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 Biomedical Imaging and Bioengineering (NIBIB)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Human Genome Research Institute (NHGRI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA))
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Dental and Craniofacial Research (NIDCR))
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)

Funding Opportunity Title

Nanoscience and Nanotechnology in Biology and Medicine (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PA-08-052

Related Notices

  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
  • August 1, 2011 - See Notice NOT-EB-11-007. The purpose of this Notice is to correct FOA to indicate that foreign institutions are not eligible to apply.

Funding Opportunity Announcement (FOA) Number

PA-11-148

Companion FOA

PA-11-149, R21 Exploratory/Developmental Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility

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

93.286, 93.113, 93.867, 93.837, 93.172, 93.866, 93.173, 93.121, 93.113, 93.859, 93.853, 93.279, 93.273, 93.361, 93.865, 93.846, 93.855, 93.856

FOA Purpose

This initiative, issued by the National Institutes of Health, encourages applications from institutions/organizations that apply nanoscience and nanotechnology approaches to address problems in biology and medicine.  The purpose of this FOA is to provide support for cutting-edge nanoscience and nanotechnology research that can lead to biomedical breakthroughs and new investigations into the diagnosis, treatment and management of an array of diseases and traumatic injuries.  Nanoscience and nanotechnology have the capacity to drive a new wave of medical innovation through the engineering of bioactive nanoscale structures, processes and systems based on the advancement of our understanding of biology at the nanoscale.  Therefore, this FOA will also support research projects that develop new or improved nanotechnology and nanoscience-based tools, methods, concepts, and devices that lead to a better understanding of basic biology in addition to conducting translational biomedical studies.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

May 5, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

May 8, 2014

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

Research Objectives

Nanoscience and nanotechnology refers to the understanding and control of matter at the atomic, molecular or macromolecular levels, at the length scale of approximately 1 - 100 nanometers.  The objective of this FOA is to encourage the study of basic biological phenomena and engineer nanotechnology solutions that will enable biomedical breakthroughs in the diagnosis, treatment, and management of diseases and traumatic injuries.  Research projects may include the development, modification, or integration of advanced nanotechnologies and nanoscience-based tools, methods, concepts, and devices in addition to engineering nanoscale structures and systems to study and understand biological processes in health and disease and to develop novel diagnostics and interventions for treating disease.  

Background

Nanotechnology emerges from the physical, chemical, biological, and engineering sciences, where novel tools and techniques are being developed to probe and manipulate single atoms and molecules. These tools have already enabled a myriad of new discoveries of how the properties of matter are governed by the atomic and molecular arrangements at nanometer dimensions. These discoveries have impacted manufacturing processes of a wide range of materials and devices resulting in substantial improvements of existing technology as well as entirely new technological innovations.  For example, nanolithography is a very active area of research used to fabricate nanometer-scale structures, meaning patterns with at least one lateral dimension between the size of an individual atom and approximately 100 nm.  Others areas include atomic layer deposition and scanning probe microscopy coupled with corresponding advances in supramolecular chemistry.  The ability to control the design properties of materials and devices at the nanoscale is also possible by exploiting strategies that are frequently complemented by bottom up engineering approaches. With the state-of the-art engineering techniques in materials science today, nanoscience and nanotechnology-based approaches are well poised to revolutionize research in biology and medicine.

Studies that employ nanotechnology techniques and concepts and are focused on biological processes will also give completely new insights into the physical relationships between cellular components and functional irregularities that trigger pathological abnormities. Here, nanotechnology and nanoscience offer a means to control the design and assembly of biomolecular processes relevant in health and disease.  For example, the processes involved in energy conversion have been studied for many years through enzymology and structural biology, advances in the development and adaptation of nanotechnology and nanoscience-based approaches have the potential to construct a biomolecular machine that uses biological energy sources such as ATP or electrochemical gradients in novel ways. The successful design and development of such biomolecular machines would demonstrate understanding of a key biological process and create opportunities for interventions based on engineering principles. Ultimately, it will be possible to understand cells from a genetic, biochemical, physiological, and engineering perspective, thus enabling the fabrication of nanoscale modules de novo for therapeutic applications. The nanoscale engineering principles derived could also lead to novel bioinspired systems and architectures, such as biocompatible nanomachines incorporating polymer-based motility inspired by lessons learned from the study of biological models. 

Nanotechnology can also be used to design multi-functional and multi-analyte diagnostic systems that not only define early stage changes or progression to a disease state, but also allow the identification of unique biological molecules, chemicals and structures not addressable by current assays.  Nascent nanotechnology-based imaging agents for inflammation, metastasis, and angiogenesis are also emerging while nanoscale multifunctional materials, capitalizing on progress in genomics and proteomics, allow targeted delivery of molecular therapies with enhanced efficacy.   Significant progress in the engineering of nanoprobes for imaging of cellular events, nanosensors to identify multi-functional analytes create opportunities to observe phenomena at the molecular level and allow researchers to study the function of biomolecules, supramolecular assemblies and organelles of living cells for further manipulation.  Despite such emerging technologies, much more progress is still needed to adapt and translate nanoscience and nanotechnology solutions to biomedical innovation and applications.

