IMPORTANT NOTE:
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.EXPIRED
Department
of Health and Human Services
Participating
Organizations
National Institute of
Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov)
Components
of Participating Organizations
National Institute of
Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov)
Title: NIBIB Quantum Projects: Exploratory Phase I (R01)
Announcement Type
This FOA is a re-issuance, with modifications,
of RFA-EB-06-001,
which was previously released November 18, 2005.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Request for Applications (RFA) Number: RFA-EB-07-001
Catalog of Federal
Domestic Assistance Number(s)
93.286
Key Dates
Release/Posted Date: November 27, 2006
Opening Date: January 5, 2007 (Earliest date an
application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): December 19, 2006
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 Date(s): January 23, 2007
Peer Review Date(s): June July 2007
Council Review Date(s): October 2007
Earliest Anticipated Start Date(s): September 15, 2007
Additional Information To Be
Available Date (Activation Date): Not Applicable
Expiration
Date: January 24, 2007
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 of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contacts
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
The NIBIB Quantum Grants (QG) will support
multi-investigator, interdisciplinary teams to develop innovative biomedical
technologies with the potential to have a profound (quantum) advance over
present-day approaches to the detection, prevention, diagnosis or treatment of
a major disease or national public health problem (e.g., leading
categories of disease burden, high-mortality diseases affecting more than
100,000 individuals annually, technologies that revolutionize over 200,000
procedures annually). For a Quantum Grant, the technology development must be
the driving force in the profound advance. The Quantum Grants are not intended
to solely increase basic scientific understanding or further a working
hypothesis. Instead, the objective is to complete, within 8-10 years of the
Phase I award, substantial preclinical studies or the first clinical utilization
of an approach to overcome a major, present-day disease or national public
health problem, or change the paradigm of detection, prevention, diagnosis, treatment
or practice of medicine for a major disease or national public health problem.
The main programmatic priority of the NIBIB Quantum program is the magnitude of
the impact of the proposed technology. A critical requirement for a successful
application will be the clear articulation of the end goal and all the
necessary steps to achieve it. It is envisioned that the research conducted would
entail significant risk in seeking a quantum impact, but this must be balanced
by outstanding scientific, technological, and management plans to achieve this
high potential payoff. This initiative is focused on major human health
problems whose morbidity and/or mortality will be mitigated by the development
of new technologies. Projects may also focus on technologies that broadly
impact and improve the practice of medicine. Projects focusing on broadly
applicable technologies must clearly define the quantum impact over present-day
approaches to the detection, prevention, diagnosis or treatment of a major
disease or national public health problem. Quantum projects should build on
the scientific advances that have occurred in many fields of medicine, the life
and physical sciences, and engineering, to develop appropriate technologies to
translate the scientific advances into a practical reality. This program
underscores the commitment of NIBIB to integrate the engineering and physical
sciences with the life sciences to improve human health.
The NIBIB mission is to improve human health by leading the development and accelerating the application of biomedical technologies. Development of biomedical technologies such as MR imaging, drug-eluting vascular stents, artificial hip and knee replacement, the cochlear implant, or the pacemaker have had a profound impact on human health and quality of life. Other systems and technologies, well into the concept or development phases, have the potential to have a similar, if not greater, impact. In some cases, realization of this potential can only be achieved if the needed intellectual and financial resources are brought to bear on a specific targeted project in a concerted fashion. The NIBIB Quantum Program is intended to bring to fruition such developments. The goal of Phase I is to support those projects with the greatest potential for developing new biomedical technologies that could have large impacts on the detection, prevention, diagnosis or treatment of a major disease or national public health problem. Phase I is to be followed by a Phase II initiative that will support technology development to enable the completion of substantial preclinical or first-in-human clinical studies, that demonstrate a potential quantum impact, by the end of Phase II.
