and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of
Participating Organizations
National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK), (http://www2.niddk.nih.gov)
National Cancer Institute (NCI), (http://www.cancer.gov)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)
National Institute on Aging (NIA), (http://www.nia.nih.gov)
National Institute of Alcohol Abuse and Alcoholism (NIAAA),
(http://www.niaaa.nih.gov)
National Institute of Allergy and Infectious Diseases
(NIAID), (http://www.niaid.nih.gov)
National Institute of Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute of General Medical Sciences (NIGMS), (http://nigms.nih.gov)
National
Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/index.shtml)
Title: Development of Assays for High-Throughput screening for use in Probe and
Pre-therapeutic Discovery (R01)
Announcement
Type
This Funding Opportunity Announcement (FOA) is a reissue
of PA-07-320.
Update: The following update relating to this announcement has been issued:
Program
Announcement (PA) Number: PA-10-213
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)
93.847, 93.395, 93.856, 93.866, 93.272, 93.279, 93.859, 93.242, 93.838, 93.233, 93.837, 93.839
Key Dates
Release/Posted
Date:
June 10, 2010
Opening Date: September 5, 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): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional
Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: September 8, 2013
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
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section IV. Application and Submission
Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission
Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement
and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The purpose of this FOA is to stimulate the development of assays for high throughput screening (HTS) relevant to processes and diseases specific to the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Cancer Institute (NCI), the National Heart Lung and Blood Institute (NHLBI), National Institute on Aging (NIA), the National Institute on Alcoholism and Alcohol Abuse (NIAAA), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute on Drug Abuse (NIDA), the National Institute of General Medical Sciences (NIGMS), and the National Institute of Mental Health (NIMH) with the intent of using the assays to screen for small molecule compounds that show desired properties as probes for use in advancing knowledge about the relevant target, identifying new targets, or serving as pre-therapeutic leads. The National Institutes of Health (NIH) is committed to a major effort to broaden access to high-throughput screening (HTS) technologies, and the information produced by these approaches, for researchers in academia, government, and non-profit institutions. Although there are academic and private sector facilities for carrying out HTS of small molecule libraries, the NIH has recently launched a Molecular Libraries and Imaging initiative as part of the NIH Roadmap for Medical Research. Molecular Libraries has transitioned to the Common Fund (http://nihroadmap.nih.gov/), but remains committed to providing access to a national network of screening and chemistry centers for HTS. The Molecular Libraries Production Centers Network provides access to a large compound library, robotics to carry out the assays, informatics to interpret the results, and synthetic and medicinal chemistry resources to optimize small molecule compounds with desired properties as probes and pre-therapeutic leads. Descriptions of the network screening and chemistry centers are available at: http://mli.nih.gov/mli/. The goal of this FOA is to establish a stream of scientifically and technologically outstanding assays that can be automated for HTS at an NIH-funded or other facility. For this FOA, emphasis will be placed on assays that provide new insight into important targets. For example, assays may involve targets indirectly related to disease, but which could provide insight into the biology of that disease(s). Other targets might be associated with rare and neglected diseases, an area of increasing focus for the NIH (http://www.nih.gov/news/health/may2009/nhgri-20.htm). One important criterion for this initiative is novelty, so the proposed assays should avoid focus on areas and approaches that have been extensively targeted in other settings. Assays should be relevant to the scope of the research for at least one of the sponsoring NIH Institutes (see below for Institute specific interests), focusing on specific diseases or on relevant basic physiology, cell biology, or developmental processes.
Nature of the Research Opportunity: This research opportunity proposes support for research and development leading to assays for use in HTS.
