Participating Organization(s) |
National Institutes of Health (NIH) |
National Heart, Lung, and Blood Institute (NHLBI) |
|
Funding Opportunity Title |
Selected Topics in Transfusion Medicine (R21) |
Activity Code |
R21 Exploratory/Developmental Research Grant Award |
Announcement Type |
Reissue of PAR-10-033 |
Related Notices
|
|
Funding Opportunity Announcement (FOA) Number |
PAR-13-025 |
Companion Funding Opportunity |
PAR-13-026, R01 Research Project Grant |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.839 |
Funding Opportunity Purpose |
This Funding Opportunity Announcement (FOA) issued by the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), encourages research grant applications from investigators who propose to study research topics in blood banking and transfusion medicine aimed at improving the safety and availability of the blood supply and the practice of transfusion medicine. Specifically, research focused on improving blood donor health, the safety and availability of blood products, and improving the practice of transfusion medicine is critical to public health. Research designed to better understand the determinants of transfusion-associated adverse events and how best to minimize transfusion risks is also important. Research is also needed to maintain an adequate blood supply by minimizing the risks associated with the donation process and developing enhanced recruitment and retention programs. |
Posted Date |
November 23, 2012 |
Open Date (Earliest Submission Date) |
January 16, 2013 |
Letter of Intent Due Date(s) |
Not Applicable |
Application Due Date(s) |
Standard dates apply but this FOA will only use the Cycle I and Cycle III R21 receipt dates (for cycles, see http://grants.nih.gov/grants/funding/submissionschedule.htm).Applications are due by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Standard AIDS dates apply but this FOA will only use Cycle I and Cycle III (for cycles, see http://grants.nih.gov/grants/funding/submissionschedule.htm). |
Scientific Merit Review |
Standard dates apply but this FOA will only use Cycle I and Cycle III (for cycles, see http://grants.nih.gov/grants/funding/submissionschedule.htm. |
Advisory Council Review |
Standard dates apply but this FOA will only use Cycle I and Cycle III (for cycles, see http://grants.nih.gov/grants/funding/submissionschedule.htm). |
Earliest Start Date |
Standard dates apply but this FOA will only use Cycle I and Cycle III (for cycles, see http://grants.nih.gov/grants/funding/submissionschedule.htm). |
Expiration Date |
New Date September 22, 2016 per issuance of PAR-16-441. (Original Expiration Date: January 8, 2017) |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) 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. 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 the 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
This FOA issued by the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), encourages exploratory/developmental research grant applications from investigators who propose to study research topics in blood banking and transfusion medicine aimed at improving the safety and availability of the blood supply and the practice of transfusion medicine.
Research in transfusion medicine and blood banking is critical to public health in the U.S., since transfusion therapy is one of the most commonly employed, and arguably least understood procedures in the U.S., affecting about six million recipients every year. Blood transfusions potentially expose recipients to transmissible biologic agents that are known or suspected to be associated with specific disorders. These agents range from major known threats such as human immunodeficiency virus (HIV), Hepatitis C virus (HCV), and Hepatitis B virus (HBV) to novel or emerging agents of public health concern such as Dengue virus or the agents causing babesiosis and malaria. Blood transfusions also pose non-infectious risks to recipients. Some of these risks are poorly understood and include transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO), alloimmunization, metabolic and coagulation abnormalities, microchimerism, and transfusion-related immunomodulation (TRIM). In addition, there are other elements such as circulating DNA and the so-called orphan viruses that have not been adequately assessed for their transmissibility through blood products and their potential clinical impact. Other important research areas are: 1) improving blood collection; 2) optimizing the laboratory screening, processing and storage of blood products; 3) evaluating the effectiveness of transfused blood products; 4) enhancing blood management; and 5) characterizing the immunologic, inflammatory, and vasoactive properties of transfusions. It is also essential to maintain an adequate blood supply by better understanding the motivations and barriers to donation, minimizing donation risks and ensuring blood donor health, and developing improved recruitment and retention programs.
Findings from this research will benefit the six million patients who receive blood products every year in the US; in particular, the chronically transfused patients such as those with sickle cell disease or thalassemia who are at higher risk of developing transfusion-associated complications. Large populations who will benefit include trauma victims, cancer patients, patients undergoing orthopedic and cardiovascular surgery, and patients admitted to intensive care units. Research aimed at minimizing the risks associated with donating and enhancing the donation experience will benefit the approximately five percent of the U.S. population who donate blood every year. Research efforts aimed at minimizing donation risks, and enhancing recruitment and retention will also help ensure a safe and adequate blood supply.