This RFA invites applications for pilot studies using the R01 grant mechanism to conduct the first phase (QG1) of a two-phase research program. This announcement for a three-year Phase I award will support pilot studies to establish the feasibility to thereafter achieve a clinically applicable technology by the end of Phase II. In conceptualizing the Phase I project, it may be helpful to work backwards from the anticipated end of Phase II and identify all the necessary steps, critical milestones, and timeline needed to realize the entire detection, prevention, diagnostic, or treatment regimen proposed. The goals of Phase I are to increase the probability of success by developing strategies to identify and overcome issues as they are envisioned and arise, perform critical feasibility tests in order to develop a complete understanding of the viability of the proposed approach, and generate all the necessary input and an overall project timeline to complete Phase II (substantial preclinical data or first clinical testing). By the completion of QG1, the investigative team should have demonstrated that achieving the proposed goal is probable by the end of the second phase (Phase II is anticipated to be five years, at three to five million dollars per year, with a competing renewal for those projects needing an additional two years, for an overall 8-10 year timeframe from the Phase I award). At a minimum, this demonstration must include documentation that all aspects of the problem have been considered, major and minor road blocks have been identified (and some overcome), the assembled research team has demonstrated feasible solutions, and a clear path forward through the end of Phase II has been charted in detail. We anticipate that an announcement for the second phase of the quantum grants will be released in the second year of the QG1 funding period. It is anticipated that in the second phase, the NIBIB will partner with other institutes and/or industry. Phase I (QG1) awards will not be renewable.
In selecting research projects for this initiative, the NIBIB is focusing on research efforts that have the following characteristics:
The technology being developed would overcome a major, present-day disease or national public health problem, or change the paradigm of detection, prevention, diagnosis, treatment or the practice of medicine
Many of the difficulties to be overcome are technological in nature
Progress will require a significant research effort, yet the path forward must be clearly charted
Demonstration of substantial preclinical or first-in-human clinical data can be accomplished in a period of 8-10 years from the Phase I award
Interdisciplinary leadership and a research team from multiple disciplines
As described, the overall goal of this two-phase program is to develop innovative technologies that have the potential to make a profound improvement in healthcare. All research components necessary for the ultimate success of the overall project must be addressed. A defining characteristic of the program is that any individual research components within the global project must all focus on the systematic and timely achievement of a well-defined final goal. The significance of each individual research plan component will be evaluated on the basis of its focus and importance to the final goal.
The following lists provide some ILLUSTRATIVE examples of what we envision as potential quantum grant topics with significant advances in health care - activities that would overcome a major disease or national public health problem (e.g., leading categories of disease burden, high-mortality diseases affecting more than 100,000 individuals annually, technologies that revolutionize over 200,000 procedures annually). THE LISTS ARE INTENDED TO BE SUGGESTIVE ONLY. Investigators are encouraged to think BEYOND THE EXAMPLES ON THE LIST. Also, some of the examples on the Quantum list may reach beyond what is possible at this time. Inclusion of an item on the list does not pre-certify that the proposed project is feasible as a Quantum project. Investigators will be required to justify the significance and approach for any proposed project. The NIBIB expects that for many proposed Quantum projects, there will already be significant ongoing activity within the research community. Although this preliminary work will certainly strengthen a proposal, the application must still outline the steps necessary to bridge the scientific gaps and enable the proposed interdisciplinary, multi-organizational team to work in concert.
For example, a significant advance in health care would occur when:
A major disease or national public health problem can now be prevented
A major condition can now be predicted that previously could not
A major disease or national public health problem that previously could not be treated can now be treated
A major disease or national public health problem that already can be treated can now be treated with significantly fewer side-effects (e.g. noninvasively)
A drastic reduction in the burden of a major disease has occurred
A diagnosis is made significantly more specific or sensitive
A diagnosis and/or treatment is improved or retains its accuracy and effectiveness, but its cost is substantially reduced
Illustrative examples of potential Quantum Projects:
A robust, early diagnostic and treatment for Alzheimer’s disease
Non-invasive technologies that provide blood chemistry without a needle stick
System for the identification and stabilization of pre-clinical vulnerable plaque in coronary arteries
A robust system for automated sensor-based control of insulin delivery ( closed loop system ) for treatment of diabetes
A system that offers significant improvement in hemodialysis through increased portability and/or decreased frequency of use
Minimally invasive, image-guided treatment for cancer that is far superior to current clinical approaches and would become the new standard of care
Regenerative or biomimetic-based cartilage repair for degenerative joint disease
See Section VIII, Other Information - Required Federal
Citations, for policies related to this
announcement.
Section
II. Award Information
1. Mechanism of Support
This Funding
Opportunity Announcement (FOA) will use the Research Project Grant (R01) award mechanism.
The applicant will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are a U.S. organization and are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).
U.S. applicants requesting more than $250,000 in annual direct costs 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.
