Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institute of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)

Title: Heart Failure Clinical Research Network Coordinating Center (U10)

Announcement Type
New

Request For Applications (RFA) Number:  RFA-HL-12-002

Catalog of Federal Domestic Assistance Number(s)
93.837

Key Dates
Release Date: June 4, 2010
Letters of Intent Receipt Date:  November 1, 2010
Application Receipt Date:  December 1, 2010
Peer Review Date(s): June-July 2011
Council Review Date: October 2011
Earliest Anticipated Start Date: January 1, 2012
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: December 2, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
    D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
         1. Principal Investigator Rights and Responsibilities
         2. NIH Responsibilities
         3. Collaborative Responsibilities
         4. Dispute Resolution Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Nature of the Research Opportunity:

The purpose of this solicitation is to request new applications for the combined Data Coordinating Center/Clinical Coordinating Center (CC) which will be part of the renewal of the Heart Failure Clinical Research Network.  A separate solicitation (RFA HL-12-001) seeks applications for the Regional Clinical Centers (RCCs).  The original Network was established to provide a mechanism to expedite clinical research that evaluates strategies to diagnose, manage and treat all forms of heart failure (HF). The renewal program will continue to provide support to develop, coordinate, and conduct multiple, collaborative, proof of concept clinical trials to improve HF outcomes. The solicitation is structured to support concurrent, small to intermediate-sized randomized clinical trials (RCTs) that can be completed within 2-5 years and is not designed to fund large, Phase III definitive studies. The CC of the Network leads and manages all aspects of the conduct of multicenter RCTs. The CC will manage site contracts, training, recruitment monitoring, regulatory compliance, patient safety, protocol development, conflict of interest and other policy development, manuals of operations, committee management, and additional clinical expertise in support of RCCs. The CC includes a Data Coordinating Center function with expertise in statistical planning in support of protocol development, data collection, maintenance of data quality and integrity.  The Data Coordinating Center component will also prepare reports to the Data and Safety Monitoring Board, coordinate site visits, and perform statistical analyses.   The two functions (data coordination and clinical coordination), should be performed at the same institution. A Multiple PI structure to facilitate implementation of all CC functions is highly encouraged.  The solicitation is open to new and currently participating centers.

Background:

Heart Failure (HF) is a common syndrome and, in contrast to other cardiovascular diseases, is responsible for an increasing number of hospitalizations and deaths each year in the U.S.  HF is expected to be an even more important cause of morbidity with the aging of the U.S. population.  Although survival after the onset of heart failure has improved, modern therapies are not curative, and the syndrome is progressive in many patients despite optimal modern therapy.  The health care costs related to HF have been estimated to be as high as $35 billion annually.

In response to this clinical problem and with the guidance of two Working Groups, the National Heart, Lung, and Blood Institute, issued RFA-HL-05-003 to form the Heart Failure Clinical Research Network. A network structure allows for efficiency in conducting multiple concurrent trials and enables a team of investigators to plan and execute serial trials based on earlier results.  The Network has been successful in conducting up to three concurrent randomized clinical trials to advance the treatment of patients with acute and chronic heart failure.  One clinical trial has been completed, two additional trials are expected to be completed in the initial funding period and the Network has received approval to begin two additional trials in the current project. Due to the success of the program, the NHLBI plans to continue the Network for an additional seven years, through this and the companion RFA HL-12-001 for Regional Clinical Centers.

Scientific Knowledge to be Achieved Through Research Supported:

The primary goal of the Network is to conduct multiple Network-wide randomized clinical trials to evaluate treatments and strategies for the management of acute and chronic HF.  The scientific agenda will be developed through collaborative decision making of the Steering Committee, consisting of the program’s CC and RCC PIs, the NHLBI-appointed Study Chair, and NHLBI representatives.  All protocols must be approved by both the NHLBI-appointed Protocol Review Committee and Data and Safety Monitoring Board. During the first funding period, the Network’s agenda included addressing practical questions in the day-to-day management of HF, such as the optimal way of administering diuretics during acute decompensation without worsening renal function and testing new therapies for HF with preserved systolic function. The Network renewal will continue its tradition of answering practical clinical questions as well as potentially testing new therapies and hypotheses formulated from the first round of studies or other advances in the field of HF research. 

