Department of Health and Human Services
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Cancer Institute (NCI) (http://www.nci.nih.gov/)
National Eye Institute (NEI) (http://www.nei.nih.gov/)
National Heart, Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/)
National Human Genome Research Institute (NHGRI) (http://www.genome.gov/)
National Institute on Aging (NIA) (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov)
National Institute of Arthritis and Musculoskeletal and Skin Disease (NIAMS) (http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidr.nih.gov/)
National Institute of Drug Abuse and Addiction (NIDA) (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov/)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/)
Title: Nanoscience and Nanotechnology in Biology and Medicine (R21)
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.Program Announcement (PA) Number: PAR-07-271
Note: This was initially published as PAR-07-034 on 12/28/2006. Replaced in total by PAR-07-271 on 1/4/2007.
Catalog of Federal Domestic Assistance Number(s)
93.394, 93.395, 93.396, 93.389, 93.867, 93.172, 93.837, 93.838, 93.839, 93.233, 93.866, 93.273, 93.855, 93.856, 93.846, 93.286, 93.173, 93.121, 93.847, 93.279, 93.113, 93.115, 93.859, 93.242, 93.853
Release/Posted Date: January 4, 2007
Opening Date: January 5, 2007(Earliest date an application may be submitted to Grants.gov)
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): February 20, June 20, October 22, 2007
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: October 23, 2007(http://grants1.nih.gov/grants/funding/submissionschedule.htm)
Due Dates for E.O. 12372
This funding opportunity (FOA) is aimed at enhancing nanoscience and nanotechnology research focused on problems in biology and medicine. Nanoscience and nanotechnology refer to research and development on the understanding and control of matter at a length scale of approximately 1 - 100 nanometers, where novel properties and functions occur because of the size.
A major challenge facing medicine is to develop novel and more sophisticated approaches for the diagnosis, treatment and management of an array of diseases and traumatic injuries. Nanotechnology and nanoscience 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.
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Nanoscience and nanotechnology refer to the understanding and control of matter at the atomic, molecular or macromolecular levels, at the length scale of approximately 1 - 100 nanometers. The purpose of this funding opportunity is to stimulate nanoscience and nanotechnology research approaches that have the potential to make valuable contributions to biology and medicine. Nanoscience and nanotechnology can bring fundamental changes to the study and understanding of biological processes in health and disease, as well as enable novel diagnostics and interventions for treating disease. Thus, advances based on nanotechnology and nanoscience could result in a new era in healthcare.
Nanotechnology emerges from the physical, chemical, biological, and engineering sciences, where novel 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. Controlling the design properties, of materials and devices at the nanoscale is made possible by exploiting strategies that are frequently complemented by top-down engineering approaches. While significant progress has been made in material science, it is apparent that nanoscience and nanotechnology-based approaches are poised to revolutionize research in biology and medicine. For example, with the significant progress in understanding the genetic basis of and biochemical pathways that are involved in disease and injury processes, there is a need for ultra-sensitive, real-time monitoring and detection technologies. Nanotechnology can 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 technologies for inflammation, metastasis, angiogenesis are emerging. In addition, nanotechnology and nanoscience offer new opportunities in the treatment and management of diseases and traumatic injuries. Nanoscale multifunctional materials, capitalizing on progress in genomics and proteomics, allow targeted delivery of molecular therapies with enhanced efficacy.
Studies that employ nanotechnology techniques and concepts and are focused on biological processes will give completely new insights into the physical relationships between cellular components and functional irregularities that trigger pathological abnormities.Nanotechnology and nanoscience offer a means to control the design and assembly of biomolecular processes relevant in health and disease. For example, although the processes involved in energy conversion have been studied for many years through enzymology and structural biology, nanotechnology and nanoscience offer a means of constructing 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. For example, the nanoscale engineering principles derived could 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.
To achieve this goal, significant progress must be made in the study of biological systems at the nanoscale. While parallel efforts in molecular biology have identified a vast number genes and proteins integral to biological processes, the manner in which these biological building blocks and processes integrate or assemble and how these processes can be constructively modified is still a mystery. An important challenge for the field is to determine the “assembly instructions” for a cell and then to implement these instructions to generate synthetic cellular components at the nanoscale.
