Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Cancer Institute (NCI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Heart, Lung, and Blood Institute (NHLBI)

Funding Opportunity Title

Pediatric HIV/AIDS Cohort Study (PHACS): 2020 (P01 Clinical Trial Not Allowed)

Activity Code

P01 Research Program Projects

Announcement Type
Related Notices
  • November 6, 2019 - Notice of NHLBI Participation in RFA-HD-20-002. See Notice NOT-HL-19-725.
  • October 10, 2019 - Notice of Pre-Application Webinar for RFA-HD-20-002. See Notice NOT-HD-19-033.
Funding Opportunity Announcement (FOA) Number

RFA-HD-20-002

Companion Funding Opportunity

None

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

 93.865; 93.393; 93.273; 93.855; 93.279; 93.173; 93.121; 93.242; 93.853, 93.837, 93.838, 93.839, 93.840, 93.233 

Funding Opportunity Purpose

The purpose of this FOA is to continue support for the Pediatric HIV/AIDS Cohort Study (PHACS) as a Program Project which addresses the clinical course of perinatally acquired HIV infection in adolescents and young adults and the oral and systemic health consequences of in utero and infant exposure to antiretroviral therapy in cohorts of children in the United States.  

Key Dates
Posted Date

October 7, 2019

Open Date (Earliest Submission Date)

November 5, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

Only accepting applications for the AIDS Application Due Date(s) listed below.

AIDS Application Due Date(s)

December 5, 2019. All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related 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.

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

Scientific Merit Review

February 2020 

Advisory Council Review

 May 2020

Earliest Start Date

 July 2020

Expiration Date

 December 6, 2019   

Due Dates for E.O. 12372

Not Applicable

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). 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information

    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    The purpose of this FOA is to continue support of a multi-disciplinary, interactive and synergistic Program Project application for the Pediatric HIV/AIDS Cohort Study (PHACS) which addresses critical scientific questions on the clinical course of perinatally acquired HIV infection in adolescents and the oral and systemic health consequences of in utero and infant exposure to antiretroviral therapy in representative cohorts of children in the United States. The findings from this domestically based initiative have great relevance internationally since millions of children with HIV in resource-constrained settings receive treatment and survive into adolescence and adulthood, and many pregnant women with HIV have access to and use combination antiretroviral therapy to prevent transmission of HIV infection to their infants and preserve their own health.

    Background

    Individuals with perinatally-acquired HIV (PHIV) now survive to adulthood but still face the developmental consequences of prolonged HIV infection, associated co-morbidities, and long-term antiretroviral therapy (ART) that can affect systemic and oral health. The number of children with PHIV born domestically has declined since 1998, but the increase in the number of children with PHIV globally and the increased availability of antiretrovirals for treatment and prevention in the face of limited clinical data on the long-term safety of these agents in infants, children and youth continue to give this cohort study critical importance both domestically and globally.

    PHACS is the only ongoing domestic clinical research network that comprehensively assesses the systemic and oral health status of two main populations – children exposed to HIV perinatally but who are uninfected (HEU), and children and adolescents with PHIV. There are over 3500 HEU individuals in the Surveillance Monitoring for ART Toxicities Study (SMARTT) with approximately 200 newborns enrolling each year. These new enrollments will continue to capture the evolving type and timing of antiretrovirals used during pregnancy. Timing of antiretroviral initiation continues to evolve, and more women are on treatment at the time of conception or earlier in pregnancy. PHACS will continue to support ongoing evaluations of in utero and postnatal exposures to new antiretroviral drugs in the HEU cohort and identify specific adverse events and potential etiologic factors. Children with PHIV are followed in a series of protocols based on the original Adolescent Master Protocol (AMP) designed to examine the impact of HIV and ART on the health and development of preadolescents, adolescents and young adults with PHIV. AMP began enrolling children with PHIV between 7 and 16 years of age in 2007. AMP Up was developed to extend follow up of adolescents with PHIV from 18 years of age as they transition to adulthood.  AMP Up Lite, was created to share similar objectives with AMP Up but with less intensive data collection. The AMP series of protocols are expected to enroll and follow at least 1,000 individuals with PHIV in the US and include appropriate control groups.  

    The transition to adulthood of youth with PHIV treated with ART provides an important opportunity for PHACS to examine a host of health outcomes, including reproduction, oral, cognitive, neurodevelopmental, mental health, substance use, behavioral, emotional, social, academic and vocational outcomes.  Since this cohort includes youth who received very early treatment and have had nearly lifelong HIV suppression, there is also a unique opportunity to glean insights that may inform HIV cure research. Collaborations will continue to be encouraged with other cohorts in both resource-rich and resource-constrained settings.

