text:
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of
Participating Organizations
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov) (No longer participating per NOT-NS-12-002)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Eye Institute (NEI), (http://www.nei.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http:www.niaaa.nih.gov)
Title: Optimization of Small Molecule Probes for the Nervous System (R21)
This Funding Opportunity Announcement (FOA) is a reissue of RFA-NS-09-003.
Announcement (PA) Number: PAR-09-251
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.
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)
93.853, 93.279, 93.866, 93.242, 93.867, 93.273
Key Dates
Release/Posted Date: August 13, 2009
Opening Date: September 16, 2009 (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, 2012
Dates for E.O. 12372
Not Applicable
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
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
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 funding opportunity is to facilitate the development of small molecule probes that will add a pharmacological dimension to basic neuroscience work, and enable proof-of-principle studies linking nervous system therapeutic targets, mechanisms or phenotypes to disease onset or progression.
NIH has made a significant commitment to probe development via Institute-specific and Blueprint for Neuroscience (http://neuroscienceblueprint.nih.gov/) support, and via Roadmap Programs associated with the Molecular Libraries Initiative (http://nihroadmap.nih.gov/molecularlibraries/). For example, Molecular Libraries Programs fund the development of novel in vitro screening assays (see: https://grants.nih.gov/grants/guide/pa-files/PAR-08-024.html). These assays can then be used to identify small molecule interactors (hits) in automated, high-throughput screening (HTS) of large, small molecule collections such as the Molecular Libraries Small Molecule Repository (http://mlsmr.glpg.com). These screening projects are performed in centers belonging to the Molecular Libraries Probe Production Centers Network (http://www.mli.nih.gov), as well as in a variety of screening centers established in recent years to address the need to develop small molecule probes as aids to hypothesis-driven research investigation, as imaging agents, and as therapeutic leads. This effort by the scientific community to automate and screen novel assays against small molecule diversity collections has created a large portfolio of neuroscience-related small molecule probe development projects. This FOA will provide a bridging step between these medium and high-throughput automated screening efforts to find small molecule interactors, and the insertion of optimized probes derived from these compounds into pharmacological studies aimed at gaining a better understanding of nervous system function, and dysfunction leading to disease states.
Successful compound screening efforts to identify small molecules typically progress to early chemistry optimization work (the generation of analogues) in order to identify features of these template molecules that contribute to the useful attributes needed in a small molecule probe, such as affinity and selectivity for a target. At the completion of this step of early structure-activity-relationship (SAR) studies investigators will have employed distinct small molecule hits that interact with their biological target to generate and test some small molecule analogues, with the aim of identifying structural features of the hit that are important to its activity. As a result, plans can be proposed for further chemical synthesis to create advanced analogues in which the biological attributes needed in a useful probe are improved. In vitro screening assays available in the principal investigators laboratory that have been miniaturized and optimized could be used to support a medium-throughput screening effort aimed at rapidly characterizing the properties of these compounds.
Many probe development projects that have succeeded in identifying chemicals possessing the basic attributes of the small molecule probe(s) they are seeking will require a continued biological screening and chemistry effort over 1-2 years to optimize these molecules so that useful probes are the end result. This FOA will provide the resources that allow an investigator to successfully identify the small molecule probe (and/or lead compound series) that is the goal of their assay development, screening, and SAR study effort. The Program specifically funds completion of the small molecule probe development when additional time and resources are needed, aims to facilitate the formation of biology and medicinal chemistry partnerships to achieve this, and encourages the use of efficient cheminformatic strategies for compound acquisition and semi-custom synthesis. At the end of the project the investigator should be able to insert these pharmacological tools into ongoing research programs as investigative tools and pharmacological imaging agents. An emphasis will be placed on the funding of small molecule probe development projects that are focused on novel nervous system targets and mechanisms for which small molecule probes and therapeutic leads are not currently available, or, projects where the currently available compounds are not optimal for the proposed use.
