Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|
Funding Opportunity Title |
Early-Stage Pharmacological Validation of Novel Targets and Accompanying Pre-Therapeutic Leads for Diseases of Interest to the NIDDK (R01) |
Activity Code |
R01 Research Project Grant |
Announcement Type |
New |
Related Notices
|
|
Funding Opportunity Announcement (FOA) Number |
PAR-13-007 |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.847 |
Funding Opportunity Purpose |
The overarching goal of this Funding Opportunity Announcement (FOA) is to promote translation of basic science research into knowledge and tools that can be utilized to provide strong justification for later-phase drug discovery and development efforts in areas relevant to the National Institute of Diabetes and Digestive and Kidney Diseases. This includes obesity, diabetes and related aspects of endocrinology and metabolism, digestive diseases, liver diseases, nutrition, kidney and urological diseases, hematology, and specific aspects of cystic fibrosis. For additional information on disease areas of interest to the NIDDK, please see http://www2.niddk.nih.gov/Research/ . Its objective is to stimulate research and technology development to promote the early-stage pharmacological validation of drug targets and accompanying small molecule chemical scaffolds or non-viral biologics that are not currently a focus within the biotechnology and pharmaceutical industries. It is expected that there is significant novelty in either the target, chemical scaffold, or non-viral biologic itself, or in the approaches used to pursue further target validation. It is not intended to support research focused on understanding normal biology, disease processes, or generating lists of putative new targets. At the end of the project period, a successful project will have provided a significant contribution to the data supporting the validity of modulating a target’s activity for safe, efficacious treatment of a disease using a small molecule or non-viral biologic approach. |
Posted Date |
October 10, 2012 |
Open Date (Earliest Submission Date) |
January 5, 2013 |
Letter of Intent Due Date |
30 days prior to application receipt date. |
Application Due Date(s) |
Standard dates, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
Standard dates apply |
Earliest Start Date(s) |
Standard dates apply |
Expiration Date |
March 8, 2016 |
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.
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
Recent significant advances in genetics, the basic understanding of physiology, and the pathogenesis of disease coupled with technological advances in areas such as bioinformatics, chemical biology, synthetic chemistry, and protein engineering have provided a rich knowledge base and strong toolbox to identify and pursue new drug targets with the goal of generating new molecular therapies for the treatment of diseases. Despite the availability of these approaches, we are facing an increased failure rate of potential therapeutics for reasons of both safety and lack of human efficacy in clinical trials. Therefore, a critical need exists to develop better strategies to validate and prioritize targets and pre-therapeutic lead molecules based on their likelihood of success to safely alter disease progress and outcomes in humans. For information on disease areas of interest to the NIDDK, please see: http://www2.niddk.nih.gov/Research/.
The process of identifying and validating drug targets, small molecule chemical scaffolds, or non-viral biologics for the treatment of human disease begins with a hypothesis and can be viewed as progressing along a continuum of increasing confidence leading to widespread acceptance of its use in patient populations. For the purposes of this FOA, these stages are defined as:
Clinical target validation: Is defined as studies conducted in human patient populations to fully understand the efficacy and safety profiles of a compound and its associated target. True validation of a target may take decades of post-regulatory approval data accumulation.
Early-stage pharmacological target validation: Is a process of pre-clinical hypothesis testing to generate data that, over time, increases confidence that pharmacological manipulation of a target may be clinically efficacious and safe. This process occurs prior to clinical testing of a new compound but should include the use of human-derived data, tissues, cells, and systems.
Target identification: The generation of scientific evidence that a target is exploitable and involved in some significant way with a disease process.
This FOA is intended to stimulate research that furthers early-stage pharmacological target validation and accompanying pre-therapeutic leads to a point where there is sufficient scientific evidence to justify larger scale drug discovery and development efforts. It is not intended to support target identification or clinical target validation. Later stage drug discovery and development efforts for targets may be pursued via mechanisms outside of this FOA such as, but not limited to, spin-off companies, licensing to or partnering with pharmaceutical companies, other funding opportunity announcements, and non-profit organizations.
Examples of the level of early-stage target, chemical scaffold, or non-viral biologic validation intended to be pursued under this funding opportunity include, but are not limited to:
- Elucidation of the initial structure-activity relationship and absorption, distribution, metabolism, excretion, and toxicity properties of a small molecule chemical scaffold to demonstrate its in vivo potential for further optimization;
- Providing strong data, using well validated and predictive animal and/or human tissue-based models, that there is a high likelihood that a target's modulation by a small molecule or non-viral biologic will treat a disease.
This funding opportunity announcement is intended to extend the level of early-stage pharmacological validation of novel targets, novel chemical scaffolds, and novel non-viral biologics that are not the focus of significant efforts in the biotechnology and pharmaceutical industry for treatment of diseases within the mission of the NIDDK. Applications must include a strong justification for the selection and appropriateness to the mission of the NIDDK of both the target and small molecule chemical scaffold or non-viral biologic as well as a discussion of the relevant prior art, intellectual property, and competitive landscape.
