaches, such as decolonization versus isolation and containment.  Proposed studies should assess the impact on invasive staphylococcal disease, and address cost effectiveness of the options investigated.  For the purposes of the MRSA eradication priority in this FOA, applications will not be accepted that involve research which introduces an intervention or that propose new data collection meeting the NIH definition of a clinical trial: a prospective biomedical or behavioral research study of human subjects designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).

CER on Detection and Management Strategies for Dementia Patients in the Community and Their Caregivers

Recognition and management of the needs of older adults with dementia living in community settings constitutes a multifaceted set of issues.  A growing body of literature suggests that dementia detection and diagnosis in primary care is poor for a number of reasons, including insufficient provider time and expertise, difficulty managing complex needs of both patient and caregiver, and low reimbursement for dementia related assessments (Boise, et al., 2004; Hinton, et al., 2007).

Once dementias are recognized and diagnosed, clinical management is often as much a matter of caring for various accompanying neuropsychiatric symptoms and behavioral disturbances (e.g., depression, anxiety, psychosis, agitation, aggression) as of treating the individual’s cognitive impairment.  However, recent studies have called into question the effectiveness and safety of the most typical practice for managing such neuropsychiatric symptoms and behavioral problems in older adults with dementia – the use of antipsychotic medications.  The effectiveness of these agents appears to be uncertain or modest at best, and is often offset by intolerable adverse side effects (e.g., Jeste, et al., 2008; Salzman, et al., 2008; Schneider,  et al, 2006; Sultzer, et al., 2008).  The FDA has issued “black box” warnings that such medications entail risks for increased mortality in older adults with dementia.  Faced with these uncertainties about prevailing practices, both providers and family members are eager for better information on the comparative risks and effectiveness of alternative strategies for caring for older adults with dementia.

In addition, caregivers are faced with a constantly changing set of challenges including: understanding the needs and behaviors of the person with dementia; increasing levels of burden and stress; and lack of time and/or of awareness of the need to care for themselves.  Both behavioral disturbances and caregiver stress are known to be critical factors influencing decisions as to whether older adults with dementia can be maintained in the community or must be placed under institutional care.

The IOM report has recommended research to “compare the effectiveness and costs of alternative detection and management strategies (e.g., pharmacologic treatment, social/family support, combined pharmacologic and social/family support) for dementia in community-dwelling individuals and their caregivers.”

Various protocols (including computerized screening measures) that have been developed for detection and differential diagnosis of dementia in the primary care office have not been compared for their relative effectiveness or ease of use (e.g., Doody, et al., 2001; Knopman, et al., 2001; Petersen, et al., 2001; Waldemar, 2007).  Attention should be paid to the validity and reliability of these protocols, the feasibility of their method of administration, and recommended treatment steps. 

With respect to managing the care of neuropsychiatric symptoms and behavioral problems in dementia patients, information is needed on the comparative effectiveness of various commonly used pharmacological approaches (e.g., antipsychotics, antidepressants, benzodiazepines), nonpharmacological alternatives (e.g., staff and/or family training in behavioral modification techniques, environmental structuring, somatic and sensorimotor interventions), and their combinations.  Attention should be given particularly to clarifying the comparative risk-benefit ratios of various interventions and to their effects on caregivers as well as on the older individuals with dementia.  For purposes of this FOA, NIMH interests are specific to research addressing these aspects of the topic area.

Several strategies for reducing informal or family caregiver burden and stress have been developed, tested, and shown to be effective (e.g., Bell, et al., 2006; Mittelman, et al.,2006).  It is now necessary to test the comparative effectiveness and cost-effectiveness of these strategies for stress/burden reduction, as well as their ease of implementation in various settings, including large scale systems, and ability to postpone institutionalization of the care recipient. 

Studies are particularly needed that address these issues in racial and ethnic minority populations and communities.  Studies are also need to understand which groups of patients that are identifiable by a specific cause of dementia or other shared clinical features will benefit from specific treatment/management strategies and which do not.