Proposals should include both a biological and chemical component. The biological component should include a plan of in vitro and, when appropriate, limited in vivo assays, each capable of measuring the activity of a test compound towards an attribute that the hit compound proposed as a starting point for modification possesses, and that needs to be further enhanced or eliminated by redesign of the hit. Examples of possible biological test activities are listed below. Proposals are expected to provide a description of the final small molecule probe that is the target of design, including a detailed description of needed attributes such as affinity, activity and/or selectivity, and a description of how this will be measured (for example: the use of measures of affinity or activity such as Ki or IC50 and/or fold-selectivity comparing two target affinity or activity values). The chemistry component should include a description of the hit scaffold molecules that will be the starting point of design, as well as information about known structure-activity relationships for these hits and the needed values for key compound attributes. A plan for the design of analogues of these small molecule hits should be provided that includes a description of the strategy and approach for optimizing molecules, and decision-making criteria for continuing, or stopping, work on a compound series. An appropriate biological component of a project that could be candidate for the Program might address (but is not limited to) the following topic areas in neurobiology, and would be expected to fit within the interests of the participating NIH Institutes:
The in vitro testing methodologies proposed would be expected to have already been developed, characterized and implemented in a medium or high-throughput screening (HTS) program in which hit compounds to the proposed target were identified and characterized. Investigators can refer to the Assay Development for HTS Program announcement (https://grants.nih.gov/grants/guide/pa-files/PAR-08-024.html) for a description of performance criteria useful in developing assays that would be suitable for use in a small molecule probe optimization plan. The investigator should be capable of running these assays at a throughput that would support the proposed chemical analogue testing program. An appropriate tier of screening assays should be proposed and prioritized (both in terms of sequence and frequency) such as to provide test information (eg; IC50, Ki) about chemical analogues for the different attributes to be encompassed in the probe design. It is generally expected that project proposals will have the ability to test 20-40 compounds every two months. A further, small molecule probe confirmation assay can be proposed as a final validation step to demonstrate its utility in the system in which it will be used.
The proposed medicinal chemistry design for the Program would be expected to address (but is not limited to) the following components:
Small molecule probe optimization supported through the R21 mechanism will be funded with up to $150,000 in direct costs each year for a period of up to two years. Projects funded with the R21 mechanism will emphasize the development of highly innovative small molecule probes and therapeutic leads that are not currently available. Some degree of risk is acceptable, particularly if innovation is high. It is expected that preliminary data will be provided in the application demonstrating that the small molecule probe candidate(s) can be developed within the project period. In addition, experimental plans aimed at the design, acquisition and testing of chemical analogues, leading to the development of small molecule probes, must be well defined in the project proposal. Applicants may propose limited follow-up studies to assess the utility of a potential probe or advanced probe candidates in the system of interest, including in vivo models.
Applicants proposing a broader program of
discovery, development and preclinical testing of novel compounds (to include
small molecule probes developed in the current program) are directed to the
PAR-07-049 (R21) and PAR-07-048 (R01) announcements. These links are: http://grants1.nih.gov/grants/guide/pa-files/PAR-07-049.html and http://grants1.nih.gov/grants/guide/pa-files/PAR-07-048.html
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
Mechanism of Support
This FOA will use the NIH Exploratory/Developmental Research Grant (R21) 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 the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 3.4, Modular Budget Component, of the Application Guide).
All foreign applicants must complete and submit budget requests using the Research & Related Budget component.
Funds Available
The total project period for an application submitted in response to this funding opportunity may not exceed two years. Direct costs are limited to $150,000 per year. It is anticipated that the budget will be divided equally between the biology and chemistry components of the proposal.
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 Institutes and Centers (ICs) provide support for this program, there is no set-aside funding for this FOA. Awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
NIH grants policies as described in the NOT-OD-05-004, November 2, 2004.
Section III. Eligibility Information
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 https://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 grant 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 https://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or
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 will be permitted only a single amendment (A1). See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and competing renewal applications that were submitted prior to January 25, 2009 will be 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. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation) applications will not be accepted.
Section IV. Application and Submission Information
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).
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.
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.
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 SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
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@example.com.
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 (MS Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, 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/PIs 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 is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following 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. Special Instructions, regarding appropriate required budget component.)
PHS398 Research & Related Budget, for Non-domestic (non-U.S.) Entities (Foreign Organizations) only
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
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: https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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.
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 13 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, a new 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 3.4 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
3.A. Submission, Review, and Anticipated Start Dates
Opening Date:September 16, 2009 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): Standard dates apply, please see https://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 the funding opportunity.
3.B. Submitting an Application Electronically to the
To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
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.
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.
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.
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 award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.
6. Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI 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. 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 Registration FAQs Important Tips -- Electronic Submission of Grant Applications.
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.
