and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Heart, Lung, and Blood Institute (NHLBI) |
|
Funding Opportunity Title |
Translation of Pluripotent Stem Cell Therapies for Blood Diseases (R01) |
Activity Code |
R01 Research Project Grant |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PA-11-186 |
Companion FOA |
Not Applicable |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.839 |
FOA Purpose |
This FOA issued by the National Heart, Lung, and Blood Institute, National Institutes of Health, encourages Research Project Grant (R01) applications from institutions and organizations that propose collaborative, multidisciplinary, multi-Project Director/Principal Investigator research for the development of new technologies needed to utilize stem cells in future cell therapies to treat sickle cell disease and other blood disorders. This initiative focuses on two key areas that are impediments to further progress: (1) development of techniques to efficiently generate hematopoietic cells by either differentiation of human pluripotent stem cells (PSC) or by cellular reprogramming to yield sufficient numbers of GMP quality cells for clinical evaluation; and (2) development of protocols that enable the efficient engraftment of hematopoietic cells derived from pluripotent stem cells or derived by cellular reprogramming. Each multidisciplinary application will designate two or more Project Directors/Principal Investigators. This program will be implemented in collaboration with the ongoing NHLBI Progenitor Cell Biology Consortium (http://www.progenitorcells.org/) and will add separate additional research projects. Extensive collaboration is expected between the existing Consortium Hubs, and the new group(s) are also expected to collaborate extensively with the Consortium Hubs. |
Posted Date |
March 28, 2011 |
Open Date (Earliest Submission Date) |
September 5, 2011 |
Letter of Intent Due Date |
Not Applicable |
Application Due Date(s) |
New applications: October 5, 2011; October 5, 2012; (Extended to November 1, 2013 per NOT-OD-14-003), Originally October 5, 2013 |
AIDS Application Due Date(s) |
January 7, 2012; January 7, 2013; January 7, 2014 |
Scientific Merit Review |
February/March 2012 |
Advisory Council Review |
May 2012 |
Earliest Start Date(s) |
July 2012 |
Expiration Date |
January 8, 2014 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (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
1. Research Objectives
Nature of the research opportunity
This initiative will support multidisciplinary, multiple PDs/PIs research projects to develop two new technologies needed to utilize pluripotent stem cells or cellular reprogramming in future cell therapies to treat blood disorders. These two areas are: (1) development of methods to: (a) efficiently differentiate human pluripotent stem cells (PSC), e.g., embryonic stem (ES) cells or induced Pluripotent Stem (iPS) cells, to hematopoietic stem cells in sufficient numbers and of GMP quality for clinical evaluation; or (b) as an alternate strategy, to direct the reprogramming of somatic cells to hematopoietic cells in sufficient numbers and of GMP quality for clinical evaluation; (2) development of protocols that enable efficient engraftment of hematopoietic cells derived from PSC or from somatic cells and that result in functional regeneration of all blood cell lineages. This program will be implemented in collaboration with the ongoing NHLBI Progenitor Cell Biology Consortium and will add separate additional research projects. Extensive collaboration is expected between the existing Consortium Hubs, and the new group(s) are expected to collaborate extensively with the Consortium Hubs. The projects in this initiative will concentrate on scientific areas that are not the current research focus of the Consortium. Utilizing the research project grant mechanism (R01), NHLBI staff will work with researchers funded by this program to assimilate the research projects funded by this additional program with the research of related Consortium Hub projects. After the projects are awarded, successful applicants will also be able to utilize the resources provided by the Consortium including the Research Cores.
It is the goal of the NHLBI to foster new collaborations and to facilitate partnerships among different disciplines with the Groups supported by this initiative. Thus applications submitted in response to the FOA must include multiple PI/PDs and two or more clustered research projects. Within each Group, the contact PI/PD will serve as the point of contact and will represent the Group to NHLBI staff and to the NHLBI Progenitor Cell Biology Consortium. PI/PDs of other research projects in the group will be collaborating PI/PDs. While the amount of effort is not prescribed, it is estimated that 3 calendar months of effort would be strongly recommended for the contact PI/PD, and it is estimated that 2.4 calendar months effort would be recommended for the other collaborating PI/PDs in the Group.
