Nanoscience and Nanotechnology in Biology and Medicine (R21)

Nanoscience and Nanotechnology in Biology and Medicine (R21) is sponsored by National Institutes of Health (NIH). Similar to the R01, this is an investigator-initiated grant mechanism that supports exploratory and developmental research grants in nanoscience and nanotechnology with applications in biology and medicine.

Expired PA-08-053: Nanoscience and Nanotechnology in Biology and Medicine (R21) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services National Institutes of Health (NIH), ( http://www.

nih. gov ) Participating Organizations Institute of Dental and Craniofacial Research (NIDCR) ( http://www. nidr.

nih. gov/ ) 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 Allergy and Infectious Diseases (NIAID) ( http://www. niaid. 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 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 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) This is a reissue of PAR-07-271 which was released on January 4, 2007. Update: The following update relating to this announcement has been issued: March 14, 2011 - This PA has been reissued as PA-11-149. This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative.

The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions.

If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions. November 27, 2009 - See Notice NOT-MH-10-006 NIMH Announces Changes in NIMH Participation, As of January 8, 2010, NIMH will terminate or withdraw its participation from this FOA.

June 16, 2009 - See Notice NOT-AI-09-045 The purpose of this notice is to announce NIAIDs participation in this announcement. 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) MAY NOT BE SUBMITTED IN PAPER FORMAT. 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). registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission Program Announcement (PA) Number: PA-08-053 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: December 18, 2007 Opening Date: January 16, 2008 (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): Standard dates apply, please see http://grants1.

nih. gov/grants/funding/submissionschedule. htm#reviewandaward 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: January 8, 2011 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. 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. Mechanism of Support.

This Funding Opportunity Announcement (FOA) will use the NIH Exploratory/Developmental Research Grant Award (R21) mechanism and runs in parallel with a FOA of identical scientific scope, PA-08- 052 , that will utilize the traditional research project grant (R01) mechanism. R21 applications may request a project period of up to two years with a combined budget for direct costs of up to $275,000 for the two-year period.

The use of the R21 mechanism is expected to encourage: 1) investigators from allied quantitative sciences such as physics, mathematics, chemistry, computer sciences, and engineering who are new to the NIH. This exploratory/developmental research program would enable successful applicants to develop a foundation for seeking R01-level support.

It will also give an opportunity to established investigators to propose high risk research projects which have the capacity for high impact. Anticipated Number of Awards. 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.

The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received. and Project Period. 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 Institutions/Organizations.

Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Small Business; For-Profit Organization (Other than Small Business); State Government; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Non-domestic (non-U.S.) Entity (Foreign Organization); Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Regional Organization; Eligible agencies of the Federal government; Faith-based or community based organizations.

Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution 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 Number of Applications.

Applicants may submit more than one application, provided each application is scientifically distinct. and Resubmissions. The R21 is not renewable.

A resubmission must include an Introduction (one page maximum) addressing the previous peer review critique (Summary Statement). Number of PDs/PIs. More than one PD/PI or multiple DPs/PIs may be designated on the application.

Application Materials. See Section IV. 1 for application General Information.

For general information on SF424 (R&R) Application and Electronic Submission, see these Web SF424 (R&R) Application and Electronic Submission Information: http://grants. nih. gov/grants/funding/424/index.

htm Electronic Submission of Grant Applications: http://era. nih. gov/ElectronicReceipt/ Hearing Impaired.

Telecommunications for the hearing impaired is available at: TTY 301-451-5936. Part I Overview Information Part II Full Text of Announcement Section I. Funding Opportunity Section II.

Award Information 2. Cost Sharing or Matching 3. Other - Special Eligibility Criteria Section IV.

Application and 1. Request Application Information 2. Content and Form of Application Submission 3.

Submission Dates and Times A. Submission, Review, and B. Submitting an Application Electronically to the NIH C.

Application Processing 4. Intergovernmental Review 6. Other Submission Requirements Section V.

Application Review 2. Review and Selection Process A. Additional Review Criteria B.

Additional Review Considerations D. Sharing Research Resources 3. Anticipated Announcement and Award Dates Section VI.

Award Administration 2. Administrative and National Policy Requirements 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 Section I. Funding Opportunity 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. 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. 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. 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 to be an exhaustive, exclusive or delimiting set of topics, rather these merely represent illustrations of projects that would be considered relevant to this The National Cancer Institute (NCI) is Early detection of the disease using imaging, In vitro early diagnostics: multiplexed sensitive and specific sensors Multi-functional therapeutics and localized therapy delivery Tools and approaches to interrogate, understand, and manipulate single cells, structures, and molecules.

