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
Cancer Institute (NCI) (http://www.cancer.gov)
Title: Image-Guided Cancer Interventions (STTR [R41/R42])
Announcement Type
This
Funding Opportunity Announcement (FOA) is a reissue of PA-07-041.
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number: PA-10-080
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) SBIR/STTR 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).
IMPORTANT: A registration process in Grants.gov and eRA Commons is necessary before submission. Applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance
Number(s)
93.394,
93.395
Key
Dates
Release/Posted
Date: January 8, 2010
Opening Date: March 5, 2010 (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
Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS
Application Due 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
Additional
Information To Be Available Date (URL Activation Date): Not Applicable
Expiration
Date: January 8, 2013
Due
Dates for E.O. 12372
Not
Applicable
Additional Overview
Content
Executive Summary
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(s) 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
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
1.
Research Objectives
Purpose
This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose the development and clinical validation of systems for image-guided interventions (IGIs) for cancer.
Specifically, the goals of this program are to provide support for:
This FOA will utilize the STTR (R41/R42) grant mechanisms for Phase I, Phase II, and Fast-Track applications and runs in parallel with a FOA of identical scientific scope, PA-10-079 that encourages applications under the Small Business Innovation Research (SBIR) program (R43/R44) grant mechanisms.
Background
Recent advances in biomedical technologies that combine imaging with energy- and drug-delivery capabilities have stimulated the need for an integrated systems development approach and subsequent clinical evaluation of IGI for cancer. IGIs may be subdivided into three general categories: image-guided-diagnosis (IGD), image-guided-surgery (IGS), and image-guided-therapy (IGT). The common theme of all IGI applications is image guidance , linking imaging and interventions. This crucial linkage implies the need for integration at both development and application stages of IGI. Historically, research on IGI technologies has primarily focused on development of components that perform certain tasks in the IGI process, such as stereotactic localization or thermal ablation of tumors. Although researchers have used these systems to establish clinical feasibility, the lack of fully integrated and optimized IGI systems has been a major obstacle in further advancement of clinical IGIs in cancer. Furthermore, the complexity of IGI methods is expected to increase as versatile new biomedical technologies, such as molecular imaging, microelectromechanical systems (MEMS), nanotechnology, and robotics, find their way into the interventional suite in order to improve target identification and treatment efficacy. Hence, there is a growing need to go beyond the clinical feasibility stage for components of image-guided systems and develop, and clinically evaluate, integrated IGI systems for treatment of a variety of cancers. The aim of this program is to stimulate a systems approach for integration and clinical testing of IGI technologies for treatment of cancer.
The importance of developing oncologic IGI techniques has been emphasized in several recent NCI Progress Review Group (PRG) reports. Moreover, the significance of small business contributions to the field of IGI was emphasized in several recent IGI-related NCI workshops. In order to meet the objectives of IGI systems integration, optimization, and subsequent clinical evaluation, partnerships between small businesses that develop the component technologies and major imaging companies that provide the imaging platforms are encouraged. Moreover, partnerships between small businesses and clinical sites may be necessary for the clinical evaluation of IGI products in cancer patients. Because of the complexity of the technologies involved, there may be a need for small companies to develop joint ventures in order to leverage the experience of different companies and to pool their resources for integration of the component technologies.
Scope
Areas of activity that are encouraged for this funding opportunity include, but are not limited to, research and development in the integration and optimization of some or all of the following component systems into an imaging system as a fully integrated IGI system, and clinical evaluations of the IGI systems for cancer. The component systems include:
(a) Energy (e.g., electromagnetic radiation, heat, cold) delivery and monitoring;
(b) Drug and gene delivery;
(c) Real-time data registration, analysis, and display;
(d) Robotics;
(e) Microelectromechanical systems (MEMS) and microfluidics
(f) Nanodevices and nanoparticles;
(g) Device tracking;
(h) Physiological monitoring;
(i) Intraluminal devices, such as balloons, stents, coils, and endoscopes.
In the context of this funding opportunity, integration refers to the integration at the hardware and software levels when appropriate, in order to allow centralized, imaging-based operation, and control of the IGI system.
