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 Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)
Title: NHLBI Program
Project Applications (P01)
Announcement
Type
New
Update: The following update relating to this announcement has been issued:
Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).
Program Announcement (PA) Number: PAR-10-285
Catalog of Federal Domestic
Assistance Number(s)
93.233, 93.837, 93.838, 93.839
Key Dates
Release Date: September 21,
2010
Letters
of Intent Receipt Date(s): September 21, 2010
Application Due Date(s): First
receipt date October 20, 2010 with standard dates applying thereafter, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due
Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date
(Url Activation Date): http://www.nhlbi.nih.gov/funding/policies/ppg.htm
Expiration
Date: (Now Expired August 6, 2013 per issuance of PAR-13-316), Originally September 8, 2013
Due
Dates for E.O. 12372
Not Applicable.
Additional Overview
Content
Executive Summary
Table of Contents
Part
I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1.
Research Objectives
Section
II. Award Information
1.
Mechanism 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
3.
Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1.
Award Notices
2.
Administrative and National Policy Requirements
3. Reporting
Section VII. Agency
Contact(s)
1.
Scientific/Research Contact(s)
2.
Peer Review Contact(s)
3.
Financial/ Grants Management Contact(s)
Section VIII. Other
Information - Required Federal Citations
Part II - Full Text
of Announcement
Section I. Funding Opportunity Description
1.
Research Objectives
Background
The National Heart, Lung, and Blood Institute (NHLBI) Program Project Grant (P01) has been in existence for over 35 years and supports research related to fundamental processes and diseases of the heart, blood vessels, lungs, and blood as well as transfusion medicine, blood resources, and sleep disorders. A program project grant application requires a minimum of three interrelated research projects that focus a number of scientific disciplines, which investigate a complex biomedical theme or research question. The projects may be supported by core units to facilitate economy of effort, space, and equipment. The NHLBI provides support for program project grants in the belief that a collaborative research effort can accelerate the acquisition of knowledge more effectively than a simple aggregate of research projects that have no interaction or thematic integration.
The Institute is particularly interested in encouraging new scientific directions in program project grants. The P01 mechanism is viewed as an opportunity to attract scientists who have not traditionally been supported by the NHLBI. However, all projects must be interrelated and have objectives that address a central theme within the scientific mandate of the Institute.
Purpose
This Funding Opportunity Announcement (FOA), issued by the NHLBI, invites Program Project applications (P01) that address the mission of NHLBI as outlined in the Background section above. This FOA continues the Program Project funding opportunity as previously detailed and structured in http://www.nhlbi.nih.gov/funding/resmech.htm. Investigators are encouraged to visit the NHLBI website for additional information about the research mission and high-priority research areas of the NHLBI http://www.nhlbi.nih.gov/about/strategicplan/index.htm.)
The purpose of Program Project (P01) grants is to support integrated, multiproject research programs that have a well-defined, central research focus or objective. The P01 is a confederation of interrelated research projects, each capable of standing on its own scientific merit but complementing one another. The P01 application must include a minimum of three individual research projects that contribute to the program objective. The NHLBI is interested in supporting new and innovative research through the program project grant. Therefore, no more than half of the projects included in a funded program project grant application may include projects that significantly overlap in time and objectives with currently funded individual research project grants, i.e., individual research project grants that would have to be relinquished if the program project grant application is funded. Each individual research project should reflect a distinct, separate, scientifically meritorious research effort led by an independent investigator, the project leader. In addition, the individual projects should be clearly interrelated and synergistic so that the research ideas, efforts, and outcomes of the program as a whole will offer a distinct advantage over pursuing the individual projects separately.
In addition to individual research projects, applicants may propose one or more shared resource core if needed for the proposed research. Each shared resource core must be utilized by two or more projects within the program. Both administrative and research support cores are allowed. New cores may be proposed and/or existing cores may be augmented to support the proposed research.