Examples of research topics:Participating NIH institutes and centers have identified areas of nanoscience and nanotechnology research in specific focus areas. Examples from each of the NIH ICs of research topics that would be considered responsive to this FOA are listed below
This is not meant to be an exhaustive, exclusive or delimiting set of topics, rather these merely represent illustrations of projects that would be considered relevant to this FOA:
The National Cancer Institute (NCI) is interested in:
1. Early detection of the disease using imaging,
2. In vitro early diagnostics: multiplexed sensitive and specific sensors
3. Multi-functional therapeutics and localized therapy delivery
4. Tools and approaches to interrogate, understand , and manipulate single cells, structures , and molecules.
Contact: Piotr Grodzinski, email@example.com
The National Eye Institute (NEI) is interested in supporting research and development involving nanoscience and nanotechnology approaches for the visual system in health and disease including:
1. Drug delivery systems,
2. Tissue engineering (self-assembly),
3. Biotic-abiotic interface with respect to implants and prosthetics.
Contact: Richard Fisher, firstname.lastname@example.org
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;
1. Development of inhaled nanoparticles for environmentally triggered release of therapeutic agents, antibodies, genes and vaccines into targeted pulmonary cells
2. Development of nano-structured surface coatings to reduce thrombosis on devices
3. Development of self-assembling scaffolds to promote regeneration of myocardium in vivo
Contact: Dennis Buxton, email@example.com
The National Human Genome Research Institute (NHGRI) is interested in projects involving nanoscience and nanotechnology to develop:
1) Innovative techniques for DNA sequencing;
2) Novel hybridization/probe-based nucleic acids tools enabling, for example, gene expression analysis, genotyping, and single nucleotide polymorphism detection and scoring.
Contact: Jeff Schloss, firstname.lastname@example.org
The National Institute on Aging (NIA) is interested in supporting research and development leading 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
Contact: Brad Wise, email@example.com
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in supporting projects to design, develop and make use of nanoscale devices for:
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 and subcellular-targeting.
Contact: R Thomas Gentry, firstname.lastname@example.org.
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is interested in supporting research and development involving nanoscience and nanotechnology approaches for musculoskeletal and skin health and disease in the areas of implants, imaging, drug and gene delivery, and functional tissue engineering.
Contact: Dr. Fei Wang, email@example.com
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is interested in:
1. The development of enabling nanotechnologies for drug and gene delivery systems and devices, sensors and micro/nanosystems, and tissue engineering
2. The development of new sets of design principles to generate biomaterials with nano-level interfacial properties for medical devices
3. The development of techniques to characterize the physical, chemical, structural, and biological properties of nanostructured assemblies/materials to advance biomedical technologies
4. The development of new materials processing methodologies for the synthesis, and/or optimization, of new or existing nanomaterials for biomedical applications.
Contact: Lori Henderson, firstname.lastname@example.org
The National Institute of Child Health and Human Development (NICHD) is interested in supporting projects that utilize nanoscience and nanotechnology 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; and
4) Manipulation of cells with carbon nanotubes and interaction of cells and nanotubes.
Contact: Michael Weinrich, email@example.com
The National Institute on Deafness and Other Communication Disorders (NIDCD) is interested in:
1. Medical implant surface coating for enhanced integration with biological tissue.
2. Targeted drug delivery.
3. Management of health and safety issues arising from the production, medical use and disposal of nanoscale materials.
Contact: Roger Miller, firstname.lastname@example.org
The National Institute of Dental and Craniofacial Research (NIDCR) is interested in research projects that focus on nanoscience and nanotechnology approaches 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.
Contact: Eleni Kousvelari Kousvelari@de45.nidr.nih.govThe National Institute on Drug Abuse (NIDA) is interested in supporting research projects on:
1. Drug development and nano formulations of existing therapeutic drugs
2. Selective and controlled drug delivery
3. Molecular and cellular imaging
Contact: Thomas Aigner, email@example.com
The National Institute of Environmental Health Sciences (NIEHS) is interested in supporting research projects for 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, and
3. Development of nanotherapeutic applications of nanotechnology to interfere in the influences of environmental factors on disease processes.
Contact: David Balshaw, firstname.lastname@example.org
The National Institute of General Medical Sciences (NIGMS) is interested in supporting research projects for 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
Contact: Cathy Lewis, email@example.com
The National Institute of Mental Health (NIMH) is interested in:
1. Drug and gene delivery and targeting to particular sites and cells in the nervous system
2. Molecular imaging probes for nervous system tissue in vitro or in vivo
3. Tools for engineering control of neuronal dendritic spines at the macromolecular level
4. Probes to report local (within particular cell compartments or subcellular loci) existence of particular sub-networks of mRNAs or proteins, their concentrations, and changes in concentration over short or long time scales.
Contact: German Cavelier, firstname.lastname@example.org
The National Institute of Neurological Disorders and Stroke (NINDS) is interested in research leading to the development and demonstration of:
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, dendritic formation, and synaptogenesis.
Contact: Joe Pancrazio, email@example.comThe National Institute of Nursing Research (NINR) is interested in supporting:
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.
