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

Mechanisms of HIV-Related Lung Disease Data Coordinating Center (DCC) (U01)

Activity Code

U01 Research Project Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HL-13-028

Companion Funding Opportunity

RFA-HL-13-026, U01 Research Project Cooperative Agreements

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.838

Funding Opportunity Purpose

The National Heart, Lung, and Blood Institute invites cooperative agreement (U01) applications to serve as the Data Coordinating Center (DCC) for the Mechanisms of HIV-Related Lung Disease Program which is designed to investigate and define cellular and molecular events, including host genetic factors, underlying the pathogenesis of HIV-associated lung diseases (e.g., COPD and pulmonary hypertension). The DCC will facilitate collaborative activities among the individual U01 Clinical/Basic research sites including support for a Steering Committee, advisory groups, development and execution of collaborative protocols and projects, data coordination, quality control, safety surveillance, and data analysis for collaborative projects.

A separate solicitation (RFA-HL-13-026) seeks applications for the Clinical/Basic research grants pertaining to this DCC.

Key Dates
Posted Date

December 14, 2012

Open Date (Earliest Submission Date)

February 19, 2013

Letter of Intent Due Date(s)

February 19, 2013

Application Due Date(s)

March 19, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2013

Advisory Council Review

August 2013

Earliest Start Date

September 2013

Expiration Date

March 20, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Research Objectives

The purpose of this funding opportunity announcement (FOA) is to invite cooperative agreement (U01) applications to participate as the Data Coordinating Center (DCC) for the Mechanisms of HIV-Related Lung Disease program. The DCC will facilitate and support the collaborative activities of the Clinical/Basic research sites which are funded through a companion FOA RFA-HL-13-026.

The Clinical/Basic research focuses on the defining the cellular and molecular events underlying the pathogenesis of HIV-associated lung diseases (e.g., COPD and pulmonary hypertension) using biospecimens and clinical data from HIV-infected patients and controls with an emphasis on clinical translation. The goals are to identify disease sub-phenotypes, potential biomarkers to predict risk, progression, and outcome, and molecular targets to help design therapeutic interventions. The inclusion of multiple Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))is strongly encouraged to facilitate collaborations among investigators with pulmonary and HIV expertise and basic and clinical research expertise. It is intended that applications will be multi-disciplinary and highly integrated.

The DCC will support collaborative activities among the individual Clinical/Basic sites including support for the Steering Committee and advisory groups, and development, integration, and execution of collaborative protocols and papers.

The DCC will promote sharing of the data, biosamples, and plans. The DCC will be responsible for arranging meetings and conference calls, preparing reports, creating and maintaining a website for the program, implementing a web based system both for data entry and to coordinate joint project activities, whenever appropriate. The DCC will be responsible for facilitating the sharing and storage of data and specimens.

The DCC will provide leadership for identifying common elements in the individual site specific projects, standardizing definitions, harmonizing data, and developing joint protocols. The DCC will work with the Clinical/Basic research site investigators to ensure that the consent language is appropriate for sharing both data and biospecimens.

The DCC will provide assistance to assure quality control, to provide safety surveillance, and data analysis for collaborative projects.

The DCC will provide an inventory and tracking for collected and banked bio-specimens, and will assist the group with providing language in the consent documents that permits both sharing of samples and data among the investigators, and consent language that permits de-identified biospecimens and linked data to be stored for future use by the wider research community. The DCC will assist the other centers in developing protocols related to the collecting, handling, storing, tracking and submitting biospecimens to a central repository.

The DCC staff must have expertise and experience in data coordination; biostatistics; information technology; bioinformatics; collection, handling and banking of biospecimens; HIV research; clinical pulmonary research; and research on basic pulmonary biology, including immunology, microbiome research and "omics" technology.

Background

Effective anti-retroviral therapy regimens (ART) have resulted in long-term survival of HIV-infected individuals and a rapidly expanding aging HIV-infected population. Infectious HIV-associated lung diseases (e.g., pneumonias and TB) and noninfectious HIV-related lung diseases (e.g., pulmonary hypertension, COPD, lung cancer and bronchiectasis) are much more prevalent in older individuals and are increasingly causes of morbidity and mortality. Respiratory disease in children who are on long-term ART is an emerging area of concern, especially in developing countries.

The pathogenesis of HIV-associated lung diseases and accelerated senescence of the lungs, which appear to be closely connected, are not well understood. HIV-related cardiovascular and blood diseases comorbidities are also poorly understood. Furthermore, mechanistic studies of lung pathology in HIV-infected individuals in relation to pathology in other organ systems are an understudied area. As a result of all of these gaps in understanding, the ability to predict risk, provide accurate prognosis and develop effective preventive or treatment therapies is lacking. Little or no information is available to guide treatment or prevent lung complications in these patients.