Applicants are referred to NHLBI’s tutorial on Preparing Multiproject Research Applications at http://www.nhlbi.nih.gov/funding/policies/ppg.htm for additional guidance on NHLBI P01s.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This
funding opportunity announcement (FOA) will use the NIH Program Project (P01) 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 non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
2. Funds Available
Because the nature and scope of the
proposed research will vary from application to application, it is anticipated
that the size and duration of each award will also vary. Although the financial
plans of the NHLBI provide support for this program, awards pursuant to this
funding opportunity are contingent upon the availability of funds.
New applications may request direct costs (not including indirect cost for collaborating institutions) for new awards for Program Project Grants (P01s) may be requested for up to $1,515,000. The most recent maximum allowable direct costs are posted on the NHLBI Web site (at http://www.nhlbi.nih.gov/funding/policies/grantcaps.htm). The allowable rate of increase in the direct costs for subsequent years is also posted on the NHLBI Web site (at http://www.nhlbi.nih.gov/funding/policies/operguid.htm). Requests for expensive items of equipment that cause an application to exceed the posted limits may be permitted on a case-by-case basis, following staff consultation. However, applicants should make every attempt to include all equipment in the ceiling amount. Applicants should discuss equipment requests with NHLBI staff early in the planning phase and must receive permission from the Institute to include equipment costs in their budget request. All requests for equipment that may cause an application to exceed the posted NHLBI limits require in-depth justification. Final decisions depend on the nature of the justification and the Institute's fiscal situation. The first year budget of a competing continuation should not exceed the budget for the previous support period.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
The following organizations/institutions are eligible to apply:
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible, however foreign collaborations are encouraged.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her 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.
More than one PD/PI, or multiple PDs/PIs, may not be designated on the application or the overall program.
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
Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.
Resubmissions. Applicants are eligible for one resubmission application, but such applications must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and renewal applications are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
Renewals. Applicants may submit a renewal application.
Section IV. Application and Submission Information
1. Address to Request Application
Information
The
current 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
Prepare all applications using the PHS 398 application forms in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).
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 IN ITEM (BOX) 2
ONLY OF THE FACE PAGE OF THE APPLICATION FORM AND THE YES BOX MUST BE CHECKED.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A.
Submission, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): September 20, 2010
Application Due Date(s): First receipt date October 20, 2010 with standard
dates aappyling thereafterplease see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due
Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
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.
Letters should be addressed to:
Program Project
Review Office
Division of
Extramural Research Activities
National Heart, Lung,
and Blood Institute
6701 Rockledge Drive,
Room 7208
Bethesda, MD
20892-7924 (Express Mail Zip: 20817)
Telephone: (301)
435-0303
FAX: 301-480-3541
Email: [email protected]
Individuals who plan to submit a program project grant application in response to PAR-09-185: Translational Programs in Lung Diseases (P01) , should review the special provisions and administrative guidelines at http://grants.nih.gov/grants/guide/pa-files/PAR-09-185.html. |
3.B. Sending an Application to the NIH
Applications must be prepared using the
research grant application forms 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 materials must be sent to:
Program
Project Review Office
Division of
Extramural Research Activities
National Heart, Lung,
and Blood Institute
6701 Rockledge Drive,
Room 7208
Bethesda, MD
20892-7924 (Express Mail Zip: 20817)
Telephone: (301)
435-0303
FAX: 301-480-3541
Email: [email protected]
Applications
must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.)
and at http://grants.nih.gov/grants/dates.htm.
Upon
receipt applications will be evaluated for completeness by CSR. Incomplete
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 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. However,
the NIH will accept a resubmission application, but such application must
include an Introduction addressing the critique from the previous review.
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.
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 renewal award
if such costs: 1) are necessary to conduct the project, and 2) 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 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 NIH Grants Policy
Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission Requirements
PHS398 Research Plan Sections
All application instructions outlined in the PHS 398 Application Instructions are to be followed, with the following additional requirements:
Applications submitted in response to this FOA must use the paper PHS 398 application package and instructions (http://grants1.nih.gov/grants/funding/phs398/phs398.html ) and include the modifications to the instructions described below, since the PHS for 398 does not have specific instructions for multi-project applications. More detail is provided in the NHLBI guidelines for preparing P01 applications http://www.nhlbi.nih.gov/funding/policies/ppg.htm
Organization: Applications should be organized as follows:
SECTION 1:
Form Page 1 - Face Page: Include the number and title of this FOA in item/line 2 of the PHS 398 application face page.