Background Information
In 2007 NIDDK, together with other NIH Institutes (NCI, NIMH, and NIAID) issued a Program Announcement for Development of Assays for High Throughput Drug Development (R01) as PA-07-320. The response to this FOA was considerable and a number of projects were funded leading to the development of new and sometimes novel assays against a host of targets. Advances in chemical biology since then have suggested a continuing need for research to develop new assays against novel and/or poorly defined targets. The emergence of HTS efforts sponsored by academia and the NIH require a steady stream of new assays. These efforts seek to develop small molecule probes with selectivity and specificity against targets for use both in academic research and as pre-therapeutic leads particularly for rare and neglected diseases. For this FOA, emphasis will be placed on assays that provide new insight into important targets. For example, assays may involve targets indirectly related to disease, but which might provide insight into the biology of relevant diseases. Other targets might be associated with rare and neglected diseases, an area of increasing focus for the NIH (http://www.nih.gov/news/health/may2009/nhgri-20.htm ). One important criterion for this initiative is novelty, so the proposed assays should avoid focus on areas and approaches that have been extensively targeted in other settings. Assays should be relevant to the scope of the research for at least one of the sponsoring NIH Institutes (see below for Institute specific interests), focusing on specific diseases or on relevant basic physiology, cell biology, or developmental processes.
Scientific knowledge to be achieved
through research supported by the special program: This FOA seeks
to apply new knowledge and screening technologies to assays developed around
novel pathways. New understandings of novel and/or understudied targets will
contribute to translation of new discoveries into useful tools for basic and
clinical research, leading to the development of potential pre-therapeutic
leads.
Objectives of this Research Program: The objective of this FOA is
to establish a stream of scientifically and technologically outstanding assays
that can be automated for HTS at an NIH-funded (or other) facility and used for
further studies that lead to interesting and important new biology. Proposed
work should include assay development plans sufficient to demonstrate
reproducibility in a low-to-moderate throughput setting and should be feasible
for adaptation to an automated, high-throughput screening approach.
Demonstration of feasibility for HTS must include:
Types of research and experimental
approaches that are being sought to achieve the objectives:
Many of the in vitro biological and disease models currently used to study the
effects of specific compounds or molecular perturbations can be adapted to HTS
formats. Relevant topics include but are not limited to:
There are a number of characteristics that make an assay suitable for HTS approaches. The assay must be robust, reproducible, and have a simple readout that is amenable to automated analysis. This FOA begins with plans sufficient to demonstrate reproducibility in a low-to-moderate throughput setting and should be feasible for adaptation to an automated, high-throughput screening approach. Importantly, assays must be possible to miniaturize the assay to at least a 96- or 384-well format and ideally to a 1536-well format. A broad range of models share these features, including molecular and biochemical assays, cellular models, cell based assays, and simple model organisms.
There must also be a clear plan for evaluating the significance of the hits obtained in a primary high-throughput screen. This plan should be feasible for the evaluation of multiple hit compounds that may be identified in a primary HTS effort. The plan should also include the requisite secondary screens to rule out artifacts and appropriate counter screens in order to prioritize compounds for further testing.
The overall goals for the use of the assay in an HTS effort should be well defined and clearly presented. This discussion should include the expected use of the compounds in the context of a larger research program. Applications that propose interaction with existing research consortia funded by one of the sponsoring NIH Institutes are encouraged (see below for Institute-specific interests).
Although desirable, experiments proposed in response to this FOA need not initially include the use of assays in high-throughput screens or even the final stages of miniaturization for HTS. Rather, the emphasis can be on designing and validating creative approaches to assaying biological and disease processes that can potentially be used for chemical genetics and drug discovery. Assays developed under this FOA will be eligible for consideration by the NIH Molecular Library screening centers either through direct collaborations or via a Fast Track access program (http://grants.nih.gov/grants/guide/notice-files/NOT-RM-09-011.html), one of several routes through which access may be gained to the MLPCN, although funding under this FOA does not constitute a commitment by NIH to screen the assay at a center or an obligation on the part of funded investigators to apply for consideration by the centers. An additional benefit obtained from collaboration with the MLPCN is access to the Small Molecule Repository of diverse small molecule compounds for use in HT screening (http://mli.nih.gov/mli/compound-repository).