    Research Objectives and Scope

    The goal of this FOA is the continuation of support for the study and follow up of three PHACS cohorts enrolled in four ongoing protocols.

    Cohorts:

    1) HEU already enrolled, plus new enrollments of approximately 200 per year (SMARTT); in addition, adequate data collection from mothers and caregivers should continue to optimize SMARTT data analyses

    2) Adolescents and young adults with PHIV of approximately 1000 already enrolled and/or with new enrollments as needed (AMP, AMP Up, and AMP Up Lite); and,

    3) Appropriate control groups 

    Protocols:

    • Surveillance Monitoring for Antiretroviral Treatment Toxicity (SMARTT), a drug toxicity surveillance system study in children exposed to prophylactic antiretroviral chemotherapy;
    • The Adolescent Master Protocol series of three related protocols (AMP, AMP Up, and AMP Up Lite) that address the impact of HIV disease and its treatment on sexual maturation, pubertal development, cardiovascular disease risk, bone and oral health, substance use, neurological and mental health outcomes, HIV-risk behaviors, cognitive, emotional, social, academic, and vocational functioning of preadolescents and adolescents and young adults with PHIV.

    The collection of basic information in areas of focus is expected to continue in the base protocols and in other supported studies. These areas include, but are not limited to:

    • Genetic, epigenetic and mitochondrial outcomes of in utero and neonatal exposure to antiretroviral drugs and HIV
    • Neurodevelopmental outcomes, including cognitive, academic, vocational, behavioral, and social outcomes
    • Central nervous system imaging correlates of neurodevelopmental, cognitive, behavioral, substance exposures and use, hearing, and language outcomes
    • Peripheral nervous system complications
    • Communication disorders or impairment of hearing and language
    • Substance use/abuse, including mental health, HIV disease outcomes, medication adherence and compliance with behavioral interventions  
    • Alcohol and drug exposures in pregnancy on outcomes in infants and children
    • Growth, endocrinologic, and bone development issues
    • Nutrition, body composition changes and tissue redistribution syndromes
    • Sexual maturation, reproductive capacity
    • Sexual health and HIV-risk behaviors
    • Oral health, including effects of treatment on oral cells and tissues, oral bone mineral density, and tooth development; oral mucosal immunity; oral disease biomarkers; oral persistence, latency and reservoirs for HIV and pathogens causing oral diseases; and
    • Interaction of oral pathogens in disease exacerbation relative to virologic, immunologic, and therapeutic status
    • Cardiovascular disease risk and complications
    • Pulmonary and renal complications
    • Viral infections associated with malignancies
    • Studies of HIV persistence, latency, and reservoirs

    PHACS will continue to follow the required numbers of participants in existing protocols that are rigorously refocused, as needed, or in focused Emerging Research Pilots (sub-studies) developed after PHACS begins to answer new questions as the research landscape evolves. Thus, PHACS will address priority scientific investigations more rapidly than could individual projects alone. The network will bring necessary expertise and resources to collaborative protocol development that will ensure feasible and acceptable study design, as well as experience in recruiting and retaining these unique populations through competitive subcontracts to clinical sites with demonstrated high level prior performance to accomplish the PHACS mission.

    Essential Features of the PHACS Structure

    The PHACS P01 Program Project

    PHACS is newly designed  as a Program Project collaborative network conducted through a P01 with a well-defined central theme and research focus. PHACS was previously supported through two U01 awards, one to support a Coordinating Center and the other for a Data and Operations Center. This infrastructure will now be provided through the Program Project which will receive direction and oversight from the multi-disciplinary PHACS Scientific Leadership Committee (SLC) and draw on support, coordination and operational infrastructure from the Scientific Administrative Core (SAC) and Data Resource Core (DRC) and the clinical sites to support up to 4 scientifically meritorious and synergistic Research Projects. Each Research Project must be centered around the themes of (1) Surveillance Monitoring for Antiretroviral Treatment Toxicity (SMARTT), a drug toxicity surveillance system in children exposed to prophylactic antiretroviral chemotherapy, and (2) The Adolescent Master Protocol series (AMP, AMP Up and AMP Up Lite) that address the impact of HIV disease and its treatment on sexual maturation, pubertal development, cardiovascular disease risk, bone health, substance use, mental health outcomes, HIV-risk behaviors, cognitive, emotional, social, academic, and vocational functioning among preadolescents and adolescents and young adults with PHIV.

