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Part I Overview Information
National Institutes of Health (NIH), (http://www.nih.gov)
National Cancer Institute (NCI), (http://www.cancer.gov)
Title: Application of Emerging Technologies for Cancer Research (R33)
This Funding Opportunity Announcement (FOA) is a reissue of RFA-CA-07-036, which was previously released January 4, 2007.
Update: The following update relating to this announcement has been issued:
December 15, 2008 - This RFA has been reissued as (RFA-CA-09-007) .
NOTICE: Applications submitted in response to this 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 4 weeks prior to the grant submission date. See Section IV.
Request For Applications (RFA) Number: RFA-CA-08-008
Catalog of Federal Domestic Assistance Number(s)
93.392, 93.393, 93.394, 93.395, 93.396
Release/Posted Date: January 9, 2008
Opening Date: February 11, 2008 (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Dates: February 11, 2008; April 29, 2008; August 24, 2008.
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 Receipt Dates: March 11, 2008; May 29, 2008; September 24, 2008.
Peer Review Dates: May/June 2008; August/September 2008; January/February 2009.
Council Review Dates: August 2008; January 2009; May 2009.
Earliest Anticipated Start Dates: September 2008; April 2009; August 2009.
Additional Information To Be Available Date (URL Activation Date): Not Applicable.
Expiration Date: September 25, 2008.
Additional Overview Content
Purpose. This Funding Opportunity Announcement (FOA) issued by the National Cancer Institute (NCI), National Institutes of Health (NIH), solicits grant applications proposing exploratory research projects to evaluate the performance of emerging molecular analysis technologies and develop applications for an appropriate cancer-relevant biological system. These systems may cover cancer-relevant molecular analyses in vitro, in situ, and/or in vivo. The thrust of effort in the projects proposed in response to this FOA must be on emerging technology application rather than on technology development. Responsive "technologies" encompass relevant methods, techniques, tools, instrumentation, and devices (but not software or informatics solutions). This FOA is part of the broader NCI-sponsored program Innovative Molecular Analysis Technologies (IMAT). Several IMAT FOAs of identical or closely related scientific scope using various funding mechanisms are available. To facilitate selection, a separate Notice in the NIH Guide for Grants and Contracts provides a brief cross-comparison and links to all the IMAT FOAs; see NOT-CA-08-003.
Mechanism of Support. This FOA will utilize the NIH Developmental Phase II Grant (R33) award mechanism and is suitable for projects where "proof-of-principle" of the proposed technology or methodology has already been established. This FOA runs in parallel with another FOA of identical scientific scope, RFA-CA-08-007, that uses the NIH R21 award mechanism and is designed to fund exploratory (pilot) projects.
Funds Available and Anticipated Number of Awards The NCI intends to commit a total of approximately $1,500,000 to this FOA in fiscal year 2009 to award approximately four to five grants.
Budget and Project Period An applicant for an R33 grant may request a project period of up to 3 years with a budget appropriate for the science proposed.
The R33 grant is not renewable.
Eligible 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); and Non-Domestic (non-U.S.) Entity (Foreign Organization).
Eligible Project 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 NIH support.
Renewals and Resubmissions. Applications can not be renewed by competing for additional project periods. Applicants may submit a "resubmission" application, but such application must include an "Introduction" addressing the previous peer review critique (Summary Statement).
Number of PDs/PIs. More than one PD/PI, or multiple PDs/PIs, may be designated on the application.
Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
Application Materials. See Section IV.1 for application materials.
General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
SF424 (R&R) Application and Electronic Submission Information at https://grants.nih.gov/grants/funding/424/index.htm; and
General information on Electronic Submission of Grant Applications at http://era.nih.gov/ElectronicReceipt/.
Hearing Impaired. Telecommunications for the hearing impaired is available at: TTY 301-451-5936.
Special receipt/submission dates are listed under "Key Dates."
Initial merit review convened by the Division of Extramural Activities, NCI.