The Group application should describe how collaborative research efforts will be managed. To promote this, each Group is encouraged to include a management plan and may identify a scientific oversight committee. To accomplish the research goals of this PAR, the management plan may address the following issues:
Each Group of research projects may chose to identify a scientific oversight committee to provide feedback on the project. The committee could include individuals included in a management plan, to provide intellectual input and leadership for the collaborative research project. If the Group has a scientific oversight committee and a management plan, funds can be budgeted for administering these activities.
Pertinent background information that establishes the need for the research
Advances in stem cell biology strongly support new approaches to the development of cell therapies. The hope for clinical applications of stem cells was strengthened with the derivation of induced pluripotent stem (iPS) cells from mice in 2006 followed the next year by the derivation of human iPS cells. These cells were first derived by the cellular reprogramming of skin fibroblasts, an easily obtained tissue, and resulted in pluripotent cells that could give rise to any cell type, as well as cells that are immunologically matched to the animal or patient.
In specific cases, proof-of-principle studies have been completed. For example, the treatment of sickle cell anemia with iPS cells has been demonstrated in a humanized mouse model. However, additional research is needed before these findings can be translated into new stem cell therapies and focused research efforts are needed to develop platform technologies that would support future clinical development.
Two key areas are engraftment and differentiation. In the proof-of-concept studies for sickle cell disease, engraftment potential was aided by transfecting murine stem cells with the transcription factor hoxB4. This procedure cannot be used clinically, at least not without further development and safer alternatives are preferred for clinical use. For cell differentiation in the preclinical study, embryoid bodies were used to obtain differentiated murine blood cells selected using antibodies to specific cell surface markers. But these preclinical approaches cannot be directly translated to human studies, and robust, scalable protocols are needed for the clinic.
The aim of this FOA is to further research in the key areas of differentiation and engraftment. Other related work will be ongoing in parallel in other research programs. This includes more efficient gene correction methods, particularly homologous recombination methods that avoid random insertion and maintain physiological genetic regulation. Also, improved stem cell safety is needed and is being pursued by other studies. Studies of these and other aspects of cell therapy may also be components of the proposed research for this program. However, the focus of applications submitted to this announcement should be on improved blood cell engraftment and regeneration or on more robust differentiation protocols or on both. This focus on robust scalable methods is intended to facilitate future translation of stem cell research into new blood cell therapies for hematological disorders.
To accomplish these objectives, this program will fund separate R01 multidisciplinary, PD/PI grants for research projects that will be in addition to the ongoing NHLBI Progenitor Cell Biology Consortium (http://www.progenitorcells.org/). This new program will build on the expertise, resources and infrastructure of the Consortium and will be closely linked to the Consortium that includes experts in stem cell biology, hematology, bioengineering, cell processing, and large animal models. This new program concentrates on two additional scientific areas that are not the focus of the current Consortium. By coordinating the research efforts in this new additional program with related Consortium projects and by potentially utilizing the same cores, the Institutes investment in both programs will be effectively leveraged. Links between the new projects in this program and the ongoing Consortium will be established by the NHLBI program officer after successful applicants are funded. Investigators applying to this program need not establish collaborative projects with Consortium investigators during the application process. However, once funded, the new group(s) will be expected to attend annual meetings, participate in Consortium committees and conference calls, share resources and reagents, and enter into collaborations with Consortum Hubs to utilize the expertise, resources, and other infrastructure, where possible, to further research progress. Information on the groups in the NHLBI Progenitor Cell Biology Consortium (PCBC) and a proposed core can be found at the PCBC web site: http://www.progenitorcells.org/.
In addition, collaboration with other ongoing NHLBI programs will be encouraged. These programs include the NHLBI Production Assistance for Cellular Therapies (PACT) and the NHLBI Gene Therapy Resource Program (GTRP). PACT (http://www.pactgroup.net/) can provide clinical grade cells and expertise on cell scale up and GMP cell processing and GTRP (http://www.gtrp.org/) can provide clinical grade vectors and expertise on vector production and pharmacology and toxicology.
