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 (STI) Cooperative Research Centers (CRC): Vaccine Development (U19 Clinical Trial Not Allowed)

Activity Code U19 Research Program – Cooperative Agreements

Announcement Type Reissue of RFA-AI-13-043

Related Notices None

Funding Opportunity Announcement (FOA) Number RFA-AI-18-005

Companion Funding Opportunity None

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.855

Funding Opportunity Purpose The purpose of this funding opportunity announcement (FOA) is to solicit applications for the Sexually Transmitted Infections Cooperative Research Centers (STI CRC) program. This STI CRC program will facilitate multidisciplinary, synergistic collaborations to support the development of vaccines to control and prevent sexually transmitted infections (STIs) caused by the following pathogens, which have limited candidates in the product development pipeline: Neisseria gonorrhoeae, Chlamydia trachomatis, and Treponema pallidum. Priority will be given to the infections for which no candidates have advanced to human clinical trials, for example syphilis.

Key Dates

Posted Date March 15, 2018

Open Date (Earliest Submission Date) May 20, 2018

Letter of Intent Due Date(s) May 20, 2018

Application Due Date(s) June 20, 2018 , by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date . Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s) Not Applicable

Scientific Merit Review October 2018

Advisory Council Review January 2019

Earliest Start Date March 2019

Expiration Date June 21, 2018

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 using ASSIST or an institutional system-to-system solution; 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 Multi-Project (M) 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 this funding opportunity announcement (FOA) is to solicit applications for a Sexually Transmitted Infections Cooperative Research Centers (STI CRC) program. This STI CRC program will facilitate multidisciplinary, synergistic collaborations to support the development of vaccines to control and prevent sexually transmitted infections (STIs) caused by the following pathogens with limited candidates in the product development pipeline: Neisseria gonorrhoeae, Chlamydia trachomatis, and Treponema pallidum. Priority will be given to the infections for which no candidates have advanced to human clinical trials, for example syphilis. Each Center program will focus on one or more of the listed pathogens, and combination vaccines (i.e. a single vaccine that protects against 2 or more of the listed pathogens) will be supported. At the end of the five-year program, each Center is expected to have identified a candidate vaccine(s) that has a highly feasible path to licensure. A highly feasible path to licensure means that information should be paired with the candidate(s), derived either from the completed studies and/or appropriate expertise, on such items as manufacturability, assay identification and validation, clinical testing, and indication, and that this information should appear reasonable and feasible to potential development partners, such as industry and non-governmental organizations.

Background

STIs remain a high public health threat 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. In 2012 there were an estimated 377 million cases of chlamydia, gonorrhea, syphilis, trichomoniasis and herpes worldwide. More than 1 million STIs occur globally every 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. Effectively addressing STIs by developing vaccines could have the following outcomes: combating antimicrobial resistance, eliminating adverse neonatal outcomes, reducing HIV transmission, preventing cancer, decreasing the burden of infertility and improving the health of young people.

Over the years, STI research has seen a rapid evolution in all areas ranging from pathogenesis, immune-responses and vaginal microbiome studies to development of drugs and diagnostics. NIAID's STI CRCs have contributed greatly to the advancement of our understanding of STIs from basic science to clinical trials. This knowledge can now be used to address one of the remaining critical challenges: the development of vaccines as a long-term method to control and prevent STIs. STI vaccine development depends on a multidisciplinary, synergistic approach that combines expertise in pathogenesis, immunology, reproductive tract physiology, animal models, and clinical research. The STI-CRC program has consistently produced high quality research using a synergistic, multi-discipline paradigm and is therefore suited for the preclinical development of STI vaccines.

Research Objectives and Scope

This FOA will focus on vaccine development for STIs. It will support multi-disciplinary, multi-project programs to advance the design of vaccine candidates warranting further preclinical and clinical development. The FOA will support the development of vaccines for the following STI pathogens that have limited candidates in the product development pipeline: Neisseria gonorrhoeae, Chlamydia trachomatis, and Treponema pallidum. Each Center program will focus on vaccine development for one or more pathogen(s); the development of combination vaccines (i.e. a single vaccine that protects against 2 or more of these pathogens) will also be supported. Examples of research areas of interest include, but are not limited to:

Immunological Improvement: approaches to elicit durable and broadly reactive antibodies, studies of novel antigen processing, presentation or priming mechanisms that generate broadly reactive T cells and approaches to increase the immunogenicity of candidate antigens.

