and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National
Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National
Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov)
Title: Point-of-Care Technologies Research Network (U54)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
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. Address to Request Application
Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application 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
A. Cooperative Agreement Terms
and Conditions of Award
1. Principal
Investigator Rights and Responsibilities
2. NIH
Responsibilities
3. Collaborative
Responsibilities
4. Arbitration
Process
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 of this RFA:
The National Institute of Biomedical Imaging and Bioengineering invites applications for Research Centers in the area of point-of-care (POC) technologies. The U54 mechanism will be used to create a national research network that works to build expertise in the development of integrated systems that address unmet clinical needs in point-of-care testing through the creation of multidisciplinary partnerships. Each POCT Center will perform five core functions (as described below) to create a dynamic structure that facilitates the translation of emerging technologies into clinical application. The Centers will work jointly to create a Research Network with broad expertise in the development of point-of-care technologies.
Point-of-care testing refers to the timely provision of clinical diagnostic information, often in decentralized settings such as in the physician’s office or in the patient’s home. The potential for point-of-care testing to profoundly change the way health care is delivered was addressed in a recent NIBIB/NHLBI/NSF workshop on Improving Health Care Accessibility Through Point-of-Care Technologies (http://www.nibib.nih.gov/publicPage.cfm?pageID=4534). Significant improvements in health care accessibility, quality, and cost are possible through merging of scientific expertise in the miniaturization, imaging, and informatics sciences with knowledge of specific clinical needs in decentralized health care settings. Workshop participants identified several challenges to realizing advances in the field, including the need for a mechanism to facilitate assessment of clinical opportunities in point-of-care testing to guide the development of emerging technologies, and the need for infrastructure to provide for the creation of multidisciplinary research collaborations that facilitate clinical testing early in the development process. There exist specific challenges with the development of point-of-care devices that require significant strengthening of the technology/clinical interface, including the need to identify the clinical benefits of performing an analysis at the point-of-care versus in the central laboratory, a need to consider integration of point-of-care devices into the health care delivery system, and technical requirements specific to the development of devices for use by generalists, such as component integration, user interfaces, and connectivity.
Through a combination of in-house effort and collaboration, the U54 Research Centers will cover facets of the development of point-of-care technologies ranging from exploratory research through early stage clinical testing. Clinical trials will not be covered within the context of this RFA, although it is expected that the Research Centers will establish collaborations within the broader clinical research community to facilitate late-stage clinical studies and to assist with overcoming technology adoption challenges. The scope of work covered within each Center will include in-house clinical testing of prototype point-of-care devices; collaborations with physical scientists, biochemical scientists, computational scientists, and engineers on exploratory technology development projects; assessment and communication of unmet clinical needs in point-of-care testing; creation of training opportunities for technology developers on clinical issues related to the development of point-of-care devices; and development of external partnerships (e.g., technology, clinical, industry, and regulatory) necessary to move enabling technologies toward clinical applications.
Physical scientists, biochemical scientists, computational scientists and engineers interested in seeking Center funding for the development of novel point-of-care technologies and systems will have opportunities throughout the initial five-year project period to interact collaboratively with the POCT Research Centers as described in Core 2.
Research Objectives:
The need to improve the quality and accessibility of care while reducing costs is widely recognized as a significant challenge currently faced by the nation’s health care system. Adding to this challenge is the need to reduce health disparities and provide care for an aging population. A recent National Academy of Engineering/Institute of Medicine (NAE/IOM) report ( Building a Better Delivery System: A New Engineering/Health Care Partnership ) has suggested that significant improvements in health care delivery can be achieved through adoption of a patient-centered approach. A critical aspect of this goal is the development of low-cost point-of-care microsystems that can be integrated into the health care delivery system through information and communications technologies. Recent efforts in the design and microfabrication of electronic, optical, mechanical, and fluidic components for sensors and imaging devices have led to major advances in sample analysis, with the ability to manipulate cells on the single cell level and detect single biomolecules in a sample. But the incorporation of these components into fully integrated systems that can handle all aspects of analysis still remains a challenge, as does providing the necessary connectivity of the analytical devices to clinical information systems and matching these devices to clinical need to facilitate integration into the health care system.