For the purpose of this FOA, the proposed nanotechnology and nanoscience-based projects must target a specific problem or need in biology or medicine.  Applications proposing only the use of commercially available nanoscale tools (e.g. commercial quantum dots as imaging agents) to study biological processes without specific technology development or application elements specific to biological processes are not appropriate for this initiative.  Nanomaterial researchers are also encouraged to adopt standards, enable data sharing, and promote interoperability.

Because this subject matter encompasses a broad spectrum of research opportunities, applicants are encouraged to review and consider the focus areas identified by the participating NIH institutes outlined below.  It is also important to note that research ideas and concepts designed to meet the goal of this FOA are not limited to these institute-specific interests or the areas described above.

Areas of Interests

Participating NIH Institutes and Centers have identified areas of interests in nanoscience and nanotechnology research relative to the goals of this FOA.  This list is not meant to be exhaustive, exclusive, or to limit creativity and innovation, but rather illustrations of studies relevant to this FOA.

The National Cancer Institute (NCI) is interested in the development of, but not limited to, the following research areas:

1. Nanotechnology-based diagnostic assays and imaging devices that would provide significantly improved sensitivity, specificity and selectivity in cancer detection;

2. Nanotechnology-based in vivo drug delivery techniques allowing for a significant increase in therapeutic index of the treatment;

3. Cancer theranostics with improved targeting, biocompatibility and imaging contrast capability;

4. Paradigm-shifting approaches to nanomaterials fabrication for cancer applications that could lead, e.g., to improved control of size, shape, surface characteristics, and lower fabrication costs.

NCI's specific areas of focus and application include:

1. Nanotechnology-based techniques enabling understanding, prevention, detection, and elimination of metastases,

2. Nanotechnology-based techniques enabling understanding and overcoming of multi-drug resistance phenomenon (MDR),

3. Nanotechnology tools and devices aimed specifically at monitoring of the tumor mecroenvironment, its heterogeneity, and its changes during tumorogenesis,

4. Nanotechnology-based techniques for improved immunotherapies,

5. Nanotechnology tools and devices which can penetrate cellular barriers that may limit devices accessibility to intended targets (notably including the blood-brain-barrier),

6. Nanotechnology-based techniques allowing for capture, monitoring, and characterization of circulating tumor cells (CTCs),

7. Methodologies for predictive modeling and understanding of nanomaterials' pharmacokinetics and pharmacodynamics in in-vivo environment.

The National Eye Institute (NEI) is interested in research and development involving nanoscience and nanotechnology approaches for the visual system in health and disease including, but not limited to:

1. Drug delivery systems,

2. Tissue engineering (self-assembly),

3. Biotic-abiotic interface with respect to implants and prosthetics.

The National Human Genome Research Institute (NHGRI) is interested in research involving, but not limited to,  nanoscience and nanotechnology to develop:

1. Innovative techniques for DNA sequencing;

2. Novel hybridization/probe-based nucleic acids tools for high throughput assays that enable, for example, gene expression analysis, genotyping, and single nucleotide polymorphism detection and scoring, and epigenomics assays.

The National Heart, Lung, and Blood Institute (NHLBI) is interested in the use of nanotechnology for the diagnosis and treatment of heart, lung, and blood diseases. Examples of NHLBI interests include, but are not limited to:

1. Development of targeted nanomaterials for the diagnosis and/or treatment of cardiovascular, lung, and blood diseases with a specific emphasis on: (i) Development of novel small molecule targeting agents for site specific delivery of the nanomaterials and (ii) Incorporation of therapeutic payload and/or imaging beacon;

2. Development of novel nanomaterials as artificial blood substitutes;

3. Development of nasal delivery nanomaterials targeted to image and/or treat pulmonary diseases

4. Development of nano-structured surface coatings on mechanical devices to reduce thrombosis and/or infection;

5. Development of nano-scaffolds to promote myocardial regeneration.

The National Institute on Aging (NIA) is interested in research and developmentsuch as, but not limited to:

1. Nanomaterials or nanoprobes for imaging, detecting and measuring biological processes that change in cells, tissues and organs with age and age-related disease;

2. Development of nanomaterials for diagnosis or biomarkers of age-related disease and associated loss of tissue function;

3. Design of nanoparticles or devices for novel drug delivery and/or for functional tissue repair and regeneration.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in projects to design, develop or make use of nanoscale devices for, but not limited to:

1. Determination of in vivo alcohol and alcohol metabolite concentrations (biosensors);

2. Monitoring acute and chronic effects of alcohol exposure (biomarkers);

3. Tissue-specific imaging and monitoring of alcohol actions;

4. Optimizing drug delivery including tissue (e.g., CNS, liver and lung) and subcellular (e.g., mitochondrial)-targeting.