Part II Full Text of Announcement
1. Research Objectives
1. Mechanism of Support
2. Funds Available
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
1. Request Application Information
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Electronic Transmission of an Application to the NIH
C. Application Processing
4. Intergovernmental Review
6. Other Submission Requirements
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
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
This Funding Opportunity Announcement (FOA) issued by the National Cancer Institute (NCI), National Institutes of Health (NIH), solicits grant applications proposing exploratory research projects focused on the application development for promising emerging cancer-relevant technologies. The emphasis of this FOA is on projects to evaluate the performance of emerging molecular analysis technologies and develop applications for an appropriate cancer-relevant biological system. "Emerging technology" is one that has passed the initial developmental stage and shows promise but has not been evaluated/developed in the context of the proposed application and has not been commercialized. Therefore, the thrust of effort in the projects proposed in response to this FOA must be on the application of emerging technology rather than on technology development. Responsive "technologies" encompass relevant methods, techniques, tools, instrumentation, and devices (but not software or informatics solutions).
Technology applications proposed for development must have the potential to substantially aid the investigations of the molecular basis of cancer (e.g., by facilitating the detection of pre-cancer or cancer-related characteristics/alterations at the molecular and cellular levels of organization and function, including cancer microenvironments). These applications may be intended for molecular analyses in vitro, in situ, and/or in vivo and may be targeted for the needs of either basic research or translational and/or clinical cancer research.
This FOA utilizes the R33 award mechanism and is suitable for projects where "proof-of-principle" of the proposed technology or methodology has already been established and supportive preliminary data are available. Applicants proposing exploratory, pilot projects should consider applying to the parallel FOA of identical scientific scope (RFA-CA-08-007) that uses the NIH R21 mechanism. Both FOAs are part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program.
IMAT Program
The IMAT Program (http://imat.cancer.gov/) is aimed at the development and integration of novel and emerging technologies in the support of cancer research, diagnosis, and treatment. Since 1998, the IMAT Program facilitates the accelerated development of various tools and methods benefiting cancer research and, ultimately, clinical oncological practice.
The IMAT Program consists of the following three related themes:
Innovative Technologies for the Molecular Analysis of Cancer, which emphasizes research projects that are centered on the inception and early stage development of new technologies for cancer research;
Application of Emerging Technologies for Cancer Research, which is designed to support research projects evaluating technologies that are ready for initial clinical or laboratory application in cancer research; and
Innovations in Cancer Sample Preparation, which is centered on the development of novel technologies of sample preparation, purification, and processing to maximize the quality and utility of biospecimens for molecular analyses of cancer cells and their host environments without compromising donor/patient health.
The IMAT program supports projects from the stage of technology inception through the feasibility/optimizations studies to the ultimate developmental and application phases. Through the use of appropriate funding mechanisms, the individual IMAT Program FOAs are focused either on: (1) the Phase I or high-risk exploratory portion of an investigator's scientific effort, with an emphasis on innovation; or (2) the developmental Phase II projects; or (3) combined phased innovation mechanism (Fast-Track for SBIR/STTR).
NOTE: Whereas the scientific scopes within the main IMAT themes remain constant, FOAs with the focus on exploratory pilot phases and on developmental phases have distinct submission requirements. The complete matrix of multiple IMAT FOAs, including their scopes and basic requirements, is outlined in NOT-CA-08-003. Potential applicants interested in IMAT initiatives are strongly advised to use that NIH Guide Notice as a "switchboard" to verify which of the closely related active FOAs might be most appropriate for them to apply to.
As increasingly evident from the discoveries made by basic research, cancer is a complex disease involving a gradual accumulation of genetic and epigenetic changes in the cell and alterations in a very large number of molecular and cellular processes. Comprehensive Identification of subsets of genes and other factors at the molecular and cellular level that can contribute to the development and progression of cancer remains a challenge. The ability to identify and characterize such cancer genes, their associated gene products, and other cancer-related molecular changes remains a high priority in cancer research. Therefore, further vigorous efforts are urgently needed to develop novel technologies for the molecular analysis of cancer and cancer microenvironment. Technological advances in these areas are increasingly often instrumental in uncovering new paradigms and developing new directions in cancer research. Novel technologies are expected to facilitate and accelerate the identification and characterization of factors that can influence cancer risk, cancer emergence and progression, effects of external/environmental factors, as well as outcomes of therapeutic interventions.
Various new technologies that have emerged from the initial developmental stages may be appropriate for addressing relevant biological, mechanistic, translational, clinical, or epidemiological problems. However, such emerging technologies require thorough testing and exploration to determine and validate their potential for cancer-relevant applications. Assessing the usefulness of emerging technologies applied in biologically or clinically relevant settings is crucial to the ultimate implementation of these technologies in cancer research and clinical practice.