It is anticipated that assays developed through this initiative will be submitted to HTS facilities, although funding for the other than pilot screening is outside the scope of this initiative. Researchers are expected to use the results from HTS as the basis for seeking additional funding from appropriate entities for lead compound development. Projects funded through this initiative will be encouraged to interact with and deposit screening data in the PubChem resource of NCBI (http://pubchem.ncbi.nlm.nih.gov).
Institute Interests
NIDDK: The NIDDK is particularly interested in proposed assays that are relevant to the mission of NIDDK, which includes obesity, diabetes, diabetic complications, endocrine disease, liver and digestive diseases, kidney and urological diseases, hematology, and inborn errors of metabolism. Alternatively, applications may focus on NIDDK-relevant basic physiology, such as glucose and lipid homeostasis, cell biology, or developmental processes. Finally, applications may propose interaction with NIDDK-funded existing research consortia, such as the Beta Cell Biology Consortium (http://www.betacell.org), the Nuclear Receptor Signaling Atlas (www.nursa.org), the Animal Models of Diabetic Complications Consortium (http://www.amdcc.org), or the Mouse Metabolic Phenotyping Centers (www.mmpc.org).
NIA: NIA is interested in assays that are relevant to diseases and conditions involved in normal aging in a variety of tissues. Examples include Alzheimer’s disease and other dementias of aging, osteoporosis, sarcopenia and other age related changes that occur during the human lifespan. NIA is particularly interested in assays that will stimulate the discovery of small molecular probes that will be useful in identifying new therapeutic targets and, novel therapeutic and imaging agents.
NCI: Assays pertinent to the mission of NCI should be justified in the application as relevant to cancer. The NCI is interested in development of assays to identify or evaluate small molecules for use in elucidating molecular, cellular, or in vivo mechanisms or processes of probable or known importance to cancer biology, and for use in developing strategies for cancer prevention, diagnosis, treatment or clinical monitoring of treatment. Assays proposed may be biochemical, cellular or model organism-based, and may be useful for discovering small molecule probes, preventive or therapeutic drug leads, or imaging agent leads. Applicants may find the NCI Developmental Therapeutics Program (http://dtp.nci.nih.gov) resources to be helpful. Collaborations between laboratories with screen development capabilities and laboratories with small molecule synthesis capabilities are encouraged.
NHLBI: The NHLBI would like to stimulate the development of assays that are pertinent to its mission to advance understanding and treatment of heart, lung, and blood diseases. Assays can focus on diagnosis, prognosis, treatment, or biological processes relevant to heart, lung, or blood diseases. Applicants may propose to develop biochemical, cellular, or model organism-based assays. Applicants are also encouraged to align their assay development with NHLBI’s on-going translational research programs, clinical trial networks, and community resource programs (http://www.nhlbi.nih.gov/resources/index.htm).
NIAAA: NIAAA is interested in applications proposing to develop
high-throughput screen (HTS) assays for novel clinically-relevant targets with
the goal of transforming target discovery into therapeutic treatment of alcohol
dependence, as well as development of ligands to be used as tools for
investigation biological processes contributing to compulsive drinking. Aspects
of alcohol consumption and alcohol-seeking are modulated through the actions of
neurotransmitter receptors and transporters, ion channels, neuromodulators,
hormones, and intracellular signaling networks. Thus, there are a number of
potential target sites for which new pharmaceutical agents may be developed,
such as effectors of opioid, serotonin, dopamine, glutamate, GABA, cannabinoid,
and adenosine receptors, modulators of neuropeptide systems (e.g., NPY, CRF,
substance P, orexin), agents that alter signal transduction pathways (such as
protein kinase effectors, protein phosphatase inhibitors, G-protein regulators
and calcium signaling disruptors), and modulators of neuroimmune and
neuroinflammatory pathways.
