and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
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 |
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. |
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 |
Not Applicable |
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.
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
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.
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.
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.
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.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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.
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
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.
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: [email protected]
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: [email protected]
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.
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.
Not Applicable.
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.
This initiative is not subject to intergovernmental review.
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.
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.
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.
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.
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).
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?
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.
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.
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:
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.
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.
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.
Not Applicable.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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.
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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