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 Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Sexually Transmitted Infections Cooperative Research Centers (STI CRC) (U19)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

Reissue of RFA-AI-08-004

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-13-043

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.855; 93.856

Funding Opportunity Purpose

The purpose of this FOA is to solicit applications for the Sexually Transmitted Infections Cooperative Research Centers (STI CRC) program.  The STI CRC program facilitates multidisciplinary, synergistic collaborations that will increase our understanding and further our knowledge of co-infections of two or more specific STIs, as well as the interactions between and among different STI pathogens that may cause or enhance polymicrobial infections of the urogenital tract, e.g., bacterial vaginosis (BV), pelvic inflammatory disease (PID), intraamniotic infection (IAI) and non-gonococcal urethritis (NGU).  This collaborative effort is expected to catalyze the discovery of new approaches to prevent, diagnose, and treat co-infections, polymicrobial infections and other clinical outcomes that affect reproductive health.   

Key Dates
Posted Date

June 28, 2013

Open Date (Earliest Submission Date)

September 23, 2013

Letter of Intent Due Date(s)

September 23, 2013

Application Due Date(s)

October 23, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March, 2014

Advisory Council Review

May, 2014  

Earliest Start Date

July, 2014

Expiration Date

October 24, 2013

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.

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 the Sexually Transmitted Infections Cooperative Research Centers (STI CRC) program is to facilitate multidisciplinary, synergistic collaborations that will increase our understanding and further our knowledge of co-infections of two or more specific STIs, as well as the interactions between and among different STI pathogens that may cause or enhance polymicrobial infections of the urogenital tract, e.g., bacterial vaginosis (BV), pelvic inflammatory disease (PID), intraamniotic infection (IAI) and non-gonococcal urethritis (NGU).  This collaborative effort is expected to catalyze the discovery of new approaches to prevent, diagnose, and treat co-infections, polymicrobial infections and other clinical outcomes that affect reproductive health.

Background

Sexually Transmitted infections (STI) remain a high public health threat and they and their associated sequelae are major causes of global maternal and infant morbidity and mortality.  STIs are increasingly shown to disproportionately impact women and infants, adolescents and young adults, racial and ethnic minorities, men having sex with men (MSM), and persons in correctional facilities.  Internationally, in women of childbearing age, STIs (excluding HIV) are second only to obstetric factors as causes of ill health and death of their newborns.  Additionally, STIs are the primary preventable cause of infertility.  Several STIs and their associated infections can increase the risk of HIV acquisition and transmission, as well as alter the course of AIDS progression.  Globally, nearly 1 million individuals acquire a STI each day.  In the U.S., there are an estimated 19 million new infections each year, with half of these new infections occurring among young people ages 15 to 24.  According to the Centers for Disease Control and Prevention, healthcare costs associated with STIs in the U.S. are estimated at $17 billion annually.

Over the years, STI research has seen a rapid evolution in all areas, spanning pathogenesis and vaginal microbiome studies, to development of drugs, diagnostics and vaccines.  NIAID’s STI Cooperative Research Centers (STI CRCs) have contributed greatly to the advancement of our understanding of STIs through every phase of STI research.  However, additional research is needed to investigate the complex interaction of co-infections, particularly the interactions between each of the pathogenic organisms and the normal human microbiome. 

STIs represent a group of infections that cluster together in the population. One or more of these infections may be present in the same patient. The microorganisms may interact with each other either synergistically or antagonistically, as well as with the normal flora. The scientific challenge is in understanding these interactions and developing paradigms to address them clinically and in a product development framework. In addition, there is a limited understanding of STI-related polymicrobial infections (those infections that incorporate several pathogens), which presents a particular challenge both in diagnosis and treatment.  Often these infections are treated by addressing the presenting symptoms without the knowledge and confirmation of the specific organisms causing the infection.  This may lead to reinfection or poor clinical outcomes.  This recompetition of the STI CRCs aims to address these gaps.