Examples of integrated IGI systems include: (i) combined imaging and ablation systems, (ii) combined MEMS, device tracking, and imaging systems, (iii) integration of various magnetic resonance pulse sequences for physiological and anatomical mapping for targeting and monitoring in IGI applications, (iv) integrated non-rigid registration, surgical, and imaging system, or (v) nanotechnology-enabled combined imaging and therapy systems. Clinically localized primary or metastatic tumors of the brain, lungs, breast, liver, kidneys, pancreas, prostate, and bone are sites where IGI is likely to find early applications. Some clinical applications of integrated IGI systems include: (i) developing a systems approach for serial acquisition of tissue specimens from solid tumors over time, including implantable devices, (ii) therapeutic delivery of energies, drugs, and genes to tumors, (iii) surgical resection of brain or other tumors guided by real-time physiological and anatomical imaging, and (iv) IG-diagnosis and therapy of small cancerous lesions in various organ systems. It is recognized that the complexity of the IG system proposed and the required level of support will depend on the scope of the proposed clinical application. Considering that some of the proposed cancer applications may require the development of complex systems, this PA would also encourage small business joint ventures to take a modular approach toward development of fully integrated systems for IGI applications in cancer.
STTR Phase I applications may be submitted in response to this initiative for research on feasibility of systems integration and projection or modeling of performance characteristics of IGI technologies. Phase II applications are expected to focus on one or both tasks of integration and clinical evaluation, depending on the maturity of technologies and complexity of each task. Therefore, technologies that are close to integration are expected to move onto early phase oncologic clinical evaluation during Phase II. This initiative supports the development of multiple prototype IGI systems as required for evaluations in multicenter clinical evaluations.
The scope of the FOA also includes the optimization of new imaging protocols, including anatomical, functional, and molecular imaging methods and related spectroscopy techniques required to improve target definition and measurement of the response to interventions, as part of the overall system integration optimization and evaluation. When appropriate, collaborations with NCI funded Centers of Cancer Nanotechnology Excellence (http://nano.cancer.gov/programs/ccne.asp), and cooperative agreement imaging research teams, e.g., Network for Translational Research (U54) and Quantitative Imaging for Evaluation of Responses to Cancer Therapies (U01), (http://imaging.cancer.gov/) are encouraged to allow for more effective translation of IGI systems. Furthermore, such collaborations may help the development of a consensus process on systems validation.
Collaboration(s) with existing NCI-funded center(s) and/or consortium/consortia (e.g., those supported by the NIH P30, U01, U10, U19, U24, and U54 grant or cooperative agreement mechanisms), where the intent is to encourage a broader consensus for the proposed translational research methods or the creation of public research resources for translational research is (are) also encouraged.
When appropriate, small business may find bioinformatics resources in NCI’s cancer BioInformatics Grid (caBIG; https://cabig.nci.nih.gov/), the NCI Image Archive (http://ncia.nci.nih.gov/), or the In-vivo Imaging Workspace (https://cabig.nci.nih.gov/workspaces/Imaging) which provide image data and open source tools of potential utility to validate IGI systems. Furthermore, adaptation of recently established, or under development, DICOM (Digital Imaging and Communications in Medicine; http://medical.nema.org/) standards for Application Hosting (Working Group 23) and Surgery (Working Group 24) will allow for more effective dissemination of IGI technologies in the medical community.
Other Relevant Funding Opportunities
Prospective applicants may also consider the following complementary FOA that supports early phase clinical trials for studying imaging and IGIs in cancer patients or academic-industry partnerships for development and validation of IGI systems:
For a complete listing of current funding opportunities in imaging prospective applicants should visit NCI’s Cancer Imaging Program website at http://imaging.cancer.gov.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism(s) of Support
This funding opportunity will use the Small Business Technology Transfer (STTR [R41/R42] grant mechanisms. Applications may be submitted for support as Phase I, Phase II, or Fast-Track grants as described in the SF424 (R&R) SBIR/STTR Application Guide.
Small business concerns that have received a Phase I STTR grant may apply for Phase II funding of that project. The Phase II must be a logical extension of the Phase I research but not necessarily as a Phase I project supported in response to this funding opportunity. STTR Phase II applications will compete with all STTR applications and will be reviewed according to the customary peer review procedures.
STTR Phase II Competing Renewal applications are not permitted under this FOA.
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.
This
funding opportunity uses Just-in-Time information concepts. The modular budget
format is not accepted for STTR grant applications. Applicants must complete
and submit budget requests using the SF424 Research and Related (R&R)
Budget component found in the application package attached to this FOA in Grants.gov/Apply. All other participating organizations, including
the single, partnering research institution, must complete and submit
requests using the Research & Related Subaward Budget Attachment(s) Form
contained in the SF424 (R&R) application package.
2. Funds Available
Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received.
