Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
 

Components of Participating Organizations

National Eye Institute (NEI)

Funding Opportunity Title

NEI Center Core Grants for Vision Research (P30)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of PAR-10-223

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-13-269

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.867

Funding Opportunity Purpose

An NEI P30 Center Core Grant combines one or more research cores for a group of R01 investigators to enhance their research, consolidate resources, avoid duplication of efforts, and/or contribute to cost effectiveness by providing a service with lower cost or higher quality than could be attempted for independent projects by several individual PDs/PIs.  Shared resources and facilities that are accessible to a group of independently funded investigators lead to greater productivity for the separate projects, and can provide instrumentation and facilities that are too costly to be maintained by an individual investigator.  The design and purpose of each P30 Center Core Grant may vary in how it serves its users.  This program is designed to enhance an institution's environment and capability to conduct vision research and to facilitate collaborative studies of the visual system and its disorders.      

Key Dates
Posted Date

July 9, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

September 30, 2013

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February/March 2014

Advisory Council Review

May 2014

Earliest Start Date

July 2014

Expiration Date

October 1, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Background

An NEI P30 Center Core Grant combines one or more research cores  for a group ofR01 investigators to enhance their research, consolidate resources, avoid duplication of efforts, and/or contribute to cost effectiveness by providing a service with lower cost or higher quality than could be attempted for independent projects by several individual PDs/PIs.  Shared resources and facilities that are accessible to a group of independently funded investigators lead to greater productivity for the separate projects, and can provide instrumentation and facilities that are too costly to be maintained by an individual investigator.  The design and purpose of each P30 Center Core Grant may vary in how it serves its users.  This program is designed to enhance an institution's environment and capability to conduct vision research and to facilitate collaborative studies of the visual system and its disorders. 

Scientific Knowledge to be Achieved

An NEI P30 Center Core Grant will increase the productivity and impact of research in eligible projects of the Core users, and will form a collaborative environment to increase scientific interactions.  A strong research base of funded projects is a qualifying requirement and a major factor in obtaining a P30 Center Core Grant award.  Any institution or consortium applying for a P30 Center Core Grant must have an active, established program in basic, epidemiological, biomedical or behavioral research in one or more of the NEI mission areas described at http://www.nei.nih.gov/funding/nprp.asp.

Types of Approaches

NEI P30 Center Core Grants consist of discrete units or cores, each devoted to a specific activity that would be impractical or less efficient to support on an individual research project grant.  The purpose of each core  is to support a resource or service that enhances or facilitates the research efforts of a group of independent investigators, each having NEI funding.  Cores may involve the purchase and maintenance of a shared instrument.  Some sharing of Core Grant resources and services with other NIH-funded collaborators and with investigators new to vision research is encouraged.

The Administrative Core supports the overall management of the P30 Center Core Grant, including an organizational structure sufficient to coordinate and integrate the activities of the Resource and Service Cores , and determine the distribution and utilization of funds. 

   esource cores  facilitate the production of materials for research, or support the purchase, maintenance, and technical support of shared equipment.  Examples may include, but are not limited to, confocal microscopy, electron microscopy, tissue and cell culture services, genotyping,  microarray analysis, mass spectrometry, high throughput sequencing, database management, hybridoma production, laboratory animal resources, image analysis, and brain and eye imaging.   Resource cores  may also help support computer experts, biostatisticians, and other individuals who can assist or collaborate with participating investigators in conducting vision research. 

Service cores  support essential laboratory or technical services provided by one or more highly skilled persons.  Examples of this type of core include, but are not limited to, electronics shop, machine shop, and photography services.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the PHS 398 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

The NEI will provide direct costs of up to $2,000,000 over a five-year period in support of a Core Grant to institutions having 8 to 19 eligible grants.  Institutions having 20 or more eligible grants may receive direct costs of up to $2,500,000 over a five-year period.

Award Project Period

The maximum project period is 5 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

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

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least6 weeks prior to the application due date.

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.