Substantial progress requires a coordinated effort since a single center is unlikely to have enough patients to adequately investigate mechanisms and markers of HIV-associated lung diseases. The investigators must agree to work collectively to share data and harmonize their methods and data, to the extent possible, to achieve adequate numbers for the collaborative protocols.

Many factors are associated with accelerated COPD and pulmonary hypertension in patients with HIV infection, but their roles need to be elucidated to enable discovery and validation of the possible biomarkers and treatment targets. Similarly, the pathogenesis of airway hyper-responsiveness and asthma-like findings in HIV-infected individuals on ART is poorly understood. Little research has been done on the mechanisms underlying the pathogenesis of lung disease in HIV-infected children who are on ART. In regard to these HIV-associated respiratory diseases, viral proteins from HIV itself, co-infections, inflammation resulting from various infectious processes, immune dysregulation (due both to the virus and immune reconstitution), toxic effects of antiretroviral drugs, and exposures to cigarette smoke or recreational drugs may all be contributing factors.

Research Scope

This FOA invites applications to participate as the DCC for collaborative projects of the Mechanisms of HIV-Related Lung Disease Clinical/Basic research sites. It is expected that there will be multiple (8-9) Clinical/Basic research sites and one DCC.  It is expected that the Clinical/Basic research projects will be multi-disciplinary and highly integrated.  

The Data Coordinating Center (DCC) will help to organize one or more collaborative projects/protocols. We expect that each of the clinical U01s will participate in at least one collaborative project/protocol. These collaborative projects/protocols may be collaborations between two or more sites or they may include all the grants funded under the FOA program.

The DCC will:

Both the DCC staff and the Clinical/Basic research site staff must have appropriate training and experience for working safely with biologically hazardous specimens that may contain dangerous microbial agents.  Applicants must indicate steps they will take to safely acquire, process, ship, store, and distribute biologically hazardous specimens that contain infectious agents.

DCC staff should have appropriate expertise and experience in project management, biostatistics, informatics and expertise in web-based data management.   In addition, DCC staff will need to have expertise and experience in working with HIV disease, clinical pulmonary research projects, basic pulmonary research, informed consents and shared data, and proteomic, genomic and other "omics" data sets. 

Prior experience in complex collaborative studies is desired.  The DCC PDs/PIs and other key staff should have knowledge of HIV studies, pulmonary clinical studies, basic pulmonary research and repositories.  

Applications for the DCC may be submitted by individuals located at the same institution as an applicant for a clinical site grant submitted under FOA RFA-HL-13-026, but an individual may not be the PD/PI of RFA-HL-13-026 and the DCC. Applications for the DCC from foreign sites will not be accepted.

Success of the program will be measured by evaluation of non-competing renewals, FOA meetings, development of collaborative projects, and publications/presentations. In addition, recruitment, completion of data collection and analysis, completion of individual site-specific and collaborative projects, and the appropriate sharing of data and specimens with investigators inside and outside the program will be monitored at regular intervals by NHLBI and external consultants, e.g., an OSMB, as appropriate.

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

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

The NHLBI intends to fund one award corresponding to a total of $720,000 for fiscal year 2013, with a total cost commitment of 3.6 million over a 5-year period, but all future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to a maximum of $480,000 direct costs in any year (excluding consortium F&A), but need to reflect actual needs of the proposed project. The proposed budget must include set aside funds in the amount of $100,000/year in direct costs each year to cover costs for collaborative research projects.

Award Project Period

5 years

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not 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 SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Applications for the DCC may be submitted by individuals located at the same institution as an applicant for a clinical site grant submitted under FOA RFA-HL-13-026, but an individual may not be the PD/PI of RFA-HL-13-026 and the DCC.

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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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
Division of Extramural Research Activities  
National Heart, Lung, and Blood Institute
National Institutes of Health
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.

SF424(R&R) Other Project Information Component

Facilities and Other Resources. Applicants from institutions that have a Clinical and Translational Science Award (CTSA) funded by the NIH National Center for Research Resources may wish to identify the CTSA as a resource for conducting the proposed research (http://www.ncrr.nih.gov/clinical_research_resources/clinical_and_translational_science_awards/).

R&R Budget Component

Application budgets are limited to a maximum of $480,000 direct costs in any year (excluding consortium F&A), but need to reflect actual needs of the proposed project. Included in the $480,000 of the DCC is a set-aside of $100,000 direct costs each year (01 -05) to cover the costs of collaborative projects. These DCC funds may be released for developing and conducting joint projects/protocols.

