PAR-14-096: NEI Collaborative Clinical Vision Research Project Grant (U10)

Department of Health
and Human Services (HHS)

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Part 1. Overview Information

Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	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	March 15, 2016 - Notice of Expiration of PAR-14-096. See Notice NOT-EY-16-001. NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number	PAR-14-096
Companion Funding Opportunity	PAR-14-097, (UG1) Clinical Research Cooperative Agreements - Single Project PAR-14-098, (UG1) Clinical Research Cooperative Agreements - Single Project PAR-14-099, (UG1) Clinical Research Cooperative Agreements - Single Project PAR-14-100, (UG1) Clinical Research Cooperative Agreements - Single Project
Number of Applications	See, Section III. 3. Additional Information on Eligibility.
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.

Key Dates

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

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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:

Improving early diagnosis of ocular diseases and their underlying processes through new screening and detection strategies
Developing and testing new interventions that prevent or treat ocular disease and resulting disability, or that identify predictors of response to treatment.

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.

Section II. Award Information

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 Renewal Resubmission Revision 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
sian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)

Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession

Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)

Foreign Institutions

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.

Required Registrations

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.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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:

To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Page Limitations

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.

Instructions for the Submission of Multi-Component Applications

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:

Overall: required, maximum of 1
Chair Admin: required, maximum of 1
Coordinating Center: required, maximum of 1
Enrollment Center: required, no maximum
Resource Center(s) optional, maximum of 5

Overall Component

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:

study timeline and its reasonableness (i.e. the likelihood of meeting study objectives within the stated timeline);
study organization and administrative arrangements for implementing the study design;
geographic and demographic characteristics (including age, gender and racial/ethnic composition) of the target population, availability of study participants, and overall study recruitment and retention strategies;
study procedures, measurements, and visit schedule;
primary outcome measure or, for early phase work, a pre-specified endpoint(s) as a measure of success;
provisions for monitoring study progress;
provisions for ensuring participant safety and well-being;
procedures for monitoring of clinical centers for adherence to protocol;
procedures to ensure quality control of data.

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:

scientific background, preliminary data and rationale for the proposed investigation;
study aims and how these aims address a public health problem and advance the field of vision research;
organizational structure and relevant roles and responsibilities of collaborating components.

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:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

Chair Admin Component

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:

Applicant Information
Type of Applicant (optional)
Descriptive Title of Applicant’s Project
Proposed Project Start/Ending Dates

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)

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Chair Admin Component)

This section should contain appropriate project expenses for this component. Fully explain and justify all requested items, especially:

the duties and responsibilities of each of the key personnel, technicians, coordinators and clerical staff as applicable;
the need for consultant services, the number of hours or days per consultant, and the basis for calculating the compensation;
the intended use of any equipment requested, the rationale for the cost model chosen, e.g., price competitiveness, and the percent of time it will be used for the study;
travel including the purpose of each trip; the number and positions of travelers; the per person cost of airfare, lodging, per diem expenditures and the mileage for local travel.

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:

scientific, clinical and administrative experience and qualifications of the Study Chair(s) and other study personnel;
past track record and/or future performance potential in clinical research (NEI-sponsored or otherwise);
plans for carrying out the leadership's roles and responsibilities on a day-to-day basis, including coordination of multiple research activities and study entities;
plans for identifying and engaging qualified investigators to participate in the study;
plans for assuring study integrity, protocol fidelity and completion;
plans for monitoring study progress and provisions for ensuring participant safety and well-being;
plans for manuscript preparation and results dissemination;
organization of and the leadership's involvement in study committees (e.g., Executive, Steering, Operations, Publications, Data and Safety Monitoring).

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

Coordinating Center Component

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:

Applicant Information
Type of Applicant (optional)
Descriptive Title of Applicant’s Project
Proposed Project Start/Ending Dates

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)

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Coordinating Center Component)

This section should contain all appropriate project expenses. Fully explain and justify all requested items, especially:

the duties and responsibilities of each of the key personnel, technicians, coordinators and clerical staff as applicable;
the need for consultant services, the number of hours or days per consultant, and the basis for calculating the compensation;
the intended use of any equipment requested, the rationale for the cost model chosen, e.g., price competitiveness, and the percent of time it will be used for the study;
travel including the purpose of each trip; the number and positions of travelers; the per person cost of airfare, lodging, per diem expenditures and the mileage for local travel.

Budget forms appropriate for the specific component will be included in the application package.