Specific Objectives and Scope of this FOA
Projects proposed in response to this FOA must be pertinent to its overarching objective, i.e., must use emerging molecular analysis technologies to develop applications for an appropriate cancer-relevant biological system. Technology proposed must meet the definition of emerging technology stated previously. Whereas some effort to improve performance and/or enhance the emerging technology to be used for application development are appropriate, projects proposing significant technology development are not appropriate. The thrust of effort must be on the development of application(s). These applications may be intended for molecular analyses in vitro, in situ, and/or in vivo and may be targeted for the needs of either basic, translational, and/or clinical cancer research. Responsive "technologies" encompass methods, techniques, tools, instrumentation, and/or devices (but not software or bio-informatics-based solutions).
Specific areas in which new technological capabilities are of particular interest include (but are not limited to) the following examples:
Technologies for the scanning for and identification of the sites of chromosomal aberrations, mutations, and polymorphisms that reflect inherited or acquired abnormalities (particular interest is in the development of scalable tools that can be applied across whole genomes, for example, to detect rare abnormalities in mixed populations of normal and abnormal cells);
Technologies for the detection and characterization of foreign nucleic acid sequences, such as DNA of as yet uncharacterized exogenous infectious agents, that might be present in human cancer cells;
Technologies for assessing the status/functionality of DNA repair machinery, particularly within the context of cancer susceptibility and sensitivity to anticancer drugs;
Technologies for the massively parallel analysis of the expression of genes that would overcome limitations of the existing multiplexed gene expression technologies;
Technologies suitable for the analysis and characterization of large numbers of samples, including populations;
Technologies for the measurement of exposure to environmental toxicants, pollutants, mutagenic factors, and/or carcinogens;
Technologies for the detection of expression of proteins and their posttranslational modifications, including technologies suitable for expansion to profiling of all proteins expressed in cells, detecting rare protein variants in mixed populations, and detecting proteins modified (adducted) by carcinogens or anticancer drugs;
Technologies for monitoring the function of specific proteins and cellular metabolic or signaling pathways, including such aspects as examination of ligand-protein and protein-protein complexes and technologies for simultaneous monitoring of functions of all members of a class of proteins or a complete metabolic or signaling pathway;
Technologies to probe and/or interrogate various cancer signaling pathways to locate novel points for intervention beyond traditional genomic and proteomic signatures;
Technologies to elucidate structural modifications of macromolecules that may be indicative of or critical to the neoplastic transformation process;
Technologies for targeted measurements made at the level of the cell, including cell-cell adhesion, cellular motility, and/or cellular adherence properties;
Technologies to quantitatively measure cytoskeletal changes and the impact of such changes on elements of metastatic potential, including increased/decreased motility, changes in intracellular mechanics, and ability of cells to interact with the environment;
Technologies for the development of biocompatible molecular and cellular labels as well as means to enable their faster and more accurate delivery to cells, and to specific cellular compartments;
Technologies/means of broad applicability to improve delivery/retention of anticancer agents; and
Technologies for the development of high-throughput, quantitative assays for epigenetic alterations linked to abnormal gene expression, e.g., DNA methylation at particular promoters and/or histone acetylation and chromatin remodeling at such sites.
For all technology applications/implementations proposed for development, applicants are expected to substantiate the ultimate value of and role for the technology in elucidating the molecular characteristics of cancer cells or the neoplastic process in laboratory and/or in the clinic. Applicants should also consider (and address in the application) the potential for ultimately transferring knowledge gained, technology and/or methodology to other laboratories or the clinic. In the case of technologies intended for use on clinical specimens or in patients, appropriate collaborations with clinical investigators are encouraged.
TECHNOLOGIES THAT ARE GENERALLY NOT APPROPRIATE FOR THIS FOA AND OTHER IMAT FOAs. TECHNOLOGIES THAT ARE GENERALLY NOT APPROPRIATE FOR THIS FOA AND OTHER IMAT FOAs. Types of projects that are outside of the IMAT scope (i.e., are non-responsive to any IMAT FOAs) include:
(i) Projects proposing software/informatics solutions, database development, data mining, statistical tools, and computational/mathematical modeling (including those applicable to drug and/or patient responses);
(ii) Projects centered on technology that has already led to the development of analytical or diagnostic product and its commercial release;
(iii) Projects proposing whole-body or in vivo imaging methods;
(iv) Projects in which the main thrust of effort is on exploring biological or clinical hypotheses (i.e., traditional hypothesis-driven projects) rather than on technology development;
(v) Projects centered on development of specific drugs or therapies; and
(vi) Any projects involving clinical and/or diagnostic trials.