Contact: Piotr Grodzinski, [email protected] 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 Tissue engineering (self-assembly), Biotic-abiotic interface with respect to implants and prosthetics.

Richard Fisher, [email protected] 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 inhaled nanoparticles for environmentally triggered release of therapeutic agents, antibodies, genes and vaccines into targeted pulmonary cells nano-structured surface coatings to reduce thrombosis on devices self-assembling scaffolds to promote regeneration of myocardium in vivo Dennis Buxton, [email protected] The National Human Genome Research Institute (NHGRI) is interested in projects involving nanoscience and nanotechnology to Innovative techniques for DNA sequencing; Novel hybridization/probe-based nucleic acids tools enabling, for example, gene expression analysis, genotyping, and single nucleotide polymorphism detection Jeff Schloss, [email protected] The National Institute on Aging (NIA) is interested in supporting research and development leading to: Nanomaterials or nanoprobes for imaging, detecting and measuring biological processes that change in cells, tissues and organs with age and age-related Development of nanomaterials for diagnosis or biomarkers of age-related disease and associated loss of tissue function; Design of nanoparticles or devices for novel drug delivery and/or for functional tissue repair and regeneration Brad Wise, [email protected] National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in supporting projects to design, develop and make use of nanoscale devices for: Determination of in vivo alcohol and alcohol metabolite concentrations Monitoring acute and chronic effects of alcohol exposure (biomarkers).

Tissue-specific imaging and monitoring of alcohol actions. Optimizing drug delivery including tissue and subcellular-targeting. R Thomas Gentry, [email protected] .

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 protected] 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: of enabling nanotechnologies for drug and gene delivery systems and devices, sensors and micro/nanosystems, and tissue engineering of new sets of design principles to generate biomaterials with nano-level interfacial properties for tissue engineering, implants, and medical devices of techniques to characterize the physical, chemical, structural, and biological properties of nanostructured assemblies/materials to advance of new materials processing methodologies for the synthesis, and/or optimization, of new or existing nanomaterials for biomedical applications development of nanomaterials and structures for novel biomedical imaging agents and molecular probes targeting preclinical and clinical applications development of nano-scale technologies for biomedical imaging Contact Lori Henderson at [email protected] The National Institute of Child Health and Human Development (NICHD) is interested in supporting projects that utilize nanoscience and nanotechnology to: Build devices that integrate with dysfunctional tissue Selective delivery of drugs and gene products Nanotexturing of surfaces and effects on cells and microorganisms; and Manipulation of cells with carbon nanotubes and interaction of cells and Contact: Michael Weinrich, [email protected] The National Institute on Deafness and Other Communication Disorders (NIDCD) is interested in supporting projects that utilize nanotechnology to address normal and disordered processes of voice, speech, language, smell, taste, balance and hearing such as: Medical implant surface coating for enhanced integration with neural or other Targeted delivery of drugs, genes and other small molecules Therapeutics to treat or inhibit middle ear biofilm formation: Roger Miller, [email protected] The National Institute of Dental and Craniofacial Research (NIDCR) is interested in research projects that focus on nanoscience and nanotechnology approaches to: Understand, control and manipulate cellular process of orofacial structures (e.g., tooth, salivary glands, bone, muscles), Develop new materials with novel properties for the repair of tooth decay and Develop new technologies for the study and the prevention of oral biofilm Contact: Eleni Kousvelari [email protected] Institute on Drug Abuse (NIDA) is interested in supporting research 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 protected] 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 Contact: David Balshaw, [email protected] The National Institute of Mental Health (NIMH) is interested in: Drug and gene delivery and targeting to particular sites and cells in the Molecular imaging probes for nervous system tissue in vitro or in vivo Tools for engineering control of neuronal dendritic spines at the 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.

German Cavelier, [email protected] 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 Biodegradable multifunctional nanoparticles for imaging and monitoring of the 4. Nanoscale imaging technologies for neuropathologies; 5. Nanoscale approaches for pharmacological and gene-based therapies to cross the blood brain barrier.

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 protected] Institute of Nursing Research (NINR) is interested in supporting: Interdisciplinary research in nanotechnology Risk and benefits of nanotechnology Development of sensing technologies that enable real-time monitoring of health indicators and responses to treatment for individuals self-managing their Technology applications for early detection of disease in at-risk populations Systems of targeted drug delivery to treat severe pain and to provide palliation at the end of life.