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:

ability to provide scientific, statistical and methodological leadership, and logistical coordination and support for the study;
data management procedures, data capture and handling techniques, data flow from the Clinical and Resource Centers, data management systems employed, data storage and security;
procedures for on-site and off-site monitoring of Clinical and Resource Centers for adherence to protocol and other data quality control and monitoring;
procedures for monitoring of clinical centers for adherence to protocol;
procedures to ensure quality control of data;
personnel training and certification;
participant safety monitoring including activities of the Data and Safety Monitoring Committee;
coordination and logistical support for study committees including meetings of the Data and Safety Monitoring Committee, Full Investigative Group, Operations, Steering and Executive Committees;
coordination and logistical support for IRB submissions and reporting;
reimbursement of study-related costs to collaborative study components;
documentation of study policies and procedures in a study-specific Manual of Procedures;
preparation of relevant study reports and meeting minutes;
scientific and administrative support for study manuscripts and presentations;
scientific, clinical and administrative experience and qualifications of the Principal Investigator and other study personnel;
leadership's past track record and/or future performance potential in clinical research (NEI-sponsored or otherwise);
ability to provide expert guidance and leadership in biostatistics, developmental study design, data management and analysis;
plans for carrying out the Coordinating Center's roles and responsibilities on a day-to-day basis, including monitoring of study procedures and processes;
- organization of and the leadership's involvement in study committees (e.g., Executive, Steering, Operations, Publications, Data and Safety Monitoring);
plans for identifying and engaging qualified investigators to participate in the study;
plans for assuring study integrity, protocol fidelity and completion;
plans for manuscript preparation and results dissemination.

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

Enrollment Center Component

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:

Applicant Information
Type of Applicant (optional)
Descriptive Title of Applicant’s Project
Proposed Project Start/Ending Dates

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)

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Enrollment Center Component)

This section should contain all appropriate project expenses. Fully explain and justify all requested items, especially:

the duties and responsibilities of each of the key personnel, technicians, coordinators and clerical staff as applicable;
the need for consultant services, the number of hours or days per consultant, and the basis for calculating the compensation;
the intended use of any equipment requested, the rationale for the cost model chosen, e.g., price competitiveness, and the percent of time it will be used for the study;
the specifics of patient-care costs not covered by third-party payments, i.e., number of patients; test or procedure to be performed; number of visits; average cost per visit; and basis for calculating charges;
travel including the purpose of each trip; the number and positions of travelers; the per person cost of airfare, lodging, per diem expenditures and the mileage for local travel.

Budget forms appropriate for the specific component will be included in the application package.

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:

how the clinic team will work efficiently and expeditiously to accrue and retain study participants and assure protocol fidelity;
plans for undertaking personnel training and certification, assuring compliance with all federal policies and regulations regarding the use of data from clinical studies involving human subjects (e.g., regulations concerning the confidentiality, integrity and security of study data and protection of human subjects);
plans for collecting, storing, transmitting, managing data and/or specimens.
plans for carrying out the clinics roles and responsibilities on a day-to-day basis and monitoring of study procedures and processes;
plans for recruiting and retaining study participants within the targeted populations;
the ability to provide high quality data on a sufficient number of participants;
the size, geographic and demographic characteristics (including age, gender and racial/ethnic composition) of the clinic's referral base, eligible patient pool, and likely enrollment of participants.
proposed collaborations with satellite Centers and individual clinicians;
the adequacy of the clinic's site-specific procedures for data collection and data management, quality control of clinical examinations and testing and monitoring of study procedures.
scientific, clinical, and administrative experience and qualifications of the PD(s)/PI(s) and other study personnel;
past track record and/or future performance potential in a leadership role in clinical research (NEI-sponsored or otherwise);
plans for carrying out the Clinical Center's roles and responsibilities on a day-to-day basis, and monitoring of study procedures and processes;
plans to participate in a cooperative and interactive manner with other Clinical Centers, the Coordinating Center, and Resource Center(s).
organization and involvement in study committees (e.g., Executive, Steering, Operations, Publications), as applicable;
plans for collaboration in manuscript preparation and results dissemination.

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

Resource Center Component(s) (Optional)

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:

Applicant Information
Type of Applicant (optional)
Descriptive Title of Applicant’s Project
Proposed Project Start/Ending Dates

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)

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Resource Center Component)

This section should contain all appropriate project expenses. Fully explain and justify all requested items, especially:

the duties and responsibilities of each of the key personnel, technicians, coordinators and clerical staff as applicable;
the need for consultant services, the number of hours or days per consultant, and the basis for calculating the compensation;
the intended use of any equipment requested, the rationale for the cost model chosen, e.g., price competitiveness, and the percent of time it will be used for the study;
the details of travel requests, i.e., the purpose of each trip; the number and positions of travelers; and the per person cost of airfare, lodging, per diem expenditures and mileage costs for local travel.