Researchers focusing on new bioinformatics or statistical techniques, tools, and software solutions should consider one of the Biomedical Information Science and Technology Initiative (BISTI) opportunities.
Researchers who emphasize the assessment of whole body or in vivo imaging technologies as the primary focus of their projects should contact the Cancer Imaging Program for information on appropriate funding opportunities.
Attributes of the NIH R33 Mechanisms in the IMAT Context. This IMAT FOA utilizes the developmental R33 funding mechanism, which is predicated upon the establishment of proof of principle through prior research, and which may or may not have been previously supported by an exploratory R21 grant.
This FOA is not limited to applications that have previously been funded for inception and development of technologies under the IMAT Program.
The R33 project is expected to generate sufficient data to fully validate the technology in a biologically relevant setting and demonstrate its full utility in addressing biological, translational, clinical and/or epidemiological questions.
Technologies resulting from a completed R33 project may subsequently be further refined (e.g., in partnership with industry) into commercial product(s).
Researchers who are uncertain which of the IMAT FOAs might be most appropriate for their intended technology development project are encouraged to contact the program official listed in this FOA.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
This Funding Opportunity Announcement (FOA) will use the NIH Exploratory/Developmental Phase II Research Grant (R33) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses just-in-time concepts. It requires that the non-modular, detailed budget format be used in the applications, irrespective of the requested budget amount; in other words, it does not use the NIH modular budget format.
U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants 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, August 23, 2006.
Exploratory/developmental grant support is for new projects only; competing renewal (formerly "competing continuation") applications will not be accepted. Up to two resubmissions (formerly "revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.
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 NIH 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.
An R33 applicant may request a project period of up to 3 years with a combined budget appropriate for the science proposed. The request should be tailored to the needs of the project. Commensurate Facilities and Administrative (F&A) costs are allowed. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this funding opportunity.
The NCI intends to commit approximately 1,500,000 dollars in FY2009 to fund approximately four to five applications.
NIH grants policies as described in the 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. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. 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 https://grants.nih.gov/grants/multi_pi.
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants may submit more than one application, provided each application is scientifically distinct.
To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
Grants.gov (http://www.grants.gov/GetStarted); and
eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm).
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
Your 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 CCR registration.
The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional 1 to 2 business days.
Direct questions regarding Grants.gov registration to:
Grants.gov Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
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."
Direct questions regarding the Commons registration to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Business hours M-F 7:00 a.m. – 8:00 p.m. Eastern Time
3) 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 application.
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 Commons account.
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 Commons.
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 4 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.
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: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-5936.
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/APPLY.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the "Credential" log-in field of the "Research & Related Senior/Key Person Profile" component must contain the PD/PI's assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see "Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications."
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget ( all foreign organizations)
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
Foreign Organizations (Non-Domestic [non-U.S.] Entities)
NIH policies concerning grants to Foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600260.
Applications from Foreign organizations must:
Request budgets in U.S. dollars.
Prepare detailed budgets for all applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms – not the PHS398 Modular Budget component). See NOT-OD-06-096 , August 23, 2006.
Charge back of customs and import fees is not allowed.
Format: Every effort should be made to comply with the format specifications, which are based upon a standard U.S. paper size of 8.5" x 11" within each PDF.
Funds for up to 8% administrative costs (excluding equipment) may be requested. See NOT-OD-01-028, March 29, 2001.
Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.
Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI.2., "Administrative and National Policy Requirements."
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact" PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in Item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of "PD/PI." Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the "Credential" field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled "Multiple PD/PI Leadership Plan" (Section 14 of the Research Plan Component in the SF424 (R&R)), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
See Section IV.3.A for details.
3.A. Submission, Review, and Anticipated Start Dates
Additional Information To Be Available Date (URL Activation Date): Not Applicable
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Descriptive title of proposed research;
Name, address, and telephone number of the PD/PI;
Names of other key personnel;
Participating institutions; and
Number and title of this funding opportunity.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed in Section IV.3.A.
