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RFA-HG-15-025: A Data Analysis and Coordinating Center (DACC) for Research Training and Career Development Activities (U24)
Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI)

Funding Opportunity Title

A Data Analysis and Coordinating Center (DACC) for Research Training and Career Development Activities (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

Reissue of RFA-HG-08-006

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HG-15-025

Companion Funding Opportunity

None

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

93.172

Funding Opportunity Purpose

NHGRI invites applications from institutions that are willing to participate as a Data Analysis and Coordinating Center (DACC) for NHGRI's research training and career development programs as a cooperative agreement.

The applicant will collaborate with NHGRI training staff, training program directors, career awardees, and grantees with diversity programs in order to track the short- and long-term progress and outcomes of Ruth L. Kirschstein National Research Service Award (NRSA) trainees and fellows, career awardees, and Diversity Action Plan (DAP) participants and to evaluate how well these programs meet each specific grant program's objectives.  

Key Dates
Posted Date

August 12, 2015

Open Date (Earliest Submission Date)

September 20, 2015

Letter of Intent Due Date(s)

September 20, 2015

Application Due Date(s)

October 20, 2015,  by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

No late applications will be accepted for this Funding Opportunity Announcement.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

December 2015

Advisory Council Review

January 2016

Earliest Start Date

April 2016

Expiration Date

October 21, 2015

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

The NHGRI is strongly committed to increasing the next generation of genomic sciences and genomic medicine researchers by supporting research training through the NRSA programs, career development through the various K career development award programs and providing opportunities for diverse populations to participate in genomics research through an R25 diversity program.   

The goal of this FOA is to support a Data Analysis and Coordinating Center (DACC) which will be responsible for: (1) long-term tracking, evaluating, and reporting on the career progression of individuals who are/have participated in NHGRI’s NRSA T32 institutional training grants, NRSA individual fellowships, career development awards  and/or Diversity Action Plan; and (2) working collaboratively with NHGRI staff to plan the annual meetings, with the DACC taking primary responsibility for the planning and logistics associated with the annual meetings of participants.

Scope and Objectives

This FOA solicits cooperative agreement applications from institutions and organizations that will:

  • Work with the grantees to refine data elements to be collected.
  • Work with the grantees to ensure that only quality data are collected and submitted to the database.
  • Develop and/or refine a database that can receive data from the grantees and allow grantees to have access to their data only.
  • Ensure the confidentiality of information put into the database.
  • In collaboration with the grantees, help define innovative strategies for long-term tracking of participants.
  • Develop a variety of analyses and reports for presentation to grantees, advisors, National Advisory Council on Human Genome Research and NHGRI staff.
  • Attend annual meetings of the Research Training Consortium and training coordinators and two meetings of the National Advisory Council for Human Genome Research during the course of this award.
  • Plan to meet annually in the Washington, D.C. metropolitan area for the annual meeting of individuals receiving support from NHGRI's research training, career development and research education programs, mentors, advisors and NHGRI program staff.  Additionally, the DACC should plan the agenda with advice from the NHGRI staff and handle the logistics of this annual meeting.

Grantees will be responsible for collecting data from participants as a requirement for demonstrating that their programs are meeting NHGRI’s diversity goals.

The DACC will obtain data from the grantees and provide feedback to grantees and NHGRI about the quality and utility of the data.  The DACC should be prepared to work with data from grantees to produce annual and cumulative reports on program progress and outcomes.  

The applicant must have demonstrated prior experience in evaluating and tracking short- and long-term research training activities.  Since the DACC will have to work closely with grantees, the applicant also must have demonstrated ability to work cooperatively within large, distributed  projects where the focus is on research training that results in getting participants to the next phase of their career development.  

The activities of the DACC should not overlap, but complement the grantees’ evaluation and trackingactivities.  As a reminder, the grantees are already required to incorporate evaluating and tracking components into their programs.  The DACC will be funded to develop, house, and maintain a database to track, store, and provide access to all of the participants and different types of research training activities that are funded under the MAP, including NRSA training activities.   Applicants for the DACC should make clear that they will avoid duplication of effortswith the grantees evaluation and tracking activities.

The DACC should use robust analyses tools capable of handling all of the data that will be used in integrative analyses.  The DACC is expected to work with the grantees to establish the exact types and formats of data that will be used in integrative analyses along with developing procedures to track and facilitate the analyses.

The awardee funded through this FOA (RFA-HG-15-025) will participate in the annual meetings of grantees and training coordinators and at least one meeting with the advisors. The annual grantee

meeting is in the spring of each year and will be held in the Washington, DC metropolitan area.