Research Objectives and Scope

The objectives of this FOA are to support a group of STI CRCs to engage in a multidisciplinary, diverse set of STI research activities and to encourage new efforts towards understanding co-infections of known STIs, as well as infections that incorporate several pathogens (polymicrobial infections) and present as specific syndromes, for example pelvic inflammatory disease (PID).  Basic, translational and/or clinical research is acceptable provided it addresses the purpose of this FOA.

It is anticipated that these efforts will provide insights into the biology of microbes, their interactions with each other, their role in pathogenesis, and their interactions with the host.  To this end, the STI CRCs are encouraged to build upon current knowledge, i.e., to utilize data from existing microbiome studies to better define the role of normal flora in STIs; to develop and evaluate control and prevention strategies to reduce the public health impact of STI infections; and to share expertise in order to maintain a vigorous and productive research agenda.  An important corollary objective is the training and mentoring of investigators new to the STI field through the establishment and management of pilot Developmental Research Projects (see below).

Examples of possible research questions to be addressed under this program include:

Topics that would be considered responsive include the study of co-infections, e.g., organisms that present in association with each other or other STIs and are often treated syndromatically versus specifically, as well as polymicrobial infections of the urogenital tract, e.g., bacterial vaginosis (BV), pelvic inflammatory disease (PID), intraamniotic infection (IAI) and non-gonococcal urethritis (NGU). 

Examples of areas that are either caused by or confounded by co-infections include:

Co-Infections with two or more organisms

In the STI clinic, co-infections add to the conundrum of treating with appropriate therapy.  Clinicians, faced with few resources to discern which or how many STIs are involved may utilize syndromatic management to provide immediate treatment.  While epidemiological data are available for infections with some organisms, such as GC, these are less available for co-infections.  Frequently, patients presenting at a STD clinic infected with a STI have a co-infection with another STI.  Given this, many clinics utilize a syndromatic management strategy, whereby patients are treated based on observed symptoms rather than a definite microbiological diagnosis.  In some cases this may lead to poor clinical outcomes that could be improved by a better understanding of the exact nature of the infecting organism.  Potentially the pathogenesis of one of the infections may be impacted by the presence of the other infection.  Better diagnostics to distinguish the infections, improved therapeutics, or strategies to prevent multiple infections could advance the understanding and management of co-infections.

Commonly seen examples include:

Pelvic Inflammatory Disease (PID)

PID is a common and serious complication of some STIs with C. trachomatis and N. gonorrhoeae considered the most common causative organisms.  However, other microorganisms, including anaerobes, have been implicated/associated with some cases of PID.  PID can damage the fallopian tubes and tissues in and near the uterus and ovaries, which may lead to infertility, ectopic pregnancy (a pregnancy in the fallopian tube or elsewhere outside of the womb), and chronic pelvic pain.  Each year in the U.S., it is estimated that more than 1 million women experience an episode of acute PID, and more than 100,000 women become infertile as a result of PID.

Intraamniotic Infection (IAI)

IAI is polymicrobial infection, primarily due to ascending colonization or infection from the vagina from organisms including sexually transmitted infections, group B Streptococcus, and BV.  IAI can be either a risk factor for, or a result of, preterm labor or Preterm Rupture of Membranes (PROM), particularly at early gestational ages.  In addition, a growing body of research has suggested that a robust fetal immune response to IAI is associated with cerebral palsy.  Current management strategies aim at treating overt IAI, but the ability to prevent IAI and detect subclinical IAI is limited.  Greater knowledge of the mechanisms of IAI and effective prevention strategies are essential to decreasing the burden of IAI.

Bacterial vaginosis (BV)

BV appears to involve the disruption of normal vaginal ecology.  BV increases susceptibility to STIs and, when present during pregnancy, may increase the risk of complications such as pre-term delivery.

