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

Ancillary Studies in Clinical Trials (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of RFA-HL-12-012

Related Notices

  • July 29, 2014 - See Notice NOT-HL-14-232. Discontinuation of grant.
  • September 28, 2012 - This RFA has been reissued as RFA-HL-14-004.
  • May 24, 2012 - Notice of Correction to RFA-HL-13-003 Ancillary Studies in Clinical Trials (R01). See NOT-HL-12-145.
  • January 27, 2012 - See Notice NOT-HL-13-139. Correction of Earliest Start Date(s).

Funding Opportunity Announcement (FOA) Number

RFA-HL-13-003

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.233, 93.837, 93.838, 93.839 

FOA Purpose

This Funding Opportunity Announcement (FOA) invites research grant applications to conduct time-sensitive ancillary studies related to heart, lung, and blood diseases and sleep disorders in conjunction with ongoing clinical trials and other large clinical studies supported by NIH or non-NIH entities. The program establishes an accelerated review/award process to support the crucial time frame in which these ancillary studies must be performed. Time-sensitive ancillary studies include those that require active longitudinal data collection and thus need to begin recruiting subjects as close as possible to the start of the parent study. The ancillary study can address any research questions related to the mission of NHLBI for which the parent study can provide participants, infrastructure, and data. The parent studies most often will be a clinical trial, but also can be an observational study or registry that can provide a sufficient cohort of well-characterized patients. Each ancillary study application must demonstrate the time-sensitive nature of the application and must explicitly address why an expedited review is essential to its feasibility.

Key Dates
Posted Date

December 7, 2011

Open Date (Earliest Submission Date)

April 24, 2012

Letter of Intent Due Date

April 24, 2012; August 24, 2012; December 24, 2012  

Application Due Date(s)

May 24, 2012; September 24, 2012; January 24, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

May 24, 2012; September 24, 2012; January 24, 2013 by 5:00 PM local time of applicant organization.

Scientific Merit Review

August/September 2012, November/December 2012, March/April 2013

Advisory Council Review

October 2012, January 2013, May 2013

Earliest Start Date(s)

(New Dates December 2012, April 2013, July 2013 per NOT-HL-13-139), Original Dates December , 2013; April , 2013; July , 2013

Expiration Date

January 25, 2013  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Clinical trials and large observational cohorts represent a substantial research investment, and are unique sources of well-characterized patient populations. They are not, however, usually structured to permit a detailed investigation of underlying mechanisms of the disease and its progression.  For example, identifying surrogate markers is crucial for predicting which patients are at high risk and for designing treatments that can be tailored and targeted to patients with specific characteristics. Such investigations often are best conducted as ancillary studies, and thus require supplementary funding. The FOA program described in this initiative has provided a flexible, cost-effective, and administratively efficient mechanism to facilitate the use of existing large patient cohorts for the study of disease processes and outcomes, genetics and proteomics, therapeutic response, quality of life, behavioral and lifestyle issues, treatment adherence, and health economics. Overall, a relatively modest investment in time-sensitive ancillary studies can result in significant scientific gains in translational and clinical research without incurring the substantial cost of recruiting a new cohort, and can lead to improved diagnostic and prognostic assessments and patient care. Experience has shown us that the standard NIH grant procedures generally take too long to initiate ancillary studies quickly enough to utilize existing large cohorts to full advantage. The purpose of this FOA is to solicit research grant applications to conduct time-sensitive ancillary studies related to heart, lung, and blood diseases and sleep disorders in conjunction with ongoing NIH- or non-NIH-supported clinical trials.  The ancillary study can address any research question related to the mission of NHLBI for which the parent study (which can also be an observational study or registry that can provide a sufficient cohort of well-characterized patients) can provide participants, infrastructure, and data.  All ancillary study applications must demonstrate the time-sensitive nature of their application and must explicitly address why an expedited review is essential to its feasibility.

Background

Clinical trials represent a substantial research investment but usually are not structured to permit a detailed investigation of underlying disease mechanisms or of behavioral or economic consequences of the disease.  The same is true of some observational studies and registries. Standard grant mechanisms often do not permit the initiation of ancillary studies in a timely fashion to take advantage of these unique and well-characterized cohorts.  This FOA provides a flexible mechanism to capitalize on the existing investment in these clinical studies by using their patient cohorts, data, and biological materials to address new research aims. Information gained from such ancillary studies will permit better correlation of clinical course and outcome and may lead to improved prognostic assessments and patient care.