Objectives:

The primary goal of the Network is to improve the treatment of HF by rigorous testing, through randomized clinical trials, interventions that aid in diagnosis, therapy, management of HF and prevention of the syndrome or its associated morbidity. 

Secondary objectives of the Network are to:

Types of research and experimental approaches that are being sought:

The emphasis will be on early phase small to intermediate-sized randomized clinical trials that help identify optimal diagnosis, evaluation, and therapy to improve ventricular function and structure.  Proposed studies should provide clinically relevant pathophysiologic information and move the field of HF treatment forward.  Trials may involve investigational drugs or other interventions or new strategies for currently used interventions.  Proposed trials should make use of the Network model.  Proposed interventions to be tested should be implementable at most, if not all, Network RCCs and/or satellites.  For acute HF, endpoints can be measured over shorter durations.  For both acute and chronic HF, meaningful composite endpoints can be chosen that accommodate trials with sample sizes of fewer  than a thousand patients.  The Network is expected to be able to concurrently successfully perform three or four trials and should be able to complete two or three waves of trials in the seven-year period. 

Examples of Research Topics:

Potential research protocols might include, but are not limited to, RCTs that:

Trials that involve techniques, procedures, or biologic agents that cannot be disseminated for implementation in a Network model will be considered non-responsive.  Large Phase III RCTs, epidemiologic or other observational studies, and protocols based on behavioral and lifestyle intervention will be considered non-responsive to this solicitation.

Project Organization:

The Heart Failure Clinical Research Network will be funded as a cooperative agreement and consist of up to nine Regional Clinical Centers, a single combined Coordinating Center performing Data and Clinical Coordination, an NHLBI-appointed Network Study Chair and the NHLBI.  Applications for Regional Clinical Centers are solicited through RFA HL-12-001.

Committees:

Steering Committee (SC)

The SC will be the main governing body of the HF Network and is expected to meet by teleconference on a bi-monthly basis. Committee members will include the Study Chair, PIs of CC and the Regional Clinical Centers, and NHLBI program staff.  The Study Chair will be appointed by the NHLBI and will be responsible for oversight of the scientific agenda and progress of the Network in achieving its scientific goals.  The responsibilities of the SC will include, but not be limited to: (1) ensuring compliance with Network policies and procedures, (2) identifying and prioritizing topics for investigation, (3) evaluating and developing protocols proposed by RCCs or others outside the Network for Network implementation, (4) ensuring that studies are appropriately carried out; (5) ensuring that data are appropriately analyzed and interpreted, and (6) ensuring that study results are published in a timely fashion.  Other governance committees may be continued or developed such as the Executive Committee, Publications Committee, and Ancillary Studies Committee.  The separate charges for these committees will be maintained in a continually updated Manual of Operations for Network activities. 

Protocol Review Committee (PRC)

An independent PRC will be appointed by the NHLBI and will meet as needed to review protocols. It will consist of a chairperson and scientists with expertise in HF research, clinical trial design, biostatistics, and other areas of expertise as needed. The PRC will evaluate protocols proposed by the SC based on the following criteria: (1) the scientific merit of the experimental design and approach, (2) the feasibility, and (3) the appropriateness of the protocol for the Network and the consistency with the mission of the NHLBI.  All new study protocols performed by the Network must be approved by the PRC before referral to the DSMB.  Minor protocol amendments, low burden ancillary studies or secondary analyses of approved trials may be directly referred to the Data and Safety Monitoring Board for consideration. 

Data and Safety Monitoring Board (DSMB)

The NHLBI will appoint a DSMB in accordance with established policies to ensure data quality and participant safety. All Network protocols must be approved and monitored by the DSMB, generally after their approval by the PRC (except in the case of minor protocol amendments or low burden ancillary studies or analyses of approved trials).  The DSMB will be responsible for providing independent advice to the NHLBI regarding the progress of each trial and the appropriateness of continuing each study. The DSMB will meet approximately every 6 to 12 months with interim meetings or calls as necessary.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the U10 award mechanism(s).
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see https://grants.nih.gov/grants/funding/phs398/phs398.html). 

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."

2. Funds Available

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

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

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution 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 program support.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at https://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see https://grants.nih.gov/grants/ElectronicReceipt/preparing.htm for instructions).