This RFA provides for the establishment of a Point-of-Care Technologies (POCT) Research Network that will work to bridge the technology/clinical gap and provide the partnerships and expertise necessary for the application of enabling technologies, such as novel sensors, lab-on-a-chip devices, non- and minimally invasive monitoring approaches, and imaging technologies, to pressing clinical needs in point-of-care testing. A major aspect of this effort is a focus on integrating components and devices to create systems that have the necessary connectivity and usability within a given health care environment.
Potential Centers could be structured around themes that address the coupling of promising technologies with clinical needs and opportunities in specific health care settings such as:
Alternatively, Centers could be focused on disease groupings for which point-of-care technologies have significant potential to address future health care challenges, such as cardiovascular and neurological disease.
The above lists are intended to be exemplary rather than exhaustive or prescriptive.
The structure of a Research Center should take into account the full range of technology and clinical partnerships necessary to facilitate the identification and integration of enabling technologies into devices that address defined clinical needs and health care delivery challenges that are specific to the intended use in a given care setting.
Organizational Structure:
Each POCT Research Center will be comprised of five Cores: (1) In-house Clinical Testing of Prototype Point-of-Care Devices; (2) Collaborative Exploratory Projects (3) Clinical Needs Assessment and Dissemination (4) Training; and (5) Administration. It is expected that the Research Centers will support projects that cover all stages of development, from exploratory research through clinical testing of prototype devices, with the distribution of funds across these projects varying according to Center focus, budget period, and availability of meritorious projects. For the initial grant period of the Center (up to five years), technology development efforts comprising Cores 1 and 2 will be supported with grant funds. The selection of projects for funding beyond those presented in the initial grant application, will be made in consultation with the Center’s Scientific Subcommittee of the Network Steering Committee, which will be formed from NIBIB staff, the Center PI, and external scientific experts. The details of the full governance structure is provided in Section VI.2.A, Cooperative Agreement Terms and Conditions of Award . Although Center institutions can receive funding for exploratory collaborative projects, it is expected that the majority of funds for exploratory projects in Core 2 will be used to fund projects outside of the U54 awardee institution. It is anticipated that beyond the initial grant period, projects in Cores 1 and 2 will be funded externally through future program announcements or through the submission of investigator-initiated applications.
Core 1: In-house Clinical
testing of Prototype Devices
Budget Limit for Core 1: $500,000 Total Direct Costs
One to two projects for clinical testing of prototype devices should be identified for technologies that have significant potential to address a clinical need in point-of-care testing, with the clinical testing plan provided for evaluation of these technologies. Information should be provided regarding the potential clinical impact that the technologies can have on improving human health. The appropriateness of the technologies for the proposed heath care application should be described, with potential characteristics including the provision of low-cost testing, robustness for use by generalists, and multiplexing capabilities for the creation of versatile platforms. A plan should be provided that details the process that will be followed to assist with transitioning the tested prototypes to the next stage of clinical testing (external to the Research Center). It is expected that the project period for projects funded under Core 1 will be up to two years to allow for several technologies to be tested and moved into the next stage of clinical testing during the five-year grant period. Exceptions to this are possible if justification is provided for an extended project period. Therefore, adequate funds should be budgeted in later years of the grant period to allow for transitioning or retiring current projects and recruiting and selecting new clinical testing projects.
A maximum of $500,000 direct costs can be budgeted in each year for the funding of clinical testing projects. The budget for Core 1 should take into account the overall budget limit of $1.2 M direct costs per year and the proposed emphasis of the Center (i.e., the distribution of funds and effort across the five Cores). It is anticipated that this distribution will change based on the availability of meritorious projects for funding through Cores 1 and 2.
A detailed plan for the process by which new projects will be solicited, reviewed, and funded must be provided. If this process is expected to differ from the approach suggested for Core 2 (see below), provide the details of the plan for selecting new projects for Core 1.
Core 2: Plan for
Identifying Collaborative Exploratory Projects
Budget Limit for Core 2: $600,000 Total Direct Costs
A plan should be presented that documents the process that will be used to identify and select meritorious collaborative exploratory projects for funding through the Center, with the first round of awards to be made in Year 1 of the grant period. This plan should include sample criteria that might be used to select exploratory projects that are appropriate for the theme identified in Core 3, as well as examples of the technology areas that are expected to have a significant impact on the goals of the Center. Specific collaborative exploratory projects should not be identified in the application.