Urethritis and Cervicitis

Urethritis, inflammation of the urethra, and cervicitis, inflammation of the cervix, may be asymptomatic or present with mucopurulent discharge.  The causative agent may be one of many organisms, including:

Required Organizational Structure

Each Sexually Transmitted Infections Cooperative Research Center (STI CRC) will be required to establish and manage a multi-disciplinary, synergistic research and technology team that incorporates collaborative projects with a focus on co-infections and polymicrobial infections associated with STIs.  Each STI CRC is expected to include researchers with unique expertise that will enhance the overall quality of the Center.  This expertise may be in genomics, bioinformatics, statistics, microbiology, epidemiology or any other discipline that will contribute to the success of the Center.  Each STI CRC must carry out at least three thematic Research Projects and support as many scientific service and/or resource cores as necessary to ensure the success of the supported Research Projects.  In addition, each STI CRC must include an Administrative Core responsible for guiding the overall activities of the Center.

Administrative Core activities to include:

Pilot Developmental Research Projects

Each STI CRC is expected to develop and implement a plan for mentoring and assisting new investigators or researchers who are changing fields that includes providing support for pilot Developmental Research Projects (DRPs).  DRPs are pilot projects that are expected to assist new investigators in bridging the critical gap between the end of a postdoctoral fellowship and successful competition for independent research.  These projects may provide an opportunity to expand on basic science hypotheses, enable testing of novel ideas, develop new technologies, or provide further training in certain areas under investigation by the Center.

Each STI CRC is limited to supporting no more than two DRPs per year, although the total number of DRPs that a STI CRC can support during the entire award project period is left to the discretion of each STI CRC. 

Pilot Developmental Research Projects are not intended for pre-doctoral candidates, but may include researchers new to the STI field.  This program is expected to increase the number of STI researchers that can use the approaches, methodologies and resources (datasets, analysis tools, etc.) generated under the Center.  The STI CRC Executive Committee will review each STI CRC’s pilot DRPs and will provide recommendations to the PD(s)/PI(s) regarding their probability for success.

Annual Programmatic Meetings

Annual Programmatic Meetings will be held to facilitate communication and collaboration among funded STI CRCs.  Responsibilities associated with organizing and attending these meetings are detailed in the cooperative agreement terms and conditions of award below. 

STI CRC Executive Committee (EC)

A STI CRC Executive Committee (EC) will be established to participate in the review and recommendation of the pilot DRPs from each STI CRC.  In addition, the EC will facilitate interaction, collaboration, and communication among the STI CRCs and NIAID Program staff.  The composition, responsibilities, and meeting/logistical requirements of the EC, whose membership includes the PD(s)/PI(s) from each STI CRC, are detailed in the cooperative agreement terms and conditions of award below.

This FOA will NOT support:

Applications proposing such studies will be considered non-responsive and will not be reviewed.   

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
Renewal

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

Funds Available and Anticipated Number of Awards

The NIAID intends to commit $11 million total costs in FY 2014 to fund up to five awards.  Future year amounts may vary depending on annual appropriations.

Award Budget

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

Award Project Period

The scope of the proposed project should determine the project period.  The maximum period is 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 eligible to apply.

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

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) and component Project Leads that are not yet registered in eRA Commons must work with their institutional officials to register. Also, institutional officials at the applicant organization should ensure that the eRA Commons account for the contact PD/PI is affiliated with their organization.

eRA Commons accounts are necessary to use ASSIST to prepare and submit applications.

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

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:

Maryam Feili-Hariri, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3146, MSC 7616
6700-B Rockledge Drive, Bethesda, MD 20892-7616
(FedEx Zip: 20817-1821)
Telephone: 301-594-3243
FAX:  301-480-2408
Email: haririmf@niaid.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12 pages

Admin Core

12 pages

Core (Use for Scientific, Service and Resource Cores)

6 pages each

Project (Use for Research Projects)

12 pages each

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 SF 424 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.