The National Institute of Allergy and Infectious Diseases (NIAID) is interested in projects implementing nanoscience and nanotechnology to address, but not limited to, the following priorities:

1. Nanotechnology-based delivery systems for: (i) Chemo-immuno-therapeutics and prevention approaches including vaccines and topical microbicides and (ii) Pathogen-specific targeting,

2. Tools and approaches to understand viral, bacterial, and fungal pathogenesis and host cellular immune response to allergens and/or infecting pathogens;

3. Bio-imaging applications for disease and treatment evaluation;

4. Rapid and potentially cost effective platforms for pathogen detection, resistance evaluations, host response, biomarker evaluation, and genetic testing in early and established disease;

5. Interrogation of the safety of current and proposed nanotechnology platforms and strategies.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is interested in research and development involving nanoscience and nanotechnology approaches for musculoskeletal and skin health and disease in the areas of, but not limited to, implants, imaging, drug and gene delivery, and functional tissue engineering.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is interested in nanoscience and nanotechnology as it relates to the Institutes' scientific program areas (http://www.nibib.nih.gov/Research/ProgramAreas) with particular emphasis on, but not limited to, the:

1. Development of enabling nanotechnologies for drug and gene delivery systems and devices, sensors and micro/nanosystems, and tissue engineering;

2. Development of new sets of design principles to generate biomaterials with nano-level interfacial properties for tissue engineering, implants, and medical devices;

3. Development of techniques to characterize the physical, chemical, structural, and biological properties of nanostructured assemblies/materials to advance biomedical technologies;

4. Development of new materials processing methodologies for the synthesis, and/or optimization, of new or existing nanomaterials for biomedical applications;

5. Research and development of nanomaterials and structures for novel biomedical imaging agents and molecular probes targeting preclinical and clinical applications;

6. Research and development of nano-scale technologies for biomedical imaging;

7. Development of predictive models and simulations for understanding nanomaterials in vivo performance (e.g, compatibility, therapeutic efficacy).

The National Institute of Child Health and Human Development (NICHD) is interested in projects that utilize nanoscience and nanotechnologysuch as, but not limited to:

1. Build devices that integrate with dysfunctional tissue;

2. Selective delivery of drugs and gene products;

3. Nanotexturing of surfaces and effects on cells and microorganisms;

4. Manipulation of cells with carbon nanotubes and interaction of cells and nanotubes;

5. Supporting the development of point of care applications that will improve the quality and access to care for women and children;

6. Supporting safe use of nanomaterials during pregnancy;

7. Supporting the development of new, and the improvement of existing, micro/nanofluidic technologies to treat infertility, preserve fertility and derive therapeutic cells from stem cells.

The National Institute on Drug Abuse (NIDA) is interested in research projects on, but not limited to:

1. Drug development and nano formulations of existing therapeutic drugs;

2. Selective and controlled drug delivery;

3. Molecular and cellular imaging

The National Institute on Deafness and Other Communication Disorders (NIDCD) is interested in projects that utilize nanotechnology to address normal and disordered processes of voice, speech, language, smell, taste, balance and hearing such as, but not limited to:

1. Medical implant surface coating for enhanced integration with neural or other biological tissues;

2. Targeted delivery of drugs, genes and other small molecules;

3. Therapeutics to better detect or treat disordered processes, such as biofilm formation in the middle ear.

The National Institute of Dental and Craniofacial Research (NIDCR) is interested in research projects that focus on nanoscience and nanotechnology approaches such as, but not limited to:

1. Understand, control and manipulate cellular process of orofacial structures (e.g., tooth, salivary glands, bone, muscles);

2. Develop new materials with novel properties for the repair of tooth decay and periodontal disease;

3. Develop new technologies for the study and the prevention of oral biofilm formation.

The National Institute of Environmental Health Sciences (NIEHS) is interested in research projects such as, but not limited to, the:

1. Evaluation of individual exposure to toxicants both external and internalized dose;

2. Evaluation of the biological response to toxicants and the correlation of response to exposure with the etiology and progression of disease and dysfunction;

3. Development of nanotherapeutic applications of nanotechnology to interfere in the influences of environmental factors on disease processes.

