Part I Overview Information


Department of Health and Human Services

Participating Organizations
 National Institutes of Health (NIH) http://www.nih.gov

Components of Participating Organizations
 National Eye Institute (NEI), (http://www.nei.nih.gov)

Title:  NEI Center Core Grants for Vision Research (P30)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PAR) Number: PAR-10-223

Catalog of Federal Domestic Assistance Number(s)
93.867

Key Dates
Release Date: June 29, 2010
Letters of Intent Receipt Date(s):  Not applicable    
Application Receipt Dates(s):  September 27, 2010, 2011, 2012
Peer Review Date(s):  February/March 2011, 2012, 2013
Council Review Date(s):  May 2011, 2012, 2013
Earliest Anticipated Start Date:  July 2011, 2012, 2013
Additional Information To Be Available Date (Url Activation Date):  Not Applicable
Expiration Date:  September 28, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing   
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Resource modules 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 modules may also help support computer experts, biostatisticians, and other individuals who can assist or collaborate with participating investigators in conducting vision research. 

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

Administrative components support 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 modules, and determine the distribution and utilization of funds.  Requests for such a component should be included in the Summary Center Core Grant Budget section, and not be presented as a separate module.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity announcement (FOA) will use the P30 award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

2. Funds Available

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 19 or fewer eligible grants.  Institutions having 20 or more eligible grants may receive direct costs of up to $2,500,000 over a five-year period.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Future year amounts will depend on annual appropriations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Foreign Institutions are not eligible.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution 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.

 Eligibility

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. 

The application must provide a table listing each eligible grant in the Resources section.   The table should include the complete grant number, title, and Principal Investigator.  List only those grants described above under Eligibility.  See Other Submission Requirements, Section IV, 6.       No other mechanisms or source of research support will be considered in determining 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.

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.  Joint applications may be submitted by investigators at neighboring, independent institutions.

For a specific module on a Center Core Grant to be funded, the module must be used to a "moderate" or "extensive" degree by at least three investigators each holding one or more awards of the types specified above.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Only one application is allowed per institution.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1).  See new NIH policy on resubmission (amended) applications (NOT-OD-09-003,

1. Address to Request Application Information

The current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398.

For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html). 

Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s):  Not applicable
Application Receipt Date(s):  September 27, 2010, 2011, 2012
Peer Review Date(s):  February/March 2011, 2012, and 2013
Council Review Date(s):  June 2011, 2012, 2013
Earliest Anticipated Start Date(s):  July 1, 2011, 2012, 2013

 3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and threesigned 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix materials must be sent to:

Sam Rawlings, 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: rawlings@nei.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

Submit applications on Grant Application Form PHS 398.  Please note that an electronic version of PHS 398 is available at the NIH web site under "Funding Opportunities" at http://www.nih.gov/grants/oer.htm.   In preparing the application, follow the PHS 398 instructions, but substitute the following special instructions where indicated.

PHS398 Research Plan Sections

All application instructions outlined in the PHS 398 Application Instructions are to be followed, with the following additional requirements:

NEI –specific P30 Center Core Grant Instructions

Research Strategy Section

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

Administrative Component:   Describe the integration, coordination, and evaluation of activities of the modules, including the establishment of priorities, allocation of resources, and scheduling for use of a module among the participating investigators.  Use of an advisory group is encouraged.

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

Modules:  Describe the Research Strategy for each Resource and Service module in a separate and internally complete six-page section.  Describe how the Center Core Grant facilities or services will enhance the research activities and accomplishments of the projects using this core. Include how the Center Core Grant 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.  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.  Methodologies already in use at the institution may be described briefly.  Methodologies new to the institution need to be described in greater detail and strategies delineated for successful implementation.  Do not present the module budget and justification in this section.

Module Resources:  Outline the facilities, equipment, etc. that would be available for the module 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.

Module Supervision:  The module should be directed by an NEI-funded, independent investigator who has the expertise to supervise its use.  Other arrangements may be proposed, but must be well justified.

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

Renewal applications must include information that demonstrates how the module has enhanced the capability of investigators and the institution for conducting vision research.  Were there adequate plans for objectively evaluating the functioning of the P30 Center Core Grant?  Examples of projects or representative publications that benefited from use of the module should be cited, particularly for investigators using the module 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 module.  It is not necessary or required to provide an exhaustive, all-inclusive accounting of module usage in the research strategy section.

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

Summary Budget:  Provide summary budget pages for the initial and entire budget periods for the Core Grant, presenting the aggregate budget for all administrative and module activities.  Provide budget justifications requests for the administrative component and any other activities not contained in the separate module budgets that will immediately follow. 

Administrative Component: Requests for salary support for the Principal Investigator may not exceed  0.6 person months.  Support for secretarial and administrative staff may be requested in the summary budget to the extent that it relates directly to the management of Center Core Grant activities, see the NIH guide announcement http://grants.nih.gov/grants/guide/notice-files/not94-276.html.  Costs for all secretarial and administrative activities (including support for the Principal Investigator) ordinarily may not exceed 15% of the total direct costs of a Core Grant award in any year.

Module Budgets: Provide separate budget pages and justifications for each module.  Module budget requests and justifications should not be repeated elsewhere in the application.

Module Directors:  Salary support may not be requested. 
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 modules (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.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. 

2. Review and Selection Process

Review Process

Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) convened by NEI in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.  

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  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 Center Core Grant investigators?

Investigator(s).  Are the PI, module directors,,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)? Do the PI and  module directors have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   Is the 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 modules?   Is there an advisory group with appropriate composition and defined responsibilities?   If an advisory group is not proposed, are there alternative procedures to administer the Center Core Grant effectively?   How will priorities be set?  How will issues regarding accessibility to 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 modules, 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 project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?  If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?   Are there plans to establish and maintain communication and cooperation among Core Grant Investigators?  Are there adequate administrative management plans for the research and service modules, 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?

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

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

How will the module enhance or facilitate the research efforts of the participating investigators?  Will the module 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 module 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 module?   Is each requested module budget item directly related to the operation of the module 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 

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.  For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications.  When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

The primary criterion is the effectiveness of the previous P30 Center Core Grant and Research and Service modules 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 module?  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?

Revision Applications.  When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project.  If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations 

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations.  Foreign organizations are not allowed for this FOA.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including; 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (Not Applicable); 2) Sharing Model Organisms ( Not Applicable); and 3) Genome Wide Association Studies (GWAS) (Not Applicable).

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Ellen Liberman, Ph.D 
Director, Center Core Grants Program
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: esl@nei.nih.gov

2. Peer Review Contacts:

Samuel C. Rawlings, 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: rawlings@mail.nih.gov

3. Financial or Grants Management Contacts:

William W. Darby
Chief, Grants Management 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: darbyw@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


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