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 Clinical Vision Research (U10)

Announcement Type
This is a new Funding Opportunity Announcement

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

• February 12, 2014 - This PAR has been reissued as PAR-14-096.
• June 7, 2013 - See Notice NOT-EY-13-002. Notice of Extension of the Expiration Date.

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 (PA) Number: PAR-10-207

Catalog of Federal Domestic Assistance Number(s)
93.867

Key Dates
Release Date: May 26, 2010
Letters of Intent Receipt Date(s): Not applicable
Application Submission Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date: July 2011
Date (Url Activation Date): Not Applicable
Expiration Date:(Extended to January 8, 2014 per NOT-EY-13-002), Originally September 8, 2013

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. The National Eye Institute (NEI) supports investigator-initiated clinical vision research projects, including clinical trials and large-scale epidemiologic studies in vision research. The intent of this funding opportunity announcement is to provide a framework for applicants proposing clinical vision research projects, including clinical trials and epidemiological studies.
• Mechanism of Support. This FOA will utilize the National Institutes of Health (NIH) cooperative agreement (U10) grant mechanism.
• Funds Available and Anticipated Number of Awards. 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. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.
• Budget and Project Period. Budgets for direct costs will vary from application to application based on the size and complexity of each award. No upper limit is set. A project duration of up to seven years may be requested based on project needs.
• Application Research Strategy Length: The U10 Research Strategy section may not exceed 30 pages each for the Study Chair and Data Coordinating Center applications, 12 pages for each Resource Center, and 6 pages for each Participating Clinic, including tables, graphs, figures, diagrams, and charts. See Table of Page Limits.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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.
• Number of PDs/PIs. Only one PD/PI may be designated on the application.
• Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.
• Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
• Renewals. Applicants may submit a renewal application.
• Application Materials. See Section IV.1 for application materials.
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY (301) 451-5936

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
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Dispute Resolution Process
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

Purpose

Clinical vision research projects, including human clinical trials and epidemiologic studies, are part of NEI’s core strategy for improving visual health and decreasing visual impairment in populations through research on the burden of disease, its causes, diagnosis, prevention, treatment and rehabilitation. Broad collaborative clinical research program goals in support of NEI s mission to protect and improve visual health include, but are not limited to:

• Determining the burden of eye diseases and their visual outcomes in a changing population, particularly disparities in the burden and the influences of sociocultural and demographic factors.
• Improving early diagnosis of ocular diseases and their underlying processes through new screening and detection strategies.
• Developing and testing new interventions that prevent or treat ocular diseases and resulting disability, and identify predictors of response to treatment.
• Identifying and assessing strategies that will overcome barriers to eye care and convert evidence-based findings into improved patient and population outcomes.

Background

The National Eye Institute (NEI) uses cooperative agreement awards to support investigator-initiated randomized clinical trials, large-scale epidemiologic studies, and human gene transfer and stem cell therapy in vision research. These projects are complex and of high public health significance. The cooperative agreement mechanism is used because it establishes an assistance relationship between NIH and the award recipient in which there is substantial NIH programmatic involvement during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient s activity by involvement in and otherwise partnering with the award recipient without assuming direction, prime responsibility, or a dominant role in the activity.

Section II. Award Information

1. Mechanism of Support

This funding opportunity announcement (FOA) will use the U10 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).

This is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

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.

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:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Small Businesses
• For-Profit Organizations (Other than Small Businesses)
• Non-domestic (non-U.S.) Entities (Foreign Organizations)

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.

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. Applicants may submit more than one application, provided that each application is scientifically distinct.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Applicants may submit a renewal application.

Section IV. Application and Submission Information

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) 710-0267, Email: [email protected].

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.

Foreign Organizations [Non-domestic (non-U.S.) Entity]

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

• Request budgets in U.S. dollars.
• Contain detailed budgets. See NOT-OD-06-096.