Further Candidate Development: approaches to address items such as manufacturability, vaccine administration, dose, and assays needed to access manufacturing quality and control such as identity, purity, and potency. Also, approaches to support assessment of clinical endpoints in future trials, for example determination of infection status, and approaches to assess participants response to vaccination such as immunogenicity assays.

New and Improved Animal Models: development of new animal models to refine formulations and delivery modalities, and to compare candidate vaccines or vaccine formulations.

Applications proposing the following types of studies will be considered non-responsive and will not be reviewed:

Applications that focus on vaccine development for pathogens other than: Neisseria gonorrhoeae, Chlamydia trachomatis and Treponema pallidum

Applications that focus on HIV/SIV/AIDS

Clinical trials: Clinical research may be supported; however, clinical trials are not to be initiated or conducted through the STI CRC Program. See NOT-OD-15-015 for the NIH Definition of a Clinical Trial.

Collaborative Interdisciplinary Teams

The scope of this work requires that interdisciplinary teams be formed that are capable of pursuing coordinated activities that bridge disparate scientific disciplines and expertise in vaccine development associated with STIs. Each STI CRC is expected to include researchers with unique and diverse expertise that will enhance the overall quality of the Center. This expertise may be in any discipline that will contribute to the success of the Center.

STI CRC Program Components

This research program will consist of an Administrative Core, Scientific Cores, and at least three Research Projects organized around a common theme or hypotheses. Component projects and cores within a single application should not only relate to a central theme relevant to the specified diseases of interest, but also relate to the other components within the same application. The components of an application include:

Administrative Core: The Administrative Core will be responsible for managing, coordinating, monitoring overall progress, and supervising the entire range of the center's activities, including the Developmental Research Program (DRP).

Scientific Core(s): Scientific Core(s) will provide shared support services to at least two Research Projects. Examples of services provided by a shared Scientific Core are: monoclonal antibody production, peptide syntheses, microbiology laboratory services, statistical support, animal core, or a clinical core that will provide clinical samples to other cores and projects.

Research Projects: Each STI CRC should propose at least three Research Projects organized around a common theme or hypotheses, to advance the design of STI vaccine candidates warranting further preclinical and clinical development.

Development and Research Program (DRP) Awards: A DRP will be implemented by each STI CRC to provide an opportunity to test 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 DRP awards per year, although the total number of DRP awards that a Center can support during the entire award project period is left to the discretion of the Center. DRP awards are intended for junior investigators (e.g., Ph.D., M.D. fellows and Assistant Professors). Note: DRP awards will be established after STI CRCs are awarded. DRP project applications should not be included with the STI CRC application.

Annual Programmatic Meetings: Annual Programmatic Meetings will be held to facilitate communication and collaboration among funded STI CRCs.

STI CRC Executive Committee (EC): An STI CRC Executive Committee (EC) will be established by the NIAID Project Scientist to facilitate interaction, collaboration, and communication among the STI CRC and NIAID staff. The EC will include the PD/PI of each STI-CRC and will meet monthly by teleconference.

Note: At the end of the five-year program, each Center is expected to have identified a candidate vaccine(s) that has a highly feasible path to licensure.

See Section VIII. Other Information for award authorities and regulations.

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. See Section VI.2 for additional information about the substantial involvement for this FOA.

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

Clinical Trial? Not Allowed: Only accepting applications that do not propose clinical trials Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards NIAID intends to commit $9 million dollars in FY 2019 to fund 3-5 awards.

Award Budget Application budgets are limited to $1.5 million direct costs per year which includes up to $60,000 in direct costs for up to two Development and Research Program (DRP) awards per year. Application budgets 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 from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

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

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)

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

For-Profit Organizations

Small Businesses

For-Profit Organizations (Other than Small Businesses)

Governments

State Governments

County Governments

City or Township Governments

Special District Governments

Indian/Native American Tribal Governments (Federally Recognized)

Indian/Native American Tribal Governments (Other than Federally Recognized)

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

Native American Tribal Organizations (other than Federally recognized tribal governments)

Faith-based or Community-based Organizations

Regional Organizations

Foreign Institutions

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

Non-domestic (non-U.S.) components of U.S. Organizations are 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.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an Application Package

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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 Multi-Project (M) 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:

Descriptive title of proposed activity

Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)

Names of other key personnel

Participating institution(s)

Number and title of this funding opportunity

The letter of intent should be sent to:

Annie Walker-Abbey, Ph.D.