Form Page 2 - Description, Performance Sites, and Key Personnel: Under Description, state the proposed program’s broad, long-term objectives, specific aims, and significance. Define the relevance of each proposed project and shared resource core to the overall theme and goals of the program. List all performance sites and all Key Personnel and Other Significant Contributors for the entire P01, beginning with the PI/PD and then listing all other Key Personnel alphabetically. Include all project and core leaders, co-leaders, co-investigators, consultants and consortium collaborators (if applicable and if these individuals will devote measurable effort to the project).
Detailed Table of Contents: Modify the PHS 398 Form Page 3 to enable reviewers to find each component of the application easily.
Form Pages 4 and 5 Detailed Budget for Initial Budget Period; Budget for Entire Proposed Period of Support: Prepare a detailed composite budget for all requested support categories for the first years using Form Page 4 and a summary budget for the entire proposed period of support using Form Page 5 of the PHS 398 application. If applicable, provide additional budget pages pertaining to Consortium/Contractual arrangements (following the standard PHS 398 instructions).
Biographical Sketches: Compile all biographical sketches (limited to four pages each) after the Overall Budget, starting with the PD/PI followed by all other investigators in alphabetical order. Do not repeat biographical sketches in the individual research projects or shared resources cores.
SECTION 2:
Overall Program Project:
Specific Aims (limited to one page): List the goals of the research and summarize expected outcomes
Overall Research Strategy. (limited to 12 pages): The program overview section describes the significance, innovation and approach of the overall application and should highlight the program's conceptual unity by describing the scientific problems to be addressed and laying out a broad research strategy to address them. It should include a description of the major research objectives and strategic plan. Explain how the proposed projects and shared resource cores (if proposed) will be coordinated and work together to address the overall goals and aims of the program more effectively than if the projects were done independently. Describe the overall institutional environment, resources and commitments that are relevant to effective implementation of the P01. Describe how the proposed projects and shared resource cores will use the facilities and resources available at the overall program level. Describe how the program as a whole will benefit from any special equipment, laboratories, patient populations, and collaborations. Renewal applications should contain a brief description of progress.
If you choose to appoint an External Advisory Committee (optional), describe the expertise and responsibilities of your potential Program Advisory Committee members. For a new application, if applicable, do not contact, recruit, or name potential members. For a renewal application, provide the names of current and former members.
Resource Sharing Plan. Include a data sharing plan for the overall Program Project if the overall budget requests $500,000 or more in direct costs for any year. Include plans for sharing of model organism and genome-wide association studies, regardless of the amount requested, if applicable.
Sections not subject to 12-Page Research Strategy Limit:
Program Related Publications
Literature Citations
Letters of Support
Resource Sharing Plan
Additional details on the content of the Program Overview section are provided in the NHLBI guidelines for preparing P01 applications http://www.nhlbi.nih.gov/funding/policies/ppg.htm
Individual Research Projects (repeat this section for each research project, numbering them 1, 2, 3, etc consecutively):
Each Program Project application must include at least three inter-related research projects. The NHLBI no longer restricts the number of individual components of a program project grant application that can be submitted from organizations other than the applicant organization. However, all program project grant applications must provide a compelling justification for how the proposed program structure will encourage and enable extensive interactions among investigators and accelerate the acquisition of knowledge. Each research project should be prepared according to the standard PHS 398 instructions as modified in the NHLBI guidelines for preparing P01 applications http://www.nhlbi.nih.gov/funding/policies/ppg.htm In addition to the standard scientific description, the interactions among projects and core facilities should be described within each Project. The following instructions are unique to multiproject applications. Introduce each project using the PHS 398 Continuation Page; do not use the Face Page form.
Individual Cores (Repeat this section for each core, naming the cores with capital letters A, B, C, etc consecutively)
The following instructions are unique to multiproject grants. Introduce each core using the PHS 398 Continuation Page; do not use the Face Page form. Use a letter, e.g., A, B, C, to designate each core unit, and give each a unique title. For easy cross-referencing, type the core's title and letter on the upper left-hand margin of all relevant pages.