In addition, for applications from foreign organizations:

• Charge back of customs and import fees is not allowed.
• Every effort should be made to comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF.
• Funds for up to 8% Facilities and administrative (F&A) costs (excluding equipment) may be requested. See NOT-OD-01-028, March 29, 2001.
• Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.
• Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI.2., Administrative and National Policy Requirements.

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s): Not applicable
Application Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

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 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)

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:

Samuel C. Rawlings, Ph.D..
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: [email protected]

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

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

Applicants must agree to accept the Cooperative Agreement Terms and Conditions of Award in Section VI.2.A. Award Administration Information . Applicants must provide a statement acknowledging and agreeing to NEI staff post-award involvement in conducting the aforementioned types of clinical research studies, and should describe plans to accommodate this involvement.

Supplementary Instructions

Clinical trial and epidemiological studies are often multi-component entities. The organizational components of these studies may be presented in one or more grant applications, depending on the nature of the studies and the institutional capacity of the applicants. Regardless of the variation in number of distinct applications or organizational structure of a clinical trial or epidemiologic study application, each component of the proposed study should use the U10 mechanism.

This U10 Funding Opportunity Announcement covers all component applications of a clinical trial including the Study Chair application and Data Coordinating Center application. For multi-center studies where the clinical enrollment center applications are submitted as separate grant applications they must use a U10 mechanism. Alternatively they can be included as subcontracts to the Study Chair or Data Coordinating Center application. Similarly, additional study resource centers, including photographic reading centers and imaging centers can submit individual U10 grant applications. Epidemiology studies may consist of one or more component applications and should also use the U10 mechanism.

An application should include information that addresses the peer review criteria, and the NIH policies on the welfare of human subjects, the inclusion of children, and the inclusion of women and minorities in study populations.

Below are the supplementary instructions for applications for each of the components. Not all trials will require separate applications for each component. For example, epidemiological studies may consist of one or more component applications; enrolling clinics may be included as subcontracts; and, in the case of single center human gene transfer and stem cell therapy, the Study Chair and Data Coordinating Center may be combined in one application. In the latter case, the Study Chair application must document the existence of appropriate statistical and data management expertise as well as experienced personnel and resources to support the activities of a Data and Safety Monitoring Committee.

Collectively, the Research Strategy section (PHS 398) of the Study Chair and Data Coordinating Center applications should logically address and explain:

• the scientific background and rationale for the proposed investigation;
• the study objectives and how these objectives address a major problem in vision research;
• the study timeline and its reasonableness (i.e. the likelihood of meeting study objectives within the stated timeline);
• study organization and administrative arrangements for implementing the experimental design;
• the geographic and demographic characteristics (including age, gender and racial/ethnic composition) of the target population, availability of study participants, and overall study recruitment and retention strategies;
• description of study procedures and visit schedule;
• description of study personnel training and certification procedures;
• description of data capture and handling techniques;
• statistical analysis plan, sample size justification and power estimates;
• provisions for monitoring study progress and, where applicable, participant safety and well-being;
• procedures for monitoring of clinical centers for adherence to protocol;
• procedures to ensure quality control of data, and
• for clinical trial applications, the primary outcome measure or, for early phase work, a pre-specified endpoint(s) as a measure of success.

Research Strategy. This section should fully describe unique contributions, strengths, and expertise that the study component can offer to the collaboration including:

• the relevant scientific, clinical, and administrative experience and qualifications of the Principal Investigator and other key personnel;
• the component s past track-record and future performance potential in clinical research (NEI-sponsored or otherwise);
• the component s ability to collect, manage, analyze and store data and/or specimens as applicable to their role in the study;
• plans for carrying out the component’s roles and responsibilities on a day-to-day basis; and
• data quality control and monitoring of study procedures.