Do not include “Facilities & Other Resources” or “Equipment” attachments to the Overall Component.  Instead, load separate attachments containing only the information relevant to each individual Research Project Component and Core Component within that component section of the application.  

Project/Performance Site Location(s) (Overall)

Enter primary site only.

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. The PD(s)/PI(s) will oversee, manage and coordinate the research of the STI CRC; ensure that the individual projects and cores are synergized to advance the goals of the Center; be responsible for overseeing the pilot Developmental Research Projects; and serve as the principal point(s) of contact for the STI CRC.

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.

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)

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed program.  Concisely and realistically describe the hypothesis or hypotheses to be tested.

Research Strategy: This section summarizes the overall research strategy for the multi-component application.  The multi-component application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another.  This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program – by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems.  As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme.  Summarize the special features in the environment and/or resources that make this application strong or unique.

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: 

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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)

For institutions/organizations proposing a single PD/PI, the PD/PI will serve as the Administrative Core Director.  For institutions/organizations proposing multiple PD(s)/PI(s), one PD/PI must be selected to serve as the Administrative Core Director.  Through the required Administrative Core functions indicated below, the Administrative Core Director provides leadership and guidance in fulfilling the stated objectives of his or her Center, and is responsible for creating within the Administrative Core an infrastructure that promotes cross-discipline interactions among all of the Research Projects and Cores, and provides oversight and governance over fiscal and resource management.

Budget (Administrative Core)

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

Pilot Developmental Research Projects (DRP):  Applicants should request funds for DRPs in the Administrative Core budget.  Individual DRP awards may not exceed $60,000 direct costs per year and are limited to no more than two years duration.  STI CRCs are limited to no more than two new DRPs per year and the total number of DRPs to be supported during the duration of the award is at the discretion of each STI CRC site.  STI CRCs are expected to initiate DRPs within the first year of the award. 

Meetings:  Applicants should request funds for the Annual Programmatic Meeting and Kick-Off Meeting in the Administrative Core budget.  Annual Programmatic Meeting of all STI CRCs funded under this FOA are to start during the second year of award and should be attended by the PD(s)/PI(s), Research Project Leaders, and Core Leaders.  These individuals should also budget and plan to attend the kick-off meeting to be held within three months of award.

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)

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Administrative Core.

Research Strategy: Applicants are to describe their plans and procedures for establishing and managing an Administrative Core that provides the organizational capacity to ensure the following:

Management Plan:  The Administrative Core should include a Management Plan that describes the organization of the proposed program and its management structure.  The Management Plan should include:

The Management Plan should also include a Staffing Plan that describes:

Developmental Research and Training Plan:  The Administrative Core should include a Developmental Research and Training Plan that describes mentoring plans for assisting new investigators or researchers who are changing careers.  The plan should describe how pilot Developmental Research Projects (DRPs) will be integrated into a new investigator’s career development objectives and should indicate how DRPs will assist in bridging the gap between early establishment of a new investigator’s career through and until successful competition for independent funding.

The Developmental Research Training Plan must also describe the internal institutional plans and procedures to ensure that all DRPs supported from this award will comply fully with all applicable Federal regulations, policies, and Guidelines for research involving vertebrate animals and human subjects, including for human subjects the evaluation of risks and protections in project proposals and appropriate ethical oversight of funded projects. 

Human Subject approval dates for DRPs (if applicable) should NOT be submitted with the application, but should be provided to the NIAID for approval with Just-in-Time information (for DRPs that are to start at the time of award), or prior to the start of the pilot DRP, and with annual progress reports.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Cores (Scientific/Service/Resources)

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.

Applicants may propose any number of Cores integral to the success of the STI CRC and the proposed Research Projects.  However, each Core must be able to support at least two Research Projects.  Cores must be well justified and clearly non-duplicative of other services or facilities available to STI CRC investigators.  Examples of services provided by a shared scientific core are monoclonal antibody production, peptide synthesis, microbiology laboratory services, and statistical support.  Shared microbiology cores could provide a source of patient specimens for clinical research.  Applications proposing Shared Resource Cores must give a clear description of the facilities, techniques, and skills that the Core will provide to Research Projects.

