Part I Overview Information


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), (www.nhlbi.nih.gov)

Title: NHLBI Research Centers at Minority-Serving Institutions (P30)

Announcement Type
New

Request For Applications (RFA) Number: RFA-HL-11-019  

Catalog of Federal Domestic Assistance Number(s)
93.233, 93.837 93.838,  93.839

Key Dates
Release Date: March 5, 2010
Letters of Intent Receipt Date: May 3, 2010
Application Receipt Date: June 2, 2010

Peer Review Date: November 2010
Council Review Date: January 2011
Earliest Anticipated Start Date: March 1, 2011 

Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: June 3, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
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 and Nature of the Research Opportunity

The Research Scientist Award at Minority Institutions (previously called the NHLBI HBCU Research Scientist Award) was originally established in 1997 to achieve the goal of identifying individuals who could provide scientific leadership and drive research development, and play a role in reducing health disparities at Minority-serving Institutions. This program used two phases to meet its objectives:  Phase I involved recruitment of an established scientist, and Phase II was the research operations phase, with the recruited scientist becoming the director of the program.  The program was developed to address challenges unique to minority institutions in performing scientific research. 

Minority-serving Institutions (MSIs) are colleges and universities that focus on serving a large percentage of minority students, but often serve non-minority students as well.  According to the National Center for Education Statistics (http://nces.ed.gov/pubs2008/2008156.pdf), the groups that fit into this category typically include:  Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Asian-serving Institutions, Tribal Colleges, and other MSIs.  Many MSIs are limited in achieving sufficient numbers of senior scientific leaders in a given research discipline, have limited resources to maintain a state-of-the-art research environment, and have a limited group of scientists with success in obtaining independent NIH funding. In order to increase the cadre and participation of new investigators trained in the biomedical and behavioral research enterprise at minority-serving institutions, as well as to reduce health disparities it is imperative to have a critical mass of well-trained scientists with active, funded laboratories at minority-serving institutions to serve as mentors.  In doing so:

Objectives and Scope

The Research Scientist Award in Minority Institutions has been instrumental in achieving its original goal to strengthen and augment research capacity and resources, and perform research to address health disparities.  However, additional resources are needed to further build these programs and support transition to independent support.  This proposed Funding Opportunity Announcement (FOA) is seeking to fund five centers through an open competition using the P30 mechanism, NIH Core Center Grants. 

These Core Center Grants are institutional awards that provide funding to:

This FOA, called the Research Centers at Minority-Serving Institutions program, will help to obtain and retain a critical mass of scientists at MSIs, while enabling the growth research programs that have already been developed.   However, the scientists recruited and/or retained through this program do not have to belong to an underrepresented minority group.  The overall purpose of the program is to support minority-serving institutions in strengthening scientific faculty; augment predoctoral and postdoctoral science education and research training; and improve research infrastructure, capabilities, and resources. 

Program Characteristics

The Research Centers program is intended to consist of two phases. Phase I (2 years), the recruitment/retention phase and establishment of the External Advisory Board (EAB), will be used to (1) identify and recruit an outside scientist with competitive, independent funding to the minority-serving institution or (2) retain a recent externally hired junior-level faculty member.  Members of the EAB will be chosen and their responsibilities delineated.  Development of the research program and research operations will begin in Phase II (5 years), at which time the Core Center will become a Specialized Research Center (under the P50 mechanism).  The primary goal of Phase II will involve the establishment of a new research program in HLBS diseases or disorders, or the development of a research program that synergizes with an existing research program.  The current FOA will support Phase I only.  The Phase II limited competition will be awarded based on success in Phase I, under a separate FOA to be released at a later date.  However, applicants should include their plans and expectations for Phase II in the Phase I application, including a plan to transition to Phase II.  Examples of activities in Phase II include laboratory training for pre- and postdoctoral trainees, collaborations within and outside of the institution and community, recruitment of additional scientists/faculty, pilot projects, development of scientific curricula and novel scientific exchange, and other relevant training (e.g., manuscript and grant writing seminars, etc.), faculty development, incentives for recruitment and retention of faculty (junior – to mid-level faculty), a plan for research balanced with training, and a creative strategy for development and training of senior-level institutional administrators. The MSI should also plan to match the costs budgeted for start-up packages for newly hired faculty.  Hiring of junior faculty is not allowable in Phase I. 

The ultimate goal of this program is to build a research program and move to a sustainable research infrastructure, allowing the institutions and investigators to become fully competitive.  Specific research examples for Phase I include, but are not limited to:

In order to assess the success of the Research Centers program, applications for this FOA should include provisions and a plan for:

Applications should also include a letter of support and commitment from the MSI acknowledging the goals, requirements, and institutional responsibilities necessary for participation in this FOA and to ensure success of the Research Center.  Additionally, if a research program currently exists, the institution/organization should provide evidence that it will continue to support the existing program, should an award be made under this FOA. If the institution/organization is planning for retention of recently hired faculty only in Phase I, proof of the faculty start date and faculty level should be provided.  The faculty start date must be within 12-18 months of the application receipt date for this FOA.