The SF424 (R&R) SBIR/STTR Application Guide indicates the statutory guidelines of funding support and project duration periods for Phase I and Phase II STTR awards. Phase I awards normally may not exceed $100,000 total for a period normally not to exceed 12 months. Phase II awards normally may not exceed $750,000 total for a period normally not to exceed 2 years. For this funding opportunity, budgets up to $150,000 total costs per year and up to 2 years for Phase I may be requested. Budgets of up to $1,000,000 total costs per year for up to 3 years may be requested for Phase II research that includes clinical evaluation as a specific aim of the proposed research. Phase II activities that do not include clinical evaluation are limited to a maximum budget of $750,000 total cost per year. Total support time for Phase I and Phase II is limited to 4 years. Total costs include direct costs, facilities and administration (F&A) costs, and fee/profit.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
Only United States small business concerns (SBCs) are eligible to submit STTR applications. A small business
concern is one that, at the time of award of STTR Phase I and Phase II, meets all of the following
criteria:
1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;
3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and
4. Has, including its affiliates, not more than 500 employees.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.
Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 C.F.R. 121.3-2(a). The term "number of employees" is defined in 13 C.F.R. 121.3-2(t).
Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Office of Size Standards (http://sba.gov/size).
One of the circumstances that would lead to a finding that an organization is controlling or has the power to control another organization involves sharing common office space and/or employees and/or other facilities (e.g., laboratory space). Access to special facilities or equipment in another organization is permitted (as in cases where the awardee organization has entered into a subcontractual agreement with another organization for a specific, limited portion of the research project). However, research space occupied by an STTR awardee organization must be space that is available to and under the control of the STTR awardee for the conduct of its portion of the proposed project.
Title 13 CFR 121.3 also states that control or the power to control exists when key employees of one concern organize a new concern ... and serve as its officers, directors, principal stockholders, and/or key employees, and one concern is furnishing or will furnish the other concern with subcontracts, financial or technical assistance, and/or other facilities, whether for a fee or otherwise. Where there is indication of sharing of common employees, a determination will be made on a case-by-case basis of whether such sharing constitutes control or the power to control.
For purposes of the STTR program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBA’s size regulations, 13 CFR 121.106 Small Business Size Regulations.
Note regarding affiliation arising under stock options, convertible securities, and agreements to merge: In determining size, SBA considers stock options, convertible securities, and agreements to merge (including agreements in principle) to have a present effect on the power to control a concern. SBA treats such options, convertible securities, and agreements as though the rights granted have been exercised. See http://edocket.access.gpo.gov/cfr_2005/janqtr/pdf/13cfr121.103.pdf.
All STTR grant applications will be examined with the above eligibility considerations in mind. If it appears that an applicant organization does not meet the eligibility requirements, NIH will request a size determination by the SBA. If eligibility is unclear, NIH will not make an STTR award until the SBA provides a determination.
Note: An applicant organization that has been determined previously by SBA to be other than small for a size standard of not more than 500 employees or for purposes of the SBIR/STTR program, must be recertified by the SBA prior to any future SBIR/STTR awards.
1.B. Eligible Individuals
Any
individual with the skills, knowledge, and resources necessary to carry out the
proposed research 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. 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.
For a STTR application, the Project Director/Principal Investigators (PD/PIs) may be employed with the SBC or the single, partnering non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual. For projects with multiple PD/PIs, the Contact PD/PI may be from either the SBC or the single, partnering research institution.
As defined in 42 CFR 52, the PD/PI is the single individual designated by the grantee in the grant application who is responsible for the scientific and technical direction of the project . When the proposed PD/PI clearly does not have sufficient qualifications to assume this role, the application is not likely to receive a favorable evaluation.
Each PD/PI must commit a minimum of 10% effort to the project and the PD/PI must have a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual. Such a relationship does not necessarily involve a salary or other form of remuneration. In all cases, however, the PD/PI’s official relationship with the grantee must entail sufficient opportunity for the PD/PI to carry out his or her responsibilities for the overall scientific and technical direction of the project. Documentation (e.g., consultant, consortium and contractual arrangements) describing the official relationship of the PD/PI with the applicant small business concern should NOT be submitted with the grant application, but a copy must be furnished upon the request of the NIH awarding component.
Following are examples of situations describing the official relationship of the PD/PI with the applicant small business organization:
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
Resubmission: Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date (and any other due dates for FY2010 funding and beyond), all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016
Renewal: Phase II competing renewal applications are not permitted under this FOA.
In STTR Phase I and Phase II, at least 40% of the work must be performed by the small business concern and at least 30% of the work must be performed by the single, partnering research institution. The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of direct and F&A/indirect costs attributable to each party, unless otherwise described and justified in Item 15, Consortium/Contractual Arrangements, of the PHS398 Research Plan component of the SF424 (R&R) application forms.