Telephone: 240-627-3390

Fax: 301-480-2408

Email: aabbey@niaid.nih.gov

Page Limitations

Component Types Available in ASSIST Research Strategy/Program Plan Page Limits Overall 12 pages Admin Core 6 pages Core (use for Scientific Core[s]) 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 SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall: required

Administrative Core: required, maximum of 1

Scientific Core(s): optional, no maximum

Research Projects: required, minimum of 3, no maximum

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.

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.

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. Describe how the proposed studies will promote a multidisciplinary, diverse set of research activities to develop new vaccines against STIs. Describe how the individual projects and cores relate to the overall goals of the Center and provide a cohesive and synergistic whole that is more beneficial than pursuing each project independently. Summarize the special features in the environment and/or resources that make this application strong or unique. Provide proposed timelines and milestones for the overall Center.

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

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

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

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:

Applicant Information

Type of Applicant (optional)

Descriptive Title of Applicant's Project

Proposed Project Start/Ending Dates

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. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

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)

In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

For institutions/organizations proposing a single PD/PI, the PD/PI must serve as the Administrative Core Lead. For institutions/organizations proposing multiple PD(s)/PI(s), the contact PD/PI must serve as the Administrative Core Lead.

Include the following information in the biographical sketch of the PD/PI to highlight previous experience in the following areas: providing leadership and guidance to scientific teams, creating an infrastructure that promotes cross-discipline interactions, and providing 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.

Development and Research Program (DRP) awards: Include a maximum of $60,000 direct costs per year (beginning in Year 1), for a maximum of two DRP awards per year; with each award not to exceed two years.

Include travel funds for the PD(s)/PI(s), Research Project Leaders and Core Leaders to attend the Kick-Off meeting, to be held within 3 months of award, in the Rockville, MD area (for a 1-day meeting).

Include travel funds for the PD(s)/PI(s), Research Project Leaders, Core Leaders, presenters, and DRP award recipients to attend the Annual Programmatic meetings, to be held annually beginning in Year 2, in the Rockville, MD area or in the location of one of the STI CRCs (2 days per annual meeting).

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: Describe plans and procedures for establishing and managing an Administrative Core that provides the organizational capacity to ensure the following:

Coordinating, supervising and managing all Center activities, including sponsoring activities to advance the Center's integration;

Assisting Research Project and Core Leaders with administrative aspects of their projects, such as gathering of progress reports and facilitating other communications with awardees and their mentors;

Promoting collaboration and coordination among Research Project and Core Leaders;

Communicating with other STI CRCs regarding collaboration and coordination of activities and projects;

Fostering outreach activities to promote collaborations with the STI communities; and

Communicating and interacting with NIAID staff.

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

A description of the organization of the STI CRC and its management structure to form a cohesive, integrated and efficient Center that provides scientific and administrative oversight, as well as fiscal accountability of all STI CRC Research Projects and Cores; and

An overview of how the Center will be coordinated, integrated, and scientifically and technically managed; how problems will be identified and resolved; how a strong collaborative environment will be established; and how communication will be facilitated.

The Management Plan should include a Staffing Plan that, without repeating information submitted on the Multiple PD/PI plan if applicable, describes: how the needs of the center will be met by the proposed structure, roles, and interactions of administrative and scientific staff.

Development and Research Program (DRP) Plan: Include a DRP plan that describes strategies to establish and manage the DRP, as well as mentor junior investigators. The plan should describe how pilot DRP awards will be integrated into an awardee's career development objectives. Include plans for the logistics for solicitation, receipt, and review of applications, as well as award. Describe the internal institutional plans and procedures to ensure that DRP award recipients 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. Note: This section should only include information about the establishment and management of the DRP and should not include any DRP proposed research projects.

