Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Research Resources (NCRR)

Funding Opportunity Title

Limited Competition for Competitive Revision Applications to Accelerating and Enhancing Collaborative Translational Science (UL1)

Activity Code

UL1 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices
  • June 14, 2011 - Notice of Changes in Key Dates for RFA-RR-11-004. See NOT-RR-11-007.
  • Funding Opportunity Announcement (FOA) Number

    RFA-RR-11-004

    Companion FOA

    None

    Number of Applications

    Only one revision application can be submitted for each active Clinical and Translational Science Award (CTSA) parent UL1 grant. Section III. 3. Additional Information on Eligibility.

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

     93.389

    FOA Purpose

    The NCRR announces that competitive revision applications to fund collaborative translational science projects with clinical significance across multiple Clinical and Translational Science Award (CTSA) institutions are encouraged. These competitive revisions are limited to the UL1 component of a CTSA award. 

    The overall aims of this announcement are the following:

    1. Provide timely funding to enable CTSA investigators to perform multidisciplinary, collaborative projects in the area of bench-to-bedside translational research that fully develops the cooperative potential of participation in the CTSA consortium.

    2. Leverage diverse and complementary CTSA consortium-wide resources, expertise, and infrastructure to enable investigators to test promising laboratory- and animal-based discoveries in various clinical settings leading to developing new or improving existing means of disease diagnosis, treatment and prevention.

    3. Broaden and strengthen translational research collaborations among different CTSA-supported investigators to accelerate and enhance translational science and demonstrate CTSA's synergistic values.

    Key Dates
    Posted Date

    March 25, 2011

    Letter of Intent Due Date

    Not required

    Application Due Date(s)

    May 26, 2011, June 28, 2011 (added per NOT-RR-11-007

    AIDS Application Due Date(s)

    Not Applicable

    Scientific Merit Review

    August, 2011, October, 2011 (added per NOT-RR-11-007)

    Advisory Council Review

    September, 2011, January, 2012 (added per NOT-RR-11-007)

    Earliest Start Date(s)

    October, 2011, February, 2012 (added per NOT-RR-11-007)

    Expiration Date

    May 26, 2011, Now June 29, 2011 (added per NOT-RR-11-007)

    Due Dates for E.O. 12372

    Not Applicable

    Required Application Instructions

    It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

    Table of Contents

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

    Part 2. Full Text of Announcement

    Section I. Funding Opportunity Description

    The CTSA program was launched as a consortium with 12 awards by the NCRR in 2006. Currently, CTSAs have grown to 55 centers/institutions across the nation with an annual budget around $500 million. Each CTSA institution has unique scientific strengths and research resources for conducting and supporting translational and clinical research. At the forefront of translational science, CTSAs are incubators of innovative ideas and platforms for exchanging scientific information, promoting collaborations, and advancing translational science. CTSAs have fundamentally transformed the academic research environment and culture as well as the way translational research is conducted and supported, creating an environment in which tools useful to clinical and translational scientists are continually developed and adapted by both research and non-research communities (see http://www.ctsaweb.org/; https://www.researchmatch.org/; http://ctsapharmaportal.org for examples and details).

    Specific Research Objectives

    As CTSAs grow in complexity, new scientific challenges and promising collaborative opportunities and needs arise. Individual CTSAs support a variety of translational research projects leading to discoveries that require testing in different clinical settings. Often, discovery institutions lack timely funding and/or the necessary facilities, expertise, or special resources to move research discoveries quickly into early-phase clinical trials (phase 0, I, and II clinical trials). To enhance translational research efficiency and quality, individual CTSAs/researchers need to reach out and collaborate with other CTSAs where essential and complementary resources such as certified GMP facilities for new drugs/agents, FDA regulatory expertise, strong statistical support, and specific patient populations reside. To be optimized, inter-institute and multidisciplinary collaboration to address these new scientific challenges and to tackle complex translational research problems, by definition, requires support from more than a single CTSA institution. Isolated efforts are not the best approach to facilitate more efficient translation of promising laboratory- and animal-based discoveries into clinical tests and applications. Therefore, the NCRR will support collaborations among CTSA awardees/institutions to accelerate and enhance translational science with potential clinical significance. This notice will foster existing and/or new scientific collaborations and partnerships among CTSA investigators to maximize synergy and address complex translational research problems, which are beyond the scope of a single CTSA awardee or institution to solve.