    • There must be a unifying, well-defined goal or central research theme to which each Research Project relates and contributes scientifically, thereby producing a synergistic environment that allows each research effort to share the creative strengths of the other projects.
    • The program involves interrelated Research Projects and collaborating investigators, yielding results beyond those achievable if each project were carried out separately. Thus, the program’s overall scientific merit is expected to be greater than the sum of its parts.
    • Each Research Project must independently have significant and substantial scientific merit, as assessed by peer review, and must complement the other Research Projects in the program.
    • Research Projects should be supported by the Scientific Administrative Core (SAC) and any other appropriate Cores in order to enhance the research objectives.
    • The PD/PI must possess recognized scientific and administrative competence, devote a substantial commitment of effort to the program, and exercise leadership in maintaining program quality.
    • Program Projects require the participation of established investigators in several disciplines or investigators with special expertise in several areas of one discipline. All Senior/Key Personnel (PDs/PIs, Project Leads, Core Leads) must contribute to, and share in, the responsibilities of fulfilling the program objectives.

    After PHACS begins, it may additionally prioritize as determined by the SLC or the External Advisory Board to develop and implement limited focused projects through Emerging Research Pilots, within the scientific scope and budget of PHACS, to address evolving scientific questions and needs. Emerging Research Pilots will be supported by the Scientific Administrative Core (SAC) and other appropriate Cores and founded on similar principles as the Research Projects above.

    PHACS Scientific Leadership Committee (SLC)

    The PHACS SLC will be responsible for PHACS governance, oversight and coordination, and will develop and implement the network research agenda. The SLC may convene additional scientific working groups or subcommittees that may expand and contract as the scientific needs of the network evolve to ensure that the PHACS research objectives and scope will be achieved. They will establish and enforce policies and procedures of PHACS. The SLC is comprised of the PD(s)/PI(s) of the SAC and DRC, research project and other SLC members and representatives from the clinical sites. Representatives from NICHD and other NIH institutes may participate as non-voting ad hoc members.

    Scientific Administrative Core (SAC)

    The Scientific Administrative Core, headed by the PHACS PD/PI(s), will be responsible for managing, coordinating, and supervising all program project grant activities, including assembling and maintaining the PHACS SLC and any of its working groups or subcommittees, establishing collaborations with other research networks, and monitoring progress with respect to milestones, implementation of the overall Project Management Plan, and the proposed timelines. The scientific and technical expertise and research teams may be distributed among various Institutions.  In such cases, the SAC will be responsible for ensuring cohesiveness and synergy among the PHACS members. The SAC will be responsible for the Outreach Activities of the PHACS program and the Research Projects. A plan for mentoring new PI's, early stage investigators, toward leadership roles in the cohort and as PI's of R01's and should be included in the application.

    Data Resources Core (DRC)

    Given the nature of this large, multi-site prospective observational multi-cohort study, a large amount of data and other resources have been and are expected to continue to be generated through the research projects at the clinical sites. This requires a centralized data and resource management entity, the Data Resources Core (DRC), with direct access to the clinical sites that is vital to the efficient and successful performance of the Program as a whole. The DRC will be responsible for supporting sample tracking, laboratory data management, data storage, and for providing data access, data transfer, and integrated data analysis as a shared resource to the Program Research Projects. The DRC will be responsible for the execution and management of performance-based subcontracts for and oversight of the clinical sites and personnel, including the Clinical Investigators, Study Coordinators and Community Advisory Board (CAB) members, associated with the maintenance and recruitment of the PHACS cohorts into all research projects.

    Optional Core

    An optional Core may be included to provide specialized or unique services, support or resources to the research projects but must not be duplicative of other services or facilities available in the required cores.

    Research Projects

    Each Research Project should contribute materially and intellectually to the specific goals and objectives of the Program Project (network), contribute expertise and/or resources toward the aims of the Program Project, include plans for data sharing as appropriate, and emphasize collaboration across all components of PHACS in order to meet the objectives of the FOA.

    Each Research Project should contain the scientific vision which anticipates the ongoing evolution of the field and an emerging scientific agenda by briefly addressing the current state of knowledge on the clinical course of perinatally acquired HIV infection in children and adolescents, and the health consequences of in utero and infant exposure to antiretroviral therapy, the significant scientific gaps and opportunities, and the research, tools, resources and collaborations needed to progress toward filling those gaps to improve health outcomes in these populations. 