The National Institute of General Medical Sciences (NIGMS) is interested in research projects such as, but not limited to,  the:

1. Development of materials/methods for imaging subcellular structures at the nanoscale in living cells;

2. Detection and manipulation of single molecules in vitro & in vivo;

3. Development of new tools to query subcellular processes at the nanoscale

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in research leading to the development and demonstration of, but not limited to:

1. Nanoscale materials that modulate differentiation, plasticity, and repair within the nervous system;

2. Nanoscale interfaces for stimulation and recording from the nervous system in health and disease;

3. Biodegradable multifunctional nanoparticles for imaging and monitoring of the nervous system;

4. Nanoscale imaging technologies for neuropathologies;

5. Nanoscale approaches for pharmacological and gene-based therapies to cross the blood brain barrier.

In addition, NINDS is interested in work to understand the interactions at the nanoscale that control growth cone dynamics, axonal guidance, dendrite formation, synaptogenesis, or neurodegenerative processes.

The National Institute of Nursing Research (NINR) is interested inapplications such as, but not limited to:

1. Interdisciplinary research in nanotechnology;

2. Risk and benefits of nanotechnology;

3. Development of sensing technologies that enable real-time monitoring of health indicators and responses to treatment for individuals self-managing their chronic conditions;

4. Technology applications for early detection of disease in at-risk populations;

5. Systems of targeted drug delivery to treat severe pain and to provide palliation at the end of life.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revision

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

Application budgets are not limited, but need to reflect actual needs of the proposed project. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

Award Project Period

The total project period for an application submitted in response to this funding opportunity may not exceed five 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.

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 not 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 (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project 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.

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.

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),

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

Not Applicable

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 incompletewill not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

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

Not Applicable.

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)  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

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. 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.

 Applicants should contact the participating IC to discuss the programmatic relevance of their research to the topics listed in Section I. Funding Opportunity Description and to the IC’s mission.  Contact information for all participating ICs is provided below.     

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 301-435-0714
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)

Piotr Grodzinski
National Cancer Institute (NCI)
Phone: (301) 594-4177
Email: grodzinp@mail.nih.gov

Yali Fu
National Cancer Institute (NCI)
Phone: (301) 496-8783
Email: fuyali@mail.nih.gov

Richard Fisher
National Eye Institute (NEI)
Phone: (301) 496-4308
Email:  fisherr@mail.nih.gov

Jeff Schloss
National Human Genome Research Institute (NHGRI)
Phone: (301) 496-7531
Email:  jeff_schloss@nih.gov

Narasimhan Danthi
National Heart, Blood, Lung Institute (NHLBI)
Phone: (301) 435-0513
Email: ndanthi@nhlbi.nih.gov

Brad Wise
National Institute of Aging (NIA)
Phone: (301) 496-9350
Email:  wiseb@nia.nih.gov

Thomas Gentry
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
Phone: (301) 443-6009
Email:  tgentry@niaaa.nih.gov

Tia Frazier
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: (240) 627-3073
Email: frazierti@niaid.nih.gov

Karl Salzwedel
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: (301) 496-5332
Email: salzwedelkd@niaid.nih.gov

Fei Wang
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: (301) 451-2818
Email: wangf@mail.nih.gov

Steven Zullo, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: (301) 451-4774
Email: zullo@helix.nih.gov

Michael Weinrich
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phone: (301) 402-4201
Email: weinricm@mail.nih.gov

Thomas Aigner
National Institute of Drug Abuse (NIDA)
Phone: (310) 435-1314
Email: ta17r@nih.gov

Roger Miller
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: (301) 402-3458
Email:  Roger.Miller@nih.gov

Nadya Lumelsky
National Institute on Dental and Craniofacial Research (NIDCR)
Phone: (301) 594-7703
Email: nadyal@nidcr.nih.gov

David Balshaw
National Institute of Environmental Health Sciences (NIEHS)
Phone: (919) 541-2448
Email: balshaw@niehs.nih.gov

Cathy Lewis
National Institute of General Medical Sciences (NIGMS)
Phone: (301) 594-0828
Email: lewisc@nigms.nih.gov

Kip Ludwig
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: (301) 496-1447
Email: kip.ludwig@nih.gov

Paul Cotton
National Institute of Nursing (NINR)
Phone: (301) 402-6423
Email: cottonp@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Nancy Curling
National Institute of Biomedical Imaging and Bioengineering
Phone: (301) 451-4782
Email: curlingn@mail.nih.gov

Chris Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: (301) 402-3458
Email:  Christopher.Myers@nih.gov

Cheryl Chick
National Human Genome Research Institute (NHGRI)
Phone: (301) 435-7858
Email:  cheryl_chick@nih.gov

Mary Greenwood
National Institute on Dental and Craniofacial Research (NIDCR)
Phone: (301) 594-4808
Email: mary.greenwood@nih.gov

Randi Freundlich
National Institute of Nursing (NINR)
Phone: (301) 594-5974
Email: freundlichr@mail.nih.gov

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.