Particular areas of interest include, but are not limited to:
- Medicinal chemistry efforts to understand the structure activity relationships of a chemical scaffold to improve its use as an early pre-therapeutic lead, possibly including initial characterization of absorption, distribution, metabolism, excretion, and toxicity properties;
- The use of computational approaches to chemical scaffold hopping to identify and test novel chemical scaffolds directed at a target, possibly including synthesis or purchase of small focused libraries;
- Protein engineering of prototype molecules that modulate the activity of key regulators of tissue and organ regeneration to generate pre-therapeutic lead molecules;
- Pharmacological testing of pre-therapeutic leads for novel targets coupled with the evaluation of novel models to better predict the efficacy of compounds (e.g. next-generation animal models, interconnected human organoid systems);
- Generation of a pre-therapeutic protein and its use in proof of concept studies in animal and/or human tissue-based models of disease;
- Protein engineering of prototype non-viral biologics to understand their structure-function relationships against a novel drug target for the purpose of developing a pre-therapeutic lead;
- The development and use of nanotechnology or bioinspired materials in conjunction with molecule optimization to result in significant enhancements to the potential therapeutic properties of the molecule (e.g. organ- or cell-type specific targeting, prolonged half-life, environment-sensitive compound release);
- The development of novel formulations, including the delivery of multiple therapeutic agents, which have the potential to significantly enhance the therapeutic potential of the molecule(s) being studied.
The following are types of applications that are not appropriate for this FOA:
- Applications for which prototype molecules have not yet been identified (e.g. assay development projects, high throughput screening of large small molecule libraries, fractionation of natural products);
- The development of novel tools, models, or technologies without an integrated plan for their use in target, chemical scaffold, or non-viral biologic target validation;
- Research focused on understanding normal biology or disease processes;
- Projects in which the primary focus is medicinal chemistry or protein engineering without an integrated plan to evaluate the validity of the target for a disease within the mission of the NIDDK;
- Applications primarily focused on identifying new targets.
1. Targets. This funding opportunity announcement is intended to cover a wide array of potential drug targets relevant to the diseases of interest to the NIDDK. Targets may be any of the three types below:
- Defined molecular targets (e.g. GPCRs, nuclear receptors, kinases, etc.);
- Biochemical or cellular pathway targets (e.g. activation of a select phosphorylation cascade, beta-cell insulin synthesis and release);
- Phenotypic targets (e.g., mechanisms of autoimmunity, organ regeneration in whole simple organisms, blood glucose lowering in diabetic models).
Applicants must include a discussion of:
- What is novel about the target or approach to the target (e.g. the target itself, a new understanding of the biology around the target, a class of compounds with novel properties at the target);
- How the target is relevant to the mission of the NIDDK;
- How pharmacological manipulation by the prototype molecules is likely to modulate disease processes.
2. Prototype molecules. The starting points for medicinal chemistry or protein engineering may have been selected through many approaches such as high throughput screening, fractionation of natural products, phage display libraries, screening in model organism phenotypic assays, etc. Applications must include an in-depth description of their initial prototype small molecules or non-viral biologic as well as a plan for the generation and/or synthesis of refined derivatives. Preliminary data should include:
- Demonstration of a reproducible response within the assays proposed for further optimization and target validation;
- Analytical data showing appropriate quality, identity and suitability of the molecule;
- Ability to serve as a tractable starting point for optimization by medicinal chemistry or protein engineering.
The submission of applications with back-up prototype molecules is encouraged to increase the overall likelihood of a successful project.
3. Assays. The application should provide a sound rationale for the choice of established in vitro and/or in vivo assays that will be used to support optimization of prototype molecules and continued target validation. These assays are expected to exhibit reproducible behavior in response to the prototype molecule and, where possible, additional control compounds. Assays should be presented within the context of a compound testing flow diagram for testing newly derived molecules and should be of sufficient throughput to support testing based on their position in the flow diagram.
It is acceptable to include the co-development of new assays (e.g. next-generation animal models, interconnected human organoids) that do not meet the requirements above, but it is expected that this co-development will incorporate benchmarking against more established assays.
4. Emerging technologies. The emergence of truly novel therapeutics may necessitate new approaches. The co-development of these technologies, tools, and models as well as the exploration of new chemical and biological space in direct support of target validation efforts within an application is appropriate. If proposing such co-development, applicants must include a section discussing why the development of these technologies is necessary to advance target validation for a disease relevant to the mission of the NIDDK and provide preliminary data that the approach is feasible. Examples of such approaches are:
- The co-development of new technological approaches for validating targets as well as generating new molecules that modulate the biological activity of these targets;
- New models that recapitulate better the human disease state or susceptibility to toxic effects;
- Accessing new molecular space for the identification of new classes of small molecule chemical scaffolds or the generation of new approaches to non-viral biologic therapeutics in order to find compounds specific for novel targets.