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
PHS398 Research Plan Component Sections
All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, incorporating "Just-in-Time" information concepts, and with the following requirements for R21 applications:
Appendix Materials
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See https://grants.nih.gov/grants/funding/424/index.htm). Also see https://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.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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)
(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which 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 (NOT-OD-07-088) and https://grants.nih.gov/grants/gwas/.
Publication of the results of the small molecule probe development and submission to the NIH PubChem database (http://pubchem.ncbi.nlm.nih.gov/) is an expectation of the award and is highly encouraged.
Foreign Applications (Non-domestic (non-U.S.) Entity)
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
Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established Public Health Service (PHS) referral guidelines.
Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by CSR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the initial merit review, all applications will:
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:
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 core review criteria, and additional review criteria (as applicable for the project proposed).
Core 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? Are there important and well-defined goals for the use of active compounds that are identified in pharmacological studies?
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?
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? Is the molecular target or mechanism proposed for small molecule probe development highly novel? Are small molecule probes currently available that fit the needs of the pharmacological studies in which the small molecule probe will be used at the end of the project period?
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?
Does the Leadership Plan ensure that there will be sufficient coordination and communication among the PDs/PIs? Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts?
Are the attributes of the small molecule probe that is the goal of the effort well defined? Does the chemical design plan for modifying proposed hit structure(s) fit the scope of resources and time that are allocated to the project, and present a reasonable prioritization of approaches? Is there an adequate plan for evaluating the activities of the compounds? Is preliminary data provided in the application demonstrating that small molecule probe candidate(s) can be developed within the project period? Are experimental plans aimed at the design, acquisition and testing of chemical analogues, and leading to the development of small molecule probes, well defined in the project proposal? Does the application address the required scope of activities (described in Section II.I.1 Research Objectives)?
If the project involves clinical research, are the plans for 1) Protections for Human Subjects, 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 CriteriaAs 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.
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.
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.
Additional Review ConsiderationsAs applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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).
Applications from Foreign Organizations. 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.
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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Anticipated Announcement and Award Dates
Not Applicable
Section VI. Award Administration Information
Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his/her Summary Statement (written critique) via the NIH eRA Commons.
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
In some instances, intellectual property considerations will be an important component in order for participants to attain full commercialization as a desired eventual outcome for successful compounds developed under this program. Regarding intellectual property issues, it is expected that the sponsoring institution will have responsibility for compliance with applicable U.S. patent law and NIH policy; including preparation of invention reports, determination of inventorship, and/or filing of patent applications regarding developed compounds, the process of synthesizing or the method of use of compounds designed and tested in the course of the proposed studies. It is important that all parties, including any medicinal chemists participating in the compound design, be given adequate consideration in inventorship determination.
For intellectual property-specific NIH Guidelines see: https://grants.nih.gov/grants/intell-property.htm.
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.
When multiple years are involved, awardees will be required to submit the Non-Competing 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.
A report to the NIH will be required every 6 months describing the progress of the small molecule probe optimization, changes made in the direction of the project, and planning of any invention statement, patent application or publication of data resulting from the work.
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:
Scientific/Research Contacts:
Rebecca Farkas, PhD
Office of Translational Research
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard
Neuroscience Center/Room 2109
Bethesda, MD 20892
Telephone: (301) 496-1779
Fax: 301-402-1501
Email: email@example.com
Hari Singh, Ph.D.
Program Director
Chemistry & Physiological Systems Research Branch
Division of Basic Neuroscience & Behavioral Research
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd, Rm. 4261 (MSC 9555)
Bethesda, MD 20892-9555
Telephone: (301) 435-1310
Fax: (301) 594-6043
Email: firstname.lastname@example.com
Suzanna Petanceska, Ph.D.
Division of Neuroscience
National Institute of Aging
National Institutes of Health
Gateway Building, Suite 350
7201 Wisconsin Avenue
Bethesda, MD 20892
Telephone: (301) 594-7754
Fax: (301) 496-1494
Email: email@example.com
Jamie Driscoll
Molecular, Cellular, and Genomic Neuroscience Research
National Institute of Mental Health
National Institutes of Health
6001 Executive Blvd, Rm. 7184 (MSC 9641)
Bethesda, MD 20892-9641
Telephone: (301) 443-5288
Fax: (301) 401-4740
Email: firstname.lastname@example.com
Jerry Wujek, Ph.D.
Resource Resources Officer
National Eye Institute
National Institutes of Health
5635 Fishers Lane, Rm. 1300
Rockville, MD 20852
Tel: (301) 451-2020
Fax: (301) 402-0528
Email: email@example.com
Mark Egli, Ph.D.