Applicants may propose one or more appropriate technical or administrative cores as needed. These shared resources must not duplicate analogous resources already established in the applicant institutions (although supplemental funding to such existing resources may be requested). Each Core should be prepared according to the standard PHS 398 instructions as modified in the NHLBI guidelines for preparing P01 applications http://www.nhlbi.nih.gov/funding/policies/ppg.htm Each core unit must provides essential facilities or services for two or more research projects. A multiproject application may include two types of cores: scientific cores and an administrative core.
Administrative Core The institution and the PI are responsible for the application and collaborative research activities. Explain the plans for organizational and administrative management of the overall program, and for coordination and communication within the program. Explain the methods that will be used for monitoring progress in the projects and effective use of the shared resource cores. The core may request funding for the program's administrative needs, for example, secretarial and other administrative services, expenses for publications for collaborative efforts, and communication expenses.
Scientific Core(s) A scientific core is a resource for the entire program. The application should list the projects it will serve and services it will provide. Describe the facilities, techniques, and skills the core will provide and the role of the Core Leader and each key participant. State the percentage of total dollars required to support each project that will use each scientific core.
Checklist Form Page
Complete one for the entire application, and place it at the end of the application.
Other Support Format Page -- Do not use this page in the PHS 398. Instead, NHLBI will request this information just-in-time, before issuing a grant award.
Budget
This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
Specific Instructions for Applications Requesting $500,000
(direct costs) or More per Year
Applicants
requesting $500,000 or more in direct costs for any year (excluding consortium
F&A costs) will require prior approval for
submission or the application will be returned unreviewed. Potential applicants must carry out the following steps:
1)
Contact the NHLBI program staff at least 12 weeks before submitting the
application, i.e., as plans are being developed for the study;
2)
Obtain agreement from the NHLBI that the Institute will accept the application
for consideration for award; and,
3)
Include a cover letter with the application that identifies the NHLBI and the staff
member who agreed to accept assignment of the application.
These instructions apply to all new, renewal, revision, or resubmission applications.
Please note that direct costs (not including indirect cost for collaborating institutions) for new awards for Program Project Grants (P01s) may be requested for up to $1,515,000.
Appendix Materials
Appendix information must be directly relevant to the application. If data are crucial to the Research Plan, put the data in the application, not an Appendix.
One Appendix for the whole application is allowed. Clearly cross-reference any materials that relate to a project or core.
For a P01, NIH appendix rules apply to each project and core. See NOT-OD-07-018.html.
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process or not reviewed.
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this should be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) ) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Section V. Application Review Information
1.
Criteria
Only
the review criteria described below will be considered in the review process.
2.
Review and Selection Process
Review
Process
Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group convened by NHLBI and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.
As part of the scientific peer review, all applications will:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Review Criteria for the Overall Program as a Whole
Reviewers will provide a single overall impact/priority score for the Program Project as a whole to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved. The overall application will be evaluated as an integrated research effort focused on a central theme. Individual research subprojects, supporting cores (if proposed), and the Program as an integrated effort are collectively considered. The relationship and contributions of each research subproject and core to the overall theme of the Program Project are evaluated.
Overall Program Impact
Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit. An application does not need to be strong in all categories to be judged likely to have a major scientific impact. For example, a program that by its nature is not innovative may be essential to advance a field.
Significance. Does the program address an important problem or a critical barrier to progress in the field? If the aims of the program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s). Are the PD/PI, collaborators, and other researchers well suited to the program? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the program is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the program?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the program? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the program involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the program proposed? Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Does the application adequately describe the scientific merit of each research project and core and the program as a whole? Are the overall program goals and scientific questions appropriate to a Program Project? Are the scientific gains and synergy achieved by combining the component projects into a multiproject program beyond the gains achievable if each project were pursued independently? Is the program cohesive with the research projects and cores fitting into a common theme? Does the PD/PI have sufficient time, effort, leadership ability, and scientific talent to develop a program of integrated research projects with a well-defined central research focus? For renewal applications, have the program's accomplishments made a major impact on the field or successfully achieved their original goals? If an Administrative Core is not proposed, are the administrative and organizational structures sound?