A maximum of $600,000 direct costs can be budgeted in each year for the funding of 3-4 exploratory technology development projects. As with Core 1, the budget for Core 2 should take into account the overall budget limit of $1.2 M direct costs per year and the proposed emphasis of the Center (i.e., the distribution of funds and effort across the five Cores, with this distribution subject to change based on the availability of meritorious projects). Each collaborative project should have a duration of no more than two years in the exploratory phase, with direct costs up to $150,000 each year. When appropriate, promising technologies developed in Core 2 can be transitioned beyond the exploratory two-year period to the clinical testing phase (Core 1).
Core 3: Clinical Needs Assessment and Dissemination
Core 3 will define the theme of the Research Center through the selection of a specific disease or health care setting emphasis area. Plans should be provided for assessment of clinical needs and opportunities as appropriate for the selected theme of the Center. In addition, plans for disseminating the information to the technology development community through various means should be detailed in the application. While it is not required that the leaders for Cores 1 and 3 be at the same institution, applicants will have to present a convincing plan for effective collaboration at a distance.
Core 4: Training
Training of physical scientists, biochemical scientists, computational scientists, and engineers on clinical issues related to the development of point-of-care devices is critical to accelerate the translation of enabling technologies into clinical use. In Core 4, each Center should propose specific and detailed plans to provide training opportunities to technology developers across various career levels, either through individual training opportunities such as fellowships or sabbatical opportunities, or through workshops that target broader audiences.
Core 5: Administration
An administrative plan appropriate for effective management of a complex Center structure should be presented in Core 5. In this section, specific plans should be included for the integration of activities within and across Cores, and for ensuring responsiveness to members of the research community who wish to access the Center. A Network Steering Committee will be created from NIBIB staff and Center PIs to provide scientific and administrative oversight. In addition, each Center will form a Scientific Subcommittee of the Network Steering Committee that will consist of NIBIB staff, the Center PI, and external scientific experts, to perform Center functions, including the review and selection of projects to be funded under Cores 1 and 2. The remaining Center PIs will serve in an advisory capacity for the respective scientific subcommittee. Applicants can provide information regarding the proposed expertise of members of the both committees, but potential members must not be approached for membership until after an award has been made. Names of potential members must not be included in the application.
Additionally, applicants should include information within Core 5 that discusses existing external partnerships or, alternatively, the nature of new partnerships that will be established to facilitate the identification of emerging technologies, the integration of these technologies into systems suitable for use in clinical settings, and the transitioning of prototype devices into clinical research networks for later stage clinical testing. The development of integrated systems for point-of-care testing applications is a complex process involving technologists, clinical researchers, end users, manufacturers, and regulatory agencies, among others. Although the full spectrum of activities ranging from early stage technology development through technology adoption will not be addressed in the context of the POCT Research Networks, establishing the necessary external partnerships early in the process can help accelerate the development and adoption of point-of-care technologies. External partners might include engineering centers with expertise in component integration, clinical research networks, user-based networks, industry researchers or manufacturing centers, and regulatory bodies. It is not expected that all Center will need to establish relationships with each entity listed, but that the full spectrum of expertise will be provided across the network of Research Centers. This section should include information about the proposed role these existing or potential partners will play in helping the Center accomplish its goals. Partners can be identified by name if letters of support are provided; otherwise applicants should discuss broadly the nature of the partnerships that will be sought to accomplish the goals of the U54 without providing specific names.
See Section
VIII, Other Information - Required Federal Citations, for policies related
to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity
will use the U54 award mechanism(s). As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
This funding opportunity
uses the just-in-time budget concepts. It also uses the non-modular budget
format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
The NIH (U54) is a cooperative agreement
award mechanism. In the cooperative agreement mechanism, the Principal
Investigator retains the primary responsibility and dominant role for planning,
directing, and executing the proposed project, with NIH staff being
substantially involved as a partner with the Principal Investigator, as
described under the Section VI. 2. Administrative
Requirements, "Cooperative Agreement Terms and Conditions of
Award".