Division of Neuroscience and Behavior
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane, Rm. 2059 (MSC 9304)
Bethesda, MD 20892-9304
Tel: (301) 594-6382
Fax: (301) 443-1650
Email: email@example.com
2. Peer Review Contacts:
Not Applicable
Financial or Grants Management Contacts:
Tiajuana Decoster
Chief, Grants Management Branch
National Institute of Neurological Disorders and Stroke
National Institutes of Health
6001 Executive Blvd, Suite 3290 (MSC 9537)
Bethesda, MD 20892-9537
Branch Telephone Number: (301) 496-9231
Fax Number: (301) 402-0219
Email: email@example.com
Christine Kidd
Grants Management Specialist
Grants Management Branch
National Institute on Drug Abuse
National Institutes of Health
6101 Executive Boulevard, Suite 270 (MSC 8403)
Bethesda MD 20892-8403
Telephone: (301) 435-1372
Fax: (301) 594-6849
Email: email@example.com
Ms. Linda Whipp
National Institute on Aging
Grants and Contracts Management Office
7201 Wisconsin Avenue, Suite 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
Fax: (301) 402-3672
Email: firstname.lastname@example.com
Claycamp, M.S., CRA
Division of Extramural Activities
National Institute of Mental Health
National Institutes of Health
6001 Executive Blvd, Rm. 6122 (MSC 9605)
Bethesda, MD 20892-9537
Telephone: (301) 443-2811
Email: email@example.com
Will Darby
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, Suite 1300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
Fax: (301) 496-9997
Email: firstname.lastname@example.com
Judy S. Fox
Chief, Grants Management Branch
Chief Grants Management Officer
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane, Rm. 3023 (MSC 9304)
Bethesda, MD 20892-1705
Telephone: (301) 443-4705
Fax Number: (301) 443-3891
Email: firstname.lastname@example.com
Section VIII. Other Information
Required Federal Citations
Vertebrate Animals:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (https://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
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, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 (https://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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the impact/priority score.
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 https://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 https://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 https://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, Minorities, and Children:
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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://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
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 (https://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject
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 https://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 https://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 Medicines 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 (https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
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.
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
Office of Extramural
Research (OER)
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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The British education system is neglecting the needs of severely and profoundly deaf children, many of whom have major reading difficulties, according to new research from City, University of London. This article was published on the City, University of London website here.
Reportedly one of the largest studies of its kind—funded by the Nuffield Foundation—researchers found that over half of the deaf children involved who communicated using spoken language and four fifths of those who used sign language had reading difficulties at least as severe as those faced by hearing children with dyslexia, and in some cases they were more severe.
There are almost 49,000 children with permanent hearing loss in the UK, according to the article, many of whom have reading difficulties. This is because reading is based on spoken language, which many deaf children struggle to acquire.
As hearing difficulties are often seen as the primary issue for deaf children, underlying reading difficulties can go unnoticed, and diagnosis of dyslexia is rare. In contrast, hearing children with reading difficulties are more likely to be described as dyslexic, and once diagnosed, can benefit from evidence-based specialist support and interventions.
To investigate the impact of deafness on reading, the researchers took 129 deaf children aged between 10-11 in their final year of primary school (Year 6), 79 of whom communicated using spoken language (oral deaf), while 50 used sign language (signing deaf). This is larger than samples included in other studies.
Specifically, the report found that literacy scores in both oral and signing deaf children were lower than expected for their age. Scores were also lower in the signing group compared to the oral group, with 48% of the oral group and 82% of the signing children reading below age level, although signing children with two deaf parents scored at the same level as the oral deaf group. Scores for spelling were better in both oral and signing groups, but were still below average. In both groups, language skills were particularly weak.
The researchers established that reading and dyslexia-sensitive tests developed for hearing children could be used successfully with oral deaf children, and many tests were also effective with signing deaf children. The authors suggest that interventions that address deaf children's key deficits of language and phonics could help improve their reading. However, there are currently no specific reading interventions for deaf children, and reading intervention research typically excludes deaf children. Appropriate, tailored support is urgently needed to prevent such children unnecessarily falling behind their peers.
Dr Ros Herman, reader in deafness and communication at City, University of London and a co-author of the report, said:
"Our research findings highlight the scale of reading difficulties among deaf children and the different profiles of struggling deaf readers. The fact that some children were reading at age level shows that poor reading is not an inevitable outcome.