NIAID: NIAID is particularly interested in applications directly addressing infectious or immune-mediated disease or basic immunology. Applications may focus on assays targeting etiologic agents of human infectious disease including, but not limited to, potential ages of biodefense (categories A, B, and C), as well as other newly emerging infectious agents. Pathogens with abnormally high global burdens of disease such as HIV, tuberculosis, and malaria, as well as toxins or arthropod vectors of infectious agents as targets will also be included. Additionally, proposals may focus on augmenting immune responses towards infectious agents, including early innate immune responses and the induction or prolongation of immunological memory to vaccination. Also of prime interest is the prevention, amelioration, or reversal of immune-mediated diseases by small molecules. Targets relevant to asthma, allergy, inflammatory diseases, transplant rejection, and all types of autoimmune diseases may be proposed. Assays that facilitate studies on basic immunological mechanisms are also appropriate.
NIDA solicits applications to develop ligand assays relevant to the understanding and treatment of drug addiction to opiates, methamphetamines, cocaine, heroin, tobacco, marijuana, and other psychoactive substances. The initial targets for most drugs of abuse are known and have been shown to be predominantly either G-protein coupled receptors, such as the dopamine receptor, an indirect site of action for cocaine and amphetamine, or ligand gated ion channels, such as the nicotinic cholinergic receptors (nAChRs), a target for nicotine. Drug addiction also involves activation of intracellular signaling proteins that can affect the response to drugs of abuse, and there is clear evidence for the involvement of numerous, specific neurotransmitter systems in addiction. Genetic polymorphisms are likely to lead to variation in the biological activity in many of these protein targets, which may be relevant to individual variability in response to drugs of abuse and, ultimately, to vulnerability to addiction. High throughput screening assays may include, but are not limited to: small molecule modulators of various known and orphan membrane GPRCs, small molecule and peptide ligands which modulate GPCR-interacting proteins, such as arrestins, and regulators of G protein signaling, small molecule modifiers of various channels, pores, and transporters, modifiers of histone, modifiers of endolipids or their metabolizing enzymes, and probes of chromatin remodeling complexes. Assays of additional interest are those identifying ligands targeting signaling pathways, synaptic transmission, cognition, learning, and memory.
NIGMS: NIGMS welcomes assays that are relevant to the Institute's mission: basic scientific research that increases understanding of life processes and lays the foundation for more applied advances in disease diagnosis, treatment, and prevention. NIGMS-funded researchers seek to answer important scientific questions in fields such as cell biology, biophysics, genetics, developmental biology, pharmacology, physiology, biological chemistry, bioinformatics, computational biology, selected aspects of the behavioral sciences, and specific cross-cutting clinical areas that affect multiple organ systems.
NIMH: The NIMH is especially interested in applications to develop high-throughput screen (HTS) assays for novel clinically relevant targets with the goal of transforming target discovery into therapeutic treatment of mental disorders such as depressive disorder, bipolar disorder, schizophrenia, anxiety disorders, panic disorder, and autism, etc. Proposed projects should be relevant to NIMHs mission of supporting basic science discoveries and translating these discoveries into new therapeutic interventions that will relieve the suffering of people with mental disorders. Applications should particularly focus on assay development using new targets emerging from genetic and proteomic research in model systems and in human diseases. Applications to discover molecular tools or probes for elucidating the basic genetic, molecular, and cellular mechanisms underlying the action of neuropsychopharmacological agents in vitro and in vivo are also appropriate. In order to identify small molecules that either perturb the system or yield molecular information, the proposal should use biological systems and measurements that are suitable for automated HTS. Targets of emphasis may include, but not limited to: 1) target-based biochemical assays and receptor-ligand binding assays such as those for enzymes, CNS receptor, G-protein coupled receptors (GPCRs), orphan GPCRs, ion channels, transporters, nuclear receptors; 2) cell-based assays could include functional assays, reporter gene assays and phenotypic assays for cellular processes and pathway analysis; and 3) non-traditional targets of interest include transcription factors, nucleic acids, multimeric proteins, membrane proteins, and polymorphic gene products; and subcellular processes such as molecular trafficking and translocation, post-transcriptional editing or splicing of gene products, and protein or RNA stabilization. Finally, NIMH encourages cross-disciplinary collaboration among NIMH-funded existing research, such as Psychopharmacology, Neuropharmacology, Molecular Pharmacology Research, and Genetic Basis of Mental Disorders Programs (http://www.nimh.nih.gov/about/organization/dnbbs/index.shtml).