    Scope

    Competitive revisions support new or additional activities not identified in the current award and reflect an expansion of the scope of the parent grant-approved activities.

    Collaborative translational studies that are still in the discovery phase and cannot be readily tested in patients or clinical settings will not be supported under this FOA.

    Collaborative projects may test novel hypotheses clinically, focus on underlying mechanisms of specific or rare diseases, generate preliminary clinical data, or translate laboratory- and animal-based discoveries into clinical applications. A variety of translational studies can be proposed. However, priority will be given to well-designed, collaborative translational studies that test discoveries from laboratory and animal studies in clinical settings, including testing novel agents, promising medical devices and novel therapeutic technologies (e.g., nanoparticle drug carriers, gene delivery systems, and other possibilities) in various clinical settings or specific patient populations (e.g., the elderly, children, or pregnant women, as a few examples). The translational research project should demonstrate the power of a collective effort derived from the CTSA consortium in bench-to-bedside translational research. A key aspect of these projects is involvement of multiple CTSA-funded grantees/institutions, each contributing resources that would not easily be available to a single institution. Those resources might include research expertise, technologies, research subjects, clinical trial and phenotyping protocols, or disease animal models. Ideally, projects supported by this award should use and/or further field-test relevant resources already developed through the CTSAs, e.g., uniform databases, streamlining regulatory approval processes, etc.

    Applicants should explain the significance of the proposed collaborative research in terms of:

    Applicants should describe how their existing resources (infrastructures/expertise) limit their ability to efficiently resolve complex, translational research problems and how these resources would be combined or supplemented to create new capabilities and develop/expand new/existing partnerships. Ideally, projects also would present an opportunity for this combination of resources to demonstrate applicability beyond the project immediately at hand, strengthening the ability of the CTSA Consortium to advance additional collaborative translational research projects in the future. Examples of appropriate translational science collaborative projects include but are not limited to: 

    1.         Collaborative projects may focus on a single disease or multiple diseases. Collaborative projects may study a specified disease condition or phenotype, or extend projects stemming from one or more CTSA pilot projects. Translational research projects that are linked by a research theme such as pharmacogenomics, metabolomics and biomarker development are also appropriate. 

    2.         Collaborative translational science studies may test novel translational research hypotheses/concepts, examine cell and animal model systems related to human studies, elucidate disease molecular pathological pathways and underlying biological mechanisms, develop and validate biomarkers, novel drug targets, new agents, new devices/tools and therapeutic technologies (drug and gene delivery systems) for humans.

    3.         Collaborative studies may include identification of promising new means for accelerating translational science discoveries into clinical applications through early clinical testing and trials.

    4.         Studies that re-purpose compounds from the CTSA Pharmaceutical Assets Portal (http://ctsapharmaportal.org) or other sources to new molecular targets for therapeutic interventions are of interest.

    Section II. Award Information
    Funding Instrument

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

    Application Types Allowed

    Revision

    The OER Glossary and the PHS398 Application Guide provide details on these application types.

    Funds Available and Anticipated Number of Awards

    A total of $2 million is anticipated to be provided to approximately four awards in FY2012. Individual award amounts and the number of awards made will depend upon the number, quality, and costs of the applications received.

    Award Budget

    The maximum funds (total cost) that each applicant can request are limited to $500,000. Awarded budgets are limited $500,000 for each application, but need to reflect actual needs of the proposed projects.

    Award Project Period

    The project period can be no longer than one year and any eligible parent grant must have at least one year left for this revision supplement award.

    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:

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

    This announcement is for revision applications to translational projects supported by Institutional Clinical and Translational Science Award under RFA-RM-10-020 or its predecessors. Applicant organizations must be current recipients of a UL1 Clinical Translational Science Award with a project end date of at least two years ahead of the stated earliest start date. The research proposed in the revision must be accomplished within one  year.

    An applicant organization is expected to submit no more than one application under this FOA.  There is no limit to the number of applications that an organization can participate as a subcontractor.

    IMPORTANT:  Revisions are used  to expand the scope of an existing grant or research protocol. The research proposed by the NIH grantee in the revision application can be either within or outside of the original scope of the NIH-supported grant project.  The funding mechanism being used to support this program, competitive revision, can be used to cover cost increases that are associated with achieving certain new research objectives that take advantage of opportunities that would increase the value of the proposed projects.