Participating Clinical Center Applications

Because the Study Chair and/or Data Coordinating Center applications provide information with which to assess issues of study importance, design and methodology, participating clinical center applications should focus on describing the clinic’s ability to provide high quality data on a sufficient number of patients to make their participation in the study desirable. Specifically, participating clinical center applications should be sure to address:

• the participating clinical center’s relevant experience and track record in clinical research (e.g., protocol adherence, recruitment and retention, forms completion), and the clinical center’s potential sources and numbers of fully-eligible patients, with supporting documentation of the same;
• any documentation of proposed collaborations with satellite centers and individual clinicians to provide patients for the study;
• the size, and geographic and demographic characteristics (including age, gender and racial/ethnic composition) of the clinic’s referral base, eligible patient pool, and likely enrollment of patients;
• the physical facilities, space and specific equipment available for examining, testing, and or providing protocol treatment of patients;
• the adequacy of the participating clinic's site-specific procedures for: data collection and data management, quality control of clinical examinations, and testing and monitoring of study procedures;
• plans for carrying out the protocol on a day-to-day basis at the clinic; and
• the appropriateness and reasonableness of all budget items requested relative to the clinic's potential for patient recruitment, and to the overall scope of the clinic's proposed activities.

If the enrolling clinics are included as subcontracts the above must be addressed in the appropriate application.

Each application will be reviewed separately and should address and explain the following as it pertains to the component’s roles and responsibilities within the study:

Personnel. This section should fully describe the roles and responsibilities of grant personnel:

• relevant experience (with specific roles) and training of all key personnel including, as applicable, principal investigators, clinicians, project directors, coordinators, technicians, data managers, statisticians, testers, and other technical staff (whether compensated or not). Applicants are encouraged to describe any unique strengths or special expertise they can offer to the collaboration;
• in instances where key personnel participated previously as a clinical trial or large-scale epidemiologic study principal investigator (e.g. as a Study Chair, PI of Coordinating Center/Other Resource Center, or PI of an Enrollment Center), the previous study’s target recruitment goals and timeline, numbers actually recruited, and actual recruitment period; and
• criteria for selecting key personnel who are yet to be identified; size of the local pool of such personnel and procedures for the search.

Budget Justification This section should fully explain and justify all requested items, especially:

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

Page Limits

The Research Strategy is limited to a maximum of 30 pages for each of the Study Chair and Data Coordinating Center components of the application, 6 pages for each Participating Clinic, and 12 pages for each Resource Center. Literature cited and Consortium/Contractual arrangements sections should be provided following the 30 page limit.

Research Strategy Study Chair	Page Limit 30
Data Coordinating Center	30
Participating Clinics	6
Resource Center	12

PHS398 Research Plan Sections

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

• Introduction (required for a resubmission or revision application) is limited to 1 page.
• Specific Aims is limited to 1 page.
• Research Strategy, including tables, graphs, figures, diagrams, and charts, is limited to a maximum of 30 pages for each of the Study Chair and Data Coordinating Center components of the application, 6 pages for each Participating Clinic and 12 pages for each Resource Center. See Table of Page Limits.

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).

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096.

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. Appendix material may include a Manual of Operations (MOP) which specifies the clinical protocol to be followed. Basic elements in the MOP may include identification of the patient population; inclusion and exclusion criteria; adequate plans for recruitment and retention of participants; experimental design; examination and testing protocols; data collection form templates; clear definition of the research hypothesis and outcome measures; quality control/assurance procedures; data management and analytical techniques; sample size estimates with justification; administrative procedures (including regulatory approvals if necessary); collaborative arrangements; duties and responsibilities of study chairperson, clinical sites, coordinating center, and other central resources such as a central laboratory; and monitoring plans to assure patient protection and data integrity.

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)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096,.

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 a NEI special emphasis panel 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:

• All applications will be discussed and assigned an impact/priority score;
• Receive a written critique.
• Receive a second level of review by the National Advisory Eye Council

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? What is the rationale of the study, including the choice of the proposed intervention? Are the specific objectives reasonable? Do they address a major problem in vision research? Is the study needed? Is the study likely to have a useful and significant outcome? Is the rationale justifiable from an ethical standpoint?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the key personnel at the administrative center and the associated centers/clinics have the appropriate expertise and experience for their roles in the research project?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves 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?