"All the children in our study were in their last year of primary school. Many are clearly ill prepared for the challenges of secondary education and are in urgent need of support to develop their literacy. Our findings suggest that these children will benefit from the specialist literacy interventions currently offered to hearing children with dyslexia, and in addition, deaf children require ongoing support to develop the language skills that underlie literacy.
"Earlier identification of deafness and advances in hearing aids and cochlear implants have undoubtedly improved the outlook for deaf children, but as more deaf children than previously have excellent speech and now attend mainstream education, there is a danger that teachers may overlook their need for support.
"More research is essential to identify effective reading interventions that address these issues so that teachers can provide the vital support needed to prevent deaf children from unnecessarily falling behind their peers."
Read the full report – "Reading and Dyslexia in Deaf Children."
Source: City, University of London


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versão On-line ISSN 2223-6279
versão impressa ISSN 0379-8577
Curationis vol.35 no.1 Pretoria Jan. 2012
The status of academic integrity amongst nursing students at a nursing education institution in the Western Cape
Cecilia J. Theart; Ilze Smit
Faculty of Health Sciences, Stellenbosch University, South Africa
Honesty is regarded as a basic ethical value in all educational programmes, and academic integrity is of undisputed importance in educational environments. The literature reviewed revealed that academic dishonesty is wide-ranging and also encountered in the nursing education environment. This phenomenon is of concern to the nursing fraternity because of the proven positive correlation between unethical academic practices and future unethical professional behaviour. Limited research data regarding academic dishonesty at nursing education institutions in South Africa and this correlation motivated the present study. The purpose was to examine the status of academic integrity amongst nursing students at a nursing education institution in the Western Cape. Formulated objectives guided investigation of several variables which impact upon academic integrity, for example the incidence of and student perceptions around academic dishonesty.
A quantitative, descriptive survey design was used, with a self-reported questionnaire (based on literature review and study objectives) designed to obtain information about academic dishonesty. Provision was also made for qualitative input from the respondents by including three open-ended questions.
It was found that academic dishonesty was a reality at the nursing education institution where this study was done. Cheating associated with plagiarism and assignments was identified as the main problem area. An unacceptably high level of dishonesty in completion of practical records was also an area of concern. The main recommendations are development and implementation of a code of honour and implementation of comprehensive academic integrity policies at the nursing education institution, with practical measures aimed at combating cheating in tests and examinations.
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Cecilia Theart
PO Box 562, Bellville 7535, South Africa
Email: firstname.lastname@example.com
Received: 28 July 2011
Accepted: 12 Dec. 2011
Published: 20 June 2012


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Quebec is a beautiful, curious little book made by an anonymous photographer. The photographs in the 48 page book document the Canadian province, however the book isn't accompanied by any text to lend specificity to the locations of the photographs. Paging through the small book is an intimate experience, guided by the nameless photographer there is a personal nature to these solitary, snow-covered images. This poetic look at winter in Quebec is carefully handmade by the photographer.
photo-eye Blog was fortunate enough to have a contributor (who, under the circumstances, decided to remain nameless as well) discuss this work with the anonymous author and maker of Quebec.
photo-eye: What reasons did you have for wanting to make this work anonymous?
Anonymous: Let me start by talking about one of the inspirations for the work, which was W.G. Sebald's book The Emigrants. He's a German author, he died recently - he lived most of his working life in England but he wrote in German - I read it in translation. The first book of his that I read and was really influenced by was this book of his called The Emigrants. It's a collection of loosely connected stories about emigrants from Nazi Germany. The book is strewn with these strange, haunting black and white photographs, and some of them look like accidental photographs, some of them are like formal photographs, banal photographs. The photographs are sort of loosely connected to the stories, and you flip through the book to find out more about the photographs, like - where did they come from? Did Sebald take them himself or did he just find them? And there's absolutely no way of finding out anything more about the photographs. And that has a strange haunting effect. So when I made Quebec anonymous I sort of wanted to create an effect like that. I subtitled the work 'image anonyme' in French, and the intention there was to make the typical English speaking viewer stop and think about the phrase a little bit. If you just said 'anonymous images,' people would immediately file it away saying, "Ah OK, it's an anonymous work, we don't know the name of the photographer, etc." But there's another way of thinking about the phrase, which is, the images themselves are anonymous, the images are nameless, I have given absolute freedom to the viewer to exercise their imagination on them. So, I mean, these were some of the things that were behind making it anonymous.