    Common Fund/Roadmap text, Collaborative Research, or Projects Greater than 5 years Duration:  See instructional documents in the NIH Guide Publishing System for the text to insert.

    Required Registrations

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

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

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

    Eligible Individuals (Program Director/Principal Investigator)

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

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.    

    2. Cost Sharing

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

    3. Additional Information on Eligibility

    Number of Applications

    For this announcement, only one application can be submitted from each CTSA institution and resubmission applications will not be allowed.     

    Section IV. Application and Submission Information

    1. Address to Request Application Package

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

    2. Content and Form of Application Submission

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

    Letter of Intent

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

    Prospective applicants may wish to submit a letter of intent that includes the following information:

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

    The letter of intent should be sent to:

    Dr. Heng Xie
    Division for Clinical Research Resources
    National Center for Research Resources (NCRR)
    6701 Democracy Blvd., Democracy I, Rm. 908
    Bethesda MD 20892-4874 (Regular mail)
    Bethesda MD 20817 (FedEx)
    Telephone: 301-443-8063
    FAX: 301-480-3661
    E-mail: XieHe@mail.nih.gov

    Application Submission

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

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

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

    Dr. Heng Xie
    Division for Clinical Research Resources
    National Center for Research Resources (NCRR)
    6701 Democracy Blvd., Democracy I, Rm. 908
    Bethesda MD 20892-4874 (Regular mail)
    Bethesda MD 20817 (FedEx)
    Telephone: 301-443-8063
    FAX: 301-480-3661
    E-mail: XieHe@mail.nih.gov

    Page Limitations

    All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

    Research Plan

    All instructions in the PHS398 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 PHS398 Application Guide, with the following modifications:

    Appendix

    Appendix material is not allowed.

    Foreign Organizations

    Not Applicable.

    3. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates. 

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

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

    4. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    5. Funding Restrictions

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

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

    6. Other Submission Requirements and Information

    Applications must be received by May 26, 2011.

    If an application is received after that date, it will not be reviewed.
    Revisions should include: same PD/PI as parent grants, same budget format, and 1-page introduction should be included (new with Enhancing Peer Review).

    Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NCRR 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.  Additional Materials are not allowed.

    Section V. Application Review Information

    1. Criteria

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

    Overall Impact - Overall

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

    Scored Review Criteria - Overall

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

    Significance

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

    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?  Is there sufficient justification for the proposed collaborative research effort?

    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 - Overall

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

    Protections for Human Subjects

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

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

    Inclusion of Women, Minorities, and Children 

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

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

     Not Applicable.

    Renewals

     Not Applicable.

    Revisions

    For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not for recommended approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident..

    Additional Review Considerations - Overall

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

    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 NCRR Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

    As part of the scientific peer review, all applications:

    Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NCRR Advisory Council or Board. The following will be considered in making funding decisions:

    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

    Section VI. Award Administration Information

    1. Award Notices

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

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

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

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

    2. Administrative and National Policy Requirements

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

    Cooperative Agreement Terms and Conditions of Award

    This FOA is intended to provide supplement funds to grants funded under previous published parent FOAs that solicit CTSA awards. The latest parent FOA (RFA-RM-10-020) can be found at the following site (http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-10-020.html). All parent FOA’s Cooperative Agreement Terms and Conditions of Award apply to this supplement FOA.

    3. Reporting

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

    A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

    Section VII. Agency Contacts

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

    Application Submission Contacts

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

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

    Scientific/Research Contact(s)

    Dr. Heng Xie
    Division for Clinical Research Resources
    National Center for Research Resources (NCRR)
    6701 Democracy Blvd., Democracy I, Rm. 908
    Bethesda MD 20892-4874 (Regular mail)
    Bethesda MD 20817 (FedEx)
    Telephone: 301-443-8063
    FAX: 301-480-3661
    E-mail: XieHe@mail.nih.gov

    Peer Review Contact(s)

    Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

    Dr. Mohan Viswanathan
    Office of Review
    National Center for Research Resources (NCRR)
    Telephone: 301- 435-0829
    Email: mv10f@mail.nih.gov

    Financial/Grants Management Contact(s)

    Ms. Vicki Maurer
    Office for Grants Management
    National Center for Research Resources (NCRR)
    Telephone: 301- 435-0837
    Email: maurervl@mail.nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

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


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