The use of a multiple PD/PI model is highly encouraged, to reflect the separate data coordination and clinical coordination functions performed at the institution. If a multiple PD/PI strategy is used then the guidelines for submissions of applications with multiple PD/PI must be used.  Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at https://grants.nih.gov/grants/multi_pi.

Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see https://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may not submit more than one application.

Resubmissions.  Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.  

Section IV. Application and Submission Information

1. Address to Request Application Information

The current PHS 398 application instructions are available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (https://grants.nih.gov/grants/funding/phs398/phs398.html).

Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form, and the YES box must be checked.

Applications with Multiple PDs/PIs 

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled “Multiple PD/PI Leadership Plan”, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: November 1, 2010
Application Receipt Date: December 1, 2010
Peer Review Date(s): June-July 2011
Council Review Date: October 2011
Earliest Anticipated Start Date: January 1, 2012

3.A.1. Letter of Intent

The letter of intent should be sent to:

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 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)

Personal deliveries of applications are no longer permitted (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

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

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

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. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: (1) are necessary to conduct the project, and (2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement https://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm) .

6. Other Submission Requirements

The U10 mechanism is a Cooperative Agreement.  Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."

The successful Coordinating Center (CC) application will be from a single institution which includes expertise in the functions typically conducted by a Data Coordinating Center (DCC) and by a Clinical Coordinating Center (CCC).  Separate expert leadership is highly encouraged for these functions.  The scientific and performance requirements for these functions are delineated separately below as an example.   Other divisions of duties that preserve the distinction between study conduct and data integrity are acceptable.  In general, the application should demonstrate expertise in statistical study design, protocol development, data collection, quality control, and management of data integrity and analyses; as well as in the clinical, regulatory, contractual, and  logistic management required in the conduct of multiple concurrent studies performed across a Network of participating RCCs and occasionally using additional satellites recruited ad hoc for specific studies.

Scientific and Performance Requirements for the DCC:

The DCC will provide expert statistical leadership for the HF Network, will maintain responsibility for data collection and data integrity, will propose and conduct appropriate study analyses, will serve as the repository for data collected, and is responsible for compliance with data sharing and other related policies.

The responsibilities of the DCC will include, but will not be limited to, the following: (1) providing statistical leadership, advice and expertise during protocol development and study implementation; (2) developing data collection and data management systems (electronic data capture systems are preferred);

(3) monitoring the quality and quantity of data received from the RCCs, satellite sites and core labs;

(4) preparing data reports for the DSMB, PRC, NHLBI, Steering Committee, and RCCs; (5) providing expert analyses using best-suited statistical concepts; (6) preparing abstracts and manuscripts;

(7) serving as the data repository for the Network, (8) complying with NHLBI data sharing and related policies, and (9) providing plans for close-out or transfer of data if required at the end of the project period delineated in this announcement.

The skill requirements for the DCC include, but are not limited to, the following:

(1) prior successful experience as a coordinating center in multicenter heart failure trials; (2) expertise in clinical trial design, biostatistics, enabling technologies, data management and multicenter coordination; (3) expert ability to design protocols and utilize data collection systems, including secure transmission via the internet; (4) training and monitoring of data collection activities for multiple North American clinical sites; and (5)  prior successful experience in team research to facilitate the Network model in all design, data collection, and analysis functions.

In the application, applicants should include specific examples of experience as a DCC and the applicant’s ability to provide statistical leadership to multicenter trials and networks. Applications should include any available assessment of the CC’s ability to support a large, multicenter clinical research network or large, multicenter randomized clinical trials (RCTs) from stakeholders including recruitment sites and sponsors.   In addition, the investigators should provide descriptions of innovative trial designs and statistical methods to facilitate the efficient conduct of smaller, multicenter clinical trials. Examples might include novel endpoints and creative study designs to maximize information yielded from smaller studies. In addition, the investigators must provide a detailed description of how the DCC will interface with the CCC.

The combined application for the separate CCC and DCC from the same institution discussing the scientific and performance requirements must follow the instructions in the PHS 398 application form, https://grants.nih.gov/grants/forms.htm, and should not exceed 12 pages total.