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?

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

Review Considerations

In addition to the above five review criteria, the following criteria will also be considered by NEI-convened review groups when assessing the scientific merit of applications:

Study Chairperson's Application

• What is the rationale for the clinical study and the reasonableness of the specific objectives in addressing a major problem in vision research?
• Is the study design appropriate for assessing the epidemiologic parameters of interest or the effect of the intervention as applicable?
• Are there plans for minimizing bias where applicable and are the criteria for study endpoints appropriate?
• What are the study procedures and administrative arrangements for implementing the study design/protocol?
• What is the justification for the sample size, the availability of the patient pool, the likelihood of achieving the target sample size in a reasonable time, the reasonableness of the general statistical approach, and the procedures for technical monitoring of the study centers for adherence to protocol and for data monitoring to determine whether protocol changes are needed?
• What are the scientific, clinical, and administrative qualifications of the Study Chairperson and other key personnel?

Participating Clinical Center Applications

• What is the adequacy of the participating clinic's procedures for: patient recruitment and patient retention and follow-up, data collection and data management, quality control of clinical examinations, training and certification of personnel, testing and monitoring of study procedures?
• What are the qualifications of all key personnel (whether compensated or not), including their experience and track record in clinical trials (NEI-supported and other)?
• What is the adequacy of the potential sources and numbers of fully-eligible patients and the documentation of any proposed collaborations; the clinic's recruitment and retention track record in clinical trials; the physical facilities and equipment available for the study?
• What is the appropriateness and reasonableness of all items requested relative to the clinic's potential for patient recruitment and to the overall scope of the clinic's proposed activities?

Coordinating Center:

• Does the center s past performance in overall study management and productivity indicate a potential for successful future performance in a clinical trial or large epidemiology study?
• What is the experience of the Principal Investigator and other key personnel in clinical research?
• What is the ability of the center to manage and to analyze data for the clinical trial or observational study?
• What is the appropriateness of the proposed procedures for data management, data storage, and analytical activities, including manuscript production and report production for Data and Safety Monitoring Committees or Data Monitoring and Oversight Boards?
• Does the center demonstrate the ability to adequately perform sample size estimates?
• What is the experience and adequacy of the plan for performing clinical center site visits, quality control and monitoring of study procedures at the clinical sites?
• What is the experience with training and certification of personnel at the training sites?

Resource Centers:

• What is the experience and expertise of personnel?
• Are the facilities and resources adequate for recording and transmitting photographic material, including digitized data?
• What is the ability and experience of the center in its organizational structure, to perform protocol procedures, conduct staff training and certification, and participate on study committees?
• What is the experience of the center in receipt and inventory, routing, storage and retrieval, and archiving of study materials?
• What is the experience of the center in timely grading of study photographic images, conduct of quality control and reproducibility measures, and report production to assess performance?

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.

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. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select 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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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:

• Scientific merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to the NEI mission.

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).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Project Director/Principal Investigator (PD/PI) Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

• Defining objectives and approaches, and planning, conducting, analyzing, and publishing results, interpretations, and conclusions of their studies. The design, methods, and procedures of the clinical study will be detailed in an awardee-prepared and maintained, study-adopted Manual(s) of Procedures and the awardees will have the responsibility of following the protocol.

• Retaining custody of and have primary rights to the data developed under these awards, subject to Government rights of access, consistent with current DHHS, PHS, and NIH policies.

• The Chairperson is responsible for the overall conduct of the clinical study and for providing scientific, technical, and administrative leadership to the study. He/She will have lead responsibility for planning and directing all phases of the study and for using the study's resources. In carrying out these responsibilities, the Study Chairperson will actively seek advice from all of the study's components, including the representative of the NEI. The Chairperson is usually the individual who developed the idea for the clinical study and is the leader in preparing the Manual of Procedures and organizing the study components.