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

Limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Science 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 (Science Core)

Complete only the following fields:

Applicant Information

Type of Applicant (optional)

Descriptive Title of Applicant's Project

Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Science Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Science 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. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities & Other Resources: Include an attachment entitled "Facilities & Other Resources" to provide information on resources available for the Scientific Core. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities available to be used for working with one or more of the following pathogens: Neisseria gonorrhoeae, Chlamydia trachomatis, and/or Treponema pallidum.

Equipment: Include an attachment entitled "Equipment" to provide information on equipment available for the Scientific Core. If there are multiple performance sites, describe the equipment available at each site. Describe any special equipment available to be used for working with biohazards or other potentially dangerous substances, as well as one or more of the following pathogens: Neisseria gonorrhoeae, Chlamydia trachomatis, and/or Treponema pallidum.

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

In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Science Core)

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

For Cores (Clinical or otherwise) obtaining samples from independently-funded clinical trials, include the following costs, when such costs are not included in the Research Projects: additional clinical trial-related activities such as the costs of re-consenting study participants; preparation of protocol or IND amendments; and additional sample collection, preparation, and shipping.

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 (Science Core)

Specific Aims: List in priority order, the broad, long-range activities and services to be provided by the Scientific Core(s). In addition, state the Core's relationship to the STI CRC's goals.

Research Strategy: Describe how the proposed Scientific Core activities will contribute to meeting the STI CRC's goals and objectives. Describe the reagents and other services to be provided by the Scientific Core, and explain the rationale for selecting the general methods and approaches proposed to accomplish the Specific Aims. Describe how the Core will serve two or more individual Research Projects and why the Core resources are not otherwise available. In addition, indicate the relevance of the Scientific Core to the primary theme of the application. Explain how requests will be prioritized and coordinated. In a clearly labeled section provide annual timelines and milestones for the proposed core services. Note: timelines for clinical research are requested as part of the PHS Human Subjects and Clinical Trials information and should not be repeated in this section.

Letters of Support: Provide letters of support from collaborators that are applicable to the Scientific Core, including a Memorandum of Understanding (MOU) or Materials Transfer Agreement (MTA) that documents availability and/or access to human materials for each source (i.e., sample availability corresponding to the outlined timelines).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, 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: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Science Core)

Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

For studies involving the use of identifiable human biospecimens collected from independently funded clinical research or clinical trials, applicants should include both historical and current study information that is clearly distinguishable within the information requested in the study record forms.

Section 2 - Study Population Characteristics

2.7 Study Timeline

If applicable, timelines should address the time needed to acquire samples from independently funded clinical research or clinical trials.

Delayed Onset Study

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

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:

Applicant Information

Type of Applicant (optional)

Descriptive Title of Applicant's Project

Proposed Project Start/Ending Dates

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. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

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 available to be used for working with one or more of the following pathogens: Neisseria gonorrhoeae, Chlamydia trachomatis, and/or Treponema pallidum.

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 available to be used for working with biohazards or other potentially dangerous substances, as well as one or more of the following pathogens: Neisseria gonorrhoeae, Chlamydia trachomatis, and/or Treponema pallidum.

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)

In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Project Lead' and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Highlight the following in the biosketch of the Project Leader: leadership skills; managerial competence to successfully plan, manage, conduct and direct a Research Project; ability to establish collaborations; as well as the record of collaborations with STI communities.

Budget (Research Project)

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

If samples for the proposed studies are to be collected from an independently-funded clinical trial include the following costs, when such costs have not been included under a Scientific Core: the costs of re-consenting study participants, preparation of protocol or IND amendments, and additional sample collection, preparation, and shipping.

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)

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: 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.

Describe the research design, conceptual procedures, and analyses to be used to accomplish the Specific Aims, emphasizing how these will contribute to vaccine development for: Neisseria gonorrhoeae, Chlamydia trachomatis and/or Treponema pallidum. Explain how the approaches and methods used will advance these candidates in the product development pipeline. In a clearly labeled section provide annual timelines and milestones for the proposed project.

Note: timelines for clinical research are requested as part of the PHS Human Subjects and Clinical Trials information and should not be repeated in this section.