    Semi-Annual Programmatic Meetings

    A one or two-day semi-annual meeting will be held, and each research project will be responsible for the meetings' organization at least once over the award period. These meetings are anticipated to be held at a location at or near Bethesda, MD or at another NICHD-approved site.

    External Advisory Board (EAB)

    An independent external advisory board (EAB) of investigators who are not current collaborators of the funded programs is expected to be constituted by the PD/PI(s) of the program project and the SAC. The advisory board will meet at least biannually to review the progress in achieving the goals of all research projects participating in the program at a PHACS meeting coordinated by the SAC. Following these meetings, the EAB will make recommendations in writing to PHACS and the SLC for the continuation or re-direction of any or all projects and activities.

    NIH PHACS Management and Oversight Committee (NIH PMOC)

    The PHACS program is co-funded by multiple NIH Institutes, however, NICHD administers the award.  Thus, PHACS will be programmatically managed by the NIH PMOC.

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

    Section II. Award Information
    Funding Instrument

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

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    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

    The following NIH components intend to commit the following amounts in FY 2020:

    • NICHD approximately $10,000,000
    • NIDA approximately $2,000,000,
    • NIAID approximately $2,000,000,
    • NIMH approximately $1,000,000,
    • NIDCR approximately $800,000,
    • NIDCD approximately $750,000,
    • NINDS approximately $500,000, and
    • NIAAA approximately $200,000;
    • NCI $500,000 to support 1 award for the PHACS

    The issuing IC and partner components intend to commit an estimated total of $17.75 million for fiscal year 2020 to fund 1 award.

    Award Budget

    Application budgets are limited to $12 million in direct costs per year 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 project period is 5 years.   

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made 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:

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

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • 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 not eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

    Required Registrations

    Applicant Organizations

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

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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

    The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST 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.

    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.

    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:

    Bill G. Kapogiannis, M.D. 
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 
    Telephone: 301-402-0698
    Email: kapogiannisb@mail.nih.gov

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    12 pages

    Sci Admin Core (Scientific Administrative Core)

    12 pages

    Data Resources Core

    12 pages

    Research Projects

    12 pages (per project)

    Optional Core

    6 pages (per core)

    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
    • Sci Admin Core (Scientific Administrative Core) [SAC]: required (maximum 1)
    • Data Resources Core (DRC): required (maximum 1)
    • Research Projects: required (minimum 3; maximum 4)
    • Optional Core: optional (maximum 2)
    Overall Component

    When preparing your application, 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.

    The P01 Program Project PD/PI (s)

    • should be established investigator(s) with demonstrated leadership and administrative capabilities in multidisciplinary research;
    • will be responsible for the projects and cores within the P01 and for communication, collaboration and coordination with other research networks and investigators;
    • will participate and collaborate with the Research Project leads, Core leads and others within the P01 to guide the Network in implementing scientific and administrative decisions;
    • should demonstrate a capacity to ensure participant recruitment based on demonstrated prior site experience and performance;
    • should demonstrate a track record of proactive community engagement in development of research activities.

    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 Overall Program.  List goals of the research and summarize expected outcomes.    

    Research Strategy:  Summarize the overall research objectives and strategic plan for the multi-project application. Applications responding to this FOA should describe the central theme of the proposed Program and explain how the proposed Research Projects are synergistic and fit under the overarching Program theme.

    • Describe the conceptual wholeness to the overall program project by giving a statement of the general problem area and by laying out a broad strategy for addressing the problems.
    • As the strategy develops, cite each research project and core to describe its place in the overall scheme.
    • Concisely describe the hypothesis or hypotheses to be tested.
    • Highlight the innovation, approach and significance across the Program Project, including in the research projects.
    • Explain ongoing, planned, and potential collaborations nationally and internationally to conduct epidemiologic and clinical research.
    • Describe the program project's plan to disseminate the research data and resources generated, as well as the protocols and reagents that may be applied to other fields of research.
    • Include an overview of the program project's outreach activities.
    • Describe the program project's commitment and plan for developing and mentoring new talent, including new PI's and early stage investigators, toward leadership roles in the cohort and as PI's of R01's.
    • Describe prior collaborative arrangements between investigators in the group to explain the development of the current application.
    • Describe a Project Management Plan that articulates the strategies and processes that will be used to manage the P01 and achieve the overall goals, including monitoring progress on achievement of Milestones, implementation of the Plan, and proposed Timelines.
    • Explain how the proposed program project would enable the stated objectives of the proposed research to be addressed more efficiently and effectively than by a group of individual research project grants.
    • Briefly describe the components of the Program Project and how they will interact and synergize to provide a program that is greater than the sum of its parts.