A small business concern may subcontract a portion of its STTR award to a Federally Funded Research and Development Center (FFRDC), either in its capacity as the Research Institution or as a participant in the STTR project in another capacity. However, STTR funds may not be used to pay for laboratory resources of non-FFRDCs, and no STTR funds may be used to pay for subcontracting any portion of the STTR award back to the issuing agency or to any other Federal government unit unless a waiver is granted by the Small Business Administration.
Applicants may submit more than one application, provided that each application is scientifically distinct. The NIH will accept as many "different" applications as the applicant organization chooses. However, the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this STTR funding opportunity and any other HHS FOA, including the current SBIR and STTR Parent FOAs.
Likewise, identical or essentially identical grant applications submitted by different organizations will not be accepted. Applicant organizations should ascertain and assure that the materials they are submitting on behalf of the principal investigator are the original work of the principal investigator and have not been used elsewhere in the preparation and submission of a similar grant application. Applications to the NIH are grouped by scientific discipline for review by individual Scientific Review Groups and not by disease or disease state. The reviewers can thus easily identify multiple grant applications for essentially the same project. In these cases, application processing may be delayed or the application(s) may be returned to the applicant without review.
It is unlawful to enter into contracts or grants requiring essentially equivalent work or effort. Essentially equivalent work or effort occurs when (1) substantially the same research is proposed for funding in more than one contract proposal or grant application submitted to the same Federal agency; (2) substantially the same research is submitted to two or more different Federal agencies for review and funding consideration; or (3) a specific research objective and the research design for accomplishing an objective are the same or closely related in two or more proposals or awards, regardless of the funding source. If there is any question concerning essentially equivalent work or effort, it must be disclosed to the soliciting agency or agencies before award.
Only one Phase II award may be made for a single SBIR/STTR project.
You may submit a STTR Phase II application either before or after expiration of the Phase I budget period, unless you elect to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I grantee organization should submit a Phase II application within the first six receipt dates following the expiration of the Phase I budget period.
STTR Phase II Competing
Renewal applications are not permitted in response to this FOA.
Section IV. Application and Submission Information
To
download a SF424 (R&R) Application Package and SF424 (R&R) SBIR/STTR
Application Guide for completing the SF424 (R&R) forms for this FOA, use
the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. 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 with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).
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 NIH eRA Commons.
Several additional separate actions are required before an applicant SBC can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
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.
To affiliate the PD/PI with the applicant small business concern:
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: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
1. Request Application Information
Applicants must
download the SF424 (R&R) application forms and SF424 (R&R) SBIR/STTR
Application Guide for this FOA using the Apply for Grant Electronically
button in this FOA or 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 STTR applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) SBIR/STTR Application Guide.
The SF424 (R&R) SBIR/STTR 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). Failure to include this data field will cause the application to be rejected.
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 has several 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
Research
& Related Subaward Budget Attachment(s) Form
PHS398
Cover Page Supplement
PHS398
Research Plan
PHS398
Checklist
SBIR/STTR
Information
Optional
Components:
PHS398
Cover Letter File
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. For STTR, the contact PD/PI may be from either the SBC or the single, partnering research institution. All funding for STTR projects goes to the small business concern, so funding for PD/PIs from other organizations must be requested via a subcontract with the small business using the Research & Related Subaward Budget Attachment(s) Form.
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 plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the Research Plan section and the 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 (NoA).
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: March 5, 2010
(Earliest date an application may be submitted to Grants.gov)
Application
Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS
Application Due 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.A.1.
Letter of Intent
A letter of
intent is not required for the funding opportunity.
3.B. Submitting an
Application Electronically to the NIH
To
submit an application in response to this FOA, applicants may use the Apply for Grant Electronically button in this FOA
or link to http://www.grants.gov/applicants/apply_for_grants.jsp
and follow steps 1-4. Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. 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.
3.C.
Application Processing
3.C.1
Submitting On-Time
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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Please note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified 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 weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR). Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PD/PI receive Commons acknowledgments. 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 the 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 or competing
renewal 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 or competing renewal 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 each 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.
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) SBIR/STTR Application Guide are to be followed, with the following requirements.
STTR Phase I applications
STTR Phase II applications
STTR Fast-Track Applications
Resubmissions
Warning: Please be sure that you observe the total 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.
Appendix Materials
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) SBIR/STTR 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. Phase I SBIR/STTR Appendix materials are not permitted unless specifically requested by NIH.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing (for example, human subject concerns, the Small Business Act provisions, etc.), this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)
(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with NIH Institute/Center (IC) program staff likely to accept assignment of their application (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)
(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.)
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.
Section V. Application Review Information
1.
Criteria
Only the review
criteria described below will be considered in the
review process.