2.
Funds Available
Because the nature and scope
of the proposed research will vary from application to application, it is
anticipated that the size of each award will also vary. Although the financial
plans of the NIBIB provide support for this program, awards pursuant to this
funding opportunity are contingent upon the availability of funds and the
submission of a sufficient number of meritorious applications.
The NIBIB intends to commit approximately $5,000,000 in fiscal year 2007 to fund five to seven grants. An applicant may request a project period of up to three years and a budget for total direct costs of up to $700,000 per year. It is anticipated that most applications will request $400,000 to $700,000 in total direct costs.
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.
F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004,
November 2, 2004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an
application(s) if your institution/organization has any of the following
characteristics:
Collaborators from and subcontracts with foreign institutions/organizations are permissible, but the award must be to a domestic organization.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Principal investigators are expected to have demonstrated experience assembling and directing a multidisciplinary research team.
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. 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 http://grants.nih.gov/grants/multi_pi.
2.
Cost Sharing or Matching
This program does not require cost
sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Applications that do not focus on
the development and application of biomedical technologies will be considered
non-responsive to this initiative.
Applications that focus only on underlying biomedical problems or mechanisms of disease, diagnosis, and prevention without a significant component to overcome a major, present-day disease or national public health problem, or to change the paradigm of detection, prevention, diagnosis, treatment or practice of medicine for a major disease or national public health problem (e.g., leading categories of disease burden, high-mortality diseases affecting more than 100,000 individuals annually, technologies that revolutionize over 200,000 procedures annually), will be considered non-responsive to this initiative.
Applications that describe only incremental advances will be considered non-responsive to this initiative.
Applications that do not include detailed milestones and a project timeline through the end of Phase II will be considered non-responsive to this initiative.
Applications determined to be non-responsive to this initiative will not be peer reviewed.
Section IV. Application and Submission Information
To download a SF424
(R&R) Application Package and SF424 (R&R) Application Guide for
completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get 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.
Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.
Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.
For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/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 has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
Required Components:
SF424 (R&R) (Cover
component)
Research & Related
Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398
Modular Budget or Research &
Related Budget, as appropriate (See Section IV.6., Special Instructions,
regarding appropriate required budget component.)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 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.
The NIBIB recognizes that applicants will be able to respond in different ways to the opportunity presented by this RFA. Applicants are strongly encouraged to contact NIBIB program staff early in the application process and they should have a thorough understanding of the intent and expectations of this RFA before developing an application. A Quantum Grants website (http://www.nibib.nih.gov/Research/QuantumGrants) will be used to post additional information about this initiative including answers to frequently asked questions and instructions on how to register for and participate in a pre-submission teleconference. The teleconference will be conducted on Thursday, December 14, 2006, from 12:30 pm to 3:30 pm [Eastern Time]. During the teleconference, the NIBIB staff will explain the goals and objectives of the RFA and answer questions. All prospective applicants are invited to participate in the teleconference. The results of the teleconference, either in the form of minutes and/or responses to the questions asked, will be available on the Quantum Grants website.
3.
Submission Dates and Times
See Section IV.3.A. for details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: January
5, 2007 (Earliest date an application may be submitted to
Grants.gov)
Letters of Intent Receipt Date(s): December 19, 2006
Application Submission/Receipt Date(s): January 23, 2007
Peer Review Date(s): June July 2007
Council Review Date(s): October 2007
Earliest
Anticipated Start Date(s): September
15, 2007
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
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 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.
The letter of
intent should be sent to:
Albert Lee, Ph.D.
Extramural Science
Programs
National Institute of
Biomedical Imaging and Bioengineering
6707 Democracy Blvd.
Democracy 2, Suite 200
Bethesda, MD 20892
Telephone: (301) 451-4772
FAX: (301) 480-1614
Email: [email protected]
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/applicants/apply_for_grants.jsp
and follow steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C.
Application Processing
Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will be evaluated for
completeness by the CSR and responsiveness by the NIBIB.
Incomplete and non-responsive applications will not be reviewed.
There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives
the Grants.gov acknowledgments. The AOR and the 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 their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction (3 pages maximum) addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
This FOA will accept NEW applications and RESUBMISSION applications previously submitted to RFA-EB-06-001.