The application must provide a table listing each eligible grant in the Resources section.  The table should include the complete grant number, title, and PD/PI. List only those grants described as being eligible. No other mechanisms or source of research support will be considered in determining eligibility. Do not include R01s in no-cost extensions, administrative supplements, revisions, and sub-contracts. 

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. However, only one P30 Center Core Grant will be made to any single applicant organization.  For multicampus institutions, no more than one P30 Center Core Grant will be made to each campus. 

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:

Institutions applying for a P30 Center Core Grant must hold a minimum of eight funded  R01 NEI grants on the receipt date.  Grant applications in administrative extensions, with or without additional funds, are not eligible.  Administrative supplements, revisions, and sub-contracts cannot be counted towards eligibility. Eligibility will be confirmed by NEI staff prior to the meeting of the Scientific Review Group (SRG). Applications from ineligible institutions will be returned to the applicant.

For a specific core  on a Center Core Grant to be funded, the  core must be used to a "moderate" or "extensive" degree by at least three investigators from institutions with 19 or fewer eligible grants and five investigators from insitutions with 20 or more eligible grants, each holding one R01 NEI grant.  

All investigators listed in the eligibility table must use at least one of the cores to a moderate extent to be considered for eligibilty.

Section IV. Application and Submission Information


1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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.

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Anne Schaffner, Ph.D..
Chief, Scientific Review Branch
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda, MD 20892-9300
Telephone: 301-451-2020
FAX: 301-402-0528
Email: aes@nei.nih.gov

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations to the Research Strategy section of each component of the application.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the PHS398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Submit only one Face Page for the entire application.  In item 2, enter "P30 – CENTER CORE GRANT FOR VISION RESEARCH."

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Key Personnel: The Director of the administrative core should be named as the PD/PI of the PD/PI of the overall Core Grant.  Key personnel are defined as the Program Director/Principal Investigator and the Core Leads.  Program Directors/Principal Investigators holding a qualifying R01 listed on the table of eligible grants in the Resources section may be named as significant contributors but should not be named as key personnel.

Table of Contents (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Provide summary budget pages for the initial and entire budget periods for the Core Grant, presenting the aggregate budget for all administrative and core  components.   Budget justification requests for the administrative core and resource/service cores should be  contained in the separate core budgets that will immediately follow. 

Budget for Entire Proposed Period of Support (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Provide summary budget pages for the entire budget period for the Core Grant, presenting the aggregate budget for all administrative core and core activities.

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide must be followedwith the following additional instructions:

The Core Center Director and all Core Director's should be named as key personnel and require biosketches.  Significant Contributors, investigators holding a qualifying R01 listed on the table of eligible grants in the Resources section,  do not require biosketches.

Resources (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: 

Provide a table listing each eligible grant.  Include the complete grant number, title, and PD/PI.  List ONLY those grants described above under eligibility.  A section for overall Institutional or Departmental resources should not be provided. 

Research Plan (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Research Strategy: Describe the overall P30 Center Core structure in a separate and internally complete six-page section.  Include the following:  Background, Administrative Core, and Institutional Commitment. 

Background:  Describe how the Center Core Grant would be used to enhance the capabilities of participating NEI-funded investigators and the institution for conducting vision research.  If pertinent, describe how Center Core Grant resources and services would be used to help initiate or to continue collaborative studies, and/or to help attract scientists to research on the visual system.

Institutional Commitment:  Describe and give examples of institutional commitment and support of the goal of fostering vision research.

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 PHS 398 Application Guide, with the following modification: 

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

Cores

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Cores)

All instructions in the PHS 398 Application Guide must be followed with the following additional instructions:

Key personnel are defined as the Program Director/Principal Investigator and the Core Leads.

Program Directors/Principal Investigators holding a qualifying R01 listed on the table of eligible grants in the Resources section may be named as significant contributors but should not be named as key personnel.

The PD/PI of the overall Core Grant should be also named as the Director of the Administrative Core.  This individual need not hold a qualifying R01.  Research/Service cores  should be directed by an NEI-funded, independent investigator holding a R01 grant who has the expertise to supervise its use.  Other arrangements may be proposed, but must be well justified.

