EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Eye Institute (NEI) |
|
Funding Opportunity Title |
NEI Collaborative Clinical Vision Research Project Grant (U10) |
Activity Code |
U10 Cooperative Clinical Research Cooperative Agreements |
Announcement Type |
Reissue of PAR-10-207 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PAR-14-096 |
Companion Funding Opportunity |
PAR-14-097,
(UG1) Clinical Research Cooperative Agreements - Single Project |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.867 |
Funding Opportunity Purpose |
The National Eye Institute (NEI) supports investigator-initiated clinical vision research projects, including multi-center clinical trials and other complex or high-risk clinical vision research studies. This funding opportunity announcement encourages applications for the Collaborative Clinical Research Project Grant, which provides the following Components: Overall, Coordinating Center, Chair Admin, Enrollment Center and optional Resource Centers. |
Posted Date |
February 12, 2014 |
Open Date (Earliest Submission Date) |
April 25, 2014 |
Letter of Intent Due Date(s) |
Not Applicable |
Application Due Date(s) |
Standard dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
AIDS Application Due Date(s) |
Standard AIDS dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
Scientific Merit Review |
Standard dates applyOf the two choices, keep only the applicable one. |
Advisory Council Review |
Standard dates apply |
Earliest Start Date |
Standard dates apply |
Expiration Date |
New Date March 15, 2016 per issuance of NOT-EY-16-001. (Original Expiration Date: May 8, 2017) |
Due Dates for E.O. 12372 |
Not Applicable |
NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Clinical research studies are part of NEI's core strategy for improving visual health and decreasing visual impairment in populations through research on prevention, diagnosis, treatment and rehabilitation. Broad collaborative clinical research program goals in support of NEI's mission to protect and improve visual health include but are not limited to:
The intent of this funding opportunity announcement is to provide a framework for applicants seeking a Collaborative Clinical Vision Research Project (U10) Grant.
The NEI uses U10 cooperative agreement awards to support investigator-initiated large-scale clinical trials, human gene-transfer and stem cell therapy studies, and other complex or high-risk clinical vision research studies. These projects are multifaceted and of high public health significance; they require clear delineation of study organization including overall study structure and the unique functions of each component. Preclinical studies for gene transfer and stem cell therapy are not supported under the U10 mechanism.
The Collaborative Clinical Research Project Grant is a complex mechanism consisting of several Components. The Overall Component includes the rationale and significance of the study and provides details of the study's protocol(s) and study organization. The Chair Admin Component provides the clinical and technical leadership in protocol development and implementation. The Coordinating Center Component provides scientific, statistical and methodological leadership, and logistical coordination and support for the study. The Enrollment Center Component provides for the organization and operation of participating clinical centers responsible for recruitment and retention of study participants and implementation of the study protocol. The optional Resource Center Component(s) provide the expertise and infrastructure for imaging, laboratory and/or other requisite services.
Due to the complexity of these studies, applicants are strongly encouraged to consult with the Scientific/Research staff indicated in Section VII. Agency Contacts well in advance of submitting an application.
Funding Instrument |
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. |
Application Types Allowed |
New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. |
Award Budget |
Application budgets are not limited but need to reflect the actual needs of the proposed project. |
Award Project Period |
The scope of the proposed project should determine the project period. The maximum period is five years. |
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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) 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.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program
Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Component Types Available in ASSIST |
Research Strategy/Program Plan Page Limits |
Overall |
12 |
Chair Admin |
12 |
Coordinating Center |
12 |
Enrollment Center |
12 |
Resource Center |
12 |
Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.
The application should consist of the following components:
When preparing your application in ASSIST, use Component Type Overall .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Overall Component)
Complete entire form.
PHS 398 Cover Page Supplement (Overall Component)
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Research & Related Other Project Information (Overall Component)
Follow standard instructions.
Other Attachments: The following items should be included as attachments.
1) Study Protocol - the filename "Study Protocol.pdf" should be used and will be reflected in the final image bookmarking for easy access to reviewers.