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 (formerly competing continuation ) 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 the PD/PI(s) 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
In the Background and Significance section of the Phase I application, clearly describe the expected outcome of the Phase II project. Articulate how the developed technology would overcome a major, present-day disease or national public health problem, or would change the paradigm of detection, prevention, diagnosis, treatment or practice of medicine. The anticipated impact and significance is the most important aspect of this program, so it is essential that the project vision be plainly evident and clearly described.
The Phase I project must present a comprehensive research plan and work scope that establishes whether the Phase II outcome is achievable. Thus, the Phase I application should include a timeline with detailed milestones charting all the critical steps through Phase II. Major challenges covering both phases of the project should be clearly identified.
The Phase I pilot study must consider the entire detection, prevention, diagnostic, or treatment regimen and address how the technology to be developed will address it. The Phase I application must present strategies to overcome issues as they are envisioned and arise, and provide the necessary input into Phase II. By completion of Phase I, the investigative team should have demonstrated that achieving the proposed goal is highly probable within the time frame and resources of the second phase. At a minimum, by the end of Phase I, the results must include documentation that all aspects of the problem have been considered, major and minor road blocks have been identified (and some overcome), the assembled research team has demonstrated feasible solutions, and a clear path forward through Phase II has been charted.
Items 2-5 of the PHS398 Research Plan component are limited to 25 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.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Special Instructions for Modular Grant applications
R01 applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component. See Section 5.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.
Appendix Materials
IMPORTANT NOTE:
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.
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations 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.
Annual Investigators Meeting
Applicants should budget for three investigators to attend a yearly progress review to be held in Bethesda, Maryland.
Plan for Sharing Research DataThe
precise content of the data-sharing plan will vary, depending on the data being
collected and how the investigator is planning to share the data. Applicants
who are planning to share data may wish to describe briefly the expected
schedule for data sharing, the format of the final dataset, the documentation
to be provided, whether or not any analytic tools also will be provided,
whether or not a data-sharing agreement will be required and, if so, a brief
description of such an agreement (including the criteria for deciding who can
receive the data and whether or not any conditions will be placed on their
use), and the mode of data sharing (e.g., under their own auspices by mailing a
disk or posting data on their institutional or personal Web site, through a
data archive or enclave). Investigators choosing to share under their own
auspices may wish to enter into a data-sharing agreement. References to data
sharing may also be appropriate in other sections of the application.
All applicants must include a plan for sharing
research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Sharing
Research Resources
NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025). (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be considered in the review process.
2.
Review and Selection Process
Applications that are
complete and responsive to this FOA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by the NIBIB in
accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
For the Quantum Grants, the Significance criterion is of paramount importance.
Note that an application does not need to be strong in all categories to be judged likely to have quantum impact and thus deserve a high priority score. For example, an investigator(s) may propose to carry out important work that by its nature is not innovative but is essential for the development of the new technology with the potential for a quantum impact. While it is envisioned that developing a technology with a quantum impact would require innovation, innovation in and of itself is not a primary goal of this initiative. Innovation would be considered within the context of the innovation required to achieve the quantum impact in the proposed work.
Significance: Does this study address an important problem?
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, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?
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? Are proposed collaborators sufficient for the project? Do they individually represent strengths in the subdisciplines essential to the project?
Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
2.A.
Additional Review Criteria
In addition to the above criteria, the
following items will continue to be considered in the determination of
scientific merit and the priority score:
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 appropriateness of the requested period of support in
relation to the proposed research may be assessed by the reviewers. The
priority score should not be affected by the evaluation of the budget.
2.C.
Sharing Research Data
Data Sharing Plan: 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 presence of a data sharing plan will be part of the terms and conditions of
the award. Program staff will be responsible
for the administrative review of the plan for sharing research data.
The funding organization will be responsible for monitoring the data sharing
policy.
2.D. Sharing Research
Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be
responsible for the administrative review of the plan for sharing research
resources.
The
adequacy of the resources sharing plan and any related data sharing plans will
be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
Reporting.
Model Organism Sharing Plan: Reviewers are
asked to assess the sharing plan in an administrative note. The sharing plan
itself should be discussed after the application is scored. Whether a sharing
plan is reasonable can be determined by the reviewers on a case-by-case basis,
taking into consideration the organism, the timeline, the applicant's decision
to distribute the resource or deposit it in a repository, and other relevant
considerations.
3.