2. Funds Available
The National Institute of
Biomedical Imaging and Bioengineering intends to commit $6,000,000 in FY2007 to
fund up to three new Centers in response to this RFA. An applicant may
request a project period of up to five years and a budget for direct costs up
to $1.2 M in each budget year. These direct costs do not include the
facilities and administration costs for subcontracts (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html).
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 the RFA are contingent upon the availability
of funds and the receipt of a sufficient number of meritorious
applications.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an)
application(s) if your organization has any of the following characteristics:
Foreign institutions and for-profits organizations are not
eligible to apply, but both organizations can participate as subcontractors or
collaborators in any of the Cores.
1.B. Eligible Individuals
Any
individual with the skills, knowledge, and resources necessary to carry out the
proposed research is invited to work with their institution to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
2. Cost Sharing or Matching
Cost sharing or the
provision of matching funds is not required for this program.
The most
current Grants Policy Statement can be found at: Http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
The
Principal Investigator of each Center must devote at least 25% of his or her
effort. Applications from Principal Investigators not devoting at least
25% effort will be returned without peer review.
An individual may be a principal investigator on
only one application submitted to this initiative.
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. 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
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A.
Receipt, Review and Anticipated Start Dates
Letters
of Intent Receipt Date(s): December 18, 2006
Application
Receipt Date(s): January 17, 2007
Peer Review Date(s): June-July, 2007
Council Review Date(s): September, 2007
Earliest Anticipated
Start Date: September
30, 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 at the beginning of this document.
The letter of intent
should be sent to:
Brenda
Korte, Ph.D.
Program Director, Division of Discovery Science and Technology
National Institute of
Biomedical Imaging and Bioengineering/NIH/DHHS
6707 Democracy Blvd, Suite
200
Bethesda, MD 20892
Telephone: (301) 402-1231
FAX: (301) 480-4973
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications must be
prepared using the research grant applications found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of
submission, two additional copies of the application and all copies of the
appendix material must be sent to:
David T.
George, Ph.D.
Director, Office of
Scientific Review
6707 Democracy Boulevard,
Suite 920
NIBIB/NIH/DHHS
Bethesda, MD 20892-5469
(20817 for FedEx and Courier services)
Telephone: (301) 496-8633
FAX: (301) 480-0675
Email: [email protected]
Using the RFA Label: The RFA label available in
the PHS 398 application instructions must be affixed to the bottom of the face
page of the application. Type the RFA number on the label. Failure to use this
label could result in delayed processing of the application such that it may
not reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form and
the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application
Processing
Applications must be received on or before the
application receipt date(s) described above (Section IV.3.A.).
If an application is received after that date, it will be returned to the
applicant without review.
Submit a complete application. Incomplete applications will be grounds for the NIH to return the application without peer review. An application will be returned if it is illegible, if the instructions were not followed, or if the material presented is insufficient to permit an adequate review.
The application must be complete and accurate at the time of submission as there is no guarantee that the Scientific Review Administrator will accept or the peer reviewers will consider late material.
Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the National Institute of Biomedical Imaging and Bioengineering Incomplete and non-responsive applications will not be reviewed.
The NIH will not accept
any application in response to this funding opportunity that is essentially the
same as one currently pending initial review, unless the applicant withdraws
the pending application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to a funding opportunity, it is to be prepared as a NEW
application. That is, the application for the funding opportunity must not
include an Introduction describing the changes and improvements made, and the
text must not be marked to indicate the changes from the previous unfunded
version of the application.
Information on the status of an application should be
checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
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. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
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 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 continuation 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Due to the
complex nature of this initiative, applicants are strongly encouraged to
contact program staff to discuss submission of an application to this RFA.
The application for a Point-of-Care Technologies Research Center must include the following five Cores: (1) conducting in-house clinical testing of prototype point-of-care devices; (2) collaborating with physical scientists, biochemical scientists, computational scientists, and engineers on exploratory technology development efforts; (3) completing clinical needs assessments in areas anticipated to advance the field of point-of-care testing and disseminating clinical needs information to the technology development community; (4) providing training to physical scientists, biochemical scientists, computational scientists, and engineers on clinical issues related to the development of point-of-care devices; and (5) providing an administrative Core to ensure that the large Center achieves its goals. Additionally, applicants should include a section within the grant application that identifies entities with which external partnerships will be established in the context of Core activities, with a description of the proposed role these partners will serve in assisting the Center to achieve its overall goals.