Scientific and Performance Requirements for the CCC:

The CCC will provide leadership on all research operational issues for the HF Network. The primary responsibilities of the CCC will be to coordinate, administer, and support clinical research activities.

The CCC responsibilities will include, but will not be limited to: (1) providing clinical and scientific leadership, advice and expertise to sites during all phases of trial development and conduct; (2) providing administrative support for the NHLBI-appointed Network Study Chair, scientific leadership, and committees; (3) organizing scientific and administrative meetings; (4) developing study materials, including manuals of operations; (5) procuring and overseeing drug manufacturing, preparation, and distribution; (6) coordinating activities with core laboratories; (7) managing and distributing all protocol funds and preparing a quarterly itemized fiscal report for the NHLBI; (8) training, certifying, and supervising all sites, including conducting site monitoring visits to RCCs and their satellites, as well as to satellite sites recruited for involvement in particular trials; (9) managing site contracts and assisting sites with submissions to IRBs; (10) preparing protocols for submission to the Protocol Review Committee (PRC), Data and Safety Monitoring Committee (DSMB), Food and Drug Administration (FDA), or other government agencies; (11) preparing and managing Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications; (12) preparing manuscripts, including editorial services and meeting support; (13) managing the network’s website; (14) developing and distributing newsletters; and (15) coordinating the transition of the first HF Network project period to the activities defined by this project period. 

The CCC will have responsibility for operational oversight and management of all RCCs and their satellites, and as necessary recruitment and management of any satellites for ad hoc participation in particular trials, including site contracts, payments, site communications, site training, and site monitoring.  The CCC will have responsibility for recruitment, contracting, and operational oversight of  any Core Laboratories required by the trials in the research agenda of the Network. The CCC should develop operational timelines and plans to transition through periods of changing workload as trials are  completed or new trials begin.

In the application, applicants should include specific examples of successful experience as a CCC and the ability to manage multicenter, randomized clinical heart failure trials.  Applicants should indicate experience and ability in managing and distributing protocol funds and site payments. Applications should include any available assessment of the CC’s ability to support a large, multicenter clinical research network or large, multicenter RCTs from stakeholders, including participating sites or sponsors.  In addition, applicants should propose a management plan that would be best suited for handling multiple, concurrent smaller studies with a clear organization plan for the various duties and tasks. The investigators must provide a detailed description of how the CCC will interface with the DCC.

In addition, applications must describe methods to coordinate study planning, implementation and the dissemination of study results. It is expected that protocols will be performed in a manner consistent with United States FDA guidelines.

HF Network and Clinical and Translational Award (CTSA) Organizations:

The NHLBI encourages academic centers participating in the Heart Failure Clinical Research Network to partner with the CTSA  if one exists at the applicant institution to enhance the scientific and operational aspects of the Network.

There are many potential ways that a HF Network CC could interface with a CTSA. Examples include using some of the educational and mentoring programs within the CTSA organization for site or other training, utilizing resources for creative or innovative study design, or drawing on regulatory expertise in preparing IND and IDE applications for submission to the FDA. The CTSA may also be able to provide expertise on how to interact with sites and subjects using newer computer and phone technology or social networking sites.

Specific Budget Requirements:

Investigators should include a detailed budget for the operating expenses of the combined Coordinating Center.  A single award will be made and separate and distinct operating budgets for the separate DCC and CCC functions are not required. See section IV.2. for information for multiple PD/PI applications.  Applicants should prepare operating budgets for seven one-year periods with maximum allowable direct costs limited to $1,550,000 per year.  The budget should include a minimum of 50% effort for the PI(s), and a half-time position should be budgeted to cover the costs associated with the management and distribution of approved Protocol Funds to the RCCs, satellites and core laboratories. Operating budgets should include costs of statistical, operational and administrative support of three to four concurrent RCTs and two or three  waves of trials.  These functions include, but are not limited to, the costs of developing a trial-specific manual of operations, developing data forms, means of transmission (electronic preferred), and data collection and organization tools, as well as quality improvement tools for the tracking of data collection and site performance. Included are pharmaceutical procurement, preparing and managing INDs or IDEs, and the required site monitoring at the approximately 40 participating clinical sites, both the RCCs and the satellites.  A yearly visit to each of these sites by the CC for site management and training should be budgeted.  The CC budget must also include support for the NHLBI-appointed Network Chair for the seven years (20% effort and travel expenses).  The CC budget must include costs for managing meetings of the DSMB, PRC, and SC. The DSMB, which consists of 9 members, is expected to meet approximately every 6-12 months with interim calls as required. The PRC meets on an irregular schedule but approximately once per year with interim calls as required.  The Steering Committee is expected to meet three times in the first year and twice a year thereafter, with biweekly teleconferences throughout the project period. Costs for other committee support, including that which may be required for event adjudication should be included.