    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:

    NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

    NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, must include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

    Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/.

    If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

    Appendix:

    Only 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)

    When involving human subjects research, clinical research, and/or NIH-defined 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

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

    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.  

    Scientific Administrative Core (SAC)

    When preparing your application, 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 (Scientific 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 (Scientific Administrative Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Scientific 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) (Scientific 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 (Scientific 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.  
    • The applicant should assemble the necessary multidisciplinary team of established investigators to establish the PHACS Scientific Leadership Committee (SLC). Disciplines should be included as required to support the purposes of this initiative.   
    Budget (Scientific Administrative Core )

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

     Funding for the overall administrative efforts, including secretarial, and/or other administrative services, expenses for publications demonstrating collaborative efforts, and communication expenses should be requested in the budget for this core. Additionally,

    • The P01 PD(s)/PI(s) will be expected to provide at least 25% FTE (3 person-months) to the Program and will lead this Core; increased effort is expected if the P01 PD(s)/PI(s) plan to also lead a research project within the P01;
    • The P01 PD(s)/PI(s) should request a discretionary budget to be used for funding of the focused Emerging Research Pilots (sub-studies), for supporting collaboration or co-endorsement agreements with other research networks as indicated, and for accommodating central sub-study-mandated requirements (e.g., specimen shipping costs) on an as-needed basis;
    • A plan for determining how the research pilots will be selected should be included.
    • Funds for two yearly PHACS meetings should be included in the budget.

    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 (Scientific Administrative Core)

    Specific Aims:  Include a brief list of Specific Aims outlining the objectives and functions of the Scientific Administrative Core.    

    Research Strategy:  

    The overview of the Scientific Administrative Core should articulate the strategy that the Program Project will adopt to achieve the scientific goals and describe the processes/approaches that will be used in decision-making and implementation of activities, including the establishment of scientific priorities, strategies used to manage the Program Project: defining scope, direction, and means, strategies used to redirect science or resources, efficient communication, frequency and means, and strategies to promote and facilitate collaboration in the Network via the PHACS Scientific Leadership Committee (SLC), including a complete description of the constitution and roles of the PHACS SLC and of the External Advisory Board (EAB) or other groups/persons in decision-making activities.  

    Specifically describe the planning and coordination of research activities and provide information on the integration of cross-disciplinary research, allocation of funds, management of resources and quality control. Describe plans for the maintenance of ongoing communication, and for the evaluation of the Program Project by internal or external Boards and indicate who will be responsible for each of these activities.

    For the Scientific Administrative Core (SAC), provide the following information:

    Objectives:

    • Describe the objectives of the SAC.

    Staffing: 

    • Describe administrative, scientific, technical, and support staff who are not designated as Key Personnel, how those individuals will interact, and mechanisms of supervision/coordination by the SAC Lead.

    Resources:   

    • Describe how the SAC resources will contribute to the objectives of the Research Projects. 
    • Describe plans for fiscal monitoring and accountability.

    Services provided: 

    • Describe the services provided to the other Cores, SLC, other committees and subcommittees, Working Groups and Research Projects.
    • Include descriptions of the logistical infrastructure to support coordination and communications among these groups.

    Administration: 

    • Describe the strategies and processes that will be used to manage the SAC and achieve the overall goals, including monitoring progress on Milestones, implementation of the Project Management Plan and proposed Timelines.
    • Provide information on how the SAC will provide oversight of the Cores and Research Projects and will promote coordination and collaboration within the program and with investigators and organizations outside the program.
    • Describe the plan for establishing and maintaining the SLC and related cores and projects. Do not contact or name any investigators, rather focus on expertise provided.
    • Describe the plan for the establishment and maintenance, including the expansion and contraction, of necessary scientific multidisciplinary specialty working groups of the SLC required to expediently address emerging scientific priorities within the scope and budget of PHACS. It is important to note that requests for discretionary funds exceeding 10% of the total annual P01 award will require prior NICHD approval.
    • Describe plans to mentor new and early stage investigators that will foster career development and promote talented junior investigators into leadership roles and independent research careers.
    • Describe a plan for how decisions will be made for identifying, reviewing and funding pilot 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:

    NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

    NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, must include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

    Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/.