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

NIH intends to fund one award, corresponding to a total of $520,000 for fiscal year 2016. Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 5 years.  

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

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

    • Hispanic-serving Institutions
    • Historically Black Colleges and Universities (HBCUs)
    • Tribally Controlled Colleges and Universities (TCCUs)
    • Alaska Native and Native Hawaiian Serving Institutions
    • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • U.S. Territory or Possession

Other

  • Native American Tribal Organizations (other than Federally recognized tribal governments)
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 not allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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.

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
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, including Supplemental Grant Application Instructions 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 required, it is not binding and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

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

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

The letter of intent should be sent to:

Tina Gatlin, Ph.D.
Telephone: 301-496-7531
Fax: 301-435-1580
Email: gatlincl@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

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

Research Strategy: In order to determine how well these programs are training the next generation of genomic sciences and genomic medicine scientists and what program changes, if any, are necessary, applicants should describe plans to  (1) systematically collect reliable data on all participants long-term  in order to track their progression through the career pipeline; (2) perform analyses on the data to determine whether participants have continued in genomics research as their careers progress; (3) prepare reports that can be used to evaluate NHGRI’s investment in these programs; and (4) provide career enhancement and development experiences beyond those included in their institutional programs through annual meetings that highlight the latest advances in genomics, and offer networking opportunities with potential mentors, and introduce participants to NIH’s grants process. 

The following items should be addressed satisfactorily by the applicant:

Coordination Functions:

  • Applicants must propose an operational structure for coordinating functions at the DACC, including lines of responsibility for professional staff at the DACC.
  • Describe how the DACC will promote collaboration amongst grantees to accomplish the goals of this FOA.
  • Describe a broad plan for how the DACC will accomplish the goal of working with grantees to demonstrate that their research training activities are contributing to the goal of increasing the number of underrepresented minorities pursuing genomics and ELSI research.  The plan should include working with grantees and NHGRI staff to refine the data elements that are essential to demonstrating progress and appropriate outcomes for the various career levels and working with grantees to ensure that comprehensive and accurate data are collected systematically on individual participants.
  • Describe how the DACC will provide expert assistance in supporting the development of an evaluation protocol and common evaluation measures (constructs and instruments).  Describe intended metrics and benchmarks to be used. 
  • Describe how the DACC will be responsible for supporting infrastructure for meetings and teleconferences. Applicants should provide logistical services for meetings, such as assuring that meetings are held and that minutes are recorded and communicated to grantees and NHGRI staff in a timely manner.
  • Applicants should describe their willingness to be flexible in assuming or relinquishing responsibilities as program needs arise.  

Capacity and Ability to Manage Data and Communications:

  • Indicate capability to utilize electronic technology to meet the goal for coordination amongst grantees.
  • Describe background, if any, of the team as a whole in developing and maintaining data management systems for collection of evaluation data.
  • Describe methods to be employed to facilitate communication between DACC staff and grantees.

Evaluation of Education/Training or Research Programs:

  • The DACC is responsible for coordinating the evaluation of grantees’ program and should have background in developing, conducting and supporting common evaluation measures.
  • Describe how the DACC will evaluate training, career and research educations programs from multiple grant-type programs.

Applicants are encouraged to describe special or unique strengths of the team as a whole that may be relevant to research education such as that described in this FOA.

Evaluation Plan:

  • Applications must include a plan for evaluating the activities supported by the award.  The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short and long-term success. Wherever appropriate, applicants are encouraged to obtain feedback from participants and grantees to help identify weaknesses and to provide suggestions for improvement.  Annual evaluation data must be provided with the non-competing continuation application (progress report) and a summary of the final evaluations must be provided to the NHGRI as part of the final report.
  • Additionally, the DACC applicant should submit an evaluation proposal to track the participants to assess their success, such as successfully to the next career phase, obtaining peer-review funding for individual fellowships, career awards or grants, publishing their research in refereed journals, and remaining in biomedical research.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date 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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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. See Section III of this FOA for information on registration requirements.

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. 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 and compliance with application instructions by the Center for Scientific Review and responsiveness by the National Human Genome Research Institute, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at bettie_graham@nih.gov when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 Center 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 Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed DACC achieve the goals of the research training and career development programs it proposes to serve?  What advantages will the DACC bring to the research training and career development programs?  Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the programs?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? 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 Center?  Do the investigators have experience in successfully coordinating and collaborating with efforts of comparable size and complexity?  Do the investigators have expertise in the areas covered in the objectives of this FOA which are (1) long-term tracking, evaluating, and reporting on the career progression of individuals who are/have participated in NHGRI’s training programs; and (2) planning and logistical support for annual program meetings? Are the PD(s)/PI(s) and any key investigators likely to be able to accomplish all the objectives in a highly collaborative, fair, and flexible manner, appropriate to the coordinating DACC roles described in this FOA?  Is the leadership approach, governance and organizational structure appropriate for the DACC?   