Table of Contents (Cores)

All instructions in the PHS 398 Application Guide must be followed

Detailed Budget for Initial Budget Period (Cores)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Administrative Core: 

Program Director/Principal Investigator:  salary support may not exceed  0.6 person months. 

Secretarial and Administrative staff:  support may be requested to the extent that it relates directly to the management of Center Core Grant activities.  Costs for all secretarial and administrative activities (including support for the Program Director/Principal Investigator) ordinarily may not exceed 15% of the total direct costs of a Core Grant award in any year.

Resource/Service Cores

Core Directors: Salary support may not exceed  0.4 person months. 

Technical Support Personnel:  Salary may be requested.
Equipment:  Requests for shared equipment are allowed.
Supplies:  Consumable supplies may be requested if they are directly related to the operation of the cores (photographic supplies, electronics parts, machine shop stock, tissue culture media, etc.).
Travel:  Not allowed.
Patient Care Costs:  Not allowed.
Other Expenses:  Equipment maintenance, computer time, and lease of computer lines are examples of the many types of allowable costs.  Human subjects reimbursement, animal care per diem charges (boarding), and costs associated with seminars, conferences, workshops, etc. are not allowed.

Budget for Entire Proposed Period of Support (Core)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Core)

All instructions in the PHS 398 Application Guide must be followed. 

Resources (Core )

All instructions in the PHS 398 Application Guide must be followed with the following additional instructions:

Outline the facilities, equipment, etc. that would be available for the core in terms of space, location, capabilities, and availability for participating investigators, using the format provided (Form Page 8-HH). Include the most important equipment items that would be made available.  If a major equipment item (e.g., an electron microscope) is located in the individual research space of an investigator, the issue of accessibility for participating investigators should be addressed in detail.

Each proposed technique or service in the Center Core Grant and its current status of staffing, space, and equipment should be described in enough detail to allow a comprehensive evaluation.

Research Plan (Cores )

All instructions in the PHS 398 Application Guide must be followed.with the following additional instructions:

Research Strategy: Describe the Research Strategy for each  Core proposed including the administrative Core.    

For the Administrative Core,  describe the integration, coordination, and evaluation of activities of the cores, including the establishment of priorities, allocation of resources, and scheduling for use of a core among the participating investigators. 

For the Resource/Service Cores, describe how  Center Core Grant facilities or services will enhance the research activities and accomplishments of the projects using this core. Include how the Core will provide increased or innovative capabilities, facilitate increased productivity or effectiveness through sharing expertise or centralizing labor-intensive tasks, foster collaborative or new research directions, bridge basic and clinical research, or attract new investigators into vision research. Methodologies already in use at the institution may be described briefly.   Methodologies new to the institution need to be described in detail and strategies delineated for successful implementation in the research strategy section.

Resource/Service Core Use and Impact:  Describe how the  core will enhance the research capabilities of investigators using the core, citing some specific examples.  Characterize the extent to which the core will be used by each investigator, employing the terms "limited," "moderate," or "extensive".  This information should be summarized in a table labeled Core Usage.

Renewal applications must include information that demonstrates how the core has enhanced the capability of investigators and the institution for conducting vision research.  Examples of projects or representative publications that benefited from use of the core should be cited, particularly for investigators using the core to a "moderate" or "extensive" degree.  Do not submit copies of any manuscripts or publications.  Renewal applications should also describe collaborative studies, attraction of investigators to vision research, and any other research-related activities made possible or facilitated by the core .  It is not necessary or required to provide an exhaustive, all-inclusive accounting of core usage in the research strategy section.

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 PHS 398 Application Guide, with the following modification:

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

Appendix for the Entire Application

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review  Applications that are incomplete will not be reviewed.  

Post-Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information


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.

