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

Research Centers for Pharmacogenomics in Precision Medicine (P50)

Activity Code

P50 Specialized Center

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-14-075

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.859

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to stimulate the formation of centers that will conduct cutting-edge research studies designed to push the boundaries for understanding and predicting therapeutic drug responses. The FOA describes research centers that examine drug actions within the context of precision medicine, or data-driven prescribing. This program will support a limited number of large-scale multidisciplinary centers, each of which will serve as a national and international focal point.  A center should be built around a tightly-focused theme and should represent innovative investigations at the forefront of understanding drug actions. The experimental approaches should go beyond pharmacogenomics, to include for example, examination of gene expression and regulation patterns, assessment of post-genomic modifications, other small-molecule “signatures” that contribute to the prediction of drug actions both therapeutic and adverse, and/or systems and pathway analysis. Other somatic mutations or genomes present, such as those of tumors, infectious agents, or resident microbes, should also be evaluated. Each center should have a clinical interaction, either as a patient-oriented core or through an established relationship with clinical studies or trials conducted elsewhere. There should be bi-directional exchange between the research and clinical components, with a mix of experimental methods yielding complementary datasets that collectively enhance the foundational understanding and prediction of drug actions. But while the research results should contribute to ultimately guiding the future of patient care, the center’s current emphasis should primarily be on making fundamental new discoveries at the forefront for the field. 

Key Dates
Posted Date

January 24, 2014

Open Date (Earliest Submission Date)

August 25, 2014

Letter of Intent Due Date(s)

30 days before the application due date

Application Due Date(s)

September 25, 2014; September 25, 2015; and September 25, 2016, by 5:00 PM local time of applicant organization.

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; February/March 2016; February/March 2017

Advisory Council Review

May 2015; May 2016; May 2017

Earliest Start Date

July 1, 2015; July 1, 2016; July 1, 2017

Expiration Date

September 26, 2016

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

You will be sent to ASSIST to prepare and submit your application. Problems accessing or using ASSIST should be directed to the eRA Commons Help Desk.
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


Purpose

The purpose of this funding opportunity announcement (FOA) is to stimulate the formation of centers that will conduct cutting-edge research studies designed to push the boundaries for understanding and predicting therapeutic drug responses.  The FOA describes research centers that examine drug actions within the context of precision medicine, or data-driven prescribing.  This program will support a very limited number of grants for large-scale centers with multidisciplinary investigative teams, each of which will serve as a national and international focal point for investigations leading to precision drug-prescribing in its respective drug/disease field. 

An application for a center should be built around a tightly focused theme and should represent forefront investigations into understanding drug actions, with the potential for high payoff.  The experimental approaches should go beyond pharmacogenomics, to include for example, examination of gene expression and regulation patterns, assessment of post-genomic modifications, other small-molecule “signatures” that contribute to the prediction of drug actions both therapeutic and adverse, and/or systems and pathway analysis.  Other somatic mutations or genomes present, such as those of tumors, infectious agents, or resident microbes, should also be evaluated.

Each center should have a clinical interaction, either as a patient-oriented core or through an established relationship with clinical studies or trials conducted elsewhere.  There should be bi-directional exchange between the research and clinical components, with a mix of experimental methods yielding complementary datasets that collectively enhance the foundational understanding and prediction of drug actions.  But while the research results should contribute to ultimately guiding the future of patient care, the center’s current emphasis should primarily be on making fundamental new discoveries, and these discoveries should enable substantial scientific advances that can potentially be pushed forward into medical practice.

Background

According to the 2011 National Research Council report entitled “Toward Precision Medicine” commissioned by the NIH, precision medicine refers to “the tailoring of medical treatment to the individual characteristics of each patient” based upon “the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease…or in their response to a specific treatment.”  The report notes that “moving toward individualized medicine requires that researchers and health care providers have access to very large sets of health- and disease-related data linked to individual patients.”  The premise is that accurate diagnosis leads to targeted effective treatment and improved health outcomes.  The report also promotes new models of population-based research that utilize electronic health records from which clinical data can be linked to molecular data, as a cost-efficient means to integrate molecular, clinical, and environmental data.