Review Criteria for Individual Research Projects Within the Program Project
Overall Impact
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Review Criteria for Cores
Administrative Core
Does the application clearly describe and justify the proposed administrative core operational plan and organizational structure? Is the proposed administrative core adequate to accomplish the objectives of the overall program? How well does it fit into the central focus of the overall program? Do the Core Leader s administrative, management, and leadership capabilities adequately provide for: internal quality control of on-going research, management of day-to-day program activities, management of contractual agreements, fair, effective communication and cooperation among program leaders and/or program investigators, resolution of disputes, development of scientific meetings and allocation of funds?
Scientific Core(s)
Is the scientific core sufficiently justified? Does it support at least two research projects? Is the core adequately connected to the central focus of the overall program? Are the facilities or services provided by the core (including procedures, techniques, and quality control) high quality? Will the services be used effectively? Are the core leader and key personnel well qualified and is there an adequate commitment of time?
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. Not applicable to this FOA.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations. Foreign applications are ineligible for this FOA.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Selection Process
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
3. Anticipated Announcement and Award Dates
Not
Applicable
Section VI. Award Administration Information
1. Award Notices
After
the peer review of the application is completed, the PD/PI will be able to
access his 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.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
A formal notification in the form of a
Notice of Award (NoA) will be provided to the applicant organization. The
NoA signed by the grants management officer is the authorizing document. Once
all administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official.
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).
3. Reporting
When
multiple years are involved, awardees will be required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy
Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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:
Director, Division of Cardiovascular Diseases
Two Rockledge Centre, Room 8128
6701 Rockledge Drive
Bethesda, Maryland 20892-7936
301-435-0422
Director, Division of Lung Diseases
Two Rockledge Centre, Suite 10018
6701 Rockledge Drive
Bethesda, Maryland 20892-7952
301-435-0233
Director, Division of Blood Diseases and Resources
Two Rockledge Centre, Room 10160
6701 Rockledge Drive
Bethesda, Maryland 20893-7950
301-435-0080
2. Peer Review Contacts:
Program Project Review Office
Two Rockledge Centre, Room 7208
6701 Rockledge Drive
Bethesda, Maryland 20892-7924
301-435-0303
3. Financial or Grants Management Contacts:
Deputy Director, Grants Operations Branch
Two Rockledge Centre, Room 7160
6701 Rockledge Drive
Bethesda, Maryland 20892-7926
301-435-0166
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.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in
advancing genome-wide association studies (GWAS) to identify common genetic
factors that influence health and disease through a centralized GWAS data
repository. For the purposes of this policy, a genome-wide association study is
defined as any study of genetic variation across the entire human genome that
is designed to identify genetic associations with observable traits (such as
blood pressure or weight), or the presence or absence of a disease or
condition. All applications, regardless of the amount requested, proposing a
genome-wide association study are expected to provide a plan for submission of
GWAS data to the NIH-designated GWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. Data repository
management (submission and access) is governed by the Policy for Sharing of
Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
Sharing of Model Organisms:
NIH
is committed to support efforts that encourage sharing of important research
resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the
same time the NIH recognizes the rights of grantees and contractors to elect
and retain title to subject inventions developed with Federal funding pursuant
to the Bayh Dole Act (see the NIH Grants Policy Statement 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.
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.
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-09-116.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is
the responsibility of the applicant to provide in the project description and
elsewhere in the application as appropriate, the official NIH identifier(s) for
the hESC line(s) to be used in the proposed research.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them
their final, peer-reviewed manuscripts that arise from NIH funds and are
accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months
after publication. As of May 27, 2008, investigators must include the PubMed Central
reference number when citing an article in NIH applications, proposals, and
progress reports that fall under the policy, and was authored or co-authored by
the investigator or arose from the investigator’s NIH award. For
more information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of
Individually Identifiable Health Information:
The
Department of Health and Human Services (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 FOA is related to one or
more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372. Awards
are made under the authorization of Sections 301 and 405 of the Public Health
Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42
CFR 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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