    If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

    Appendix:

    Only 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 (Scientific Administrative Core)

    When involving human subjects research, clinical research, and/or NIH-defined 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

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

    Data Resources Core (DRC)

    When preparing your application, 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 (Data Resources 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 (Data Resources Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Data Resources 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) (Data Resources 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 (Data Resources 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 (Data Resources Core)

    Budget forms appropriate for the specific component will be included in the application package. The P01 PD(s)/PI(s) should include in their budget under the “Other Expenses” category an amount each year for subcontracts to clinical sites.  The budget should also include, at a minimum, salary and administrative support for the DRC Lead, and staff required to achieve the activities, including travel to two annual meetings (Bethesda, MD). The DRC budget should also include a funding request for Community Advisory Board (CAB) staff support and travel of CAB representatives to one 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 (Data Resources Core)

    Specific Aims:  Include a brief list of Specific Aims outlining the objectives and functions of the DRC.     

    Research Strategy: 

    The applicant should briefly discuss the plans and activities of the statisticians, data management specialists, and epidemiologists who will be responsible for the DRC.  It is expected that the PD(s)/PI(s) of the P01 will identify and establish relationships needed with current PHACS sites to allow continued follow up of the cohorts.

    For the Data Resources Core (DRC), provide the following information:

    Objectives:  Describe objectives of the DRC. 

    Staffing:  Describe scientific, technical, and support staff.

    Resources:  Describe how DRC resources, including the clinical site infrastructure, will contribute to the objectives of the Research Projects.  

    Services provided:   Describe current and projected services to other Core and Research Components and clinical sites, as well as the process for prioritizing requests for use of Core facilities by the various Research Projects. If a Core already exists, include a description of past services provided, new technologies developed, changes in protocols or Core administration, and other significant developments.

    Management:  Describe overall management of the Core, decision-making process for use of Core services, and plans for cost-effectiveness and quality control.

    Utilization of Core: 

    • Provide a summary of past and/or projected usage of Core services (e.g., analyses performed, services provided, etc.).  Include estimates of the percentage use of each Core unit by the affiliated Research Project components.
    • Provide information on innovative capabilities in data analysis and visualization, including artificial intelligence (AI) strategies and enhanced data integration workflows and pipelines, and how these will be developed to serve as community accepted standards.
    • Discuss how the core will implement new, improved and enhanced bioinformatics analysis pipelines and web-based screening and follow-up of enrolled patients.
    • Describe the plans for statistical and data management support and for creating and maintaining the necessary clinical infrastructure to implement the research projects. 
    • Explain how strategies for the maintenance and oversight of the clinical sites associated with the PHACS cohorts will be administered.
    • Describe the personnel involved in maintaining and operating the clinical sites and Community Advisory Board (CAB).
    • Describe plans for outreach and dissemination of Information internally and externally including by maintaining a function website
    • Describe the strategies and processes that will be used to manage the DRC and achieve the overall goals, including monitoring progress on Milestones, implementation of the Project Management Plan and proposed 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:

    NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

    NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, must include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

    Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/.

    If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

    Appendix:

    Only 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 (Data Resources Core)

    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

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).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:  Please provide a Project Narrative for each Research Project.

    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.   
    Budget (Research Project)

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

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

    PHS 398 Research Plan (Research Project)

    Specific Aims:  Provide Specific Aims for the Research Project.

    Research Strategy: 

    • Following the instructions in the SF424 (R&R) Application Guide, start each section with the appropriate section heading—Significance, Innovation, Approach.
    • Cite published experimental details and provide the full reference in the Bibliography and References Cited section.
    • Clearly describe the project's objectives and explain its relevance to the overall program's theme. 
    • Specify the biomedical significance of the work proposed.
    • As part of the Research Strategy, include information on preliminary studies, data, and/or prior experience pertinent to this application.
    • Describe the Research Project's use of Core services, including why the services are needed and the advantages and cost effectiveness of Core usage for the Project. 
    • Provide a timeline and recruitment objectives if pertinent.
    • Describe the strategies and processes that will be used to manage the research project and achieve the overall goals, including monitoring progress with respect to Milestones, and proposed 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:

    NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

    NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, must include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

    Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/.

    If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

    Appendix:

    Only 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)

    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

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

    Optional 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 (Optional 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 (Optional Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Optional 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) (Optional 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 (Optional 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 (Optional Core)

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

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

    PHS 398 Research Plan (Optional Core)

    Specific Aims: Include a brief list of Specific Aims outlining the objectives and functions of the Core. 