The Program

Each ancillary study application submitted under this FOA will propose to study a new research question in the areas of heart, lung, blood, and sleep disorders.  The research will be conducted in the venue of a “parent study” that will provide patients and/or patient materials and infrastructure that will facilitate the research and make it more efficient than initiating the same research de novo.  The parent study will most often be a Phase II-III clinical trial, since these studies often have large, well-characterized cohorts and frequently lack the resources to study ancillary questions in a timely fashion.  However, observational studies and registries that share these characteristics may also qualify as parent studies under this FOA.

Parent studies must be funded independently and will not receive support under this FOA. The objectives of the parent study (unlike those of the ancillary study) need not be related to the NHLBI’s mission, so long as the parent study provides an appropriate venue for the proposed ancillary study. Parent studies need not be funded by the NHLBI; they may be funded by other Institutes or government agencies or by private sponsors.   However, the objective(s) of the ancillary study must fall within the mission of the NHLBI.  Information about clinical trials currently supported by a variety of public and private entities can be obtained from http://www.clinicaltrials.gov/.

Ancillary studies supported under this program might involve the entire cohort participating in a parent study or selected subsets of the participants, depending on the scientific questions posed and the sample size required to answer them.  They may even draw patients from two or more parent studies if they have obtained the support of these studies and if their research plan is feasible.  In general, this FOA will not support the recruitment of patients who are not already enrolled in the parent study or studies; however, recruitment of a small number of normal controls is acceptable provided that the cost is minimal (e.g., no more than one budget module). A Monitoring Plan for the ancillary study as appropriate should be described in the Research Strategy/Human Subjects section.

The Program Director(s)/Principal Investigator (s) of the proposed ancillary study must provide documentation of permission from the parent study to use its patient cohorts, data, and biological materials and that there is adequate time remaining in the parent study to complete the ancillary research project as scientifically and technically appropriate.  Ancillary studies must not interfere with the parent study or unduly burden participants.  All approved procedures and policies of the parent study must be followed.   

This program encourages basic scientists and clinical investigators from academia and industry to work together.  In addition, this FOA encourages junior investigators to take a leading role in clinical research with the support and collaboration of senior investigators.  In general, the Program Director(s)/Principal Investigator (s) of the ancillary study should not be a principal investigator of the parent study. However, partnerships in which a senior investigator from the parent study mentors a junior PI/PD in the conduct of the ancillary study are appropriate.

This program will use a modified application process, expedited peer review, and modular funding.  This accelerated approach is expected to decrease the time from application to funding to approximately 20 weeks.

Research Scope

Ancillary studies must focus on areas that will not already be studied in the parent trial, such as: 

The following are examples of research that might be proposed under this program. These are only examples and are not meant to be inclusive.  Applicants may also propose other ancillary studies consistent with the goals of this program.

1.  Cardiovascular:  Mechanisms underlying cardiovascular diseases; cardiovascular disease risk factors; and sequelae of cardiovascular diseases, including hypertension, heart failure, sudden death, and sleep disordered breathing; studies of cardiac energetics before and after control of metabolic abnormalities; imaging studies to elucidate disease progression or to clarify the mechanism of action of interventions; identification and validation of biomarkers of cardiovascular diseases.

2.  Pulmonary:  Pathophysiological and inflammatory mechanisms of lung diseases such as asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, acute respiratory distress syndrome (ARDS), pulmonary hypertension, interstitial pulmonary fibrosis, and bronchopulmonary dysplasia (BPD); role of genetic factors in the clinical heterogeneity of lung diseases; host response to lung injury; airway injury and repair; airway/tissue and vascular remodeling;  regulation of vessel tone; mechanisms underlying the maintenance and severity of asthma; surrogate markers of lung diseases including rejection and infection in transplant patients.

3.  Hematological:  Mechanistic studies and biomarker research on non-malignant hematologic disorders, including hemoglobinopathies and disorders of thrombosis and hemostasis.  Examples include mechanisms of action of therapeutic agents in sickle cell disease, identification of biomarkers of sickle cell crisis and other organ damage, and biomarkers to predict clinical events in disorders of thrombosis and hemostasis.  Mechanistic studies and biomarker research on the outcomes and complications associated with cellular therapies and the transfusion of blood products.  Examples include identifying the immune mechanism of cellular therapies, biomarkers to predict graft vs. host disease and immune and other effects of transfusion.  

4.  Behavioral:  Behavioral and psychosocial aspects of disease progression; lifestyle factors and their assessment or relationship to biomarkers; gene-environment interactions; adherence to treatment; quality of life indices; relationships with sleep; delivery of health services; and health economic factors.