See Section VIII, Other Information - Required Federal
Citations, for policies related to this
announcement.
Section
II. Award Information
1. Mechanism of Support
This
FOA will use the NIH Research Project Grant (R01) 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). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component.
U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.
2.
Funds Available
A range of budgets may be possible for the work proposed in this FOA. Due
to the focused scope of this FOA a period of support of up to three years will
be allowed.
Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the IC(s) provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
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:
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://grants.nih.gov/grants/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 that each application is scientifically distinct.
Resubmissions. Applicants may
submit a resubmission application, but such application must include an
Introduction addressing the previous peer review critique (Summary
Statement). Beginning with applications
intended for the January 25, 2009 official submission due date, all original
new applications (i.e., never submitted) and competing renewal applications are
permitted only a single amendment (A1). See new NIH policy on
resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing
renewal applications that were submitted prior to January 25, 2009 are
permitted two amendments (A1 and A2). For these grandfathered
applications, NIH expects that any A2 will be submitted no later than January
7, 2011, and NIH will not accept A2 applications after that date.
Renewals. Applicants may submit a renewal application.
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 PD(s)/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 301-710-0267, Email: [email protected].
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 for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).
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 required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. 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 Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget,
as appropriate (See Section IV.6. regarding
appropriate required budget component.)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign
Organizations (Non-domestic [non-U.S.] Entities)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/polic`y/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from Foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.
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 on 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.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled 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: September 5, 2010 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): Not Applicable.
Application Due Date(s): Standard dates apply, please
see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s):
Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.A.1. Letter of Intent
A letter of intent is not required for this 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 Center for Scientific Review, NIH. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the 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 their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
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.
PHS398 Research Plan Component Sections
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Budget Component
U.S. applicants submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.
U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.
Specific Instructions for Applications Requesting $500,000 (direct
costs) or More per Year
Applicants requesting
$500,000 or more in direct costs for any year (excluding consortium F&A
costs) must carry out the following steps:
1) Contact the IC program staff at least 6 weeks
before submitting the application, i.e., as plans are being developed for the
study;
2) Obtain agreement
from the IC staff that the IC will accept the application for consideration for
award; and,
3) Include a cover letter with the application that
identifies the staff member and IC who agreed to accept assignment of the
application.
This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004.
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).
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.
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, investigators 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 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/.)
Results from primary screens of assays developed through this initiative will be expected to be released to PubChem (http://pubchem.ncbi.nlm.nih.gov/) within two weeks of validation.
Foreign Applications (Non-domestic [non-U.S.] Entities)
Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States
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
Applications
submitted for this funding opportunity will be assigned on the basis of
established PHS referral guidelines to the ICs for funding consideration.
Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) 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 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.
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 scored 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, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, 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
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, 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?
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.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Applications from Foreign Organizations. As applicable for the FOA or submitted application, reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
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 funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
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.
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.
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
When multiple
years are involved, 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.
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.
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):
Ronald Margolis, Ph.D.
Division of
Diabetes, Endocrinology, and Metabolic Diseases
National
Institute of Diabetes and Digestive and
Kidney Diseases
6707
Democracy Boulevard, Room 693
Bethesda,
MD 20892-5460
Telephone:
(301) 594-8819
Fax: 301-435-6047
Email: [email protected]
Robert G. Lees, Ph.D.
Program Director
Grants and Contracts Operations Branch
Developmental Therapeutics Program
National Cancer Institute, NIH
6130 Executive Boulevard, Room 3024
Bethesda, MD 20892-7456
(For express delivery: Rockville, MD 20852)
Telephone: 301-496-8783
Fax: 301-402-5200
Email: [email protected]
Lorenzo Refolo, PhD
Program Director
Division of Neuroscience
National Institute on Aging
Gateway Building, Suite 350
7201 Wisconsin Avenue
Bethesda, MD 20892 (20814 for Express Mail)
Telephone: 301-594-7754
Fax: 301-496-1494
Email: [email protected]
Pankaj
Qasba, Ph.D.