• The principal investigator of each resource core center (e.g., Data Coordinating Center) will play an important role in the design, implementation, and execution of the clinical study. Each principal investigator is responsible for all aspects of the operations of his/her resource center and for the local implementation of the study protocol. The resource core centers are involved in performing specified support functions such as training and certification of clinical center staff, designing and maintaining quality assurance programs, data management, data analysis, and preparing publications.

• The principal investigator of each participating clinical center has the primary responsibility of identifying and recruiting eligible patients at his/her center. He/She will be responsible for the follow-up, as specified in the study protocol, of each patient enrolled in the clinical study and for submitting required data to the resource center(s). The principal investigator is also responsible for ensuring that his/her clinic personnel are trained and certified to carry out study procedures.

The grantee institution will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

An NIH Project Scientist [or Project Coordinator, or Project Collaborator, or Intramural Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The appropriate NEI extramural program director from the Division of Extramural Research whose name appears on the Notice of Grant Award will participate with and assist, but not direct:

a. The Study Chairperson and Coordinating Center Director in the nomination and selection of an independent Data and Safety Monitoring Committee (DSMC) or Data Monitoring and Oversight Committee (DMOC), as applicable.

b. The Study Chairperson, Coordinating Center Director, and, when appropriate, the Executive Committee, in assuring that patient information handbooks, recruitment information, press releases, and publicity exhibits are properly prepared and disseminated.

c. The Study Chairperson and Coordinating Center Director in the identification of additional participating clinics, if necessary, in order to enhance patient recruitment.

d. The Executive Committee in routine performance monitoring of the entire study including matters of quality control within and among various components, and in the determination of inadequate patient recruitment or failure to comply with the protocol on the part of individual clinics.

e. The Editorial Committee in the preparation and review of study results for publication.

f. The DSMC or DMOC, as applicable, as an ex officio member and will participate in all decisions of the Committee, e.g., to proceed from one phase of the study to the next, to implement protocol changes, to evaluate patient recruitment issues, to approve any ancillary studies, to plan data analysis, to announce study findings, and to determine the timing of release of any interim or final reports.

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

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

Data and Safety Monitoring Committee (DSMC): A group composed of individuals, not directly involved in patient care or data collection in the trial, who are responsible for periodically reviewing accumulated data for evidence of adverse or beneficial treatment effects; for initiating recommendations for modification of the study protocol, including termination of the treatment when appropriate; and for assessing data quality and clinic performance.

Executive Committee: Composed of the Study Chairperson, who serves as Chair, directors of the resource core centers, the NEI representative, and a small group of clinical center principal investigators who are elected by the full group of participating clinical center principal investigators for a set term. This committee acts as the administrative and executive arm of the clinical trial. It makes decisions on day-to-day operational issues; considers and adopts changes in study procedures as necessary; reviews and implements recommendations from the DSMC; reviews progress of the trial in achieving its main goal and takes steps required to enhance likelihood of success; and, reviews data collection practices and procedures as summarized in performance monitoring reports for clinical centers to identify and correct remediable deficiencies.

Editorial Committee: This committee has the responsibility for reviewing manuscripts produced by the study investigators and for assisting in the preparation of the main trial results. Its members are the Study Chairperson, coordinating center director, the NEI representative, and several clinical center investigators elected by the full group of participating clinical center principal investigators.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Dispute Resolution Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to dispute resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) 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:

Donald F. Everett, M.A.
Division 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: [email protected]

Natalie Kurinij, Ph.D.
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: [email protected]

Maryann Redford, D.D.S., M.P.H.
Division 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: [email protected]

Eleanor Schron, Ph.D.
Division 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: [email protected]

2. Peer Review Contacts:

Samuel C. Rawlings, Ph.D.
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: [email protected]

3. Financial or Grants Management Contacts:

Mr. William W. Darby
Chief Grants Management Officer
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 496-9997
Email: [email protected]

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/.