Pharmacogenomics refers to the application of knowledge derived from the human genome to predicting drug actions and patient responses.  Important pharmacogenomic achievements to date include the discovery of variation (common and rare), mechanistic understanding of function, and demonstration of the clinical impact of sequence variation found in important pharmacogenes, such as those enzymes or proteins involved in drug molecule absorption and transformation (e.g., oxidative metabolism, conjugation, transport, and elimination).  These processes collectively contribute to blood drug levels, and can be modeled as pharmacokinetics.  Other important pharmacogenes comprise well-known targets of drug action (e.g., adrenoreceptors, dopaminergic receptors, purinergic receptors, ion channels), as well as other regulators of health and disease (e.g., enzymes like vitamin K oxidoreductase or HMG Co-A reductase, products of tumor suppression genes, and the major histocompatibility complex).  These processes collectively contribute to pharmacodynamics, and determine drug effects assuming that a therapeutic concentration is available at the site of action.  A list of known very important pharmacogenes is available at the knowledge base PharmGKB.  Pharmacogenomic biomarkers are reflected in the labeling of nearly 150 different drugs listed in the Table of Pharmacogenomic Biomarkers in Drug Labeling maintained by the Food and Drug Administration.  The Clinical Pharmacogenetics Implementation Consortium (CPIC) is systematically describing gene-drug combinations of known clinical utility, and making specific recommendations for actions to be taken to implement this information in health care practice, based upon evaluation of the experimental evidence; CPIC guidelines are freely available and routinely updated. 

But pharmacogenomics is more complex than single gene-drug interactions, as is the underlying pathology or manifestation of disease.  Regulatory control of transcript production and stability, protein expression, and modification of proteins are all subject to variation.  Proteins act in concert and are part of pathways; pathways interact with other signaling modules to share information and restore homeostasis.  Dynamic pharmacological phenomena such as tolerance, tachyphylaxis, and up- or down-regulation of receptors contribute to drug responses.  This information is genetically encoded in the host genome and affected by other factors such as health and disease, age and physiological competence, the environment and diet, and other drug interactions.  The host microbiome, a collection of bacterial genomes, can also impact drug actions; enterohepatic cycling as a result of deconjugation by resident gut microbes prolongs drug effects.  Additionally, selection of drug therapies should focus on the presence of any other resident genomes, for example a tumor or an infectious agent.  For the last decade treatments in cancer have been closely tailored to the characteristics of the tumor.  For example, following the discovery that trastuzamab interferes with HER-2, many drugs have been developed that target overactive epidermal growth factor receptor (EGFR) receptors, such as gefitinib and erlotinib.  Often these drugs are approved along with diagnostics that can identify the particular somatic mutation which is present.  Understanding all of the relevant contributing genetic and clinical factors is essential to predicting drug responses.

As the technologies have improved, costs are rapidly declining, and secure data storage methods linked to electronic health records are becoming available, collection of complete or partial genome sequence information for medical applications is becoming more common.  It is easily foreseeable that this will become part of routine preemptive and/or diagnostic clinical data collection in the relatively near future.  It is now possible to envision discovery studies going beyond genome sequencing to include other comprehensive sets of information that are rapidly becoming accessible.  Single cell sequencing technology is revealing previously unsuspected tissue- and cell-specific differences beyond the germ-line.  Modern research approaches have enabled collection of other information sets, for example: transcriptomics (complete set of RNA transcripts, reflecting abundance and stability at a point in time), epigenomics (instructive markers or modifications of the DNA sequence), proteomics (complete complement of proteins and their associated modification), metabolomics (complete set of small molecules <1500 MW), along with lipidomics (complete set of lipid molecules), and the microbiome (collective genome of the resident microflora).  The horizon is very near for the research application of these multidimensional approaches. 

Capturing and integrating large diverse data streams reveals multiple challenges that should be addressed.  They include collecting the data and metadata sets, standardizing and harmonizing the data, quality control and data clean-up, and processing, analyzing, and interpreting the data.  For specific applications in precision medicine, information handling must consider but is not limited to:  distinctions between data collected for research purposes and that made available for immediate patient care, accurate and appropriate linkage to clinical data from electronic health records, stable and secure data storage and access, combination and coalescence of different data sets, resolution of ambiguities and conflicting data, and the biological and medical interpretation of data sets with respect to determining therapeutic responses.  Additionally, the impact is not always predictable for single and multiple occurrences of variation in sequence (or markers or profiles), considered singly and in combination; ideally data-mining algorithms and models will uncover the contributions of critical factors or modules that will form the basis for emerging consensus recommendations from data-intensive approaches.   

