Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title

Enhancing Zebrafish Research with Research Tools and Techniques (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PAR-08-139

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-11-131

Companion FOA

PAR-11-130: Genetic Screens to Enhance Zebrafish Research (R01)

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.847, 93.865, 93.396, 93.867, 93.233, 93.837, 93.838, 93.839, 3.,172, 93.866, 93.273, 93.173, 93.121, 93.279, 93.113, 93.859

FOA Purpose

This FOA encourages investigator-initiated applications designed to exploit the power of the zebrafish as a vertebrate model for biomedical and behavioral research. Applications proposing to develop new research tools or techniques that are of high priority to the zebrafish community and that will advance the detection and characterization of genes, pathways, and phenotypes of interest in development and aging, organ formation, neural processes, behavior, sensory processing, physiological processes, and disease processes are welcome. This effort stems from an NIH initiative developed by the Institutes and Centers of the Trans-NIH Zebrafish Coordinating Committee (TZCC) under the co-chairmanship of NICHD and NIDDK.

Key Dates
Posted Date

March 30, 2011

Open Date (Earliest Submission Date)

August 19, 2011

Letter of Intent Due Date

August 19, 2011, August 19, 2012 and August 19, 2013

Application Due Date(s)

September 19, 2011; September 19, 2012; September 19, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

February/March, 2012; February/March 2013; February/March, 2014

Advisory Council Review

May 2012; May 2013; May 2014

Earliest Start Date(s)

July 2012; July 2013; July 2014

Expiration Date

September 20, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This FOA encourages investigator-initiated applications to develop new, high-priority research tools or techniques of high priority to the zebrafish community that will help exploit the power of the zebrafish as a vertebrate model for biomedical and behavioral research. Applications proposing tools or techniques that will enhance the ability to detect or characterize genes, proteins, molecules, and pathways of interest in development and aging, organ formation, neural processes, behavior, sensory processing, physiological processes, and disease processes are welcome. A companion FOA (PAR-11-130; Genetic Screens to Enhance Zebrafish Research) is specifically encouraging applications for new genetic screens.

PAR-02-142, PAR-05-080, PAR-07-145, PAR-08-138 and PAR-08-139 were issued because it was clear that there was a critical need for non-hypothesis-driven proposals to be reviewed as a group within a single framework rather than in standing study sections. These FOAs encouraged applications proposing to develop tools, high priority resources, and genetic screens to identify additional mutants in zebrafish. A number of projects have been funded that have been instrumental in developing and fine tuning tools and methodologies that are important for the research infrastructure of the zebrafish community.

As a result of discussions held with the zebrafish community during 2010, the TZCC (http://www.nih.gov/science/models/zebrafish/) has decided to continue encouragement of non-hypothesis-driven applications. This FOA specifically encourages applications proposing new genetic screens for the purposes of identifying novel genes, pathways, and phenotypes of interest to the participating Institutes. In addition, applications are encouraged that propose pilot testing of existing phenotypic screening methods as applied to high-throughput characterization of mutants generated by large-scale mutagenesis projects. A companion FOA, PAR-11-130, is encouraging applications for the development of for mutant screens in zebrafish.

The objective of this FOA is to continue to broaden the range, power, and utility of tools for biomedical and behavioral research using zebrafish, by developing research tools of high priority to the zebrafish community. Methodology developed and data generated as a result of the FOA are expected to be made widely available to the research community as described by NIH Grants Policy (Principles and Guidelines for Recipients of NIH Research Grants and contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, December 1999, http://www.ott.nih.gov/policy/rt_guide_final.html and the NIH Model Organism Sharing Policy, http://grants.nih.gov/grants/policy/model_organism/index.htm ).

Objectives to be addressed in applications submitted in response to the FOA include, but are not limited to, the following:

Development and/or application of novel methods of mutagenesis (e.g., insertional, site-specific, conditional knockout vectors or systems).

Development of techniques supporting more efficient targeting of induced local lesions in genomes, such as Zn finger nuclease technology.

Development of technologies for gene inactivation and for gene expression manipulation including, but not limited to, morpholino oligonucleotides, new types of antisense technology, techniques for homologous recombination, techniques for gene trapping, and strategies for directing gene misexpression, or other transgenic methodologies.