2. Review and
Selection Process
Review Process
Applications submitted for
this funding opportunity will be assigned to the ICs for funding consideration
on the basis of established PHS referral guidelines.
Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.
As part of the initial merit review, all applications will:
Enhanced Review Criteria
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
All STTR Applications
Overall Impact. Reviewers will provide an overall impact 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 scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored 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 proposed project have commercial potential to lead to a marketable product, process or service? 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. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Phase II Applications
In
addition to the above review criteria:
1. How well
did the applicant demonstrate progress toward meeting the Phase I objectives,
demonstrating feasibility, and providing a solid foundation for the proposed
Phase II activity?
2. Did the
applicant submit a concise Commercialization Plan that adequately addresses the
specific areas described in the SF424 (R&R) SBIR/STTR Application Guide and
the SBIR/STTR Information component?
3. Does the
project carry a high degree of commercial potential, as described in the
Commercialization Plan?
Phase I/Phase II Fast-Track
Application Review Criteria
For
Phase I/Phase II Fast Track applications, the following criteria also will be
applied:
1. Does the Phase I application specify clear,
appropriate, measurable goals (milestones) that should be achieved prior to
initiating Phase II?
2. Did the applicant submit a concise
Commercialization Plan that adequately addresses the specific areas described
in the SF424 (R&R) SBIR/STTR Application Guide and the SBIR/STTR
Information component?
3.
To what extent was the applicant able to obtain letters of interest, additional
funding commitments, and/or resources from the private sector or non-SBIR/STTR
funding sources that would enhance the likelihood for commercialization?
4. Does the
project carry a high degree of commercial potential, as described in the
Commercialization Plan?
Phase I and
Phase II Fast-Track applications will receive single ratings for the overall
impact/priority score and scores from the
assigned reviewers for each of the core review criteria.
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. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
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.
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.
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.
2.B.
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/priority score.
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).
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:
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.
Selection Process
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended STTR applications. The following will be considered in making funding decisions:
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 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.
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 also Section IV.5., Funding
Restrictions .
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.
For Fast-Track applications, the Phase II portion may
not be funded until a Phase I final report and other documents necessary for
continuation have been received and assessed by program staff that the Phase I
milestones have been successfully achieved.
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.
3. Reporting
NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.
Failure to submit timely final reports may affect future funding to the organization or awards with the same principal investigator.
For details about each specific required report, see the section on Award Guidelines, Reporting Requirements, and Other Considerations , in the SF 424 (R&R) SBIR/STTR Application Guide.Section VII. Agency Contact(s)
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 Contact(s):
David Beylin, M.S., M.B.A.
SBIR
Development Center
National
Cancer Institute (NCI)
31 Center Drive,
Building 31, Room 10A19, MSC 7432
Bethesda, MD 20892-7432
Telephone:
(301) 496-0079
Email: [email protected]
Keyvan Farahani, Ph.D.
Cancer Imaging Program
Division of Cancer Treatment and Diagnosis
(DCTD)
National Cancer Institute (NCI)
6130 Executive Boulevard,
EPN; Suite 6000, MSC 7412
Bethesda, MD 20892-7412
Rockville,
MD 20852 (for express/courier delivery)
Fax: 301-480-3507
E-mail: [email protected]
2. Peer Review Contact(s):
Not
Applicable
3. Financial or Grants Management Contact(s):
Rosemary
Ward
Office of
Grants Administration
National
Cancer Institute (NCI)
6120
Executive Boulevard, EPS Room 243, MSC 7150
Bethesda,
MD 20892-7150 (for U.S. Postal Service express or regular delivery)
Rockville, MD 20892 (for non-USPS delivery)
Telephone:
(301) 496-3182
Fax:
301-496-8662
Email:
[email protected]
Section VIII. Other Information
Required Federal Citations
Use of
Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this 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.
Policy for Genome-Wide Association Studies
(GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.
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.
Access to Research Data through the Freedom of
Information Act:
The 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 the 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.
Inclusion of Women And Minorities in Clinical
Research:
It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH
definition of clinical research; updated racial and ethnic categories in
compliance with the new OMB standards; clarification of language governing
NIH-defined Phase III clinical trials consistent with the SF424 (R&R); 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 Requirement:
In accordance with the NIH Public Access Policy, investigators funded
by the NIH must submit or have submitted for them to the National Library of
Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an
electronic version of their final, peer-reviewed manuscripts upon acceptance
for publication, to be made publicly available no later than 12 months after
the official date of publication. The NIH Public Access Policy is
available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access
webpage at http://publicaccess.nih.gov/.
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) 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. 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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