PE: The images are all located in Quebec, but you don't point out the particulars of each image. Was that also part of trying to engage the viewer's imagination?
A: Exactly, that's definitely one big idea there -- to set the viewer's imagination free. But then there's something else going on there. Frankly, especially with a few of the images, I was really conflicted. I really wanted to tell the story of the photograph - like the story of the icebreaking ferry, and how that icebreaking ferry fits in to this entire story of Quebec -- what Quebec is in my imagination. But at the same time it's what Quebec is in my imagination, if I were to talk about the ferry, why don't I talk about all the other things that constitute my Quebec? The Catholicism of Quebec, the French speaking thing about Quebec, all these remote hydro-electric plants that they have and these remote logging camps in Quebec and all these things. When I am working in Quebec they work at the back of my mind and they give flavor to the work, but all those elements are not necessarily explicit in the work itself. So to label that image 'icebreaking ferry' would be to sort of, you know, abruptly cut up the story, which is kind of meaningless to me. If you have to tell the story, tell the entire story, or let the reader go where he will.
PE: As you were making the images did you have to make multiple trips to Quebec?
A: Oh yeah, I've been going there for three years now, three winters now.
PE: So as you go, are there people you make contact with who know who you are and know that you're making a photo project or do you let that anonymity play into making the photographs, too?
A: I don't make contact with too many people. There's maybe a youth hostel way up in a place called Sept-Iles where I talked with the woman who runs the hostel, but otherwise, you know, I don't really have that much human contact. It would probably even change my interaction with the place if I had a lot of contact with the people there.
PE: I'd like to ask you a little more about the book itself. One of the things that actually drew me to it is that I like smaller prints and smaller books. What made you decide to print the book this way?
A: Well, one of the things is probably this advent of digital printing. Everybody wants to print big and impress with the size and everything. You know this painter who was played by Max von Sydow in Woody Allen's Hannah and Her Sisters? He's approached by this rock star who's come into money and he wants to buy something big and colorful - and the painter's very, very unhappy and storms out saying "I don't sell my paintings by the yard." So, I don't want to impress by the yard, I want to draw the viewer in. Force them to pay close attention and even the smallness of the size also goes with this small range of tones in the images themselves so they're kind of both designed to produce a more intense, more intimate experience.
PE: Yeah, I think that's definitely effective. Are any of these images a series outside of the book or do you think having it in this book form is critical?
A: Well, the book form has a certain rhythm to it -- you proceed from one image to the next. But what I print as a book is not necessarily the set I print as single images. There are some of my favorite images that are not in the book because they don't fit in the rhythm of the book. I definitely make stand-alone single prints. They're a little bigger, but that's mostly just to take into account the greater viewing distance that you have with it on the wall than with the book, but the general mood is the same.
PE: So at some point do you think there'll be an anonymous showing of these images as well as other images from this Quebec series?
A: Ah, well, that's not entirely in my control, right? But definitely if the opportunity presents itself, definitely.
PE: You chose to print and bind the book yourself, is this something you think you'll continue to do with other work?
PE: Excellent. It's a very fun book to hold and read through and it does feel very personal in that way, I think because of the handmade attention. Are you working on another series like the Quebec series or are you planning one?
A: Firstly, I think the Quebec series - I don't think the series is done yet. This was the third year I went there and this year I went in one direction as far as the road would take me. And I turned around there. But there is a boat that goes beyond that because there are still villages, and the only way they can be supplied is by boat. The boat runs I think ten months of the year or nine months of the year, so one of the things I want to do next year is take one of the last boats of winter. It runs mid January before it all freezes in and it stops at various small villages and again comes back. One of the things I would like to do is go with that boat and come back with that boat. And other than that I discovered other things about the place -- there are other extensions of the world that I have seen. This winter was an unusually warm winter so what I managed to see was what happens in a simulated way -- what happens just before winter sets in or what happens when winter is just leaving. There's kind of a funny in between season where there are patches of snow, patches of grass, patches of mud - and so this in between season has this particular feeling. That would be another extension of the world. So these are the other kind of ideas I'm working on.
PE: Do you think all black & white still? Or some color?
A: No, I think they will be black & white. It just fits the mood. Color would just be too distracting.
See Quebec at photo-eye Bookstore.
Read Nicholas Chiarella's review of Quebec in photo-eye Magazine.