Letters of Support: Provide letters of support from collaborators that are applicable to the Research Project, including a Memorandum of Understanding (MOU) or Materials Transfer Agreement (MTA) that documents availability and/or access to human materials for each source (i.e., sample availability corresponding to the outlined timeline).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, 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: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research Project)

Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

For studies involving the use of identifiable human biospecimens collected from independently funded clinical research or clinical trials, applicants should include both historical and current study information that is clearly distinguishable within the information requested in the study record forms.

Section 2 - Study Population Characteristics

2.7 Study Timeline

If applicable, timelines should address the time needed to acquire samples from independently funded clinical research or clinical trials.

Delayed Onset Study

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. 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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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 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 Center proposed).

Are the overall Center goals significant and focused on studies that promote a multidisciplinary, diverse set of STI research activities, encourage new efforts towards developing new vaccines against STIs?

Are the proposed timelines and milestones for the overall Center adequate?

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?

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)?

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

Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Overall Impact - 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 - 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? Is there a strong scientific premise for the project? 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?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project ? If Early Stage Investigators or those 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 ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

If applicable, for studies using identifiable human biospecimens collected from independently-funded clinical research or clinical trials, are the timeline and documentation adequate/feasible to successfully obtain the samples and implement the proposed project(s)?

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 – Administrative Core, Scientific Core(s)

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 – Administrative Core, Scientific Core(s)

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 Administrative Core Director adequate to manage the overall Center?

Is the plan to establish and manage the 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?

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

Scientific Cores (if applicable)

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?

If applicable, for Cores using identifiable human biospecimens collected from independently-funded clinical research or clinical trials, are the timeline and documentation adequate/feasible to successfully obtain the samples and implement the proposed project(s)?

Additional Review Criteria - Overall, Core(s) and Research Projects

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall, Core(s) and Research Projects

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 Allergy and Infectious Diseases in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Will receive a written critique.

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

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

Scientific and technical merit of the proposed project as determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

Priority will be given to those infections for which no candidates have advanced to human clinical trials, for example syphilis.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 Part 75, 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:

Retaining custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

Participating in Executive Committee (EC) meetings, teleconferences, and other activities to be defined over the course of the award period.

Keeping the NIAID Program Official and NIAID Project Scientist apprised of any potential impediments to execution of the goals of any one Research Project or Core.

Establishing the Annual Programmatic Meeting agenda.

Extending invitations to the NIAID Program Official and the NIAID Project Scientist for specific Center meetings, including the Annual Programmatic Meetings.

Developmental Research Program (DRP) awards: The PD(s)/PI(s) or designee will be responsible for the DRP awards within each STI CRC, to include coordinating the issuance of all funds to DRP awardees, and interfacing with NIH Grants Management offices and sponsored projects (grants) offices at awardees' institutions. The PD(s)/PI(s) will provide fiscal oversight of the DRP, and will be the fiscal contact to the STI CRC's DRP investigators. Finally, the PD(s)/PI(s) will ensure that all DRP awards involving human or animal subjects have the appropriate clearances (e.g., IRB, FWA, IACUC, human subject's research training, and other required documentation) prior to implementation.

Annual Programmatic Meetings: The PD/PI will assume responsibility for organizing at least one 2-day Annual Programmatic Meeting of all Centers during the award period.

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

The NIAID Project Scientist will keep the Center informed about other ongoing studies supported by NIAID.

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.

STI Executive Committee (EC): The NIAID Project Scientist will serve as a non-voting member of the STI 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.

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

Coordinating the monthly Executive Committee conference calls; and

Organizing a Kick-off Meeting to be held within four months of award.

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

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.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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





Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)

Contact Center Telephone: 800-518-4726

Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)

Email: GrantsInfo@nih.gov (preferred method of contact)

Telephone: 301-945-7573





Scientific/Research Contact(s)

Thomas Hiltke, Ph.D.

National Institute of Allergy and Infectious Diseases (NIAID)

Telephone: 240-627-3275

Email: thiltke@mail.nih.gov

Peer Review Contact(s)

Annie Walker-Abbey, Ph.D.

National Institute of Allergy and Infectious Diseases (NIAID)

Telephone: 240-627-3390

Email: aabbey@niaid.nih.gov

Financial/Grants Management Contact(s)

Jenny Greer

National Institute of Allergy and Infectious Diseases (NIAID)

Telephone: 240-669-2949

Email: jenny.greer@nih.gov





Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.