For this FOA, please note the following:

Emphasis will be placed on assessing the quality and productivity of the research conducted by the primary users of the core, the benefits that would be derived from the core, the quality of the products, and the efficiency of services provided by the core.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the P30 Center Core 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 P30 Center Core 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 P30 Center Core 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 P30 Center Core 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? Does the P30 Center Core Grant provide resources and/or services to meet the scientific needs of the research base?  Will the P30 Center Core Grant be used by multiple investigators?  What is the likelihood that the Center Core Grant will increase efficiency, accelerate progress and promote new research directions and scientific collaborations among P30 Center Core Grant investigators?  

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the P30 Center Core? 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? Is the Program Director/Principal Investigator qualified and in a position to administer this P30 Center Core Grant effectively?  How strong is the research track record of the participating investigators?   Is the level of independent, peer-reviewed research support from the NEI/NIH appropriate for the number of participating investigators?   Is it likely that the participating investigators, as a group, will remain productive and competitive?  Are procedures proposed or in place to ensure smooth administration of the Center Core Grant overall, and of the individual Research and Service cores?  If an advisory group is proposed, does ithave an appropriate composition and defined responsibilities? If an advisory group is not proposed, are there alternative procedures to administer the P30 Center Core Grant effectively?   How will priorities be set?  How will issues regarding accessibility to P30 Center Core Grant facilities be handled? 

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?  Does the P30 Center Core Grant use innovative ways to communicate or integrate activity among the resource and service cores, or across basic and clinical research?  Are there innovative methods for allocating resources or promoting new cross-departmental or multi-disciplinary collaborations? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the P30 Center Core? 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 P30 Center Core involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  Are there plans to establish and maintain communication and cooperation among investigators?  Are there adequate administrative management plans for the research and service  core, including implementation, allocation, user prioritization, quality control, and utilization of services?  How well do the management plans address accountability, flow of authority, dispute resolution, evaluation, and integration with the institution’s fiscal and academic administration?

Will the core be directed by an NEI-funded, independent investigator with the appropriate scientific credentials?   If other arrangements are proposed, are these appropriate?

How will the coreenhance or facilitate the research efforts of the participating investigators?  Will the core support a resource or service that would be impractical or less efficient to support on an individual research grant?  What will be the overall level of use for the core and is this level appropriate?  Are the resources appropriate?   Are Core Grant facilities easily accessible to members of the group?  If not, will this be an impediment to full utilization of the core?   Is each requested core budget item directly related to the operation of thecore and adequately justified? 

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? What is the extent of the commitment and support by the Institution to the goal of fostering research on the visual system and its disorders?   Are examples provided of significant space commitments, faculty positions, payment or partial payment of salaries for support staff, purchases of equipment, or financial support of new construction or renovation?   

Additional Review Criteria Overall

As applicable for the P30 Center Core 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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 P30 Center Core.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

The primary criterion is the effectiveness of the previous P30 Center Core Grant and Research and Servicecores in enhancing the capabilities of participating investigators and the institution for conducting vision research.  What has been the quality of publications by participating investigators and the impact of these publications on the field?  To what extent did these research activities benefit directly from the services and resources provided by the P30 Center Core Grant?  To what extent did the P30 Core Center Grant facilitate collaborative studies or help attract investigators to vision research?  What was the quality of the products and services provided by the core?  Were the facilities and resources provided by the P30 Center Core Grant shared effectively and efficiently?  Was there a high level of use and sharing of any equipment provided in the previous funding period?

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the P30 Center Core 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

Not Applicable

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  to the appropriate NIH Institute or Center and 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:

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

Not Applicable

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Ellen Liberman, Ph.D 
Director, Center Core Grants Program
Division of Extramural Research National Eye Institute (NEI) 
Telephone: 301-451-2020
Email: esl@nei.nih.gov

Peer Review Contact(s)

Anne Schaffner, Ph.D.
Chief, Scientific Review Branch
Division of Extramural Research
National Eye Institute
Telephone: 301-451-2020
Email: aes@nei.nih.gov

Financial/Grants Management Contact(s)

William W. Darby
Chief, Grants Management Branch
Division of Extramural Research
National Eye Institute 
Telephone: 301-451-2020
Email: darbyw@nei.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.


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