Program Director
Blood Diseases Branch
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute, NIH
6701 Rockledge Drive, MSC 7950
Bethesda, MD 20892-7950
Telephone: 301-435-0050
Fax: 301-480-0867
E-mail: [email protected]
Mark Egli, Ph.D.
Division of Neuroscience and Behavior
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane
Room 2059 MSC 9304
Bethesda, MD 20892-9304
Federal Express: Rockville, MD 20852-1705
Telephone: 301-594-6382
Fax: 301-443-1650
Email: [email protected]
Martin John Rogers, Ph.D.
Program Officer,
Preclinical Parasite Drug Development Parasitology
and International Programs Branch Division of Microbiology and Infectious
Diseases
National Institute of Allergy and Infectious Diseases
6610 Rockledge Drive, Room 3124
Bethesda, MD 20892-6604 [for express mail use Bethesda, MD 20817]
Telephone: 301-402-8304
Fax: 301-402-0659
Email: [email protected]
Paul Hillery, Ph.D.
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4265
Bethesda, MD 20892-9555
Phone: 301-435-1306
Email: [email protected]
John M. Schwab, PhD
Program Director
Division of Pharmacology, Physiology,and Biological
Chemistry
National Institute of General Medical Sciences
National Institutes of Health
Bldg 45, Room 2As.43A
45 Center Drive
Bethesda, MD 20892
Telephone: 301-594-3827
Fax: 301-480-2802
Email: [email protected]
Ingrid Li, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7192
Bethesda, MD 20892-9641
Telephone: (301) 443-1421
Fax: (301) 402-4740
Email: [email protected]
2. Peer Review Contact(s):
Not Applicable
3. Financial/Grants Management Contact(s):
Todd Le
Grants
Management Branch
National
Institutes of Diabetes and Digestive and Kidney
Diseases
6707
Democracy Boulevard, Room 726
Bethesda,
MD 20892-5456
Phone:
301-594-7794
Fax:
301-594-9523
Email: [email protected]
Shane
Woodward
Branch Chief
Grants Management Portfolio Branch B
Office of Grants Administration
National Cancer Institute
6120 Executive Plaza South, Suite 243
Bethesda, MD 20852
Phone: 301-496-8791
Fax: 301-496-8601
[email protected]
Ms.
Shelia Ortiz
Office of Grants Management
Division of Extramural Research Activities
National Heart, Lung and Blood Institute
6701 Rockledge Drive, MSC 7926
Rockledge II, Room 7171
Bethesda, MD 20892
Phone: 301-435-0166
Email: [email protected]
Judy
Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room3023
Rockville, MD 20852
Phone: (301) 443-4707
Fax: (301) 443-6077
Email: [email protected]
Ryan
Blakeney
Grants Management Branch
National Institute on Aging
7201 Wisconsin Avenue
Gateway Bldg Suite 350, MSC 9205
Bethesda, MD 20892
Phone: 301-451-9802
Fax: 301-402-3672
Email: [email protected]
Ann
White Devine
Chief, Branch C
Grants Management Program
National Institutes of Allergy and Infectious Diseases
Phone: 301-402-5601
Email: [email protected]
Pamela
Fleming
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4000
Bethesda, MD 20892-9560
Phone: 301-253-8729
Fax: 301-594-6849
E-mail: [email protected]
Lisa
Moeller
Team Leader, GAB/PPBC
National Institute of General Medical Sciences
Division of Extramural Activities
45 Center Drive, Room 2AN50B
Bethesda, MD 20892-6200
Phone: 301-594-3914
Fax: 301-480-2554
E-mail: [email protected]
Rebecca
D. Claycamp, MS, CRA
Chief Grants Management Officer
National Institute of Mental Health
6001 Executive Boulevard, Room 6122
Bethesda, MD 20892-9605
Phone: 301-443-2811
Fax: 301-443-6885
E-mail: [email protected]
Section VIII. Other Information
Required Federal Citations
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 Policy 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 the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 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/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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