5.  Sleep:  Sleep-disordered breathing (sleep apnea) phenotypes and the impact of lifestyles characterized by insufficient sleep on cardiovascular, lung and blood diseases and risk factors; markers of human sleep apnea and sleep duration, quality, genotypes, and sleep timing that can be used to stratify apnea severity, and predict the cardiovascular, lung, and blood disease risk; variations in sleep timing and duration (including racial and ethnic differences) associated with disease risk; and the validation of efficient strategies to define normal and abnormal phenotypes through questionnaires or simple non-invasive testing.

Responsiveness

Renewals are not allowed and the proposed studies for this FOA must be able to be completed in four years.

Additional funds to extend the parent grant will not be allowed.  Applications in which the critical time lines for the parent study and ancillary study are incompatible or ambiguous will not be considered to be responsive.

The intent of this FOA is to fund applications that require an expedited review and award. Applications will be considered responsive only if they demonstrate the need for expedited review and award in order to complete the proposed work.  

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

The NHLBI intends to fund 8-12, corresponding to a total of $4.8 million, for fiscal year 2013. Future year amounts will depend on annual appropriations.

Award Budget

An application may request a budget for direct costs up to $250,000 (10 modules) per year, excluding subcontractor or consortium facilities and administrative (F&A) costs.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is four 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

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) 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. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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:

The letter of intent should be sent to:
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed,

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:  

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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 submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be assigned to the NHLBI, NIH and evaluated for completeness by the Center for Scientific Review and responsiveness by NHLBI, NIH. Applications that are incomplete and/or non-responsive will not be reviewed.

SPECIAL INSTRUCTIONS

Additional Instructions for Applications in Response to this FOA

All ancillary study applications MUST include a letter or statement documenting that patients, samples, data and/or materials are available from the parent clinical trial and that the proposed ancillary study has the approval of the parent study's organization/leadership.  This letter must also address the agreement between the parent and ancillary study regarding the requirements under the new NHBLI Policy for Distribution of Data (See Section IV.6. for more information). This letter should be included as an upload in item 14 of the PHS398 Components “Letters of Support.”  Applications not containing such documentation will be considered incomplete.  In addition, a memorandum of understanding between the ancillary study and parent study must be provided prior to funding.

All ancillary study applications must include a paragraph with the heading “Time-Sensitivity” under “Research Strategy” to explain the time-sensitive nature of the proposed ancillary study.  Investigators who could complete the same work using the regular submission process should not apply to this FOA.  Examples of characteristics that would support the case for time-sensitivity issues include (1) the need for support to collect samples or data prior to end of recruitment, (2) the need to perform analysis on soon-to-be-collected fresh specimens, or (3) the need for collecting post-intervention data in a trial that will end soon.

Applicants must include a paragraph or time line to demonstrate that there is adequate time left in the parent study to carry out the ancillary study. This documentation should be included with the letter of approval from the parent study and uploaded to item 14 in the PHS 398 components as above.

A brief Protocol Summary of the parent trial and the IRB-approved informed consent documents must be included in item 12 of the SF424 of your application.  The draft protocols and draft consent forms for the ancillary study should also be included in item 12 of the SF424. IRB approval is not required at the time of submission for the ancillary study protocol and related documents.  Successful applicants will be required to submit this information at the time of award.  NIH will treat as confidential any scientific, preclinical, clinical, or formulation data and information that the sponsor deems to be proprietary.

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

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

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

Significance

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

Investigator(s)    

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

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

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:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NHLBI 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(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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’s business official.

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

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

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

Not Applicable.

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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

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)

Suzanne Goldberg, R.N., M.S.N.
Atherothrombosis and Coronary Artery Disease Branch
Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8143 (MSC 7956)
Bethesda, MD 20892-7940
Telephone: (301) 435-0532
Fax: 301-480-3667
Email: goldbergsh@mail.nih.gov

Peter Kaufmann, Ph.D.
Behavioral Medicine Branch
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10100 (MSC 7936)
Bethesda, MD 20892-7936
Telephone: (301) 435-2467
Fax:  (301) 480-1773
Email: kaufmannp@nhlbi.nih.gov

Phyllis Mitchell, M.P.H.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 9148 (MSC 7950)
Bethesda, MD  20892
Telephone: (301) 435-0065
Fax:  (301) 480-0867
Email: mitchelp@mail.nih.gov

Gail Weinmann, M.D. 
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10188 (MSC 7952)
Bethesda, MD  20892-7952
Telephone:  (301) 435-0233
Fax: (301) 480-3547
Email: weinmang@nhlbi.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Anthony Agresti
Office of Grants Management
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7158
Bethesda, Maryland 20892
Telephone: (301) 435-0186
Fax: (301) 451-5462
Email: agrestia@nhlbi.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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