Budget forms appropriate for the specific component will be included in the application package.

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:

personnel available to perform the necessary work;
protocols for the timely receipt, inventory, routing, processing, analysis, storage, retrieval and archiving of requisite images and/or biological samples and related data;
training and certification of study clinic personnel in image capture, specimen collection or local laboratory procedures;
transmission of Resource Center results to the Coordinating Center;
standardization and ongoing quality control;
documentation of Resource Center procedures in the relevant section of the Manual of Procedures;
preparation of Resource Center reports;
organizing and conducting of on-site and off-site monitoring of Resource Center procedures as needed;
scientific expertise for study manuscript preparation and presentation;
scientific, clinical and administrative experience and qualifications of the Principal Investigator and other study personnel;
past track record and/or future performance potential in a Resource Center role in clinical research (NEI-sponsored or otherwise);
ability to provide expert guidance in the collection, analysis and interpretation of images or biological samples and corresponding data as applicable;
plans for carrying out the Resource Center's roles and responsibilities on a day-to-day basis, and monitoring of study procedures and processes;
organization and involvement in study committees (e.g., Executive, Steering, Operations, Publications, Data and Safety Monitoring);
plans for manuscript preparation and results dissemination.

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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 Institutions

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.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

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 ellenliberman@nei.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

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.

1. Criteria

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.

Overall Impact - Overall

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).

Scored Review Criteria - Overall

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?

Scored Review Criteria - Chair Admin Component

Significance

Investigator(s)

Innovation

Approach

Environment

Scored Review Criteria - Coordinating Center Component

Significance

Investigator(s)

Innovation

Approach

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

Scored Review Criteria - Enrollment Center Component

Significance

Investigator(s)

Innovation

Approach

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

Scored Review Criteria - Resource Center Component

Significance

Investigator(s)

Innovation

Approach

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

Additional Review Criteria - Overall

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.

Additional Review Considerations

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.

2. Review and Selection Process

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:

Will receive a written critique.

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:

Scientific and technical merit of the proposed project as determined by scientific peer review.
Availability of funds.
Relevance of the proposed project to program priorities. See NEI Strategic Plan at http://www.nei.nih.gov/strategicplanning/

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. 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:

the PD(s)/PI(s) in the nomination and selection of an independent Data and Safety Monitoring Committee;
the PD(s)/PI(s) and, when appropriate, the Executive Committee, in assuring that patient information handbooks, recruitment information, press releases, and publicity exhibits are properly prepared and disseminated;
the PD(s)/PI(s) in the identification of additional participating clinics, if necessary, in order to enhance patient recruitment;
the Executive Committee in routine performance monitoring of the entire Study, including matters of quality control within and among various components, and in the determination of inadequate patient recruitment or failure to comply with the protocol on the part of individual clinics;
the Editorial Committee in the preparation and review of study results for publication;
the Data and Safety Monitoring Committee as an ex officio member and will participate in decisions of the Committee, e.g., to proceed from one phase of the study to the next, to implement protocol changes, to evaluate patient recruitment issues, to approve any ancillary studies, to plan data analysis, to announce study findings, and to determine the timing of release of any interim or final reports.

The NEI reserves the right to curtail, withhold, or terminate support for the study, for an individual award, or support for a participating consortium, in situations involving: inadequate patient recruitment, follow-up, data reporting, or quality control; a major breach of the study protocol; a substantive change in the agreed-upon protocol to which the NEI does not agree; statistical evidence that the major study endpoint has been reached ahead of schedule; or human subject ethical issues that dictate a premature termination. Prior to taking such actions, NEI will consult with and receive recommendations from the Data and Safety Monitoring Committee.

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.

3. Reporting

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.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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: commons@od.nih.gov

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: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Donald Everett, MA
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: everettd@mail.nih.gov

Maryann Redford, DDS, MPH
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: redfordm@mail.nih.gov

Eleanor Schron, PhD, RN, FAAN
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: Schrone@mail.nih.gov

Louise Wideroff, PhD
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: Louise.Wideroff@nih.gov

Peer Review Contact(s)

Anne Schaffner, PhD
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: aes@nei.nih.gov

Financial/Grants Management Contact(s)

William Darby
National Eye Institute (NEI)
Telephone 301-451-2020
Email: darbyw@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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.