Contact: Paul A. Cotton, [email protected] addition, this program encourages nanotechnology and nanoscience: to control the design of biomolecular processes relevant in health and disease, and 2) to support the development of multifunctional nanodevices and materials.

The following are representative research examples: Development of new molecular imaging probes and technologies that allow for a quantitative understanding of how biological systems work on the nanometer scale, and how these systems are integrated within cells.

Development of quantitative analysis tools to learn how cell functions are regulated and can be manipulated in a predictable manner are urgently needed for the advancement of cell biology and medicine. Development of biomimetic nanoprobes to accurately address the structures and functions of biomolecules, supramolecular assemblies and organelles of living cells and provide read-outs on their activities.

Development of nanotechnology tools to study the physical relationships of biomolecular processes and elucidate the design principles of self-assembly in medically relevant strategy to build nanodevices that recapitulate biological functions in order to recreate functional nanosystems for diagnosis and/or treatment of multifunctional nanodevices that simultaneously detect, diagnose, treat, and monitor response to the therapy.

Engineer smart multifunctional nanosystems that can be integrated into biological tissue to allow FOA, applications are expected to engage in the study of one or more of the nanoscale science and engineering to create novel, or to improve existing, Developing new instrumentation that has nanoscale precision for characterizing, measuring, synthesizing, or designing materials, structures, devices or systems; Using in a novel way a device, technique or engineered tool that is not normally used in molecular or cell biology, but that has been specifically developed to be used at the self-assembly processes that can result in designed nanostructures; Developing or utilizing a particle, device or system whose functional principle is based on a novel property at the nanoscale.

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 FOA.

Applicants should contact the participating IC to discuss the programmatic relevance of their research to the qualities listed above and to the ICs mission. A list of participating ICs, their research interest and contact information are provided under Section I. Funding Opportunity Description See Section VIII.

Other Information - Required Federal Citations related to this announcement. 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 6 pages for the Research Plan. This FOA uses Just-in-Time information concepts.

It also uses the modular as well the non-modular budget formats (see. (see http://grants. nih.

gov/grants/funding/modular/modular. htm . must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA.

See NOT-OD-06-096 , Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation) applications will not be accepted.

Applicants may submit a resubmission, but such application must include an Introduction addressing issues raised in the previous critique (Summary 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. 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 NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation.

See NOT-OD-05-004 , You may submit an application(s) if your institution/organization has any of the following characteristics: Institution of Higher Education Private Institution of Higher Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education) Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education) For-Profit Organization (Other U.S. Territory or Possession Indian/Native American Tribal Government (Federally Recognized) Indian/Native American Tribal Government (Other than Federally Recognized) Indian/Native American Tribally Non-domestic (non-U.S.) Entity (Foreign Organization) Hispanic-serving Institution Historically Black Colleges and Tribally Controlled Colleges and Hawaiian Serving Institutions agencies of the Federal government or community based organizations.

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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants. nih.

gov/grants/multi_pi . All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era. nih.

gov/ElectronicReceipt/preparing. htm for instructions). The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project.

Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application.

Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.

nih. gov/grants/multi_pi . 2.

Cost Sharing or Matching This program does not require cost sharing as defined in the current NIH Grants Policy Statement . Applicants may submit more than one application, provided each application is scientifically distinct. Section IV.

Application and Submission Information 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: Grants. gov ( http://www. grants.

gov/GetStarted ) eRA Commons ( http://era. nih. gov/ElectronicReceipt/preparing.

htm ) should work with their institutions/organizations to make sure they are registered in the eRA Commons. additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows: Organizational/Institutional Registration in Grants.

gov/Get organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants. gov registration process. If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time.

A valid TIN or EIN is necessary for The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days. regarding Grants. gov registration to: Grants.

gov Customer Support Business Hours: M-F 7:00 a. m. - 9:00 p.

m. Eastern 2) Organizational/Institutional Registration in the eRA Commons To find out if an organization is already Commons-registered, see the " List of Grantee Organizations Registered in NIH eRA Commons. regarding the Commons registration to: Phone: 301-402-7469 or 866-504-9552 (Toll Free) Business hours M-F 7:00 a.

m. 8:00 p. m.

Eastern Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide . The individual(s) designated as PDs/PIs on the application must also be registered in the NIH eRA Commons.

In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the Each PD/PI must hold a PD/PI account in the Commons.

Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization.

PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons. This registration/affiliation must be done by the AOR/SO or their designee who is already registered in the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

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 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 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 one FOA. For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: [email protected] .

Telecommunications for the hearing impaired: TTY Content and Form of Application Submission 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 . 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/PIs 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 . 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