Development of new genetic or genomic tools or technologies that are of high priority for the zebrafish community.

Development of techniques or technologies for measuring or characterizing proteins or other important molecules in vivo.

Development of novel tools and methods for high-throughput phenotypic screening to support the characterization of mutants generated by large-scale mutagenesis projects. The focus of the application must be restricted to development of the screening tool and a small pilot or validation screen.

Applications that propose novel phenotyping methods or genetic screens will not be accepted in response to this FOA, and should be submitted to PAR-11-130. In addition, large-scale screening efforts and the establishment of screening centers as community resources are outside the scope of this FOA.

Interests of Participating Institutes

The participating NIH Institutes have provided a brief outline of their interests as they relate to the goals of this FOA. These brief mission statements are intended to indicate the breadth of the biomedical areas of interest in which zebrafish are likely to be a useful model.

NCI: Development of novel zebrafish research tools/technologies that would advance the identification and characterization of genes/pathways that affect growth and development; in particular, genes/pathways that when altered result in uncontrolled or cancerous growth.

NEI: Research that falls within the mission of the NEI, especially research that uses zebrafish to understand visual development, repair and regeneration of the eye, including the cornea, lens, retina and areas of the nervous system that deal with visual processing. Other basic research using zebrafish to examine vision loss and visual processing is also important to NEI.

NHGRI: Proposals for the development of high throughput, widely applicable technologies or methodologies to examine gene function on a genomic scale. This could include initial development of high throughput or large-scale methods for examining gene expression, development of tools for comprehensive mutational analysis or genome-scale identification of regulatory regions. NHGRI will not accept applications under this program announcement that propose to support software for resources such as databases or web-based tools.

NHLBI: Tools to characterize cellular and molecular functions of zebrafish genes that have potential to model human cardiovascular, blood, and pulmonary, or sleep disorders. Tools to elucidate topics including: the genetic basis of disorders of cardiovascular development and function; the effects of mutations on subsequent organ development leading to such disorders as arrhythmia, cardiac hypertrophy, dilated cardiomyopathy, and heart failure; developmental aspects of endothelial dysfunction as the basis for vascular disorders; developmental defects in hematopoiesis and the relationship to disorders of the hematopoietic system; genetic basis of angiogenesis, and vasculogenesis; and, the genetic basis, regulation, and role of biological clock mechanisms in development and circadian behavior.

NIA: Development of tools and technologies that contribute to the identification and characterization of cellular and molecular pathways that influence normal aging and age-related diseases.

NIAAA: Development of tools to enhance the use zebrafish as a model for the understanding of the mechanisms for alcohol-induced disorders, including organ damage, and the application of Zebrafish model for alcohol-induced teratogenicity resulting in fetal alcohol spectrum disorders. This includes research projects aimed at developing tools for the study of factors that mediate sensitivity and resistance to alcohol, and tools to enhance the use of other approaches, including research on stem cells, in order to define the mechanisms of alcohol’s effects on human health.

NICHD: Tools or techniques to elucidate the cellular, biochemical, molecular, and genetic mechanisms underlying normal and defective development. This includes, but is not limited to, the study of general mechanisms of pattern formation and cell lineages, cell specification, differentiation, migration, and fate during early development and formation of organs/systems such as the fin, heart, nervous system, neural crest, and immune system.

NIDA: Tools designed to enhance identification of mechanisms underlying tolerance, sensitization, and addiction to drugs of abuse such as nicotine, amphetamine, cocaine, opiates, barbiturates, cannabinoids, and hallucinogens, as well as identification of genetic suppressors and enhancers of the teratological effects of drugs of abuse on the development and function of the nervous system and behavior. Development of tools or techniques to elucidate processes and genetic mechanisms involved in the development of brain regions, neural circuits, and neurotransmitter systems mediating the hedonic and addictive properties of drugs of abuse.

NIDCD: Development of tools and technical methodologies to identify and characterize genes and proteins in normal and disordered development in the areas of hearing, balance, smell, taste, voice, speech, and language. The development and application of the tools should provide insight into the cellular, molecular, and biochemical and sensory processing mechanisms governing the proliferative, regenerative, lineage determination, and developmental capacities of sensory cells and tissues governed within the NIDCD mission areas.

