Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
 

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

Funding Opportunity Title

Clinical Trials Development Resource for Hematologic Disorders (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HL-12-016

Companion FOA

RFA-HL-12-023

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.839

FOA Purpose

This FOA issued by the National Heart, Lung, and Blood Institute (NHLBI) invites applications to provide a Resource of expert consultants to assist investigators in the development of multi-site clinical trials for hematologic disorders supported by the Clinical Trials Planning Studies for Rare Thrombotic and Hemostatic Disorders (U34)  (RFA-HL-12-023) and the NHLBI Clinical Trial Pilot Studies (R34) (PAR-10-005) awards.  Academic institutions, particularly those with Clinical Trial Units, School of Public Health and Clinical and/or Translational Science Awards (CTSA) programs, are encouraged to apply.

Key Dates
Posted Date

May 2, 2011

Open Date (Earliest Submission Date)

September 13, 2011

Letter of Intent Due Date

September 13, 2011

Application Due Date(s)

October 13, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February/March 2012

Advisory Council Review

May 2012

Earliest Start Date(s)

July 2012

Expiration Date

October 14, 2011

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.

Looking Ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The objective of this FOA is to provide critical and necessary support in the development of feasible and well designed multicenter clinical trials focused on hematologic disorders. The Clinical Trials Development Resource will provide clinical trial methodology expertise to assist grantees of the Clinical Trials Planning Program for Rare Hemostatic and Thrombotic Disorders (U34) (RFA-HL-12-023)  and the NHLBI Clinical Trial Pilot Studies (R34) (PAR-10-005) awards in the area of blood diseases and resources.

Background

Carefully designed and precisely implemented clinical research is needed to guide health care delivery for individuals with blood disorders or those receiving blood-based products. However, the subject matter experts most aware of the clinical needs may not have the resources necessary to successfully develop, conduct and complete these challenging trials. Expertise is needed to navigate the specific hurdles inherent in the study of patient populations with rare hematologic disorders or to recruit target subject populations that are not under the hematologist’s direct clinical care.

Multicenter clinical trials frequently have a 6-12 month delay in start-up and difficulty meeting accrual timelines. Many studies have a substantial unobligated balance during the first 2 years and request a no cost extension to complete subject enrollment and data analysis. Therefore there is a need for expert assistance in the planning, timely initiation and successful completion of investigator- initiated clinical trials.

The successful planning and execution of clinical trials require access to the appropriate resources in clinical trials design and methodology.  Although there are existing institutional consultative resources, a recent NCRR/NHLBI evaluation of the availability of resources to the hematology clinical research community indicated that these units may have difficultly providing timely and specialized services within the context of specific institutional objectives and are unable to expand services without additional funding. Therefore, a centralized and specialized Resource, focused on providing clinical trial design, methodology expertise and assistance to the hematology community would be essential, especially at the planning stage.

Scope

The Clinical Trials Development Resource for Hematologic Disorders will provide consultative services for the development of multi-site clinical trials to grantees of the Clinical Trials Planning Studies for Rare Thrombotic and Hemostatic Disorders (U34) program and to grantees of the NHLBI Clinical Trial Pilot Studies (R34) (PAR-10-005) program, in the area of blood diseases and resources.  The primary objective of this program would be to assist in the development of well designed and feasible investigator-initiated clinical studies that would be initiated in a timely manner and successfully completed. 

The types of services that the U24 Clinical Trials Development Resource for Hematologic Disorders would be expected to offer would include but are not limited to:

•   Assistance in clinical trial design and recruitment strategy, and addressing in particular the special needs for studies in rare diseases and pediatric populations.

•   Biostatistical support.

•   Consultative assistance in developing site and subject recruitment strategies.

•   Guidance on regulatory issues and needed documentation.

•   Bioethics consultation.

•   Consultative assistance in preparing clinical protocol, manual of procedures, training materials, consent forms and data safety monitoring plan.

•   Guidance in planning a multi-site clinical trial, including multiple-site  IRB approval, contracting, as well as efficient and cost effective trial management.

•   Assistance on preparation of agreements as necessary for industry collaborations.

•   Assistance in identifying and establishing collaborations with patient advocacy groups, professional societies (e.g. the Society for Clinical Trials) and other organizations that could aid in implementation of the trial.

•   Development of investigator-targeted education in clinical trials methodology as well as approaches for formal and informal U34 investigator interactions.