SF424 (R&R) Cover (Core Scientific/Service/Resources)

Complete only the following fields:

PHS 398 Cover Page Supplement (Core Scientific/Service/Resources)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Core Scientific/Service/Resources)

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.

Facilities & Other Resources: For each individual Core, include the attachment “Facilities & Other Resources” to provide information on resources available for that Core.  If there are multiple performance sites, describe the resources available at each site.  Describe any special facilities used for working with biohazards or other potentially dangerous substances.  Include a description of how the scientific environment in which the core service or resource will be conducted contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.).

Equipment: For each individual Core, include the attachment “Equipment” to provide information on equipment available for that Core.  If there are multiple performance sites, describe the equipment available at each site.  Describe any special equipment used for working with biohazards or other potentially dangerous substances.

Project /Performance Site Location(s) (Core Scientific/Service/Resources)

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 (Core Scientific/Service/Resources)

Budget (Core Scientific/Service/Resources)

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

Each individual Core Component should have a separate budget that details the costs required to support that Core.

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  (Core Scientific/Service/Resources)

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Core.  Concisely and realistically describe the hypothesis or hypotheses to be tested.  In addition, state the core’s relationship to the STI CRC’s goals and how they relate to the individual Research Projects or to other Cores in the application.

Research Strategy: Use this section to describe how the proposed Core activities will contribute to meeting the STI CRC's goals and objectives and explain the rationale for selecting the general methods and approaches proposed to accomplish the Specific Aims.  In addition, this section should indicate the relevance of the Core to the primary theme of the application.  Provide justification for the Core to support at least two of the proposed three or more Research Projects. 

Experimental details should be cited using the “Bibliography and References Cited” attachment in the Other Project Information form and need not be detailed in the Research Strategy.  For renewals, Preliminary Studies for new Cores and progress reports for established Cores must be included as part of this section and must be contained within the page limits.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Research Projects

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.

A minimum of three individual Research Projects is required.

Each of the three or more individual Research Projects must present a unified, approach to the overall goals of the STI CRC.  These collaborative projects may build on the information that is available to the STI community and/or may consider utilizing the newest available technology to discover novel and innovative ways of addressing any gaps in knowledge.  Projects may propose research with simple organisms that cause STIs or those multi-organism polymicrobial infections.  These projects should advance the overall knowledge and understanding of the contributing role of unique STI organisms and polymicrobial infections to women’s overall health and wellbeing. 

SF424 (R&R) Cover (Research Projects)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Projects)

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:  For each research project, succinctly outline the specific research goals and the Center’s plan for attaining these goals.

Facilities & Other Resources: For each individual Research Project, include the attachment “Facilities & Other Resources” to provide information on resources available for that project.  If there are multiple performance sites, describe the resources available at each site.  Describe any special facilities used for working with biohazards or other potentially dangerous substances.

Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.)  For Early Stage Investigators, describe institutional investment in the success of the investigator.

Equipment: For each individual Research Project, include the attachment “Equipment” to provide information on equipment available for that project.  If there are multiple performance sites, describe the equipment available at each site.  Describe any special equipment used for working with biohazards or other potentially dangerous substances.

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

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 Projects)

Budget (Research Projects)

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

Each individual Research Project Component should have a separate budget that details the costs required to support that Research Project.

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 Projects)

Specific Aims: List, in priority order, the broad long-range objectives and goals of the proposed Research Project.  Concisely and realistically describe the hypothesis or hypotheses to be tested.  In addition, state the individual Research Project’s relationship to the STI CRC’s goals and how they relate to other Research Projects or Cores in the application.