Provide a detailed description of the study protocol. The description should include, but not be limited to:
2) Statistical Analysis Plan - the filename "Statistical Analysis Plan.pdf" should be used and will be reflected in the final image bookmarking for easy access to reviewers.
Provide a detailed statistical analysis plan including information on sample size justification, power estimates, interim monitoring, handling of missing data, and planned primary and secondary data analysis.
Project/Performance Site Location(s) (Overall Component)
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Research & Related Senior/Key Person Profile (Overall Component)
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
Budget (Overall Component)
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
PHS 398 Research Plan (Overall Component)
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.
Specific Aims: Specific aims should include an overview of the study, highlighting the rationale and its public health relevance and significance, and should describe the organizational structure and relevant roles and responsibilities of collaborating components.
Research Strategy: Provide a detailed description of the study including the:
A detailed description of the study protocol is required and must be included as an attachment under the section "SF424(R&R) Other Project Information".
Include a study timeline and discuss its reasonableness (i.e. the likelihood of meeting study objectives within the stated timeline). Clearly indicate the timeline for applicable activities: the completion of start-up activities; enrollment of first patient; enrollment of 25%, 50%, 75% and 100% of the projected recruitment for study subjects; completion of patient follow-up; completion of data collection; completion of primary and secondary endpoint data analyses; completion of final study manuscript; close-out of the project.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Appendix material should include a Manual of Procedures. Basic elements in the Manual of Procedures may include, but are not limited to: plans for recruitment and retention of participants; examination and testing procedures; data collection and consent form templates; data capture, management, and analytical procedures; policies governing patient protection and data integrity; administrative procedures (including regulatory approvals if necessary); collaborative arrangements, duties and responsibilities of Study Chair, clinical sites, Coordinating Center and other central resources such as an imaging center or central laboratory, and study publications and procedures.
When preparing your application in ASSIST, use Component Type Chair Admin
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Chair Admin Component)
Complete only the following fields:
PHS 398 Cover Page Supplement (Chair Admin Component)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Chair Admin Component)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Project /Performance Site Location(s) (Chair Admin Component)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Chair Admin Component)
Budget (Chair Admin Component)
This section should contain appropriate project expenses for this component. Fully explain and justify all requested items, especially:
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Chair Admin Component)
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.
Specific Aims: Specific aims should describe the clinical, scientific and technical leadership in protocol development and implementation and the coordination of clinical activities, study committees, meetings, conference calls and site visits to assure study integrity, protocol fidelity, completion, manuscript preparation and results dissemination.
Research Strategy: Fully describe the relevant contributions, strengths and expertise that the leadership can offer to the collaboration, including:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Chair Admin Component)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Chair Admin Component)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Coordinating Center
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Coordinating Center Component)
Complete only the following fields:
PHS 398 Cover Page Supplement (Coordinating Center Component)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Coordinating Center Component)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Project /Performance Site Location(s) (Coordinating Center Component)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Coordinating Center Component)
Budget (Coordinating Center Component)
This section should contain all appropriate project expenses. Fully explain and justify all requested items, especially:
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Coordinating Center Component)
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.
Specific Aims: Specific aims should describe the scientific, statistical and methodological leadership and logistical coordination and support for the study and should provide a detailed description of the statistical considerations underpinning the study design. If there are additional aims, list them in this section.
Research Strategy: Provide a detailed description of the Coordinating Center including:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Coordinating Center Component)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Coordinating Center Component)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Enrollment Center
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Enrollment Center Component)
Complete only the following fields:
PHS 398 Cover Page Supplement (Enrollment Center Component)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Enrollment Center Component)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Facilities and Other Resources: Provide information on the physical facilities, space and specific equipment available to conduct the study protocol.
Project /Performance Site Location(s) (Enrollment Center Component)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Enrollment Center Component)
Budget (Enrollment Center Component)
This section should contain all appropriate project expenses. Fully explain and justify all requested items, especially:
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Enrollment Center Component)
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.