Applications may propose interaction with NIDDK-funded existing research consortia, such as the Beta Cell Biology Consortium (www.betacell.org), the Nuclear Receptor Signaling Atlas (www.nursa.org), the Diabetic Complications Consortium (www.diacomp.org), the Mouse Metabolic Phenotyping Centers (www.mmpc.org), the Intestinal Stem Cell Consortium (iscc.coh.org), or the GenitoUrinary Development Molecular Anatomy Project (www.gudmap.org).
Applicants are encouraged to take advantage of the resources provided by the National Center for Advancing Translational Sciences' Clinical Translational Science Awards (CTSAs) program, (http://www.ncats.nih.gov/research/cts/ctsa/ctsa.html) to leverage resources for therapeutic discovery in areas described in this FOA. CTSA resources include, for example, core facilities, super computer centers, biostatistics, bioinformatics, community engagement network, tissue repositories, and animal models. For more information about resources available at individual CTSAs, please contact the Program Officials listed at http://www.ncats.nih.gov/research/cts/ctsa/contact/contact.html.
Applicants that have not yet identified prototype chemicals as start points should consider the Molecular Libraries Program (http://mli.nih.gov/mli/) and the following FOAs: Development of Assays for High-Throughput screening for use in Probe and Pre-therapeutic Discovery (R01) http://grants.nih.gov/grants/guide/pa-files/pa-10-213.html; Solicitation of Assays for High Throughput Screening (HTS) to Discover Chemical Probes (R01) (http://grants.nih.gov/grants/guide/pa-files/PAR-12-058.html).
Projects at the stage of needing pre-clinical development activities should contact the NIH program for Bridging Interventional Development Gaps (http://www.ncats.nih.gov/research/reengineering/bridgs/bridgs.html).
Funding Instrument |
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
Application Types Allowed |
New 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 |
Applications are limited to $500,000 in direct costs per year and the budget must reflect the scope of the proposed project. |
Award Project Period |
The scope of the proposed project should determine the project period. The maximum project period is 5 years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
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
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
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- U.S. Territory or Possession
Other
- 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
- Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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 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.
- System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the SAM.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
- Grants.gov
- eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at least
4-6 weeks prior to the application due date.
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 PD(s)/PI(s), visit the Multiple
Program Director(s)/Principal Investigator(s) Policy and submission details in
the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R)
Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
- To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
- Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
- Of an application with a changed grant activity code.
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.
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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
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 1-page 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 to:
Dr. Aaron Pawlyk
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes, Digestive and Kidney
Diseases (NIDDK)
6707 Democracy Boulevard, Room 788B
Bethesda, MD 20892
Telephone: 301-451-7299
Email: [email protected]
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 submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Milestones and Timeline
Applicants are required to include project performance and timeline objectives as a component of the Research Strategy; this does not extend the 12-page limitation of this section. Applications lacking the Milestones and Timeline section will be deemed incomplete. This section should be limited to 1 page and should include:
- An explanation of how iterative rounds of compound generation and compound testing will be used to assess the validity of target manipulation for disease treatment throughout the project period;
- A clear description of all interim objectives to be achieved during the course of the project and how they relate to the overall goal of extending both target and molecule validation;
- A detailed schedule or timeline for the anticipated attainment of each milestone and the objective of extending both target and molecule validation;
- Plans for the future pre-clinical development of the resulting molecules.
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, with the following modification:.
- All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
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 (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
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.
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.
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(s)/PI(s) 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 System for Award Management (SAM). 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.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Important Update: See
NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.
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.
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).
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? Is there a valid scientific and therapeutic need for additional target validation within the proposed NIDDK-relevant disease area?
Investigator(s)
Are the PD(s)/PI(s), 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the team members possess the scientific expertise to effectively pursue target validation with the goal of translating the knowledge gained to disease relevant applications?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the project pursue a target, chemical scaffold, or biologic that is not already the subject of significant translatable efforts in the biotechnology or pharmaceutical industry towards an NIDDK-relevant disease? If appropriate, does the application address the intellectual property and competitive landscapes? If co-development of a new animal model or other technology is proposed, will it address a clear need and significantly advance drug discovery efforts in the field?
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? Does
the approach propose research that will initiate, continue, or enable the
translation of basic research towards strong validation of a target, chemical
scaffolds, or biologic within the mission of the NIDDK? Have the investigators
proposed realistic and achievable milestones and timeline for the proposed
work? Have they included a realistic plan for future pre-clinical development
of compounds?
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? Does the scientific environment provide the necessary resources to effectively pursue target validation with the goal of translating the knowledge gained to an NIDDK-relevant disease application?
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
Not Applicable
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s)convened by the Center for Scientific Review, 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:
- May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact/priority score.
- Will receive a written critique.
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. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC). The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
After the peer review of the application is completed, the PD(s)/PI(s) 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.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
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.
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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Aaron C. Pawlyk, Ph.D.
Program Director for Pharmacogenomics and Drug Discovery
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK)
Telephone: 301-451-7299
Email: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Diana O'Donovan
Senior Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK)
Telephone: 301-594-8868
Email: O'[email protected]
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.
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.