Research Strategy: Use this section to describe how the proposed research will contribute to meeting the STI CRC’s goals and objectives and explain the rationale for selecting the methods to accomplish the Specific Aims.  In addition to stating the biological significance of the research, indicate the project's relevance to the primary theme of the application.

Experimental details should be cited using the “Bibliography and References Cited” attachment of the Other Project Information form and need not be detailed in the Research Strategy.  Preliminary Studies for new Research Projects must be included and must be contained within the page limits.

Describe the research design, conceptual procedures, and analyses to be used to accomplish the Specific Aims of the project.  Describe any new methodology and its advantage over existing methodologies.  Describe any novel concepts, approaches, tools, or technologies for the proposed studies.  Discuss associations with clinical project(s).  Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims.  As part of this section, provide a tentative sequence or timetable for the 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 modification:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the 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.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.

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

Post-Submission Materials

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

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 proposed STI CRC  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 project or core 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 projects and cores 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?

Are the overall Center goals significant and focused on studies that promote a multidisciplinary, diverse set of STI research activities, encourage new efforts towards understanding co-infections of known STIs, and propose research activities on infections that incorporate several pathogens (polymicrobial infections) and present as specific syndromes?  Does the STI CRC address new opportunities or critical gaps to address important questions in studying single organism or polymicrobial STIs?  Do all of the individual projects relate to the overall goals of the Center and provide a cohesive and synergistic whole?  Is the STI CRC as a whole scientifically compelling?  

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?

Do the PD(s)/PI(s) have the leadership and scientific ability, scientific and technical skills, and managerial competence to develop, manage, and direct an integrated and focused research Center, including the time commitment and demonstrated ability to establish and manage collaborations? For applications designated multiple PD(s)/PI(s), are the proposed plans both adequate and appropriate to ensure that there will be sufficient coordination and communication among the PD(s)/PI(s)?   

Innovation

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

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? 

Will the integration of the individual projects into a single Center be more beneficial than pursuing each project independently?   

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?

Overall Impact – Individual Research Projects

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 – Individual Research Projects

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?

Investigator(s)

Are the PD(s)/PI(s), Project Leaders, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Does the Project Leader have documented training, leadership skills, scientific and technical skills, and managerial competence to successfully plan, manage, conduct and direct a Research Project?  Does he/she have time commitment as well as demonstrated ability to manage this project and establish collaborations?  Does the Project Leader have a successful record of collaborations with the STI communities and appropriate track record for collaborative activities?  Are the proposed key personnel /staff for the project appropriate and do they have the expertise to carry out the work?

Innovation

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

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

Overall Impact – Individual Cores

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the core 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 core proposed).

Review Criteria – Individual Cores

Reviewers will consider each of the review criteria below, as appropriate for the individual core, in the determination of scientific merit and provide an overall impact score for each Core, but will not give separate scores for these items.

Administrative Core

Are the Management and Staffing Plans appropriate to facilitate attainment of the objectives of the proposed Center?

Are the experience, level of commitment, and availability of the Admin Core Director adequate to manage the overall Center?

Is the plan to establish and manage the pilot Developmental Research Program adequate and appropriate?

Are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the program appropriate?

Are the proposed timelines and performance objectives for the overall Center adequate?

Is the management plan for fiscal accountability and communication within the Center appropriate?

Scientific Cores

Are the proposed scientific Cores justified and relevant to the theme of the overall Center?

Is adequate justification provided that each Core will support at least two Research Projects?

Additional Review Criteria - Overall, Research Projects, and Cores

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable  

Renewals

For Renewals, the committee will consider the progress made in the last funding period. .

Revisions

Not Applicable 

Additional Review Considerations - Overall, Research Projects, and Cores

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 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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIAID, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA.  Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council. l 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.

