and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating
Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of
Participating Organizations
National
Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidr.nih.gov/)
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 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)
Announcement Type
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:
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: 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
Key Dates
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
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
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
1. Criteria
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
3. Reporting
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 Description
Research Objectives
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.
Background
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 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 including:
1. Drug delivery systems,
2. Tissue engineering (self-assembly),
3. Biotic-abiotic interface with respect to implants and prosthetics.
Contact: Richard Fisher, [email protected]
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 protected]
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, [email protected]
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 protected]
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, [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]
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is interested in nanoscience and nanotechnology as it relates to the Institutes scientific program areas (http://www.nibib.nih.gov/Research/ProgramAreas) with particular emphasis on:
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 tissue engineering, implants, and 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
5. The research and development of nanomaterials and structures for novel biomedical imaging agents and molecular probes targeting preclinical and clinical applications
6. Research and development of nano-scale technologies for biomedical imaging
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:
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 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:
1. Medical implant surface coating for enhanced integration with neural or other biological tissues
2. Targeted delivery of drugs, genes and other small molecules
3. Therapeutics to treat or inhibit middle ear biofilm formation:
Contact: 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:
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 [email protected]
The 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 protected]
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, [email protected]
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, [email protected]
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 protected]
The 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, [email protected]
In addition, this program encourages nanotechnology and nanoscience:
1) 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:
For this FOA, applications are expected to engage in the study of one or more of the following:
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
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 6 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.
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.
3. Other-Special
Eligibility Criteria
Applicants may submit more than one application,
provided each application is scientifically distinct.
Section IV. Application and Submission Information
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
2) Organizational/Institutional Registration in the eRA Commons
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 one FOA.
For further assistance, contact GrantsInfo: Telephone
301-710-0267, Email: [email protected].
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/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.
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:
Required 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 Checklist
PHS398 Modular Budget or Research
& Related Budget, as appropriate (See Section
IV.6., Special Instructions, regarding appropriate required budget component.)
Research & Related Budget (required for foreign applications)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign Organizations (Non-domestic (non-U.S.)
Entity)
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.
SPECIAL INSTRUCTIONS
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 13 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, 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 3.4 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.
3.A. Submission, Review, and
Anticipated Start Dates
Opening Date January 16, 2008 (Earliest date an application may be submitted
to Grants.gov)
Letters of Intent Receipt Date(s): N/A.
Application Submission/Receipt Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
AIDS Application Submission/Receipt Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
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
3.B. 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.
3.C. Application Processing
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.
Organizational DUNS
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 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:
Appendix Materials
NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.
Note: While each section of the PHS398 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 monitor better 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.
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 impact/priority score.
Sharing Research
Resources
NIH 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.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be considered in the
review process.
2. Review and
Selection Process
Applications 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 NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research. Because the Research Strategy is limited to 6 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
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 impact/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.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Environment: 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:
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Resource Sharing Plans.
Reviewers will comment on whether the following Resource Sharing Plans, or the
rationale for not sharing the following types of resources, are reasonable: 1)
Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm);
2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html);
and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
2.C. Sharing Research Data
The reasonableness of the data sharing plan or the rationale for not sharing
research data may be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the impact/priority score.
2.D. Sharing Research Resources
NIH 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.
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 Reporting.
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
3. Anticipated Announcement and Award Dates
Not Applicable
Section VI. Award
Administration Information
1. Award Notices
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.
3. Reporting
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 Section I. Funding Opportunity Description and below:
Piotr Grodzinski, [email protected]
Richard Fisher, [email protected]
Dennis Buxton, [email protected]
Jeff Schloss, [email protected]
Brad Wise, [email protected]
R Thomas Gentry, [email protected].
Dr. Fei Wang, [email protected]
Lori Henderson. [email protected]
Michael Weinrich, [email protected]
Roger Miller, [email protected]
Eleni Kousvelari [email protected]
Thomas Aigner, [email protected]
David Balshaw, [email protected]
German Cavelier, [email protected]
Joe Pancrazio, [email protected]
Paul A. Cotton, [email protected]
2. Peer Review Contacts:
Not Applicable
3. Financial or
Grants Management Contacts:
Bill
Wells, [email protected]
William W. Darby, [email protected]
Ron Caulder, [email protected]
Cheryl Chick, [email protected]
Linda Whipp, [email protected]
Judy Fox, [email protected]
Sheila S. Simmons, [email protected]
Nancy Curling, [email protected]
Bryan S. Clark, [email protected]
Chris Myers, [email protected]
Mary Daley, [email protected]
Yinka Abu, [email protected]
Dwight Dolby, [email protected]
Carper, Victoria, [email protected]
Tijuanna Decoster [email protected]
Brian Albertini [email protected]
Section VIII. Other Information
Required Federal Citations
Vertebrate Animals:
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 impact/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, Minorities, and Children:
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-09-116.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.
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.
Healthy People 2010:
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
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