Innovation

Does the application propose novel organizational concepts, management strategies, or electronic and information technologies in coordinating the research training and career development programs? Are there innovative and useful approaches to project coordination and logistical support?  Does the applicant make a strong case for effectively reaching an audience in need of the DACC’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?  

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the Center is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program?  Are the proposed approaches likely to accomplish the major goals of collecting accurate and up-to-date data on participants, developing analyses and reports that accurately track and informatively report the career path of participants long-term, facilitating a successful annual meeting, and coordinating appropriate activities with grantees and NHGRI staff?  Will these approaches be responsive to the changing needs of the program over time? Does the proposed DACC have adequate capability to utilize electronic technology to meet the coordination goals?  Is the proposed plan for promoting collaboration across sites adequate?  Is the plan for evaluation sound and likely to provide information on the effectiveness of the program?

If the Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the program it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel?  Are resources available within the scientific environment to support electronic information handling?  Are resources available within the scientific environment to support electronic information handling?   

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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 National Human Genome Research Institute, 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:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

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 appropriate National Advisory Council or Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
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 terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this 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:

  • Defining, within the context of this FOA, objectives and approaches, and for planning, conducting, analyzing, and publishing results, interpretations, and conclusions of their studies;
  • Agreeing to accept close coordination, cooperation, and participation of NHGRI staff in those aspects of scientific and technical management of the NHGRI training and career development programs as described under "NIH Staff Responsibilities";
  • Adhering to the NHGRI policies regarding intellectual property, data release and other policies that might be established during the course of this activity (see https://grants.nih.gov/grants/sharing.htm);
  • Working cooperatively with:  (a) principal investigators of NRSA training programs and DAPs and (2) individual fellows and career awardees;
  • Participating in conference calls and meetings with external scientific advisors to the program that may be retained by NHGRI, as needed;
  • Retaining custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
  • Ensuring that NHGRI has access to all primary data that are collected on participants under this award; and facilitate transfer of primary data to new database structure, if necessary.

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

An NHGRI Project Scientist will have substantial programmatic involvement during the conduct of this

activity in order to provide technical assistance, advice and facilitate coordination.  However, the role of NHGRI will be to facilitate and not to direct the activities.

The Project Scientist will:

  • Participate in the group process of setting research priorities, deciding optimal research approaches, and contributing to the development of the agenda and logistics for the annual meeting. The Project Scientist will assist and facilitate the group process and not direct it;
  • Negotiate goals, including timelines, with the awardee as necessary;
  • Liaise and coordinate with the NHGRI research training, career development, and DAP grantees programs to identify methods for ensuring that the program is meeting their needs;
  • Serve as a liaison between the awardee and any external scientific advisors to the program that may be retained by NHGRI and the National Advisory Council for Human Genome Research;
  • Periodically report progress to the NHGRI senior leadership;
  • Provide advice on the management and technical performance of the awardee;
  • Participate in data analyses, interpretations, and where warranted, may be a co-author on publications (Publications should provide appropriate attributions of authorship from all those who provided intellectual input, such as members of the DACC team, the NIH representatives, and grantees);
  • Assist awardee in the development, if needed, of policies for dealing with situations that require coordinated action;
  • Retain the option to recommend the withholding or reduction of support from any cooperative agreement that substantially fails to maintain state-of-the-art capabilities, or fails to comply with the Terms and Conditions of the award.    

Areas of Joint Responsibility include:

Coordinate the annual training meeting, including but not limited to development of the agenda, selection of meeting date, and selection of invited speakers.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between awardee and the NIH may be brought to Dispute Resolution.  A Dispute Resolution Panel composed of three members will be convened.  The three members will include:  A designee chosen by the DACC without NIH staff voting, one NIH designee, and a third designee with expertise in research training and career development programs.  In the event that the third designee cannot be agreed upon by both parties, the DACC will designate.  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 Research Performance Progress Report (RPPR) 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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

 Tina Gatlin, Ph.D.
National Human Genome Research Institute (NHGRI))
Telephone: 301-496-7531
Email: gatlincl@mail.nih.gov

Peer Review Contact(s)

Rudy Pozzatti, Ph.D
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8739
Email: pozzattr@exchange.nih.gov

Financial/Grants Management Contact(s)

Ms. Susan Toy
National Human Genome Research Institute (NHGRI)
Telephone: 301-443-4935
Email: toys@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 Part 75.

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