Research efforts related to hematopoietic stem cell biology, cell biology, cell processing, or animal models will be provided through the research projects supported by this initiative. The projects are intended to accelerate the development of the technology platform needed to enable pluripotent stem cells to be differentiated into engraftable blood cells on the scale required for clinical use. Additional expertise in bioinformatics, genomics and epigenomics, transcriptomics, and proteomic technologies may also be included in the proposals for this initiative.
Scientific knowledge to be achieved through research supported by the special program
The program is intended to lead to robust generation of clinically useful blood cells from the differentiation of pluripotent stem cells into human hematopoietic stem cells. Current protocols using ES cells or iPS cells yield hematopoietic cells that have provided valuable information on mechanisms and in preclinical proof of concept studies. Protocols that yield human hematopoietic stem cells in sufficient numbers for clinical studies need to be developed. As an alternate strategy, a process for directly reprogramming somatic cells to hematopoietic cells could also lead to a sufficient number of GMP quality cells for clinical evaluation. Furthermore, this research program is intended to lead to new translational strategies supporting cell expansion, differentiation, and GMP cell processing for new blood cell therapies. The initial efforts will determine feasibility and, if successful, lead to future early-phase clinical studies.
Objectives of this research program
Acquisition of new scientific knowledge on the engraftment and differentiation of hematopoietic stem cells derived from pluripotent stem cells or, alternatively the reprogramming of somatic cells to yield hematopoietic cells. This knowledge can be used to develop platform technologies to support the future clinical development of new blood cell therapies.
Types of research and experimental approaches that are being sought to achieve the objectives
Appropriate research and experimental approaches include but are not limited to the following topics.
A PD/PI planning to apply should: (1) recruit a team of the required experts in one or more topics relevant to the research objectives, and (2) should enter into a collaborative effort with one or more additional PDs/PIs that have also formed a similar team but with different expertise. The resulting group of multi-PDs/PIs should be integrated into a collaborative, multidisciplinary research unit as described in the application’s multi-PD/PI Leadership plan.
Examples of research topics
Appropriate topics include but are not limited to the topics below:
Annual Grantee Meeting: Upon initiation of the program, annual meetings will be held in conjunction with the NHLBI Progenitor Cell Biology Cell Consortium (PCBC) to encourage the exchange of information among the investigators who participate in this program and with investigators in the PCBC. In the preparation of the budget for the grant application, applicants should include travel funds for one meeting each year to be held in or near Bethesda, MD, for the Principal Investigators and key collaborators. At these meetings awardees will be expected to share their results and to help evaluate the progress of the Centers. Attendance at these meetings is expected.
Funding Instrument |
Grant |
Application Types Allowed |
New The OER Glossary and the SF 424 (R&R) 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. |
Award Budget |
Application budgets are not limited, but need to reflect actual needs of the proposed project. The total annual cost for individual awards is expected to vary, depending on the scope of the project and the number of participating institutions. |
Award Project Period |
Scope of the proposed project should determine the project period. The maximum period 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:
Nonprofits Other Than Institutions of Higher Education
For profit Organizations
Governments
Other
Foreign (non-U.S.) components of U.S. Organizations are not allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (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.
All Program Directors/Principal Investigators (PD/PIs) 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 four (4) 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 Project Director/Principal
Investigator (PD/PI) 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 SF 424 (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 in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
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.
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 application submission. 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 modifications:
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-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of 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 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 SF 424 (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/PIs must include their eRA Commons ID in the Credential
field of the Senior/Key Person Profile Component of the SF 424(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 Central Contractor Registration (CCR). 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 requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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
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
For Renewals, the committee will consider the progress made in the last funding period..
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/priority 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) 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:
Applications will be assigned on the basis of established PHS referral guidelines 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
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 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.
Cooperative Agreement Terms and Conditions of Award
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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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
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submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
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process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
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registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
John Thomas, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Rockledge II, Suite 350
Bethesda, MD 20892-7950
Telephone: (301) 435-0065
Fax: (301) 451-5453
E-mail: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Kevin Heath
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
Room 7160E, MSC 7926
6701 Rockledge Drive
Bethesda, MD 20892-7926
Telephone: (301) 435-0166
FAX: (301) 451-5462
E-mail: [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.
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