Applicants should request the award of the Protocol Funds in the CC application.  These Protocol Funds do not require a detailed budget as they will be distributed based on the requirements of the protocols selected by the Steering Committee for implementation after award of the RCCs and approval by the Protocol Review Committee (PRC). The CC should request not more than $2,400,000 in Protocol Funds per year.  The final amount will be determined by NHLBI.  These funds will be managed by the CC and distributed to participating RCCs and their satellites, any additional satellite sites recruited for specific trial implementation, and required Core Laboratories.         

CC applications will describe methods to coordinate trial planning, implementation, and dissemination of study results.  CC must include budget and justification for any additional costs of this collaborative effort. 

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see https://grants.nih.gov/grants/funding/phs398/phs398.html). 

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and https://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by National Heart, Lung, and Blood Institute and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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? 

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.

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.

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, see https://grants.nih.gov/grants/olaw/VASchecklist.pdf. For additional information, see https://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Resubmission Applications.  Resubmissions are not allowed for this FOA.

Renewal Applications. Renewals are not allowed in this FOA.

Revision Applications.  Revision applications are not allowed for this FOA.

Additional Review Considerations

As applicable for the project proposed, reviewers will address 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. Applications from Foreign instituties are not allowed.

Select Agents 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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm), (2) Sharing Model Organisms (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html), and (3) Genome Wide Association Studies (GWAS) (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection Process

The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Also Section IV.5. Funding Restrictions.

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 (https://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (https://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS 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.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator(s)  will have the primary responsibility for expert statistical study design and analyses, data collection and integrity, compliance with data sharing and other related policies, monitoring the submission of data from the participating RCCs and satellites, preparing required reports for regulatory and oversight bodies, preparation of abstracts and manuscripts and providing plans for close-out or transfer of data if required at the end of the project period. In addition the Principal Investigator(s) will provide clinical advice and administrative support for the conduct of multiple concurrent randomized clinical trials, estimation of protocol costs and disbursement of Protocol Funds, manuals of operations and training materials, certification and supervision of all enrolling sites, contract execution, protocol finalization and distribution, and other requirements delineated in Section III.6.        

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 HHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

The NHLBI Project Scientist and staff will work closely with the Study Chair, CC, and RCCs to ensure proper conduct of the Network. The NHLBI Project Scientist will be responsible for: (1) overseeing the activities of the Network, along with the Study Chair, to ensure that studies are properly conducted and completed in a timely fashion; (2) providing advice and guidance to ensure that the Network runs in accordance with NHLBI policies and procedures, and is consistent with the mission of the NHLBI to improve public health; and (3) serving as a point of contact for investigators with the NHLBI, disseminating information from the Institute and communicating with Institute leadership to ensure that the Network operates smoothly.

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.

2.A.3. Collaborative Responsibilities

See Section I.1, Program Organization and Committees.
Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Dispute Resolution Process

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 regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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.

The CC must submit quarterly budget reports for the CC operating budget and disbursement of Protocol Funds.

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.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Alice Mascette, MD
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
Rockledge 2, MSC 7956
6701 Rockledge Drive, Room 8170
Bethesda, MD 20892-7956
Telephone: (301) 435-0504
FAX: (301) 480-7404
E-mail: mascetta@nhlbi.nih.gov

2. Peer Review Contacts:

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3. Financial or Grants Management Contacts:

Anthony Agresti
Office of Grants Management
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7158
Bethesda, MD 20892-7926
Phone: (301) 435-0186
Fax:     (301) 451-5462
E-mail: Agrestia@nhlbi.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (https://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (https://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, state and federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see https://grants.nih.gov/grants/gwas/.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement https://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: (a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and (b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (https://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008, to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible online journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40-hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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