NIDCR: Research to develop tools for the study of all aspects of normal and abnormal craniofacial development, including the origins of the cranial neural crest and craniofacial placodes, complex origins of craniofacial disorders, cell lineages, migration and differentiation, cell signaling, gene and protein regulation, patterning, and imaging of the developing craniofacial structures.

NIDDK: Research that develops tools or techniques to facilitate the study of diabetes, particularly studies on pancreatic beta cell function and development, obesity and mechanisms underlying satiety, other endocrine and metabolic diseases, hematologic disorders, physiology and diseases of the digestive system, liver, kidney, and urinary tract. Studies that develop tools aimed at clarifying the cellular and molecular events that dictate tissue and organ formation in all these systems are considered of relevance. In addition, studies that create resources or tools that will facilitate the use of zebrafish to model physiological processes such as renal function, fluid and electrolyte balance, are relevant to NIDDK.

NIEHS: NIEHS is interested in the development of tools and resources to advance the understanding of the mechanisms for perturbation of a pathway by an environmental agent or exposure to further elucidate environmentally relevant diseases. This includes tools and resources that allow the prediction of the functional significance of genetic variants through the development of high-throughput relatively predictive Zebrafish models. For example, the utilization of Zebrafish to analyze variants or mutations in a single gene or multiple genes that appears to interact with exposure or environmental factors resulting in disease development; the utilization of Zebrafish to analyze the functional validation of genetic variants or SNPs identified in GWAS or gene-environment studies of complex diseases, particularly those that may be epigenomically regulated or regulated by environmental exposures; and the utilization of Zebrafish as a moderate-throughput tool for functional exploration of significance of CNVs associated with complex disease risk. It also includes tools and resources that enhance the utilization of strain-specific susceptibility to toxic compounds in the Zebrafish model organism to understand human susceptibility as well as the development of zebrafish as a moderate-throughput tool to identify environmental toxicants capable of inducing epigenetic changes.

NIGMS: Development of innovative, widely applicable methods for mutagenesis, gene inactivation, and manipulation of gene expression. Novel methods for visualizing recombination, transposition, or any aspect of gene expression in living cells or organisms are of particular interest.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revisions

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

The Participating Institutes anticipate that projects supported by this FOA will require direct costs of less than $500,000 per year. Application budgets need to reflect the actual needs of the proposed project.

Award Project Period

A project duration of up to five years may be requested.

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

Section III. Eligibility Information

1. Eligible Applicants
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 SF 424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

An individual principal investigator may submit only one application per year in response to this announcement. There is no limit to the number of different applications that an applicant institution may submit.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent, preferably by email, to:

Dr. Rebekah S. Rasooly
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases/NIH
Two Democracy Plaza
6707 Democracy Boulevard, MSC 5458
Bethesda, MD 20892-5458 (Courier use Zip 20817)
301-594-6007, FAX 301-480-3510
rr185i@nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed,

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide. Investigators may request funds in their applications to defray reasonable costs associated with sharing materials. See Section IV.6 for details.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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 Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

As per NOT-OD-04-042 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html), investigators may request funds in their applications to defray reasonable costs associated with sharing materials or data or transfer of model organisms and associated data to appropriate repositories. These costs should be considered in developing the budget for the project. For applications with modular budgets, this cost estimate should be included as part of the resource sharing plan. For non-modular applications with detailed budgets, the cost estimate should be justified as part of the requested budget.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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 review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

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

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?

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?

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/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

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

Revisions

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

Additional Review Considerations

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

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

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

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

Scientific/Research Contact(s)

Rebekah S. Rasooly, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-6007
Email: rr185i@nih.gov

A complete list of programmatic contacts for the participating TZCC Institutes and Centers can be found at http://www2.niddk.nih.gov/Research/ScientificAreas/Kidney/ToolsForZebrafishResearch.

Peer Review Contact(s)

John Burch, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-408-9519
Email: John.Burch@nih.gov

Financial/Grants Management Contact(s)

Ms. Pamela Love
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-6198
Email: Pamela.Love@nih.gov

A complete listing of Grants Management contacts for the participating TZCC Institutes and Centers can be found at http://www2.niddk.nih.gov/Research/ScientificAreas/Kidney/ToolsForZebrafishResearch

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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NIH Funding Opportunities and Notices



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