Prior Approval of Pilot Projects

Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

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:

In addition, the PD(s)/PI(s)’s primary responsibilities for overseeing DRPs and organizing Annual Programmatic Meetings extend as follows:

Pilot Developmental Research Projects (DRPs)

The PD(s)/PI(s) or designee will be responsible for the pilot Developmental Research Projects.  This will include coordinating the issuance of all funds to pilot Developmental Research Project (DRP) awardees, and interfacing with NIH Grants Management offices and sponsored projects (grants) offices at awardees' institutions.  In addition, he/she will provide fiscal oversight of the entire DRP program, and will be the fiscal contact to their STI CRC’s DRP investigators.

Annual Programmatic Meetings

Each Center will assume responsibility for organizing at least one 1½ to 2 day Annual Programmatic Meeting of all Centers during the award period.  These meetings are anticipated to be held at a location at/near Bethesda, Maryland or at another agreed-upon site following consultation with NIAID staff.  Each Center should include funds to accommodate travel and attendance at yearly meetings by the PD(s)/PI(s), the Project Leaders and Cores leaders, and other key personnel, who are expected to attend. Costs associated with organizing the Annual Programmatic Meeting are not allowable expenses. Travel and per diem costs to attend the Annual Programmatic Meeting must be included in the budget.

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

The role of the NIAID/NIH Project Scientist in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PD(s)/PI(s).

The NIAID Project Scientist will work closely with the PD(s)/PI(s) and other STI CRC member scientists to facilitate collaborations and to leverage the resources available to the Center.

The NIAID Project Scientist will monitor the progress of the STI CRC, help coordinate research approaches among all STI CRCs funded through this FOA, and contribute to the shaping of research projects or approaches as warranted.  The NIAID Project Scientist will support and facilitate this process but will not direct it.

The NIAID Project Scientist will keep the Center informed about other ongoing studies supported by NIAID to avoid duplication of effort and encourage sharing/collaboration in infectious diseases research.  The NIAID Project Scientist will coordinate access for the Center to other NIAID resources, as well as assist the research efforts of the Center by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies as appropriate.

The NIAID Project Scientist will serve as a non-voting member of the STI Executive Committee (EC) and will assist in developing the operating guidelines and consistent policies for dealing with situations that require coordinated action.

The NIAID Project Scientist will retain the option to recommend, with the advice of the EC, the withholding or reduction of support from any cooperative agreement that substantially fails to achieve its goals according to the milestones agreed to at the time of the award or fails to comply with the Terms and Conditions of the award.

Additionally, an agency program official or NIAID program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

In addition to the general responsibilities indicated above, NIAID staff will also be responsible for:

Areas of Joint Responsibility include:

The NIAID Project Scientist will provide overall coordination across all funded Centers, and will coordinate with the PD(s)/PI(s) to facilitate the achievement of program goals.

STI Executive Committee (EC)

A STI CRC Executive Committee (EC) will be established to participate in the review and recommendation of the pilot Developmental Research Projects (DRPs) from each Center.  The PD(s)/PI(s) from each STI CRC and the Project Scientist named in the award notice will form the EC.  The EC will select one PD/PI from among the awarded STI CRCs to serve as Chair of the Committee.  The EC must meet face-to-face within three months of award at a location to be determined by NIAID Project Scientist.  This will be in conjunction with the Kick-Off Meeting.  The EC will meet annually in conjunction with the Annual Programmatic Meetings, and additionally as needed via conference calls with NIAID Program staff to facilitate interactions and collaborations across the STI CRCs.  Meetings may also be used to address common training needs, develop cross-Center initiatives, or host invited speakers.

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 Executive 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 Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Telephone: 800-518-4726
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

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

Scientific/Research Contact(s)

Carolyn Deal, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-0443
Email: cdeal@niaid.nih.gov

Peer Review Contact(s)

Maryam Feili-Hariri, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-594-3243
Email: haririmf@niaid.nih.gov

Financial/Grants Management Contact(s)

Samantha Tempchin
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-4580
Email: samantha.tempchin@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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