During the five-year funding period the Resource will need to have the expertise and capacity to provide services for ten U34 Clinical Trials Planning Studies for Rare Thrombotic and Hemostatic Disorders grants and approximately ten R34 NHLBI Clinical Trial Pilot Studies Hematologic Disorder grants.  It is anticipated that the U34 grants will be awarded over the first three years of the program.  Detailed information on this program can be found in the companion FOA announcement.  The U34 grantees will be required to meet with the Resource early in the first year of their award to jointly develop a timeline for the planning activities and identify Resource services that will aid in accomplishing the goals of their clinical trial planning grant. Grantees of the R34 with programs in hematologic disorders will be offered the utilization of resource services during the funding period of their grant.  The Resource should have flexible staffing and a well defined process to interact with U34/R34 investigators who are expected to have diverse clinical programs and consultative service needs.  The Resource should be able to add the necessary expertise, based on the requirements of the specific U34/R34 needs.  The professional expertise should be a priority over the geographical location during a selection of the consultants.  In addition, the Resource will organize an annual meeting/workshop for the U34/R34 investigators to provide information on topics of clinical trial development and management.  The Resource will also provide a system for monitoring and evaluating the utilization of the consultant services requested by and provided to the investigators.   

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

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 NHLBI intends to commit $475,000 in total costs [Direct plus Facilities and Administrative (F&A) costs] in FY 2012, $700,000 in total costs in FY 2013 and $775,000 in total costs per year in FY 2014, 2015 and 2016 to support up to 2 awards.

Award Budget

Direct costs may be up to $300,000 in the first year of funding, up to $450,000 in year 2, and up to $500,000 per year in years 3 to 5.  The costs should reflect the increased demand for Resource services in the future years and the actual needs of the proposed project.

Award 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.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

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

All Program 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program 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 PHS398 Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit 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.  

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

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

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

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

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

Research Plan

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

The research strategy should include a description of the available resource services; a plan for communication with and delivery of services to the U34/R34 investigators; an outline for how services will be delivered to multiple U34/R34 programs; a plan for organization of an annual meeting/workshop for the U34/R34 investigators; and a description of the overall capabilities of the resource to meet the needs of the program.   

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.

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be 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 NHLBI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

To what extent will the implementation of the proposed Resource advance investigators in the development of multi-site clinical trials for hematologic disorders?  How will the services provided by the Resource enhance the clinical trials in hematologic disorders?    

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 

Does the leadership team collectively have the requisite scientific and administrative expertise and experience to develop and manage the proposed Resource? Do the investigators propose a method for flexible personnel or consultants to meet the changing needs of the U34/R34 investigators?   

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? 

Are the types of available resource services clearly described?  Is there appropriate evidence of commitment by the key investigators and collaborators to providing the consultative services in a timely manner?  Are there adequate plans to ensure effective communication with the U34/R34 investigators?  Is the plan to provide the variety of services to multiple investigators over the course of the program feasible?   Will the proposed Resource have the expertise and capacity to provide services to all the U34/R34 investigators? 

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? 

Are the institutional or multi-institutional resources and infrastructure available appropriate to accomplish the goals of the Resource?   

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

  Not Applicable. 

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

Applications will be assigned to the NHLBI 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 National Heart, Lung, and Blood Institute Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/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.

Section VI. Award Administration Information

1. Award Notices

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

•   Carrying out the activities essential to maintenance and further development of the Clinical Trials Development Resource

•   Scheduling meetings with the U34 and R34 investigators and coordinating all the services provided by the Resource

•   Developing and maintaining a system to monitor and evaluate services requested and provided by the Resource

•   Providing information to the NIH Project Officer regarding Resource services

•   Attending and participating in Steering Committee activities and organizing, attending and participating in annual meeting/workshop with U34 and R34 investigators

•   Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

•   Serve on Steering Committee and may serve on other study committees, when appropriate.

•   Assist in the interactions between U34/R34 investigators and Resource

•   Review and comment on critical stages of Resource development and services available and provided

•   Retain the option of recommending modification or additional endeavors to Resource program within the constraints of the approved budget to meet the needs of the U34/R34 investigators

•   Implement adjustments to the Resource if performance falls below acceptable standards

•   Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

•   Quarterly Steering Committee conference call meetings, jointly organized by the Awardees and the NIH.

•   The awardees in conjunction with the NIH will annually plan and hold a meeting/workshop for the U34 and R34 investigators designed to provide information on topics of clinical trial development and management. 

•   All other responsibilities are divided between awardees and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

Scientific/Research Contact(s)

Andrei L Kindzelski, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0070
Email: kindzelskial@nhlbi.nih.gov

Rebecca P. Link, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0070
Email: linkr@nhlbi.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Patricia Reyes
Office of Grants Management
Division of Extramural Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7140, MSC 7926
Bethesda, MD 20892-7926
Telephone: 301-435-0166
Fax: 301-451-5462
Email: reyesp@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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NIH Funding Opportunities and Notices


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