Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title

Administrative Coordination Hub for the Pharmacogenomics Research Network, PGRN (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-GM-15-004

Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.859

Funding Opportunity Purpose

This purpose of this funding opportunity announcement (FOA) is to solicit applications for an Administrative Coordination Hub for the Pharmacogenomics Research Network (PGRN). The main areas of responsibility will include meetings support, communications, and coordination of nascent network collaborations.    Advance consultation is highly encouraged to ensure that a proposed application fits within this FOA.   

Key Dates
Posted Date

June 18, 2014

Open Date (Earliest Submission Date)

September 8, 2014  

Letter of Intent Due Date(s)

September 8, 2014

Application Due Date(s)

October 8, 2014, 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.

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

February/March 2015

Advisory Council Review

May 2015

Earliest Start Date

July 1, 2015

Expiration Date

October 9, 2014  

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 purpose of this funding opportunity announcement (FOA) is to solicit applications for an Administrative Coordination Hub for the Pharmacogenomics Research Network (PGRN).  The main areas of responsibility will include meeting support, communications, and coordination of nascent network collaborations   Advance consultation is highly encouraged to ensure that a proposed application fits within this FOA.  

Background

The Pharmacogenomics Research Network (PGRN) has been funded since 2000 by multiple Institutes and Centers of the NIH. The vision of the PGRN is “To lead discovery and advance translation in genomics, in order to enable safer and more effective drug therapies.” The network has identified major indicators of success as:  discovery of novel insights into mechanisms relating genomic variation to differences in drug responses; demonstration of the use and utility of genomic information to improve outcomes for drug therapies; and incorporation of genomics data to predict and personalize medicine in routine clinical practice. To accomplish this vision, the PGRN has already established network resources, trans-network projects, and other collaborative network efforts to benefit the scientific research community.

In Fall of 2013, the National Advisory General Medical Sciences Council recommended that after fifteen years of continuous funding, the network should be transitioned into the regular research grant funding stream. Therefore, only limited specialized funding opportunities are being made available as part of a transition plan, in an overall program for Pharmacogenomics in Precision Medicine. The Advisory Council was highly supportive of the continuation of network activities in a model that allows all investigators with an interest in pharmacogenomics to indicate a desire to participate in the network, starting in July 2015.

The Advisory Council also recommended that NIGMS strengthen its commitment to diversity across all of its program areas and funding opportunities. Therefore, applicants for this FOA are strongly encouraged to identify creative ways to encourage the participation of individuals from diverse backgrounds underrepresented in biomedical research in the future network.

Objective

The Administrative Coordination Hub will provide the coordinating infrastructure for the Pharmacogenomics Research Network, beginning in 2015.  The PGRN will include the Research Centers for Pharmacogenomics in Precision Medicine (P50), the Enabling Resources for Pharmacogenomics (R24), the Pharmacogenomics Knowledge Base (R24), along with other investigators working in the field supported by Research Project Grants (Parent R01) and Research Program Project Grants (P01) as well as other grant mechanisms of the NIH.  In other words, all investigators with an interest in pharmacogenomics who are funded through these and other mechanisms may indicate a desire to participate in the network beginning in July 2015.  Many network-wide functions will be based upon the existing network and other successful models, and investigator input will be sought as the new network is established.  An Administrative Coordination Hub is envisioned as the most cost-efficient and scientifically productive way to organize and coordinate the infrastructure of the network. 

Scope

The Administrative Coordination Hub will support functions that benefit all investigators working in the scientific field, by catalyzing and supporting efforts that logistically go beyond any single research site.  Consistent with the goal, activities will include, but not be limited to, these three main areas:

  • Meetings.  The hub will organize the facilities and registration for two meetings per year, typically one larger annual investigators’ scientific meeting open to all, and one smaller “specialty” meeting, the focus of which will be determined each year by the interests of the network participants.  The annual scientific meeting planning will occur together with the Research Centers for Pharmacogenomics, as part of their outreach efforts.  The purpose will be to engage a broad range of investigators in presenting their work and discussing the most cutting-edge areas, and to offer the opportunity to as many scientists as reasonably possible to participate in learning from the network.  The focused “specialty” meetings will be of interest to subsets of researchers focused on selected aspects of pharmacogenomics in precision medicine.   For example, focused topics could include data and methods exchange around genome-wide sequencing and analysis in pharmacogenomics; design of pragmatic clinical studies to generate evidence of clinical utility of genomic information; or development of modern model systems to support studies of pharmacogenomics in precision medicine.

  • Communications.   The hub will be responsible for creating and maintaining an appropriate web presence for the PGRN; currently, the website is www.pgrn.org.  The purpose is to have an interface for the investigative community that displays the network activities and priorities and explains how to get involved.  The website should also enable internal communications between network participants.  The hub will manage and schedule the membership of the network and its meetings, conference calls, and selected reports, as well as arrange and moderate the monthly on-line Research in Progress Seminars (RIPS).  The hub will track publications and collaborations created between network members.  The hub will also monitor and report to the membership on the enabling resources’ opportunities and activities, and available services and deliverables.

  • Collaborations.   To promote a collaborative and synergistic network, the hub will “incubate” nascent scientific areas through collaborative information-gathering efforts, which might later become independently supported projects.  This scientific activity was possible in the past through the PGRN, but because the network is not being renewed in the same manner as a large number of cooperative agreements (see the Background above), a different mechanism is needed to facilitate the discussion, development, and coalescence of collaborative activities, which will likely become the subject of future research efforts.  Previous network projects of the PGRN have “spun off” into working groups and in some cases created community projects; now this model needs to be adapted to a network that is open to all with an interest in the field.  The hub is expected to work closely with the PGRN and NIGMS staff to identify the appropriate activities.  The purpose is the exchange of critical information to establish whether collaborations might be feasible.  The hub could conceivably facilitate sharing ideas, technology, data, methods, or reagents.  These activities cannot be completely determined in advance and will be new community-driven collaborations; they will be determined by the interests of the network participants.  There will be a consensus-driven process developed within the PGRN based upon interests, participation, and leadership.  NIGMS will work with the network to identify practical, achievable goals that are prioritized by the network members.  If promising, these collaborations will become the subject of future research and resource efforts.

As a cooperative agreement awardee, the recipient of the Administrative Coordination Hub (U24) should expect to work together with NIH Research/Scientific staff to ensure that the plans dovetail well with the NIH plans for the network transition.  This is an open competition and advance consultation is available to and encouraged for all potential applicants. 

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

NIGMS intends to commit approximately $500,000 total costs in FY 2015 to fund one award.

Award Budget

An applicant may request a budget of up to $350,000 direct costs per year (excluding consortium F&A and equipment).  Budgets should reflect the actual needs of the proposed activities.

Award Project Period

An applicant may request a project period of up to five 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

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

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

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
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.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • 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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.
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 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:

  • 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:

Rochelle M. Long, Ph.D.
National Institute of General Medical Sciences
Telephone: 301-594-3827
Fax: 301-480-2802
Email: rochelle.long@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.

The budget request should be commensurate with all of the required elements and include the equipment, software, licensing agreements, and staffing required to accomplish the tasks requested of the Administrative Coordination Hub.  The hub will support the meetings to the extent possible with its budget; modest registration fees may be required of the participants if the funds awarded are insufficient to entirely cover meeting costs.  The applicant should anticipate that NIH will make electronic communications services available, including a conference telephone line and videoconferencing capability.

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: 

Specific Aims:  Provide a succinct description of the overall plans for the Administrative Coordination Hub.  The proposed activities should support the objective to provide the infrastructure for the Pharmacogenomics Research Network, beginning in 2015.

Research Strategy:   Provide detailed plans to accomplish the specific aims of the Administrative Coordination Hub.  Plans should include an explanation of the staffing requested, clear delineation of responsibilities, and the background and experience of the proposed participants.  Address each of the following required activities:

  • Meetings:  Plans should describe the arrangements to allow convening and staffing the scientific meetings.  There will typically be two 2-day meetings held annually in Bethesda, MD or at locations convenient for the attendees and acceptable to the NIH.  Arrangements should include reserving the meeting rooms, audio-visual needs, poster boards, and blocking the hotel rooms (sleeping rooms to be paid by meeting attendees).  The hub should be prepared to set the possible meeting dates, create the meeting registration site, set and collect registration fees as needed, prepare the participants list, and prepare the scientific program by working with the responsible Research Center for Pharmacogenomics in Precision Medicine or alternative group taking the leadership for the scientific agenda.  It is estimated that the investigators’ scientific meeting might be expected to attract about 150 people each time, and the “specialty” meeting might be expected to attract half as many.

  • Communications:  Plans should describe the arrangements to accomplish tasks related to website development and maintenance, scheduling teleconferences for working groups in the network, and continuing the on-line PGRN seminar series (RIPS).  The hub should plan to feature investigators and their projects, highlight notable scientific successes, assemble and keep current lists of publications, and prepare summary scientific reports of network accomplishments and collaborations.  The hub should prepare an electronic yet printable network brochure and keep it updated.  The hub should plan to creatively demonstrate the use of social media and current web-based opportunities (e.g., examine the model of TedTalks) for outreach. 

  • Collaborations:  Plans should describe the anticipated nascent collaborative activities that a network might support, beginning in 2015.  Because the PGRN has been in existence since 2000, possible examples and ideas can be ascertained by past experience with PGRN members and/or discussion with possible future network members and/or with NIH Research/Scientific Staff listed in this FOA.   The hub should contribute to scientific leadership by facilitation (defined as enhancing interactions, removing barriers, or enabling groups).  Future activities will be determined by the scientific priorities and interests of the network participants, and so flexibility will be required.  An application should demonstrate familiarity with the areas that comprise pharmacogenomics, computational competence, and experience in leading collaborative efforts.  The hub staff should think creatively about how an open membership network can optimally function; an application could discuss individual and group incentives and rewards in this scientific arena, and provide examples of past experience in this style of team research and networking. 

Letters of Support:  General letters of support from individuals or groups who will not be substantially involved should NOT be provided.  Documentation should only be from someone named in the application who might be expected to contribute in a substantive way to the proposed resource.  Letters, if any, should be concatenated into a single PDF 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:

  • Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

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

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.

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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

In order to expedite review, applicants are requested to notify the NIGMS Referral Office by email at paul.sheehy@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 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?

Additionally, how will the proposed support of meetings, communications, and collaborations promote the objective of the Pharmacogenomics Research Network, PGRN, to benefit the entire scientific community?   

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?

Additionally, how do the proposed leadership and experience match with the need to provide infrastructure for the Pharmacogenomics Research Network, PGRN? 

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?

Additionally, how will the proposed activities creatively enable nascent collaborations within the membership of the Pharmacogenomics Research Network, PGRN?  

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? 

Additionally, how will the proposed approaches optimally accomplish each of the three goals for the Pharmacogenomics Research Network, PGRN (meetings, communications, and collaborations)?  

If the project 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 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?   

Additionally, how does the proposed environment align with the objective to provide infrastructure for the Pharmacogenomics Research Network, PGRN? 

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

Not Applicable

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 Institute of General Medical Sciences, 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 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 National Advisory General Medical Sciences Council. 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.
  • Continuity.
  • Alignment with institute goals.
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:

The awardee will have the primary responsibility for the design, execution, and maintenance of all activities provided by the Administrative Coordination Hub in support of the major areas of responsibility (meetings, communications, and collaborations).  The awardee agrees to accept the close interaction of NIH staff to promote discussion of the scientific priorities of the network membership and to work towards providing an infrastructure and activities that support those scientific priorities.  The awardee agrees to coordinate with each Research Center for Pharmacogenomics in Precision Medicine to program a scientific investigators’ meeting, described as an outreach activity in the FOA PAR-14-075.  The awardee will retain custody of and primary rights to their own data developed under the award, subject to current Government policies regarding rights of access.

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

The NIGMS scientific coordination staff (Project Coordinator) will have the primary responsibility for assisting in, and ensuring, the consultation of all of the network membership including the centers, resources, knowledge base, along with other investigators working in the field supported by other grant mechanisms of the NIH.  The PGRN operates as a rotating leadership model with a chair and a vice-chair selected from among the members; the NIGMS Project Coordinator will appoint the network Chair and vice-Chair.  The NIGMS Project Coordinator will ensure that other relevant NIH institutes remain informed and will bring current NIH policy and practices to the attention of the awardee for the Administrative Coordination Hub.  The dominant role and prime responsibility for the activities described in the application reside with the awardee for the project as a whole.  In addition to the Project Coordinator, an NIGMS Program Official with the normal stewardship and programmatic responsibilities will be assigned and named in the award notice.

Areas of Joint Responsibility include:

The awardee and NIGMS Project Coordinator will work jointly to establish the scientific priorities of the network participants and network infrastructure needs.  Accordingly, they will cooperatively consider and mutually agree upon tasks consistent with the scientific priorities of the network.  Each of the major areas (meetings, communications, and collaborations) could be modified, as needed, following assessment and establishment of practical, achievable goals that fit within the Administrative Coordination Hub scope, budget, and staffing.  Temporary working groups may be established to aid in reaching these goals.  Both NIH and hub staff representatives will attend all scientific meetings, calls, and videoconferences of the network.  All parties will agree to cooperate fully with any independent administrative evaluation as may be called for the Director, NIGMS, at any time.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

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

Scientific/Research Contact(s)

Rochelle M. Long, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3827
Email: rochelle.long@nih.gov

Peer Review Contact(s)

Helen R. Sunshine, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email: sunshinh@nigms.nih.gov

Financial/Grants Management Contact(s)

Lisa A. Moeller
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3914
Email: moellerl@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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