Bilateral Collaborations to Advance Science and Technology Important to Understanding, Preventing, and Treating Blinding Eye Diseases, Visual Disorders, and their Complications (PAR-21-249)

Bilateral Collaborations to Advance Science and Technology Important to Understanding, Preventing, and Treating Blinding Eye Diseases, Visual Disorders, and their Complications (PAR-21-249) is sponsored by National Eye Institute (NEI). This opportunity supports mission-aligned projects and measurable outcomes.

Expired PAR-21-249: India Collaborative Vision Research Program (R01 Clinical Trial Not Allowed) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Eye Institute ( NEI ) Funding Opportunity Title India Collaborative Vision Research Program (R01 Clinical Trial Not Allowed) R01 Research Project Grant NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available.

See Notice NOT-OD-22-018 . September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022.

August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) encourages Multiple Principal Investigator (Multi-PD/PI) applications from United States (U.S.)-based institutions with an Indian institution partner to establish bilateral collaborations that will advance science and technology important to understanding, preventing, and treating blinding eye diseases, visual disorders, and their complications.

Applications are encouraged from organizations/institutions that propose to conduct research on the basic biology and/or genetics of ophthalmic diseases through collaborations with Indian investigators on the following: diabetic retinopathy, glaucoma, age-related macular degeneration, retinitis pigmentosa, including rare and genetic diseases such as congenital cataracts, as well as other eye conditions such as ocular inflammation/uveitis, refractive error, low vision, and corneal injury.

Basic, translational, or epidemiological research may be proposed. Clinical trials will not be supported under this FOA. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide ,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description Several eye diseases such as diabetic retinopathy, AMD, and glaucoma are complex and influenced by multiple genetic, epigenetic, and environmental factors including family, nutrition, and exposure to toxins. During the past decade, progress has been made identifying these factors.

In AMD, for example, environmental factors including smoking and sunlight have been shown to increase risk, and a diet rich in fatty acids has been shown to decrease risk. There are likely other unknown factors that are involved in precipitating AMD and other ocular diseases.

Large scale genomic, proteomic, metabolomic, and informatic methods using emergent or current technologies to study unique populations are encouraged to identify new factors that can affect susceptibility to these diseases and/or ocular infections, as well as biomarkers that will provide the basis for accurate diagnostic tests and predict treatment outcome.

There are also many eye conditions and complications such as inflammation that affect some intracommunity populations to a much greater extent, providing a valuable resource for learning more about visual restoration as well as the pathogenesis and physiology of a disorder.

For instance, the impact of environmental pollutants, including those generated by cooking stoves, on the development of cataracts, as well as the susceptibility of toxins to cause infections, such as ocular TB and trachoma, are not well understood.

Research on these populations that will further our understanding of neural plasticity including neurogenesis, cognition, and processing after the treatment of visual disorders and injury are also of interest to NEI and the DBT. This FOA is intended to support collaborations between the U.S. and India that focus on the basic biology, epigenetic, and/or genetics of ophthalmic diseases and visual disorders.

Applications may include, but are not limited to collaborations addressing the following areas: Family based genome wide association studies (GWAS) on available cohorts of consanguineous families from India to identify genetic variants that predispose to both Mendelian and complex forms of eye disease; Validation of novel GWAS findings in appropriate animal models; Identification of biomarkers that predict and/or assess risk and response to interventions; Studies of environmental factors that predict risk of eye diseases such as imprinting and other epigenetic effects; Studies to determine the underlying biology of ocular diseases including, AMD, diabetic retinopathy, glaucoma, retinitis pigmentosa, cataracts, myopia and presbyopia; Studies focusing on the basic science of neuroplasticity of vision including perceptual learning and adaptation after eye injury; Studies of the mechanisms through which environmental pollutants/toxins contribute to ocular diseases and their complications including infection and inflammation; Identification of factors that influence the success of corneal transplantation and recovery after surgery.

The FOA requires that the collaboration between the U.S. and Indian research teams be submitted as a Multiple Principal Investigator (Multi-PD/PI) application with both of the lead scientists from each country as the PD/PI. Applications may be derived from existing collaborations with an established history of interaction, or from new partnerships developed in response to this FOA.

The collaboration must be based on interactive relationships that maximize the expertise of the individual U.S. and Indian research teams. Through this FOA, U.S. and Indian collaborating investigators should work together to develop and submit an application to National Institutes of Health (NIH) and the India Ministry of Science and Technology's Department of Biotechnology (DBT).