Thus, pharmacogenomics is an important element, but not the only aspect of precision medicine.  The practice of personalized and predictive medicine encompasses all approaches and methods that can be utilized to discover, understand, and apply knowledge acquired by molecular measurements linked to medical histories and health records.  This will ensure greater efficacy and cost efficiency in attaining desirable drug effects, and safety in avoiding adverse side effects, compared to one-size-fits-all prescribing.  According to the report “Towards Precision Medicine” cited above, integrating “emerging research on the molecular makeup of diseases with clinical data on individual patients could drive the development of a more accurate classification of diseases and ultimately enhance diagnosis and treatment”.  NIH supports research investments consistent with the long-term aim of turning discoveries into health.  Making discoveries that enable future tailoring of medical treatment to the individual characteristics of the patient is the goal of the Research Centers for Pharmacogenomics in Precision Medicine program.

Scope of Research

Research themes proposed by the applicant investigative team need to be tightly focused and well-integrated between the research and clinical components.  The approaches should effectively demonstrate a paradigm directed at discovery and mechanistic understanding to predict clinical drug responses, and perhaps to develop new drug treatments.  A center should justify the therapeutic area proposed for study and make the argument (e.g., economically, or number of prescriptions) that a drug or drug class is used in very significant proportions of certain populations in the United States, and/or presents a novel opportunity for a drug or drug class (e.g., one that is potentially applicable to several different disease areas, such as for cardiovascular disease risk or for glycemic control, and also for cancer prevention).  The discoveries to be made should have the potential to be pushed forward into clinical application, and it is critical that the scientific advances will have a substantial impact.

A research center should provide a model for interactions between research projects and clinical therapeutics, and should comprehensively address mechanistic questions about drug responses in patients.  Discoveries made should offer the promise of changing the standards of care when moved forward into medical practice.  This program is not intended to simply facilitate implementation of known information; the research should be designed to uncover new basic science, determine functional implications and ascertain the potential clinical value, leading ultimately to applications in precision medicine.  A successful center will go well beyond a collection of independent research projects.  It should be multidisciplinary and feature team approaches that demonstrate tightly integrated interdependence and continuity. 

Applicants will need to particularly justify why the proposed research can be conducted more effectively and efficiently as a center rather than through other grant mechanisms.  Continued funding will not be offered in the future unless the value of using the center (P50) mechanism is clearly demonstrated.  This FOA has specific requirements and does not include research activities that can be supported by other NIH grants, such as regular research grants (R01) or program project grants (P01).  For information about these and other mechanisms, see this information page

Research Objectives

The objectives of the Research Centers for Pharmacogenomics in Precision Medicine program overall include, but are not limited to:

The centers will anchor the Pharmacogenomics Research Network of the future, beginning in 2015, and will lead the plans for information exchange and problem-solving in the field.  The Research Centers for Pharmacogenomics in Precision Medicine will participate (along with other relevant NIH initiatives) in making new original scientific discoveries and collaborative contributions, assessing research opportunities, and making recommendations for the field to achieve precision medicine.

Clinical Component

A research center is required to have a clinical interaction, either as a patient-oriented core or project, or through an established relationship with clinical studies or trials conducted elsewhere.  A research partnership may be developed with a health-care delivery system with an associated biobanking process.  This clinical component should not represent the majority of the research funding, in terms of expenditures, staffing, or duration of the award. 

The purpose of the relationship is to ensure that the most appropriate and optimal specimens are utilized for studies in precision medicine.  For example, patient-derived materials could be used for analysis directly, or to create models such as inducible pluripotent stem cells differentiated for study.  It is critical to justify the patient population, its characteristics and controls, and its utility for studies to discern drug actions as conducted in the center.  There should be bi-directional exchange between the research and clinical components, with a mix of experimental methods yielding complementary datasets.

Administration and Management

Multidisciplinary leadership of a research center by program directors/principal investigators (PDs/PIs) from different, complementary backgrounds is required; an application must be for a multiple PD/PI award.  An administrative core is mandatory and should include a management plan that ensures timely progress.  All anticipated interactions between investigators, projects, and any cores should be described specifically.  A substantial commitment of effort is expected for leadership of a center and management activities. 

An external advisory group of up to five members should be planned (and described by expertise but not named in the application) to aid the center leadership in assessing progress and scientific opportunities.  Research studies conducted in these centers will go beyond routine scientific investigations in complexity.

Data Sharing

Consistent with the value of the investment and the NIH vision of the future and the goals of this program, these research efforts towards precision medicine are expected to proactively address data sharing.  NIH views on the challenges and future of managing, evaluating, and sharing large diverse data sets (“Big Data”) are articulated at the BD2K website. 

A research center should anticipate and address the obstacles and support the culture of data sharing.  For example, attention should specifically be paid to making informed consent documents as forward-looking as possible.  Study protocols, analysis tools and software, data summaries and other metadata should be made widely available to the scientific public.  All data types are expected to be shared as soon as is reasonably possible utilizing the most appropriate publicly available repositories, consistent with achieving the goals of this program. 

Outreach

A research center should be capable of achieving leverage through activities that go beyond this center grant; this can be accomplished by coordinating activities at an institution committed to leading implementation of the science.  A center is expected to have some activities ongoing consistent with being a national and international focal point for pharmacogenomics in precision medicine, and have evidence of a demonstrated collaborative attitude towards research.   

Each center will be required to participate in and take a leadership role for the Pharmacogenomics Research Network.  The network will be evolving to match scientific opportunities for information transfer and problem solving to the research community’s needs.  A center should be prepared to program and organize a future meeting of the members; the purpose is to engage investigators and to offer the opportunity to as many scientists as reasonably possible to participate in learning from the network.

Enhancing Diversity

NIH recognizes a compelling need to promote diversity in the biomedical, behavioral, clinical, and social sciences workforce.  NIH expects efforts to diversify the workforce to include the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden perspectives in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly, applicants are encouraged to diversify their investigator populations and thus increase participation of individuals currently underrepresented in the biomedical, behavioral, clinical, and social sciences such as:  individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue careers in health-related research.

Interest Statement

NIGMS supports a broadly based range of research aimed at the molecular-level understanding of fundamental biological, cellular, and organismal processes.  NIGMS is particularly interested in research approaches designed to uncover new fundamental basic science, determine functional implications and ascertain the potential clinical utility, leading ultimately to applications in precision medicine.  Where appropriate, NIGMS will make every effort to partner with categorical institutes of the NIH in support of successful awards. 

Requirements

To summarize the above, applications to this program should demonstrate all of the following:

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission
Revision

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

Funds Available and Anticipated Number of Awards

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

Award Budget

An applicant may request a budget of up to $1.75 million direct costs per year (excluding consortium F&A).  Budgets should reflect the actual needs of the proposed center. 

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

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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

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

Required Registrations

Applicant Organizations

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.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants can access 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

The letter of intent should be sent to:

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

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Admin Core

6

Core (use for Research Cores)

6

Project (use for Research Projects)

12


Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.  These requested PDFs should be submitted as attachments in the Other Attachments field on the Other Project Information form. 

Other Attachments: The following should be submitted as separate PDF attachments.

Center organizational structure:  A diagram should be prepared with the organizational structure, leadership, management/administration, and interactions between research projects and cores.  This should demonstrate how the center will achieve its stated goals.  Submit as a PDF entitled Center_organizational_structure. 

Center timeline:  A timeline should be prepared with the center goals identified and completion of major progress points indicated.  Identify key contributions by research projects and research core(s) (if applicable).  Identify major decision points as appropriate.  Include data release dates consistent with the sharing plans.  Submit as a PDF entitled Center_timeline.

Project/Performance Site Location(s) (Overall)

Enter primary site only.  However, if one of the PD/PIs for the center is named from a different institution, include information for that site as well.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

Multiple PD/PIs:  An application must be for a multiple PD/PI award.  Leadership of a center by PD/PIs from different, complementary backgrounds is required.  The selection should be related to the investigators' expertise and experience, and their ability to add to the scientific breadth of the leadership in accomplishing the center's goals.  PD/PIs may come from different institutions.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

The applicant will not be able to enter the salaries for any individuals involved in the center leadership here; that information will be placed in the Administrative Core.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan          (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims:  Provide a succinct description of the center's overall scientific goals, the expected outcomes, and the clinical impact should those goals be achieved.  

Research Strategy:  Provide a description of the overall experimental strategy and explain how it addresses the objectives for the Research Centers for Pharmacogenomics in Precision Medicine program.  Describe how the component projects and core(s), if present, will be built around a theme that represents cutting-edge investigations into understanding drug actions.  Describe how these discoveries will have the potential for being moved forward into clinical research and practice.   Explain the synergy to be achieved by funding this research as a center, and how it will serve as a focal point in the field.  Justify why the proposed research can be conducted more effectively and efficiently as a center rather than through other grant mechanisms.

Describe how the center will be a model for interactions between research projects and clinical therapeutics and will comprehensively add to the knowledge about drug responses in patients.  Explain the plans for a clinical interaction, either as a patient-oriented project or core, or through an established relationship with clinical studies or trials conducted elsewhere.  Consistent with the goals of this program, the clinical component is not expected to represent the majority of the center effort.

A successful center must go well beyond a collection of independent research projects.  It must be multidisciplinary with team approaches that show tightly integrated interdependence and continuity.  There should be bi-directional exchange between the research and clinical components that enhances the foundational understanding and prediction of drug actions. 

Letters of Support:

The requested letter(s) should be submitted as an attachment in the Letters of Support field on the Research Plan form.  All letters should be concatenated into a single PDF attachment.

Institutional commitment:  A strong institutional commitment is required.  This should be stated in a letter describing the expected interactions between the center and institution(s).  Explain how center discoveries can be leveraged and/or implemented.  Submit as a PDF (containing all letters, if there is more than one) entitled Center commitment. 

Clinical Interaction (optional):  If the clinical interaction is through an established relationship with clinical studies or trials conducted elsewhere, permissions granted should be documented in a letter or letter(s) clearly outlining the relationship and timeline.  Specifically address any limitations dictated by informed consent(s) that might limit data sharing.  Ensure that the clinical interaction is consistent with the data sharing plan for this initiative and that this is reflected in the letter(s) of support.  Submit as a single PDF (containing all letters, to follow the institutional commitment letter(s) described above. 

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 modifications:

Consistent with achieving the goals of the program:

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.   

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Place into the Administrative Core budget the funds as needed for salaries and benefits of the multiple PD/PIs for the application overall, the salaries and benefits for any other personnel dedicated to the administration and management of the center, as well as funds for key professionals involved in any centralized functions or services.  A substantial commitment of effort to leadership of a center is expected (for example, 25% total effort or three person-months) by the named PD/PIs, in addition to their roles on research projects or cores.

Funds should be requested in the Administrative Core to support the travel of the PD/PIs and possibly other individuals named as key personnel (a maximum of five investigators total per center) to attend meetings of the Pharmacogenomics Research Network, which are expected to take place once per year for five years at the NIH or another approved site. 

No funds should be requested to organize the meetings of the Pharmacogenomics Research Network; these will be provided most likely through a network Coordinating Center or alternative means available, including the use of any unobligated funds available at a center.

Include any funds needed to support the travel of members of an external advisory group to attend annual meetings to evaluate the center.  Allow costs for up to five people, traveling from domestic locations for a one-and-a-half day meeting, as well as the appropriate levels of honoraria.

If expenses are expected for data deposition, funds may be requested in the Administrative Core budget section of the application, or they may be placed in the individual research projects and cores.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Administrative Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims:  Describe the plans for center leadership and explain the PD/PIs' specific roles and responsibilities in the management of the center.  Refer to the diagrams requested as PDFs in the Overall section of the application.

Research Strategy:  Ensure that the timeline and management plan are consistent with timely progress, allow for key decision points, and will support resolution of disputes if any occur.  All anticipated interactions between investigators of the projects, and core(s), if present, should be described sufficiently to ensure a thorough understanding of communication and decision-making. 

An external advisory group of up to five people should be planned (and described by expertise, but not named in the application) to aid the center leadership is assessing satisfactory progress and recognizing scientific opportunities.  Evaluations by the external advisors should aid the center leadership in determining the appropriate trade-offs between substantial risk, prudent management, and potential for high pay-off.  Include plans to appoint and convene this group of up to five members at least annually, and to document its findings and recommendations as well as the center's changes in direction or approaches made in response.  This information should be included in the regular progress reports submitted to NIH.

Plans should be made to organize a meeting of the Pharmacogenomics Research Network one time in 2015-2020, to take place at the NIH or another approved site.  The proposed theme or organizing principles and meeting structure (typically, for up to two days of programming) should be briefly described in this section of the application.

Letters of Support: Include here if relevant to the Administrative Core.

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 modifications:

Consistent with the achieving the goals of the program:

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  (Administrative Core)

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 (Administrative Core)

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

Research Core

When preparing your application in ASSIST, use Component Type ‘Core.’

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

SF424 (R&R) Cover (Research Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Research Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Core)

Budget (Research Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Research Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the function of the research core, and provide a brief description of the core's scientific interactions in support of the research projects.  

Research Strategy: A research core should offer specific access, materials, approaches, analysis, technology, or methods.  The function must support the aims of the research projects of the center.  In general, a core should support more than one research project, or its particular function should be placed into the project it supports unless strong justification is provided otherwise.

Original research should not be described in a research core section; an exception is for any methodological development and refinement for which a compelling argument can be made that the research functions are clearly and exclusively in support of a core's main mission. 

Letters of Support: Include here if relevant to the Research Core.

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 modifications:

Consistent with achieving the goals of the program:

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  (Research Core)

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 (Research Core)

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

Research Project

When preparing your application in ASSIST, use Component Type ‘Project.’

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Research Project)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Provide a succinct description of the research project's specific scientific goals, the expected outcomes, and the impact should those goals be achieved.   

Research Strategy:  A research project must present strategies that are well-delineated and that address testable hypotheses with the most appropriate scientific approaches and methods.  All research studies should support the overall goals of the center.    

Statistical and analytical approaches should be described clearly and completely and placed in the research project section where the data are obtained.

A center’s emphasis must primarily be on making fundamental new discoveries and acquiring a mechanistic functional understanding, with the potential for eventual clinical application, and this should be accomplished through the research projects.

Letters of Support: Include here if relevant to the Research Project.

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 modifications:

Consistent with achieving the goals of the program:

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  (Research Project)

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 (Research Project)

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

Foreign Institutions

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit 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) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the 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.

NIH may attach other Terms and Conditions consistent with agreements for data sharing, software sharing, and related activities, if mutually negotiated with an institution's Office of Technology Transfer prior to an award being made.  

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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

In order to expedite review, applicants are requested to notify the NIGMS Referral Officer by email at paul.sheehy@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name(s), 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 - Overall

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 center proposed).

Scored Review Criteria - Overall

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

Significance

Does the center address an important problem or a critical barrier to progress in the field? If the aims of the center 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 does the center address the goals of the program overall to make fundamental new discoveries for understanding and predicting drug responses that ultimately will be expected to have clinical value in the field?  Are the component projects and any core(s) synergistic and tightly-focused?  Is the overall research theme justified as having a substantial effect, if the investigations are successfully executed?  Will the center achieve being a focal point in its field?

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 project? 

Additionally, how is the multidisciplinary leadership team optimized to successfully lead these investigations, and to manage the center as a whole?  Do the investigators present evidence of experience with or potential for leading large groups in proven collaborations?  

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 are the studies proposed cutting-edge for the field?  How do they push the boundaries and propose any new paradigm(s) for predicting drug actions clinically?

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 project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

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?    

Additionally, are well-integrated interdependence and continuity demonstrated in the research plans?  Are the analysis approaches appropriate for data-intensive methods?  Is the clinical component arranged to provide the most optimal specimens from humans and/or patients for these studies?  Have the projects and any core(s) achieved bi-directional exchange between the research and clinical components?  Will the center potentially accomplish research advances that could not be conducted effectively or efficiently with other grant mechanisms?     

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 are the center components located so that they can be leveraged to apply or implement research discoveries?  Will the environment enable the center leadership to capitalize on existing investments? 

Additional Review Criteria - Overall

As applicable for the center 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 center 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

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

Renewals

Not Applicable

Revisions

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

Additional Review Considerations - Overall

As applicable for the center 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) Genome Wide Association Studies (GWAS)

Budget and Period of Support

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

Overall Impact - Research Project

Reviewers will provide an overall impact score for each research project, to reflect their assessment of the likelihood of the project to contribute scientifically to the center, in consideration of the following review criteria and additional review criteria (as applicable for the center proposed).  Reviewers will further recommend whether a project should be included in or excluded from the center.

Review Criteria - Research Project

Reviewers will consider each of the review criteria below in the determination of scientific merit, but will not 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 or core address an important problem or a critical barrier to progress in the field? If the aims of the project or core are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?   

Investigator(s)

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

Innovation

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

Approach

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

If the project or core 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?   

Review Criteria - Administrative Core

Reviewers will assign a merit descriptor (outstanding, acceptable, or unacceptable) that reflects:

Review Criteria - Research Core

Reviewers will assign a merit descriptor (outstanding, acceptable, or unacceptable) that reflects:

Additional Review Criteria - Research Project or Research Core

As applicable for the project or core proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, 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 center 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

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

Renewals

Not Applicable

Revisions

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

Additional Review Considerations - Research Project or Research Core

As applicable for the project or core proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing any 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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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:

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. 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:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.  The observations and recommendations of the external advisory group, which should be convened by the grantee with meetings to take place each year, are to be included in the annual progress report to NIH.

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)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 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
TTY: 301-451-5936
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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