As many of these issues may ultimately require studies involving multiple research sites, support under this FOA may be requested for planning appropriate research protocols and/or building infrastructure elements, such as registries of dementia patient-caregiver dyads or research networks, needed to conduct larger, longitudinal CER studies on dementia detection and management strategies.  Support may also be requested for CER studies using archived data or large administrative data sets in which various outcomes can be compared for both dementia caregivers and care recipients who have been subjected to differing protocols for the detection and/or management of dementia and/or for burden reduction among dementia caregivers. 

3. Scope and Specific Requirements

This FOA solicits applications for small, 3-year projects proposing analyses of archival or administrative datasets, pilot clinical trials, observational studies, planning of future definitive research protocols, building of research networks or registries, or demonstration projects from multidisciplinary teams with relevant expertise to conduct CER studies of upper endoscopy in GERD, MRSA eradication methods, or dementia detection and management strategies. The research proposed must address the IOM recommendation for studies in the selected area. 

The scope of possible approaches to the CER problems in these targeted areas has been left open. There are a wide range of valid sources for information and prior research findings that can support such CER efforts. The general guideline is that the results of grants following from this FOA should set the stage for other, future studies definitively establishing the relative effectiveness of the interventions compared. But such research may be facilitated or shown feasible as the result of a small-scale randomized clinical trial (RCT) or clustered randomized trial (CRT), secondary analysis of provider performance or claims data, an observational study of health care delivery programs, or other valid methods. 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 $1.25 million.

References.

Bell SH., et al. for the Resources for Enhancing Alzheimer’s Caregiver Health (REACH II) investigators, 2006.  Enhancing the quality of life of dementia caregivers from different ethnic or racial groups. Ann Intern Med., 145:727-738.

Boise, et al. 2004.  Dementia assessment in primary care: Results from a study in three managed care systems. J Gerontol., 59(6):M621-26.

Doody, R, et al., 2001.  Practice parameter: Management of dementia (an evidence-based review) Report of the Quality Standards Subcommittee of the American Academy of Neurology.  Neurology, 56:1154-1166.

Hinton, L, et al. 2007.  Practice constraints, behavioral problems, and dementia care: Primary care physicians’ perspectives. J Gen Intern Med, 22(11):1487-1492.

Jeste DV, et al., 2008.  ACNP White Paper: Update on use of antipsychotic drugs in elderly persons with dementia.  Neuropsychopharmacology, 33:957-970.

Knopman, D, et al. 2001.  Practice parameter: Diagnosis of dementia (an evidence-based review) Report of the Quality Standards Subcommittee of the American Academy of Neurology.  Neurology, 56:1143-1153.

Mittelman MS, et al., 2006.  Improving caregiver well-being delays nursing home placement of patients with Alzheimer disease.  Neurology, 67:1592-1599.

Petersen, R, et al. 2001.  Practice Parameter: Early detection of dementia: Mild cognitive impairment (an evidence-based review) Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology, 56:1133-1142.

Salzman C, et al., 2008.  Elderly patients with dementia-related symptoms of severe agitation and aggression: Consensus statement on treatment options, clinical trials methodology, and policy.  J Clin Psychiatry, 69(6):889-898.

Schneider LS, et al. for the CATIE-AD Study Group, 2006.  Effectiveness of atypical antipsychotic drugs in patients with Alzheimer’s disease.  NEJM, 355:1525-1538.

Sultzer DL, et al., 2008.  Clinical symptom responses to atypical antipsychotic medications in Alzheimer’s disease: Phase 1 outcomes from the CATIE-AD effectiveness trial.  Am J Psychiatry, 165:844-854.

Waldemar G, et al., EFNS, 2007.   Recommendations for the diagnosis and management of Alzheimer’s disease and other disorders associated with dementia: EFNS guideline.  Eur J Neurol., 14(1):e1-26.