Specific Aims: Specific aims of the Enrollment Center Component should describe the organization and operations of clinical centers responsible for recruitment and retention of study participants and implementation of the study protocol. If there are additional aims, list them in this section.
Research Strategy: Provide a detailed description of the administrative arrangements necessary for organizing and supporting participating clinical centers. Identify and justify the number of clinical centers required to participate in the proposed study.
For the participating clinical center(s), provide a description of:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Enrollment Center Component)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Enrollment Center Component)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Resource Center
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Resource Center Component)
Complete only the following fields:
PHS 398 Cover Page Supplement (Resource Center Component)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Resource Center Component)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Project /Performance Site Location(s) (Resource Center Component)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Resource Center Component)
Budget (Resource Center Component)
This section should contain all appropriate project expenses. Fully explain and justify all requested items, especially:
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Resource Center Component)
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.
Specific Aims: Specific aims should provide a detailed protocol outlining the responsibilities and operations of the Resource Center and describe overall leadership for the Resource Center. If there are additional aims, list them in this section.
Research Strategy: Provide a detailed description of the Resource Center including:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Resource Center Component)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Resource Center Component)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
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 only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD(s)/PI(s) and component Project Leads must include their
eRA Commons ID in the Credential field of the Senior/Key Person Profile
Component of the SF424(R&R) Application Package. Failure to register
in the Commons and to include a valid PD/PI Commons ID in the credential field
will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
In order to expedite review, applicants are requested to notify the NEI Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact 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 review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific 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?
Evaluate the rationale and public health significance of the study. Is there previous research to support the rationale? Is the proposed intervention justified?
Investigator(s)
Are the PD(s)/PI(s), 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? Evaluate the proposed leadership and organizational structure 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 human subjects and/or NIH-defined clinical research,
are the plans to address 1) the protection of human subjects from research
risks, and 2) inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion or exclusion of
children, justified in terms of the scientific goals and research strategy
proposed?
Evaluate the appropriateness of the study protocol. Have patient safety and ethical considerations been adequately addressed? Evaluate the appropriateness of the milestone plan.
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?
Reviewers will consider each of the review criteria below in the determination of scientific 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(s)/PI(s), 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 human subjects and/or NIH-defined clinical research,
are the plans to address 1) the protection of human subjects from research
risks, and 2) inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion or exclusion 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?
Reviewers will consider each of the review criteria below in the determination of scientific 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(s)/PI(s), 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 human subjects and/or NIH-defined clinical research,
are the plans to address 1) the protection of human subjects from research
risks, and 2) inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion or exclusion of
children, justified in terms of the scientific goals and research strategy
proposed?
Evaluate the appropriateness of the proposed sample size and procedures for data management, data storage, and analytical activities, including manuscript production and report production for Data and Safety Monitoring Committees. Assess the plan for performing clinical center site visits, quality control and monitoring of study procedures at resource and clinical centers.
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?
Reviewers will consider each of the review criteria below in the determination of scientific 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(s)/PI(s), 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 human subjects and/or NIH-defined clinical research,
are the plans to address 1) the protection of human subjects from research
risks, and 2) inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion or exclusion of
children, justified in terms of the scientific goals and research strategy
proposed?
Evaluate the organizational and administrative arrangements proposed for organizing, managing and supporting participating clinical centers. Evaluate the adequacy of the clinical center's procedures for: patient recruitment and patient retention and follow-up, data collection and data management, quality control of clinical examinations, training and certification of personnel, testing and monitoring of study procedures. Assess the adequacy of the potential sources and numbers of fully-eligible patients and the documentation of any proposed collaborations; the clinic's recruitment and retention track record in clinical trials; the physical facilities and equipment available for the study.
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?
Reviewers will consider each of the review criteria below in the determination of scientific 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(s)/PI(s), 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 human subjects and/or NIH-defined clinical research,
are the plans to address 1) the protection of human subjects from research
risks, and 2) inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion or exclusion of
children, justified in terms of the scientific goals and research strategy
proposed?