Applications submitted to this FOA should have a clear and direct link to advancing the field and/or the practice of blood banking and transfusion medicine. The research should be hypothesis-driven and pertinent to the donation, and/or transfusion of red blood cell units, platelet units, granulocyte units, whole blood units, cryoprecipitate, and/or plasma (such as fresh frozen plasma and 24 hour plasma) units manufactured per US standards. Basic, animal model, early human physiological, epidemiological, comparative effectiveness, and/or behavioral research projects can be proposed. Multi-center phase II or III randomized clinical trials will not be supported by this FOA. Phase II or III multi-center randomized clinical trial applications responsive to NHLBI’s mission can be submitted to PAR-10-096 and follow the application processes provided at http://grants.nih.gov/grants/guide/pa-files/PAR-10-096.html.
Examples of research topics include, but are not limited to, those listed below:
- Novel donor recruitment and retention strategies including targeted interventions to recruit underrepresented donor populations.
- Strategies to optimize the donation environment and enhance donor coping skills and satisfaction.
- Studies to promote blood donor health.
- Evaluation of blood donor factors that are potentially associated with the quality of the blood products and/or recipient safety.
- Impact of changes in blood donor health/behavioral screening strategies on safety and availability of donor products.
- Evaluation of new strategies to enhance blood collection, processing and storage such as new containers, new additive solutions, new apheresis techniques, or rejuvenation methods.
- Studies to evaluate donor laboratory screening/confirmatory testing methodologies and algorithms and their impact on transfusion safety and availability.
- Use of novel methods to safeguard the blood supply including research on pathogen reduction.
- Infectious complications of blood transfusion including known, and novel or emerging agents of concern.
- Non-infectious complications of blood transfusion including for example, alloimmunization and its consequences, transfusion-related acute lung injury (TRALI), metabolic, hemostasis and coagulation abnormalities, and/or transfusion-related immunomodulation (TRIM).
- Immunomodulatory, inflammatory and vasoregulatory properties of transfused blood components including platelet, red blood cell, plasma, and/or granulocyte products.
- Studies of the storage lesion components and their associations with transfusion-associated adverse events.
- Development of effective animal models to study transfusion complications.
- Development of methods and/or identification of biomarkers to evaluate the effectiveness of transfused blood products.
- Blood product utilization patterns and comparative effectiveness studies of various transfusion practices.
- Research to optimize knowledge transfer and patient blood management.
- Evaluation of the impact of introducing a new blood product preparation, modified product, or transfusion strategy on transfusion-associated adverse events and recipients clinical outcomes.
- Studies to develop a blood product from stem cells or their progenitors for transfusion to humans.
Research topics that are not appropriate for this FOA include:
- Research on oxygen-carrying red blood cell substitutes and research on products derived from plasma such as coagulation factors or immunoglobulin products.
- Research on hematopoietic stem cells and their progenitors are not eligible unless the purpose of the research is to produce a human red blood cell, platelet, or white blood cell product that can be used to transfuse humans and be effective at oxygenating tissues, hemostasis, or combating infections, respectively.
- Multicenter, phase II or III randomized clinical trials; investigators interested in conducting multicenter phase II or III randomized clinical trials should see PAR-10-096 (http://grants.nih.gov/grants/guide/pa-files/PAR-10-096.html).
- Non-hypothesis driven research related to commercialization; investigators interesting in conducting such research should see information on SBIR/STTR (http://grants.nih.gov/grants/funding/sbir.htm).
The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research.
The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.
Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.
Funding Instrument |
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
Application Types Allowed |
New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards issued is contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. |
Award Budget |
The total project period for an application submitted in response to this funding opportunity may not exceed two years. Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. |
Award Project Period |
The total project period for an application submitted in response to this funding opportunity may not exceed two 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
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
- Non-domestic (non-U.S.) Entities (Foreign Institutions)
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations
as described in the SF424 (R&R) 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.
- System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
- Grants.gov
- eRA Commons
All Program Directors/Principal Investigators (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
least 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 PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
- To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
- Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
- Of an application with a changed grant activity code.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) 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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
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 SF424 (R&R) Application Guide, with the following modification:
- All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application before the deadline in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
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 submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the
Credential field of the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Important Update: See
NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.
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.
For this particular announcement, note the following:
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
Reviewers will provide an overall impact 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?
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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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 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
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not Applicable
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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 score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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 CSR, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
- May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an Overall Impact/Priority Score.
- Will receive a written critique.
Applications will be assigned to the appropriate NIH Institute or Center. Applications 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 National Heart, Lung, and Blood Advisory Council.. The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
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.
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, SAM
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.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Service Desk (Questions regarding ASSIST, 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]
Shimian Zou, Ph.D
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Rockledge II, MSC 7950
6701 Rockledge Drive
Bethesda, MD 20892-7950
Telephone: 301- 435-0065
Fax: 301-480-0867
Email: [email protected]
Katherine M. Malinda, PhD
Chief, Vascular and Hematology (VH) IRG
Center for Scientific Review
National Institutes of Health
6701 Rockledge Dr., MSC-7806, Room 5212
Bethesda, MD 20892
Telephone: 301-435-0912
Fax: 301-480-2644
Email: [email protected]
Lauren Ruane
Office of Grants Management
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Bethesda, MD 20892-7950
Telephone: 301-435-0166
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.