    Research Strategy:   Provide the following information:

    Objectives: Description of the objectives of the Core.

    Staffing:  Brief description of scientific, technical, and support staff.

    Resources:  Description of how Core resources will contribute to the objectives of the Research Projects, SAC, DRC.    

    Services provided:  Description of current and projected services to other Core and Research Components, as well as the process for prioritizing requests for use of Core facilities by the various Research Projects.

    Management:  Description of overall management of the Core, decision-making process for use of Core services, and plans for cost-effectiveness and quality control.

    Utilization of Core:  Provide a summary of past and/or projected usage of Core services (e.g., assays performed, etc.).  Include estimates of the percentage use of each Core unit by the affiliated Research Project components.    

    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:

    NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

    NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, must include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

    Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/.

    If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

    Appendix:

    Only 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 (Optional Core)

    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

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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. Applications submitted to the NIH in support of the NIH mission 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 overall program 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 overall program 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 program that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the program address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed program rigorous?  If the aims of the program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the program? 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 program 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 program?

    Specific to this FOA: Are Early stage investigators (ESI) involved in leading different components of the program application? If a multi PD/PI application, are they part of the leadership plan?

    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 program? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed program? 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 program 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 program 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 individuals of all ages (including children and older adults), 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 program proposed? Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?    

    Review Criteria - Science Administrative Core

    Reviewers will evaluate the following items in determining scientific and technical merit. Reviewers will provide a single impact score for the Science Administrative Core. Reviewers will not give separate scores for the individual items. Reviewers will not provide criteria scores.

    • Have the planning and coordination of research activities been adequately described?
    • Have the strategies and processes to be used for P01 management to achieve the overall goals, including monitoring progress with respect to Milestones, implementation of the overall Project Management Plan, and proposed Timelines been discussed?
    • Has information on the integration of cross-disciplinary research, allocation of funds, management of resources and quality control been provided?
    • Are the plans for the maintenance of ongoing communication, and plans for evaluation of the Program Project by internal or external advisory board been clearly delineated? 
    • Are the qualifications, experience, and commitment of the Core director and other Core personnel appropriate?
    • Are the Core's governance and organizational structure appropriate?
    • Is the Core cost-effective, and are there appropriate quality control measures?
    • Evaluate how decisions will be made for identifying, reviewing and funding pilot projects and describe their adequacy and rigor. 
    • Has a plan been provided to mentor new and early stage investigators that will foster career development and promote talented junior investigators into leadership roles and independent research careers?
    Review Criteria - Data Resource Core

    Reviewers will evaluate the following items in determining scientific and technical merit. Reviewers will provide a single impact score for the Data Resource Core. Reviewers will not give separate scores for the individual items. Reviewers will not provide criteria scores.

    • Is the plan for services to be provided to the other Core, Research Projects, and the process for prioritizing requests for use of Core facilities by the various Research Projects adequately formulated?
    • Is the design of overall management of the Core, decision-making process for use of Core services, and plans for cost-effectiveness and quality control included?
    • Have a description and rationale been provided for how DRC resources will contribute to the objectives of the Research Projects? 
    • Is there a discussion of how the core will implement new, improved and enhanced bioinformatics analysis pipelines and web-based screening and follow-up of enrolled patients?
    • Has information been provided on innovative capabilities in data analysis and visualization, including artificial intelligence (AI) strategies to enhance data integration workflows and pipelines, and how these will be developed to serve as community accepted standards?
    • Has a description of plans for statistical and data management support and for creating and maintaining the necessary clinical infrastructure been provided? 
    • Have strategies for the maintenance and oversight of the clinical sites associated with the PHACS cohorts been described?
    • Have the personnel involved in maintaining and operating the clinical sites and the Community Advisory Board (CAB) been discussed?
    • Have plans for outreach and dissemination of Information internally and externally including by maintaining a functional website been addressed?
    • Are the qualifications, experience, and commitment of the Core director and other Core personnel appropriate? Are the Core's governance and organizational structure appropriate?
    • Is the Core cost-effective, and are there appropriate quality control measures?
    Review Criteria - Optional Core

    Reviewers will evaluate the following items in determining scientific and technical merit. Reviewers will provide a single impact score for any optional Core(s). Reviewers will not give separate scores for the individual items. Reviewers will not provide criteria scores.