It is recognized that the applications submitted in response to this RFA will be longer and more complex than many other NIH applications. For clarity, the Research Plan must be divided into sections according to the above-defined five Cores. It is not necessary to subdivide each of these Cores into the traditional a-d format specified in the PHS 398 application.
The overall page limitation for Cores 1 through 5 is 60 pages.
The
following are suggested page limits per Core:
Core 1 (In-house Clinical Testing of Prototype Devices): 30 pages
Core 2 (Plan for Identifying Collaborative Exploratory Projects): 10 pages
Core 3 (Clinical Needs Assessment and Dissemination): 10 pages
Core 4 (Training): 5 pages
Core 5 (Administration): 5 pages
The budget should be completed as described in the instruction sheet for the PHS 398 application. The budget section should begin with an overall budget for the Center, followed by budget forms for each of the five Cores. Budget pages should be provided for any sub-contractual or consortium arrangements. Estimated costs for the projects to be selected through Cores 1 and 2 in future years of the grant period should be included in the Other Expenses section of the budget form. Each budget page should be labeled clearly. The budget justification should follow the forms for Core 5 and should include the justification for key personnel and equipment. The Principal Investigator must devote at least 25% effort to the project.
The annual progress report for the U54 award will use the standard PHS 2590 form. Supplementary information may be requested as an attachment to the standard progress report as deemed necessary by NIBIB program staff or the Scientific Steering Committee.
Because of the complexity of the POCT Research Centers, program staff will likely conduct periodic administrative site visits. U54 Centers should be prepared for an annual site visit as well as an annual grantees meeting, and should include associated expenses in the budget (e.g., travel expenses for collaborators).
Intellectual
Property Plans are just-in-time requirements, and as such, it is not necessary
to include a final plan in the grant application. Final plans will be
expected prior to an application being awarded. Applicants are encouraged
to confer with their institutions technology transfer office(s) on the
development of a final Intellectual Property Plan for submission prior to
award. If applicants or their representatives require additional guidance
in preparing such plans, they are encouraged to contact NIBIB staff for
additional information.
Plan for Sharing Research
Data
The 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 website, 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 requires that
grant awardee recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources 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, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section
V. Application Review Information
1. Criteria
The following will be
considered in making funding decisions:
2. Review and Selection Process
Applications that are
complete and responsive to the RFA 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:
The
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application. Note that an application does not need to be
strong in all categories to be judged likely to have major scientific impact
and thus deserve a high priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative but is
essential to move a field forward.
Significance: Does this study address an
important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design,
methods, and analyses adequately developed, well integrated, well reasoned, and
appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative tactics
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 investigators
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 investigative team bring complementary and
integrated expertise to the project (if applicable)? Is the expertise
of Center staff appropriate for the multidisciplinary nature of the effort?
Environment: Does the scientific environment in which the work will
be done contribute to the probability of success? Do the proposed studies
benefit from unique features of the scientific environment, or subject
populations, or employ useful collaborative arrangements? Is there evidence of
institutional support?
Core
Evaluations: In addition to the above
criteria, the following items will be considered in the determination of
scientific merit and the priority score:
2.A.
Additional Review Criteria:
In addition to the above
criteria, the following items will 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 Research Plan, Section E on
Human Subjects in the PHS Form 398).
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 Research Plan, Section E on Human Subjects in
the PHS Form 398).
Care and
Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five items described under Section F of the PHS Form
398 research grant application instructions will be assessed.
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: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
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. The funding organization will be responsible for monitoring the data
sharing policy.
2.D. Sharing Research Resources
NIH policy requires that
grant awardee 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/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). 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 will be considered by Program staff of the funding organization
when making recommendations about funding applications. Program staff may
negotiate modifications of the data and resource sharing plans with the awardee
before recommending funding of an application. The final version of the data
and resource sharing plans negotiated by both will become a condition of the
award of the grant. 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.
3. Anticipated Announcement and Award Dates
N/A
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 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
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 (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the
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 Also 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The following Terms and
Conditions will be incorporated into the award statement and will be provided
to the Principal Investigator as well as to the appropriate institutional
official, at the time of award.