Richard Aragon, Ph.D.
Office of Technology and Industrial Relations
Building 31, Room 10A52, MSC 2580
Email: raragon@mail.nih.gov
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 2 business days to view the application image.
If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the Division of Receipt and Referral, Center for Scientific Review, NIH, after 2 business days.
Prior to the submission deadline, the AOR/SO can "Reject" the assembled application and submit a changed/corrected application within the 2-day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after 2 business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.
If the 2-day window falls after the submission deadline, the AOR/SO will have the option to "Reject" the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn't transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
If the AOR/SO chooses to "Reject" the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after 2 days.
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 resubmission with substantial changes of a developmental grant application previously submitted in response to this FOA. Such application must include an "Introduction" addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
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.
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."
PHS398 Research Plan Component Sections
All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R33 applications:
R33 applications will use the "Just-in-Time" concept.
The non-modular, detailed budget format is to be used irrespective of the requested budget amount; in other words, the solicited R33 applications should not use the NIH modular budget format.
Items 2-5 of the Research Plan of the R33 application may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts.
Introduction (required for a resubmission application) is limited to 3 pages.
While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Other Specific Instructions for Preparation of an R33 Application
R33 applicants must present detailed preliminary data in support of the feasibility of the proposed technology or approach that is proposed for development. Whereas R33 applications by definition must deal with technologies that are beyond the inception stage, applicants must demonstrate the innovation of the particular technology or approach proposed for development in the terms of applied science (e.g., by pointing to a gap in currently available capabilities or to a potential for substantial improvements/advantages over the currently used solutions). Please note that there is a strict 25-page limit for R33 applications.
Preliminary Studies/Progress Report. This section must document that feasibility studies have been completed, and progress achieved, equivalent to that expected through the support of an R21 project. The applicant must clearly describe how the exploratory/developmental study is ready to be scaled up to an expanded application stage. In the event that an applicant feels that the technology is too proprietary to disclose, the applicant must at a minimum provide a demonstration (results) of the capabilities of the proposed technology. Preliminary data relevant to both the technology evaluations and the pilot biological study should be presented.
Note for R33 applicants proposing to continue research begun under R21 support: the Research Design and Methods attachment must quote the final Milestones from the R21 Notice of Award and discuss the extent to which these milestones have been achieved. This discussion should comprise no more than three pages (which count toward the 25-page limit).
Other Budgetary Requirements. An annual meeting of all investigators funded through this program will be held to share progress and research insights that may lead to further progress in the program. Applicants should request travel funds in their budgets for the PD/PI and one additional senior investigator to attend this annual meeting.
Intellectual Property Management Plan
Certain research plans will require collaboration and coordination between investigators at different institutions, some of whom may not be NIH funding recipients and who may have pre-existing intellectual property obligations to third parties. It is anticipated that commercial embodiments of the results of such research may incorporate single inventions shared by several institutions, or multiple inventions each from a separate institution. Therefore, prior to funding, R33 grant applicants must address how they will coordinate patent prosecution and licensing activities, if necessary to enable a licensee to access the bundle of intellectual property needed to take a product to market on commercially viable terms. Suggested strategies include: (1) assigning intellectual property rights to related inventions to an invention management firm; (2) designating one organization to take the lead on patenting and licensing related inventions; and (3) agreeing in advance that if multiple parties are to independently license-related inventions, the total of stacked royalties will not exceed a predetermined percentage rate.
The technology transfer/ intellectual property management/licensing officer or equivalent of the PI's institution is expected to submit an intellectual property management plan, including at least those elements above. Alternatives to the suggested strategies, which accomplish the same goals, will be considered. Intellectual property management plans are a just-in-time requirement and do not need to be included in the grant application but plans will be required before an R33 grant can be awarded.
The applicant's institution should avoid exclusively licensing those inventions that are research tools unless either: (1) the field of use of the exclusive license is restricted to commercial use; or (2) the exclusive licensee will make the research tool available on reasonable terms. Applicants are directed to the NIH policy on the dissemination of biological research resources ("research tools") at http://www.ott.nih.gov/policy/rt_guide_final.html.
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 https://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 https://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. 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 (i.e., those from Non-Domestic [non-U.S.] Entities)
Indicate how the proposed project has specific relevance to the mission and objectives of the NIH IC and has the potential for significantly advancing the health sciences in the United States.