    • Is the plan for services to be provided to the other Core and Research Projects, and the process for prioritizing requests for use of Core facilities by the various Research Projects adequately formulated?
    • Is the design of overall management of the Core, decision-making process for use of Core services, and plans for cost-effectiveness and quality control included?
    • Have a description and rationale been provided for how Core resources will contribute to the objectives of the Research Projects and other Cores? 
    • Has information been provided on innovative capabilities for services provided, data analysis and visualization and dissemination of results?
    • Has a description of plans for statistical and data management support been provided? 
    • Are the qualifications, experience, and commitment of the Core director and other Core personnel appropriate?
    • Are the Core's governance and organizational structure appropriate?
    • Is the Core cost-effective, and are there appropriate quality control measures?
    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 the prior research that serves as the key support for the proposed project rigorous?  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 Project Leads, 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?

    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 investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed? 

     3) Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?”

    Specific to this FOA: Has the research project's use of the Core services, including why they are needed, been adequately explained?

    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?   

    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 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 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 Individuals Across the Lifespan  

    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 individuals of all ages (including children and older adults) 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 Center for Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

    As part of the scientific peer review, all applications:

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

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

    Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development (NACHHD 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.  
    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.

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

    Prior Approval of Discretionary Funds

    Projects and activities proposed by the PHACS PI/PD through the Scientific Administrative Core (SAC) requesting discretionary funds that exceed 10% of the annual direct costs of the P01 award will require prior approval by NIH prior to initiation.  The awardee institution will provide NIH with written study protocols, budgets and justification and other relevant informational materials to support the request.

    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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.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

    Not Applicable

    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, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Sean Altekruse, DVM, MPH, PhD
    National Heart, Lung, Blood Institute (NHLBI)
    Telephone: 301-435-1290
    Email: altekrusesf@mail.nih.gov

    Bill G. Kapogiannis, M.D. 
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD))
    Telephone: 301-402-0698
    Email: kapogiannisb@mail.nih.gov

    Vikrant Sahasrabuddhe, M.B.B.S., M.P.H., D.Ph.
    National Cancer Institute (NCI)
    Telephone: 240-276-7332
    Email: sahasrabuddhevv@mail.nih.gov

    Kendall Bryant, PhD
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Telephone: 301-402-9389
    Email: kbryant@willco.niaaa.nih.gov

    Melanie Bacon, R.N., MPH
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301-451-2747
    Email: mbacon@niaid.nih.gov

    Karen Sirocco
    National Institute on Drug Abuse (NIDA)
    Telephone: 451-8661
    Email: siroccok@nida.nih.gov

    Howard Hoffman, MA
    National Institute on Deafness and Other Communication Disorders (NIDCD)
    Telephone: 301-402-1843
    Email: hoffmanh@nidcd.nih.gov

    Gallya Ganott DMD, PhD
    National Institute of Dental & Craniofacial Research (NIDCR)
    Telephone: 301-594-7985 
    Email: isaac@nidcr.nih.gov 

    Pim Brouwers, PhD
    National Institute of Mental Health (NIMH)
    Telephone: 301-443-6100
    Email: ebrouwer@mail.nih.gov

    May Wong, PhD
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-1431
    Email: wongm@ninds.nih.gov  

    Peer Review Contact(s)

    John Pugh, Ph.D.
    Center for Scientific Review
    Telephone: 301-442-1059
    Email: pughjohn@mail.nih.gov

    Financial/Grants Management Contact(s)

    Lynn Rundhaugen
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-480-4546
    Email: lynn.rundhaugen@nih.gov

    Bryan Clark, MBA
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    Telephone: 301-435-6975
    Email: clarkb1@mail.nih.gov  

    Sean Hine
    National Cancer Institute (NCI)
    Telephone: 240-276-6291
    Email: hines@mail.nih.gov

    Judy Fox
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Telephone: 301-443-4704
    Email: jfox@mail.nih.gov

    Ann Devine
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301-402-5601
    Email: adevine@niaid.nih.gov

    Pamela Fleming
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-435-1369
    Email: pfleming@nida.nih.gov

    Chris Myers
    National Institute on Deafness and Other Communication Disorders (NIDCD)
    Telephone: 301-435-0713
    Email: myersc@nidcd.nih.gov

    Diana Rutberg
    National Institute of Dental and Craniofacial Research (NIDCR)
    Telephone: 301-594-4798
    Email: dr258t@nih.gov

    Rita Sisco
    National Institute of Mental Health (NIMH)
    Telephone: 301-443-2805
    Email: rita.sisco@nih.gov

    Tijuanna DeCoster, Ph.D.
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-9231
    Email: decostert@mail.nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

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

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.