The Indian application should follow DBT guidance using the 'Proposal Submission form for R&D Projects' format available at the DBT eProMIS portal: http://www. dbtepromis. nic.

in/sample_forms. htm . In addition to a detailed research plan, the application must include a leadership plan that describes the roles, responsibilities, and working relationship of the PD/PIs, as well as information about performance sites, the proposed work to be accomplished at each site, and a complete budget for the collaboration.

Only those applications that are determined to be meritorious will be considered for joint funding and will be supported by the DBT and NIH under this program. The DBT will provide funds for the Indian component and NIH will fund the US component.

The NIH Research Project Grant will directly support salaries of U.S. personnel and research activities within the U.S. It is anticipated that the Indian award will fund the Indian component and will support research activities within India, salaries of Indian research personnel, and other research cost as per DBT norms.

All research in India will be conducted in accordance with both U.S. and Government of India regulations for the protection of human subjects. Note: Organizations must register and apply with their eRA Commons. All U.S. and Indian applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration.

D.

Applications Not Responsive to this FOA The following applications will be considered non-responsive and will not be reviewed for this FOA: Applications that include clinical trials Applications that include research topics that do not fall within the NEI mission and/or the NIH referral guidelines such as the diagnosis and treatment of ocular cancers Applicants are encouraged to confer with an appropriate NEI Scientific/Research Contact to discuss the relevance of the research topic to the NEI mission.

See Section VIII. Other Information for award authorities and regulations. Section II.

Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Application budgets are limited to $250,000 annual direct cost, but need to reflect the actual needs of the proposed project. The project period is limited to three years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.

gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants.

gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants. gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA requires that the collaboration between the U.S. and Indian research teams be submitted as a Multiple Principal Investigator (Multi-PD/PI) application with both of the lead scientists from each country as the PD/PI. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ) Section IV. Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants.

gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants. gov Workspace are available in Part 1 of this FOA.

See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise.

Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages.

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. Other Attachments: Applications are required to include a Collaborative Strategy.

The Collaborative Strategy should include a description of how the proposed collaboration will be maintained throughout the duration of the award.

The following areas should be addressed: Management plan detailing how existing resources will be utilized Planned interaction and responsibilities of key personnel Description of how research teams will communicate (e.g., video/teleconference, web meeting) Plans for making decisions (including those on scientific direction) and procedures for resolving conflicts Available resources (e.g. patient samples, data, and reagents) and details of how these resources will be shared as appropriate.

How the collaboration brings complementary or unique expertise to the project that will enhance the research and stimulates collaborative basic, translational, or applied research between U.S.-based researchers and Indian researchers Provide the information as a single PDF file with the name “Collaboration. pdf. ” SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Letters of Support: Applicants must include a Letter of Support co-written and so-signed by the PD(s)/PI(s) of the NIH application and the Indian collaborating partner and co-signed by the authorizing institutional officials confirming the new or existing collaboration and confirming that the U.S. awardee organization will provide a copy of the NIH submitted application to the DBT through their Indian collaborating partner.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 1. Section III.

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4. Submission Dates and Times Part I.

Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration.

NIH and Grants. gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.

gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. 5.

Intergovernmental Review (E. O. 12372) This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement . 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date.

Section III. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide .

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII .

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide. See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness, compliance, and responsiveness with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete, non-compliant and/or non-responsive will not be reviewed. In order to expedite review, applicants are requested to notify the NEI Referral Office by email at [email protected] when the application has been submitted.

Please include the FOA number and title, PD/PI name, and title of the application. Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy . Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review. Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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

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

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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? Is the proposed project likely to stimulate collaborative basic, translational, or applied research between U.S.-based researchers and Indian researchers? Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project?

If Early Stage Investigators or those 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 U.S. and Indian collaborators bring complementary or unique expertise to the project that will enhance the research project?

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 U.S.-Indian collaboration enhance the existing research capacity at each site? Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?

Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Does the application provide appropriate plans for the collaborative research, demonstrating the integration of the U.S. and Indian collaborator efforts, including communication plans, process for making decision on scientific direction, and procedures for resolving conflicts? Does the application provide appropriate contingency plans and/or solutions for addressing setbacks and delays?

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?

Is the collaboration plan well-defined with clearly identified responsibilities for the U.S. and Indian collaborators, and does it take advantage of the strengths of each collaborator?

Additional Review Criteria As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects .

Inclusion of Women, Minorities, and Individuals Across the Lifespan When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages