Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)  

Funding Opportunity Title

Limited Competition: NHLBI Research Centers at Minority Serving Institutions - Phase II (P50)

Activity Code

P50 Specialized Center

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HL-13-011

Companion Funding Opportunity

NoneNone

Number of Applications

Only one application is permitted per institution/organization Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.233, 93.837 93.838,  93.839

Funding Opportunity Purpose

This FOA issued by the National Heart, Lung, and Blood Institute (NHLBI) is a limited competition to solicit applications from investigators funded under Phase I of the NHLBI Research Centers at Minority-Serving Institutions program. http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-11-019.html  The purpose is to establish research centers to augment and strengthen research capabilities and resources in biomedical and behavioral research related to heart, lung, and blood diseases and disorders, with  the ultimate goal to increase diversity in the biomedical and behavioral research enterprise.  The program is intended to occur in two phases:  Phase I (the recruitment/retention phase and establishment of the External Advisory Board, 2 years) and Phase II (the development of the research program and research operations, 5 years).  This FOA is intended to support Phase II only, and is dependent upon the success from Phase I. 

Key Dates
Posted Date

April 4, 2012

Letter of Intent Due Date

May 13, 2012

Application Due Date(s)

June 13, 2012

AIDS Application Due Date(s)

September 7, 2012

Scientific Merit Review

October/November 2012

Advisory Council Review

January 2013

Earliest Start Date(s)

April 1, 2013

Expiration Date

September 8, 2012

Due Dates for E.O. 12372

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background and Nature of the Research Opportunity
The mission of the National Heart, Lung, and Blood Institute (NHLBI) is to provide global leadership for research, training, and education programs to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives.  The NHLBI stimulates basic discoveries about the causes of disease, enables the translation of these discoveries into clinical practice, fosters training and mentoring of emerging scientists and physicians, and communicates research advances to the public.

American Indians, Alaska Natives, Asians, Blacks or African-Americans, Native Hawaiians and other Pacific Islanders, and Hispanics or Latinos experience much higher risks and poorer health status than the general population. Many of the diseases and disorders that disproportionately affect the health of racial and ethnic minority populations in the United States receive high priority in NHLBI research areas to advance the foundation of knowledge in the biomedical sciences focused on reducing and ultimately eliminating health disparities.

Basic and translational research on diseases with high prevalence in minority populations, as well as clinical research studies designed and conducted with a significant number of participants from disparate U.S. populations, is critically needed if the burden of diseases on these populations is to be effectively decreased or eliminated.

The National Institutes of Health is compelled by the preceding information in this section to expand opportunities for new clinical investigators from underrepresented racial and ethnic backgrounds, individuals with disabilities, and individuals from disadvantaged backgrounds as one approach to achieving the Healthy People 2010 goals of reducing health disparities and increasing the quality and years of healthy life for all Americans.

In order to increase the cadre and participation of new investigators trained in the biomedical and behavioral sciences 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:

The Research Scientist Award at Minority Institutions (previously called the NHLBI HBCU Research Scientist Award) was originally established by NHLBI 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 (MSIs). 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. It 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 have been needed to further build these programs, increase capacity, and facilitate transition to independent support.  In 2011, the NHLBI began a new program, NHLBI Research Centers at Minority-Serving Institutions (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-11-019.html).  Phase I of this program funded five centers through an open competition using the P30 mechanism, NIH Core Center Grants. The goals of Phase I were to recruit investigators to establish a new center, or retain a recently hired junior-level faculty that can establish a new research center and/or build upon an existing research program and resources.

Rationale and Justification for Limited Competition
Historically, minority institutions have trained scientific and medical professionals who are uniquely positioned to train and engage minority populations in biomedical research, as well as in the translation of research advances into culturally competent, measurable and sustained improvements in health outcomes.  The NIH, through the NHLBI, has made a significant investment in supporting MSIs to identify established scientists to develop or enhance research centers studying heart, lung, and/or blood diseases and disorders. The development of this infrastructure provides MSIs the ability to increase research capacity and contribute to diversity in the biomedical workforce, while capitalizing on existing resources and forging into new areas of scientific interest.  No equivalent infrastructure specific for heart, lung, and blood diseases and disorders exists. This proposed Funding Opportunity Announcement (FOA) is seeking to fund up to five centers through a limited competition using the P50 mechanism, NIH Specialized Center Grants.  This competition is only open to the five centers currently funded in Phase I through the P30 mechanism under the same program name.  This FOA will support Phase II only, the goals of which are research operations and development of the research center. Limiting the competition to members of the current NHLBI Research Centers MSI program will capitalize on the existing research infrastructure and programs, efficiencies, and other scientific strengths, and will thus greatly facilitate establishing a new or scaling up the current center to conduct new as well as more complex, heart, lung, and blood disease research. The overall purpose of the program is to support MSIs in strengthening scientific faculty research and career development; augment predoctoral and postdoctoral science education and research training; and improve research infrastructure, capabilities, and resources. 

Program Characteristics
The second Phase of the Research Centers involves development of the research program and research operations (5 years), at which time the Core Center (from Phase I) 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 heart, lung, and/or blood diseases or disorders, or the development of a research program that leads to a program in heart, lung, and/or blood diseases or disorders through interactions with an existing research program.  The Phase II limited competition awards are dependent upon success in Phase I.  Examples of activities in Phase II include laboratory experience for pre- and postdoctoral trainees, collaborations within and outside of the institution and community, recruitment of additional scientists/faculty, pilot research projects, development of scientific curricula and novel scientific exchange, and other administrative 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 equally support the costs budgeted in the grant for start-up packages for newly hired faculty. 

The ultimate goal of this program is to build a research center and move to a sustainable research infrastructure, allowing the institutions and investigators to become fully competitive.  Specific research examples for a Phase II Research Center 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:

Tracking and Reporting on the Items Listed Above
Applications must include a detailed timeline and milestones for key activities.  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. Proof, in the form of a letter, from the recruit hired or retained from Phase I, and their commitment to the Center in Phase II, should be provided.  The Center Director start date must be within 3 months of the application award date for this FOA.

The NHLBI will use the metrics above to evaluate the overall success of each funded Research Center.  After three years, the NHLBI will perform an administrative review of the success of the entire program to determine whether to continue funding as currently configured.  Discontinuation of the program is a policy option that will be made at the discretion of the NHLBI.

External Advisory Board
The External Advisory Board (EAB), such as that established in Phase I, is 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.  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 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.  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.  Any new members to the EAB should not be named prior to a funding decision, however, applicants may specify additional expertise that is needed on the EAB. 

Budgetary Guidelines
Allowable budgetary costs for awards under this FOA may be divided into three categories:
Administrative, Developmental, and Research.  The allowable costs may include, but are not limited to:

Administrative

Developmental

Research

Funds may not be used to purchase equipment, unless it is included as a part of the start-up package for faculty recruitment.  Phase II funds may be used to support animal research or human subjects research.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

NHLBI intends to fund up to 5 awards, corresponding to a total of $7 million for fiscal year 2013. Future year amounts will depend on annual appropriations.

Award Budget

The direct costs requested should not exceed $950,000 per year: total costs should not exceed $1.4 million each year for 5 years . Annual increases for recurring costs due to inflation will not be awarded..

Award Project Period

The project period for this award is 5 years.

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

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

The Institution should designate a senior-level PD(s)/PI(s) to lead the Specialized Center, carry out the project, and work with investigators to develop relevant research projects.  The PD(s)/PI(s) of Phase II may be different than that of Phase I.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit only one application.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. Resubmission applications may not be submitted in response to this FOA.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

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

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and 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)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files 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

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

The P50 application Research Strategy section of the PHS398 is limited to 30 pages including tables, graphs, diagrams, and charts.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

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 and existing 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 provide career development and training opportunities to faculty and students, and contribute to increasing diversity in the biomedical and/or behavioral workforce.

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.  Provisions for significant changes in key personnel should be included.

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 the research capabilities at the institution.  In addition, plans for the Center Director and other faculty/staff should be delineated including their specific responsibilities, research projects, new scientific collaborations, and training opportunities.  Additional support letters from established collaborations within or outside of the institution should also be included.  These support letters are not included in the Research Component page limits.  A timeline outlining the key activities and milestones must be included.

Institutional Commitment:  
The application must outline plans to create and sustain a supportive research environment after NHLBI funding has ended.  Institutional commitment to any existing research programs and how awards under this FOA will complement or enhance those programs to build the center must be included. 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.  Highest program priority will be given to those applications that confirm an institutional commitment beyond the end of this award. 

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

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modification:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Foreign Institutions

Not Applicable.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be postmarked on or before the due dates in Part I. Overview Information.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115, with the following modifications:

Investigators should provide an update on the status of the recruit or retainee from Phase I, and the role they will play in the Phase II Specialized Center. A letter of acceptance from this individual indicating their willingness to participate in Phase II should be included in this update.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

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 review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific 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 capability and capacity in the heart, lung, or blood areas of science at a minority-serving institution?  

Investigator(s)

Are the PD(s)/PI(s), 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(s)/PI(s), 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 develop a relevant research program?  Does the PD/PI have expertise relevant to 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 to establish a research Center?  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 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 the expectations and goals of the research Center feasible, innovative, and of high scientific/technical merit?  What is the quality of the plans for the External Advisory Board (EAB)?  Are the duties and responsibilities for the EAB clearly outlined?  To what extent will the proposed research Center benefit minority students?  How will the research Center complement existing research programs and how will it augment education and research training?  To what degree will the proposed research Center address topics in HLB diseases and disorders? 

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 HLB diseases and disorders?  Is the MSI committed to the success of the overall research Center proposed? Likewise, is there a commitment to the recruitment and retention of other faculty (e.g., providing a plan for start-up packages), and to training/career development for students, 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?  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 of experienced mentors at the MSI with appropriate expertise and funding available to support a viable program?    

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, 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 on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider 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

Not Applicable.

Select Agent 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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NHLBI in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NHLBI Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

 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

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Tamara Kees
Division of Extramural Research Affairs
National Heart, Lung, and Blood Institute
Rockledge II, Room 7174
6701 Rockledge Drive
Bethesda, MD 20892-7926
Telephone: (301) 435-0166
Fax: (301) 451-5462
Email: tkees@nhlbi.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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