Contact: Paul A. Cotton, firstname.lastname@example.org
In addition, this program encourages nanotechnology and nanoscience to:
1) control the design of biomolecular processes relevant in health and disease, and 2) the development of multifunctional nanodevices and materials. The following are representative research examples:
For this FOA, applications are expected to engage in the study of one or more of the following:
Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism of Support
This Funding Opportunity Announcement (FOA) will use the R21 award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project. Under this program announcement, applicants may request direct costs of up to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. An R21 application should not exceed 15 pages for the Research Plan.
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
The total project period for an application submitted in response to this funding opportunity may not exceed two years. Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.
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.
Facilities and Administrative (F&A) costs requested by
consortium participants are not included in the direct cost limitation. See NOT-OD-05-004,
November 2, 2004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your institution/organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual 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.
Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants may submit more than one application, provided each application is scientifically distinct.
To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for
this FOA, link to http://www.grants.gov/Apply/
and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able to use
any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA),
although some of the "Attachment" files may be useable for more than
For further assistance, contact GrantsInfo: Telephone 301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/APPLY.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Modular Budget
Research & Related Budget (required for foreign applications)
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
Foreign Organizations (Non-domestic
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” (Section 14 of the Research Plan Component in the SF424 (R&R)), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3. Submission Dates and Times
See Section IV.3.A for details.
Submitting an Application Electronically to the NIH
To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will
be evaluated for completeness by the Center for Scientific Review, NIH.
Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.
6. Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Research Plan Component Sections
While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts and with the following requirements for R21applications:
The following materials may be included in the Appendix:
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may be delayed in the review process.
Foreign Applications (Non-domestic (non-U.S.) Entity)
Plan for Sharing Research Data
All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Sharing Research Resources
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”
Only the review criteria described below will be
considered in the review process.
2. Review and Selection Process
submitted for this funding opportunity will be assigned to the ICs on the basis
of established Public Health Service
(PHS) referral guidelines.
Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://cms.csr.nih.gov/ResourcesforApplicants/) will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an application does not need
to be strong in all categories to be judged likely to have major scientific
impact and thus deserve a high priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative but is
essential to move a field forward.
Significance: If the Specific Aims of the study are achieved, will they provide significant advances in the selected area of nanoscience and nanotechnology research? Is the research likely to provide pilot data to effectively assess the feasibility of new nanotechnologies that could have major impact in a specific area of biology and/or medicine and built a foundation for a future R01 application? Is the research likely to have a potential for wide applicability? Does it involve high risk nanoscience and nanotechnology experiments that could lead to a groundbreaking, research topic?
Approach: Are the approaches and methods adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For technology development projects, are the milestones sufficiently specific and quantitative to guide both the research and subsequent evaluation of success or failure of the proposed concept?Innovation: Does the project propose new approaches or explore new research paradigms or new concepts that will affect biomedical, basic or clinical sciences? Are extant approaches or concepts applied to new scientific problems in novel ways?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
2.A. Additional Review Criteria:
In addition to the above criteria,
the following items will continue to be considered in the determination of
scientific merit and the priority score:
Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
of Human Subjects from Research Risk: The involvement of human subjects and
protections from research risk relating to their participation in the proposed
research will be assessed. See item 6 of the Research Plan component of
the SF424 (R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See item 7 of the Research Plan component of the SF424 (R&R).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
Sharing Research Data
2.D. Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.
Program staff will be responsible for the administrative review of the plan for sharing research resources.
The adequacy of the resources
sharing plan and any related data sharing plans will be considered by Program
staff of the funding organization when making recommendations about funding
applications. The effectiveness of the resource sharing will be evaluated as
part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations
After the peer review of the application is completed, the PD/PI will be able to access his/her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under
consideration for funding, NIH will request "just-in-time"
information from the applicant. For details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., “Funding Restrictions.”
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.
The following terms and conditions will be incorporated into the NoA and will be provided to the PD/PI and the appropriate institutional official at the time of award.
accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Staff Contact information listed under: Part II Full Text of Announcement and below:
Piotr Grodzinski, email@example.com
Richard Fisher, firstname.lastname@example.org
Dennis Buxton, email@example.com
Jeff Schloss, firstname.lastname@example.org
Brad Wise, email@example.com
R Thomas Gentry, firstname.lastname@example.org.
Dr. Fei Wang, email@example.com
Michael Weinrich, firstname.lastname@example.org
Roger Miller, email@example.com
Eleni Kousvelari Kousvelari@de45.nidr.nih.gov
Thomas Aigner, firstname.lastname@example.org
David Balshaw, email@example.com
Cathy Lewis, firstname.lastname@example.org
German Cavelier, email@example.com
Joe Pancrazio, firstname.lastname@example.org
Paul A. Cotton, email@example.com. Peer Review Contacts:
3. Financial or Grants
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why sharing is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Access to Research Data through
the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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