2.A. Cooperative Agreement
Terms and Conditions of Award
The following special
terms of award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when State and local Governments are eligible
to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for
this program will be the cooperative agreement (NIH U54), an
"assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role; it is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this
concept, the dominant role and prime responsibility resides with the awardees
for the project as a whole, although specific tasks and activities may be
shared among the awardees and the NIH as defined below.
The
Point-of-Care Technologies Research Network consists of the Center awardees
under RFA-EB-06-002.
Principal
Investigators and Center staff as appropriate are expected to participate in an
annual grantees meeting.
Awardees will retain custody of and have primary
rights to the data and software developed under these awards, subject to
Government rights of access consistent with current HHS, PHS, and NIH policies.
2.A.2. NIH
Responsibilities
An NIH Project Scientist
will have substantial programmatic involvement that is above and beyond the
normal stewardship role in awards, as described below. The Project
Scientist will:
Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. This individual may also serve as a NIBIB Project Scientist.
The NIBIB Program Director will:
The Network Steering Committee will be composed of the PI
from each project funded through RFA-EB-06-002 and the NIBIB Project Scientist.
Subcommittees of the Network Steering Committee will be created for each Center
to perform Center functions, including the review and selection of projects to be funded
under Cores 1 and 2. These Scientific Subcommittees will consist of the
Center PI, the NIBIB Project Scientist, and scientific experts from the field
who are not part of the Center. The remaining Center PIs will serve in an
advisory capacity for the respective Scientific Subcommittee.
Each Network Steering
Committee member will have one vote and will be required to accept and
implement policies approved by the Committee. The Network Steering
Committee may, as it deems necessary, invite additional, non-voting scientific
advisors to meetings at which research priorities and opportunities are
discussed.
The Network
Steering Committee will meet once a year at a minimum, with additional meetings
scheduled as necessary to accomplish the goals of the Research Center Network.
2.A.4. Arbitration
Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. An
Arbitration Panel composed of three members will be convened. It will have
three members: a designee of the Network Steering Committee chosen without NIH
staff voting, one NIH designee, and a third designee with expertise in the
relevant area who is chosen by the other two; in the case of individual
disagreement, the first member may be chosen by the individual awardee. This
special arbitration procedure in no way affects the awardee's right to appeal
an adverse action that is otherwise appealable in accordance with PHS
regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be
required to submit the PHS Non-Competing Grant Progress Report, Form 2590
annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement. The
annual progress report for the U54 award will use the standard 2590 form as
well as supplementary information as agreed upon by the Network Steering
Committee. This additional information may include the progress made
within the Center as well as the relationship between the Center and
collaborators.
Section
VII. Agency Contacts
We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:
1. Scientific/Research Contacts:
Brenda
Korte, Ph.D.
Program Director, Division of Discovery Science and Technology
National Institute of
Biomedical Imaging and Bioengineering/NIH/DHHS
6707 Democracy Blvd, Suite
200
Bethesda, MD 20892
Telephone: (301) 402-1231
FAX: (301) 480-4973
Email:
[email protected]
2. Peer Review Contacts:
David T.
George, Ph.D.
Director, Office of
Scientific Review
6707 Democracy Boulevard,
Suite 920
NIBIB/NIH/DHHS
Bethesda, MD 20892-5469
(20817 for FedEx and Courier services)
Telephone: (301) 496-8633
FAX: (301) 480-0675
Email: [email protected]
3. Financial or Grants Management Contacts:
Mr.
Angelos Bacas
Grants Management
Specialist
National Institute of
Biomedical Imaging and Bioengineering, NIH
6707 Democracy Blvd, Suite
900, MSC 5469
Bethesda, MD 20892
Telephone: (301) 451-4785
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
(45CFR46) 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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, 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 new PHS Form 398; 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 (http://publicaccess.nih.gov/publicaccess_Manual.htm).
Standards for Privacy
of Individually Identifiable Health Information:
The Department of Health
and Human Services (DHHS) 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 DHHS Office for Civil
Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant
Applications or Appendices:
All applications and proposals
for NIH funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, internet addresses
(URLs) must be used for publicly accessible on-line journal
articles. Unless otherwise specified in this solicitation,
Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health
Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This 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 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 NIH Grants Policy
Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
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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