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 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. The NIH has designated a cumulative total of $15,000,000 in FY(s) 2010, 2011, and 2012 to fund 12-18 grants (4-6 in each of the 3 targeted areas), contingent upon the submission of a sufficient number of scientifically meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 3 years. Although the size of award may vary with the scope of research proposed, applications must stay within the budgetary guidelines for this FOA; total costs are limited to $1,250,000 over an RC4 three-year period, with no more than $500,000 in total costs allowed in any single year. 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) 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 $15,000,000 for fiscal years 2010, 2011, and 2012

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.

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.

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
PHS398 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. 

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

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): August, 2010
Earliest Anticipated Start Date(s): August 31, 2010

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 non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons https://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 or renewal 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 or renewal 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).

None of the funds appropriated or otherwise made available in ARRA may be used by any state or local government, or any private entity, for any casino or other gambling establishment, aquarium, zoo, golf course, or swimming pool. (ARRA Sec. 1607)

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: 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 

Only the review criteria described below will be considered in the review process.

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 the NIH 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 establish the likelihood that more definitive CER can subsequently be completed in the research area addressed?

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 clinical area addressed and in CER 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 patient and/or provider populations or to 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.”  

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[1]. 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 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):

For research on upper endoscopy in GERD:

James Everhart, M.D., M.P.H.
Division of Digestive Diseases and Nutrition
National Institute Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Rm 655, MSC 5450
Bethesda, MD 20892-5450
Telephone:  (301) 594-8878
Fax:  (301) 480-8300
Email:  everhartj@mail.nih.gov

For research on MRSA eradication methods:

Dennis M. Dixon, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
6610 Rockledge Drive, Rm. 4218, MSC 6604
Bethesda, MD 20892-6604
Telephone:  (301) 496-7728
Fax:  (301) 402-2508
Email:  dmdixon@niaid.nih.gov

For research on dementia detection and management strategies:

George Niederehe, Ph.D.
Division of Adult Translational Research and Treatment Development 
National Institute of Mental Health
6001 Executive Boulevard, Room 7220, MSC 9634
Bethesda, MD 20892-9634
Telephone: (301) 443-9123
Fax:  (301) 443-1424
Email: 
gniedere@mail.nih.gov

Sidney M. Stahl, Ph.D.
Division of Behavioral and Social Research
National Institute on Aging
7201 Wisconsin Avenue, #533
Bethesda, MD 20892-9205
Telephone:  (301) 402-4156
Fax:  (301) 402-0051
Email:  Sidney_Stahl@nih.gov

2. Peer Review Contact(s):

Katherine Bent, Ph.D.
Division of AIDS, Behavioral and Population Sciences
NIH/Center for Scientific Review
6701 Rockledge Drive (Rockledge 2), Room 3160, MSC 7770
Bethesda, MD 20892-7770
Telephone:  (301) 435-0695
Fax:  (301) 480-1056
Email:  bentkn@csr.nih.gov

3. Financial/Grants Management Contact(s):

For research on upper endoscopy in GERD:

Mr. Kieran Kelley, MAS
Senior Grants Management Specialist
National Institute of Diabetes, Digestive and Kidney Diseases
Two Democracy Plaza, Room 724
6707 Democracy Boulevard, MSC 5456
Bethesda, MD 20892-5456
Telephone:  (301) 594-2193
Fax:  (301) 594-9523
Email:  kelleykieran@niddk.nih.gov

For research on dementia detection and management strategies:

Rebecca Claycamp, MS, CRA
Chief, Grants Management Officer
National Institute of Mental Health
6001 Executive Blvd, Rm 6115, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-2811
Fax:  (301) 480-1956
Email: rclaycam@mail.nih.gov

Ms. Linda Whipp
Grants Management Officer
National Institute on Aging
GWY – Gateway Building, 2N212
7201 Wisconsin Ave.
Bethesda, MD  20892-9205
Telephone:  301-496-1472
Fax:  301-402-3672
Email:  whippl@gw.nia.nih.gov

For research on MRSA eradication methods:

Ms Ann Devine
Grants Management Program
NIAID, NIH
6700B Rockledge Drive, Room 2114
Bethesda, MD 20892
Phone: 301-402-5601

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/.


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


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