External Advisory Board

The EAB will be composed of approximately six external scientists and will primarily serve to advise the Research Center leadership and institution, and provide an evaluation of the research program.  Names of potential EAB members should be included in the application, and expenses for EAB activities should be budgeted for in the application.  In Phase I, the role of the EAB is to assist in the recruitment and retention process and review the qualifications and credentials of the candidates for the position of the recruited, established scientist.  During Phase II, the EAB, along with any additional ad hoc individuals with specific expertise, will provide scientific and administrative review of the research program and yearly program review/evaluation.  They may provide recommendations to the awardee institution and the NHLBI regarding scientific program progress and related activities, recruitment and retention of new scientific staff and faculty, and modifications to the scope of the research program.  The EAB should meet in person at least once per year, but may occur more frequently, if necessary via conference call.  The PI will select the members of the EAB, and the EAB members will select the Chair of the EAB. NHLBI staff will serve as non-voting members to the EAB, and approve the selection of the members and Chair of the EAB.  The EAB will nominate an Executive Secretary who will prepare minutes for each meeting.  A copy of the signed minutes (signed and approved by the Executive Secretary and the EAB Chairperson) will be forwarded to the other EAB members and Principal Investigator within 30 days of the meeting.  Other policies and procedures of the EAB will be developed once an award is made.

Budgetary Guidelines

Allowable budgetary costs for awards under this FOA may include, but are not limited to:

Funds may not be used to purchase equipment.  Additionally, for this FOA (Phase I), funds may not be used to support animal research or human subjects research.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the P30 award mechanism(s).

The Project Director/Principal Investigator (PD/PI) 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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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:

You may submit an application if your institution is a minority-serving institution that offers the M.S., Ph.D., M.D., or other professional degree in the biomedical or behavioral sciences. Minority-serving Institutions (MSIs) are colleges and universities that focus on serving a large percentage of minority students, but often serve non-minority students as well.  Groups that fit into this category typically include:  Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Asian-Serving Institutions, American-Indian-serving Institutions, and other minority-serving institutions.  Applications will not be accepted from institutions that do not meet these criteria.

Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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 program support.

The Institution should designate a PD/PI who is a senior official with appropriate institutional authority to carry out the project and work with Core Center investigators to develop relevant research projects, such as an Associate Dean/Director for Research, or a faculty member at the Full Professor level (or equivalent) (e.g., Department Chair/Division Chief). The PD/PI of Phases I and II may differ, but the institution should describe the proposed program organization for Phase II in the Phase I application.

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. Only one application per institution/organization is permitted.

Resubmissions.   Resubmission applications are not permitted in response to this FOA.

Renewals.   Renewal applications are not permitted in response to this FOA.

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) 435-0714, Email: GrantsInfo@nih.gov.

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 and 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.

Additional information is available in the PHS 398 grant application instructions.

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: May 3, 2010
Application Receipt Date: June 2, 2010
Peer Review Date(s): November 2010
Council Review Date: January 2011

Earliest Anticipated Start Date: March 1, 2011

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Rockledge II, Room 7214
Bethesda, MD 20892-7924 (Express mail zip 20817
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the 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 material must be sent to:

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Rockledge II, Room 7214
Bethesda, MD 20892-7924 (Express mail zip 20817
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or 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 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 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 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

Facilities & Other Resources:

Institutional Environment Resources. Any institution submitting an application in response to this FOA must show evidence of an existing research infrastructure that can support some aspects of the research program. Features of the institutional environment that are relevant to effective implementation of the overall program must be described.  Available resources (e.g., clinical and laboratory facilities, patient populations, space, etc.) should be described.

Research Strategy Requirements:

Infrastructure.  The application should include a description of how the proposed activities will augment and strengthen the research capabilities and resources, as well as enhance the science faculty and training at the MSI.

Organizational and Administrative Infrastructure.  The chain of responsibility for decision-making and administration, beginning at the level of the institution's President and including all key staff should be described, in detail and by diagram, if appropriate.  Individuals responsible for the day-to-day administrative details, program coordination, and planning and evaluation of the program should also be identified.  Any organizational or administrative changes that will occur in the structure during Phase II should also be identified and described.

Research Program.  The existing research program that is the basis for the grant application should be described along with future plans and how this award will enhance them.  In addition, plans for the recruited research scientist should be delineated.

Institution Commitment.  The application must outline plans to create and sustain a supportive research environment after NHLBI funding has ended; describe opportunities for the recruited scientist and the expectation for the overall research program in Phase II; describe the commitment to any existing research programs and how awards under this FOA will complement or enhance those programs. The plan of the institution to obtain additional research support outside of this award, e.g., private sector and/or NIH, should be described.  The institution should detail any specific resources that it is willing to provide.  Additional support letters from established collaborations should also be included.  These support letters are not included in the Research Component page limits.  Highest program priority will be given to those applications that confirm an institutional commitment beyond the end of this award. 

Recruitment and/or Retention Plan.  Applicants should describe the individuals to be involved in recruitment/retention activities, their specific responsibilities, and a timetable outlining the recruitment/retention activities during Phase I.  The qualifications and skills of the individual to be recruited or retained; the relative importance of those skills to the research program and the infrastructure needs of the institution; and the Institution's plan for identifying, recruiting, and retaining such an individual must be also described. 

Additional:

 Applicants should include the cost for coordination among investigators to attend annual investigators meetings and workshops in the budget.  Approximately 3-5 persons (e.g., PIs, key personnel, trainees) from each Research Center should plan to attend these meetings, which are projected to last 1.5 days.

PHS398 Research Plan Component Sections

All application instructions outlined in the PHS398 Application Guide are to be followed, with the following additional requirements:

Budget Component

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

Appendix Materials

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.

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

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 and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer 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. 

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? Does this project strengthen and augment research capacity in the heart, lung, blood or sleep areas of science at a minority-serving institution?

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? Does the PD/PI have the ability and institutional authority to provide scientific and administrative leadership and direction for the Research Center, and to work with the senior-level scientist hired under this FOA to develop a relevant research program?  Does the PD/PI have expertise relevant to heart, lung, blood, or sleep (HLBS) diseases and disorders research, and if not, is the PD/PI’s expertise likely to synergize with an existing research program in the HLBS field(s)?  Is there confidence that the selected research personnel will be successful in sustaining the proposed research program and training students and fellows?

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? Does the application identify critical research needs and seek innovative ways and include expectations to establish a research program (in Phase II)?  Does the application use innovative means or methods to encourage minority students and trainees in careers in biomedical and behavioral sciences related to HLBS diseases and disorders?  Is the proposed research program likely to synergize with any existing program and introduce new, innovative research directions?  Is a novel infrastructure proposed for the future research center?

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? Are plans included for the identification, recruitment and/or retention of a scientific faculty member?  Are these plans adequate and appropriate for furthering the scientific mission of the Research Center?    Are the expectations and goals of the research program (for Phase II) feasible, innovative, and of high scientific/technical merit?  Are plans included for appropriate members of the External Advisory Board (EAB)?  Are the duties and responsibilities for the EAB clearly outlined?  Are these plans appropriate and likely to lead to a successful program?  To what extent will the proposed research center benefit minority students?  How will the proposed new research program complement existing research programs and how will it augment education and research training?  To what degree will the proposed research center address topics in HLBS?

 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?  Does the institution have prior research experience relevant to HLBS diseases and disorders?  Is the MSI committed to the success of the overall research program proposed, including recruitment plans for the research scientist?  Likewise, is there a commitment in Phase II to the recruitment and retention of other faculty (e.g., providing a plan for start-up packages), to the training for students and fellows, and faculty?  Will there be a plan for administrative development?  Has the organizational and administrative infrastructure been adequately described?  What evidence is provided that the institution is strongly committed to fostering the development of the Research Center, and continued support of any existing research programs/centers?  What additional facilities and resources are proposed for Phase I and Phase II and how would they augment and complement existing facilities and resources?  Are plans described to create and sustain a supportive research environment and to obtain additional, outside funding? Will the research activities and resources of the Center assist in developing and strengthening collaborations within and outside of the institution? Is there a sufficient number if experienced mentors at the MSI with appropriate expertise and funding available at the applicant institution of at a partner institution to support a viable program?   

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications.  Resubmission applications are not permitted in response to this FOA.

Renewal Applications.  Renewal applications are not permitted in response to this FOA.

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 are not eligible 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

The following will be considered in making funding decisions:

NIH considers the following in evaluating Center grant applications:

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.

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 Notice of Award will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See 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).

3. Reporting

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.

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:

Dina N. Paltoo, Ph.D., M.P.H.
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
Rockledge II, Room 8220
6701 Rockledge Drive
Bethesda, MD 20892-7940
Telephone: (301) 435-0513
Fax:  (301) 480-1454
Email: paltood@mail.nih.gov

2. Peer Review Contacts:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3. Financial or Grants Management Contacts:

Ronald Caulder
Division of Extramural Research Affairs
National Heart, Lung, and Blood Institute
Rockledge II, Room 7162
6701 Rockledge Drive
Bethesda, MD 20892-7926

Telephone: (301) 435-0148
Fax:
Email: caulderr@mail.nih.gov

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/.

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 public 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-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.


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NIH Funding Opportunities and Notices


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