Evaluate the experience of the center in receipt and inventory, routing, storage and retrieval, and archiving of study materials. Assess the center's track record in timely grading of study images and conduct of laboratory procedures.
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?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, 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. For additional
information on review of the Human Subjects section, please refer to the Guidelines
for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
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 on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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.
Resubmissions
For Resubmissions, 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.
Renewals
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
For Revisions, 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.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
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.
Select Agent 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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NEI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Eye Council. The following will be considered in making funding decisions:
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 eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
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. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
NEI Involvement Statement:
Applicants must provide a statement acknowledging and agreeing to NEI staff post-award involvement in conducting the aforementioned types of clinical research studies, and should describe plans to accommodate this involvement.
Cooperative Agreement Terms and Conditions of Award:
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility resides
with the awardees for the project as a whole, although specific tasks and
activities may be shared among the awardees and the NIH as defined below.
The Program Director(s)/Principal Investigator(s) (PD(s)/PI(s) will have the primary responsibility for:
The overall conduct of the clinical trial and for providing scientific, technical, and administrative leadership to the study. He/she will have lead responsibility for planning and directing all phases of the study and for using the study's resources. In carrying out these responsibilities, the PD(s)/PI(s) will actively seek advice from all of the study's components, including the representative of the NEI.
The PD(s)/PI(s) of each Component will play an important role in the design,
implementation, and execution of the clinical trial. Each PD(s)/PI(s) is
responsible for all aspects of the operations of his/her component and for the
local implementation of the study protocol.
The PD/PI of each participating clinical center has the primary responsibility
of identifying and recruiting eligible patients at his/her center. He/she
will be responsible for the follow up, as specified in the study protocol, of
each patient enrolled in the clinical trial and for submitting required data to
the resource center(s). The PI is also responsible for ensuring that
his/her clinic personnel are trained and certified to carry out study
procedures.
Awardees will retain custody of and have primary rights to
the data and software developed under these awards, subject to Government
rights of access consistent with current DHHS, PHS, and NIH policies.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The appropriate NEI Program Director from the Division of
Extramural Research whose name appears on the Notice of Grant Award will
participate with and assist, but not direct:
Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Areas of Joint Responsibility include:
Data and Safety Monitoring Committee: A group composed
of individuals, not directly involved in patient care or data collection in the
trial, who are responsible for periodically reviewing accumulated data for
evidence of adverse or beneficial treatment efforts; for initiating
recommendations for modification of the study protocol, including termination
of a treatment when appropriate; and for assessing data quality and clinic
performance.
Executive Committee:
Composed of the PD(s)/PI(s) from the study's Components, the NEI
representative, and a small group of clinical center PIs who are elected by the
full group of participating clinical center PIs for a set term. This
committee acts as the administrative and executive arm of the clinical
trial. It makes decisions on day-to-day operational issues; considers and
adopts changes in study procedures as necessary; reviews and implements
recommendations from the Data and Safety Monitoring Committee; reviews progress
of the trial in achieving its main goal and takes steps required to enhance likelihood
of success; and reviews data collection practices and procedures as summarized
in performance monitoring reports for clinical centers to identify and correct
remediable deficiencies.
Editorial Committee:
This committee has the responsibility for reviewing manuscripts produced by the
study investigators and for assisting in the preparation of the main trial
results. Its members are the Study Chairperson, coordinating center
director, the NEI representative, and several clinical center investigators elected
by the full group of participating clinical center s.
Dispute
Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]
Grants.gov Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]
Donald Everett, MA
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]
Maryann Redford, DDS, MPH
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]
Eleanor Schron, PhD, RN, FAAN
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]
Louise Wideroff, PhD
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]
Anne Schaffner, PhD
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]
William Darby
National Eye Institute (NEI)
Telephone 301-451-2020
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
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.
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