Anticipated Announcement and Award Dates
Not Applicable.
Section VI. Award Administration Information
1.
Award Notices
After the peer review of the application
is completed, the PD/PI will be able to access his or her Summary Statement
(written critique) via the NIH eRA Commons.
If
the application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification
in the form of a Notice of Award (NoA) will be provided to the applicant
organization. The NoA signed by the grants management officer is the
authorizing document. Once all administrative and programmatic issues have been
resolved, the NoA will be generated via email notification from the awarding
component to the grantee business official.
Selection of an
application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. These costs may
be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant
and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3.
Reporting
Awardees
(three investigators/grant) will come to Bethesda yearly to
report on their progress. The yearly review will focus on progress over the past year, milestone
status, and on the evolving approaches to areas where progress may have been less
than expected.
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 Contact(s):
Albert Lee, Ph.D.
Extramural
Science Programs
National
Institute of Biomedical Imaging and Bioengineering
6707
Democracy Blvd.
Democracy
2, Suite 200
Bethesda, MD 20892
Telephone: (301) 451-4772
Fax: (301) 480-1614
Email: [email protected]
2. Peer Review Contact(s):
David T. George, Ph.D.
Office of Scientific Review
National
Institute of Biomedical Imaging and Bioengineering
6707
Democracy Blvd.
Democracy
2, Suite 920
Bethesda,
MD 20892
Telephone: (301) 496-8633
Fax: (301) 480-0675
Email:
[email protected]
3. Financial/Grants Management Contact(s):
Florence Turska
Office
of Grants Management
National
Institute of Biomedical Imaging and Bioengineering
6707
Democracy Blvd.
Democracy
2, Suite 900
Bethesda,
MD 20892
Telephone: (301) 451-4782
Fax: (301) 451-5735
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. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
Access
to Research Data through the Freedom of Information Act:
The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided
guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of
Model Organisms:
NIH is committed
to support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of
Women And Minorities in Clinical Research:
It is the policy
of the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a clear
and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43). All investigators proposing clinical research
should read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of
Children as Participants in Clinical Research:
The NIH
maintains a policy that children (i.e., individuals under the age of 21) must
be included in all clinical research, conducted or supported by the NIH, unless
there are scientific and ethical reasons not to include them.
All
investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required
Education on the Protection of Human Subject Participants:
NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH applications for research involving human subjects
and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human
Embryonic Stem Cells (hESC):
Criteria for
federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS) system
(http://www.nihms.nih.gov/) at PubMed
Central (PMC) an electronic version of the author's final manuscript upon
acceptance for publication, resulting from research supported in whole or in
part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH is
requesting that authors submit manuscripts resulting from 1) currently funded
NIH research projects or 2) previously supported NIH research projects if they
are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms,
cooperative agreements, contracts, Institutional and Individual Ruth L.
Kirschstein National Research Service Awards, as well as NIH intramural research
studies. The Policy applies to peer-reviewed, original research publications
that have been supported in whole or in part with direct costs from NIH, but it
does not apply to book chapters, editorials, reviews, or conference
proceedings. Publications resulting from non-NIH-supported research projects
should not be submitted.
For more
information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov// and view the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable
Health Information:
The Department
of Health and Human Services (HHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the HHS
Office for Civil Rights (OCR).
Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be
self-contained within specified page limitations. For publications listed in
the appendix and/or Progress report, Internet addresses (URLs) 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 PMD 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 PA is related to one or more of the priority
areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems
Agency review. Awards are made under the authorization of Sections 301 and 405
of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles,
and other considerations described in the NIH Grants
Policy Statement.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Loan Repayment
Programs:
NIH encourages applications
for educational loan repayment from qualified health professionals who have
made a commitment to pursue a research career involving clinical, pediatric,
contraception, infertility, and health disparities related areas. The LRP is an
important component of NIH's efforts to recruit and retain the next generation
of researchers by providing the means for developing a research career
unfettered by the burden of student loan debt. Note that an NIH grant is not
required for eligibility and concurrent career award and LRP applications are
encouraged. The periods of career award and LRP award may overlap providing the
LRP recipient with the required commitment of time and effort, as LRP awardees
must commit at least 50% of their time (at least 20 hours per week based on a
40 hour week) for two years to the research. For further information, please
see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
|
| ||||||
 |
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||