Plan for Sharing Research Data
Data sharing is important to the IMAT program as an avenue to promote and disseminate technologies to be developed. Therefore, all applicants must include a plan for sharing research data in their application. The data sharing policy is available at https://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Sharing Research Resources
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 https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., "Reporting."
Only the review criteria described below will be considered in the review process.
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCI in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score;
Receive a written critique; and
Receive a second level of review by the National Cancer Advisory Board.
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:
Scientific merit of the proposed project as determined by peer review;
Availability of funds; and
Relevance to program priorities.
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PDs/PIs? Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?
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?
Feasibility: Does the applicant demonstrate feasibility with sufficient preliminary experiments and technical data to support proof of principle of the technology/hypothesis and provide a solid foundation for the proposed Phase II activity? For R33 applications to continue research begun under R21 support did the applicant address whether and how the final milestones from the R21 Notice of Award were accomplished?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
Resubmission Applications (formerly "revised/amended" applications): In addition to the above criteria, the following criteria will be applied to resubmission applications: Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the "Human Subjects Sections" of the PHS398 Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the "Human Subjects Sections" of the PHS398 Research Plan component of the SF424 (R&R).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the "Other Research Plan Sections" of the PHS398 Research Plan component of the SF424 (R&R).
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
2.C. Sharing Research Data
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy (https://grants.nih.gov/grants/policy/data_sharing).
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 at https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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.
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."
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.
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:
2. Peer Review Contacts:
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
3. Financial or Grants Management Contacts:
Ms. Emily Linde
Office of Grants Administration
6120 Executive Boulevard, EPS Room 243
E-mail: lindee@mail.nih.gov
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (https://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); and 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, https://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 (https://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://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 https://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time, the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement). Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research" (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://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 (https://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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from: 1) currently funded NIH research projects; or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.
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 2 years to the research. For further information, please see http://www.lrp.nih.gov.


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text:
Isabelle Graw interview Basquiat
Becky Johnston and Tamra Davis interview Basquiat
Henry Geldzahler interview Basquiat
Annina Nosei's memories of Basquiat
Art Analysis
Jean-Michel Basquiat : Videos
An extensive and interesting collection of videos about Basquiat.
Interviews with the artist, testimonies, art analysis, and documentaries such as "Jean-Michel Basquiat: The Radiant Child", famous documentary film produced and directed by Tamra Davis.
It is also present the movie Downtown 81, film starring Basquiat and awarded at the 2000 Cannes Film Festival.
Downtown 81
Video focused on analyzing the meaning of words in Basquiat's work. The video was made by NAHMAD CONTEMPORARY on the occasion of the exhibition 'Words Are All We Have: Paintings By Jean-michel Basquiat' (May 2nd – Jun 18th 2016).
Video produced by the NAHMAD CONTEMPORARY on the occasion of the 'Jean-Michel Basquiat | Xerox' Curated by Dieter Buchhart March 12 – May 31, 2019.
The exhibition is the first concentrated examination of the extraordinary body of work that the artist created using Xerox photocopies as his principal medium and compositional focal point.
Panel Discussion on May 3rd, 2019: Diego Cortez, Jeffrey Deitch, and Jordana Moore Saggese in discussion with Dieter Buchhart.
An interesting video shot at the Barbican Art Gallery on the occasion of the exhibition 'Basquiat Boom for Real' (Thu 21 Sep 2017 — Sun 28 Jan 2018). The video contains the art analysis of some of Basquiat's works.
Video produced by PHILLIPS in which Zach Miner, Head of the Contemporary Art Evening Sale, and Benjamin Godsill, Contemporary Art Specialist, discuss Warhol and Basquiat's collaboration as being a moment far ahead of its time.
From the inside out – Basquiat's Red Skull (1982). Video produced by Christie's for Post-War and Contemporary Art Evening Auction – London 6 October 2017 in which the painting Red Skull was sold.
Video produced by Sotheby's for the auction on 3 October 2019 in London in which the work "Pyro" was sold.
Urban chaos, graffiti-like figures, silkscreened animals, architectural shrines and curious scientific models converge and collide with dizzying force in Jean-Michel Basquiat's spectacular painting, 'Pyro'.
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redpajama_set_name: RedPajamaCommonCrawl


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