Grantee Meetings. Upon initiation of the program, the NHLBI together with the Data Coordinating Center (DCC) will arrange for up to two meetings in the first year and yearly meetings in years 2-5 to establish and consolidate networking among the investigators who participate in this program. In preparation of the budget for the grant application, applicants should include travel funds for two 1 day meetings for year one and one 1 day meetings in years 2-5 to be held in or near Bethesda, Maryland, for the PDs/PIs and up to two additional key collaborators. At these meetings awardees will be expected to share their results, coordinate joint projects and to help evaluate the progress of the overall program and the individual sites.

Applications for the DCC must set aside $100,000/year in direct costs in all years to cover costs for collaborative studies. These collaborative studies will require further development by the Steering Committee, approval by the Monitoring Board (if appropriate) and the NHLBI Program Office and may require approval of a scientific advisory committee or ad hoc reviewers before being initiated and before funds are released by the DCC.

Applications for the DCC should also include funds to pay for up to one additional meeting a year each, in Bethesda, Maryland, of an outside scientific advisory committee that would review and follow the program and review collaborative protocols and of an Observational Study Monitoring Board (OSMB) that would review and follow protocols conducted at the clinical sites. This would include funds to pay for travel of the Committee/Board members (at government rates), and/or to set up teleconferences and to provide honoraria.

PHS 398 Research Plan Component

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

Specific Aims

List each aim for your DCC and how it supports the Research Objectives of this program described above.

Research Strategy

Use this section to describe how this Data Coordinating Center will facilitate collaborative activities among the individual U01 Clinical/Basic research sites and thereby help them investigate and define the cellular and molecular events, including host genetic factors, underlying the pathogenesis of HIV-associated lung diseases (e.g., COPD and pulmonary hypertension).

Describe how you will provide the following responsibilities in the development of this DCC:

Both the DCC staff and the Clinical/Basic research site staff must have appropriate training and experience for working safely with biologically hazardous specimens that may contain dangerous microbial agents. Applicants must indicate steps they will take to safely acquire, process, ship, store, and distribute biologically hazardous specimens that contain infectious agents.

Applicants should describe their experience and expertise in HIV studies, pulmonary clinical studies, basic pulmonary research and repositories. Applicants should describe prior experience with complex collaborative studies project management in addition to, biostatistics, informatics and web-based data management. Applicants should also describe the DCC staff expertise and prior experience in working with HIV disease, clinical pulmonary research projects, basic pulmonary research, informed consents and shared data, and proteomic, genomic and other "omics" data sets.

Letters of Support

Applicants from institutions that have a Clinical and Translational Science Award (CTSA) funded by the NIH National Center for Research Resources may wish to identify the CTSA as a resource, If so, a letter of agreement from either the CTSA program director or principal investigator should be included with the application in the Letters of Support attachment.

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.

3. Submission Dates and Times

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

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

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

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

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 SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

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 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? Does the planned project address a significant public health concern? Will the DCC complement the clinical centers in achieving investigation and definition of the cellular and molecular events, including host genetic factors, underlying the pathogenesis of HIV-associated lung diseases (e.g., COPD and pulmonary hypertension).? To what extent will the DCC be able to facilitate collaborative activities among the individual U01 Clinical/Basic research sites.?

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? Does the DCC staff have appropriate expertise & experience in project management, biostatistics, informatics & expertise in web-based data management, working with HIV and pulmonary research studies, and "omics" data sets?

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? Will the DCC develop appropriate and innovative interfaces to facilitate multi-disciplinary basic HIV-related pulmonary research?

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?  Does the applicant present a reasonable description of plans for data management, quality control of forms, coordination of activities, support for harmonizing data, developing joint protocols, provision of statistical support, support for interacting with other programs that are not part of the FOA, working with biospecimens, publication support, meeting coordination and administrative support?


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 score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Applications including Foreign Components

Reviewers will assess whether the any foreign components that are part of the proposed project present 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. Assignment to a Scientific Review Group 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 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/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

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

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

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

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

Areas of Joint Responsibility include:

Dispute Resolution:

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

3. Reporting

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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 301-710-0267
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)

Hannah H. Peavy, M.D.
Lung Biology and Disease Branch
Division of Lung Diseases
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Dr. MSC 7952
Bethesda, Maryland 20892-7952
Telephone: 301-435-0222
Fax: 301-480-3557
Email: peavyh@nhlbi.nih.gov

Peer Review Contact(s)

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
National Institutes of Health
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

Financial/Grants Management Contact(s)

Howard Moore
Division of Extramural Activities
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7156
Bethesda, MD 20892-7926 (Express Mail Zip: 20817)
Telephone: 301-435-0166
Fax: 301-451-5462
Email:mooreh@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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