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 Institute of Dental and Craniofacial Research (NIDCR)

Funding Opportunity Title

Women’s HIV Epidemiology Cohort Studies (R01 Clinical Trial Not Allowed)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of RFA-HD-18-018

Related Notices
  • January 22, 2019 - Notice of Change Application Due Date(s) for RFA-HD-19-024. See Notice NOT-HD-19-002.

Funding Opportunity Announcement (FOA) Number

RFA-HD-19-024

Companion Funding Opportunity

None

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

 93.865, 93.121    

Funding Opportunity Purpose

NICHD plans to establish new epidemiology cohort(s) of least 2000 participants to stimulate research on a wide range of HIV research hypotheses pertinent to reproductive age women.  The purpose of this Funding Opportunity Announcement (FOA) is to support new and innovative epidemiology research in reproductive age women living with HIV.   

Key Dates

 

Posted Date

January 16, 2019

Open Date (Earliest Submission Date)

March 4, 2019

Letter of Intent Due Date(s)

March 4, 2019

Application Due Date(s)

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

AIDS Application Due Date(s)

New Date - May 14, 2019, 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 these dates.

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.

Scientific Merit Review

July 2019

Advisory Council Review

October 2019

Earliest Start Date

December 2019

Expiration Date

New Date May 15, 2019 per issuance of NOT-HD-19-002. (Original Expiration Date: April 5, 2019 )

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


Table of Contents

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

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


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

The purpose of this Funding Opportunity Announcement (FOA) is to support new and innovative epidemiology research in reproductive age women living with HIV. NICHD plans to establish new epidemiology cohorts of least 2000 participants to stimulate research on a wide range of HIV research hypotheses pertinent to reproductive age women. This new research will help to define and understand clinical outcomes over the course of young women's reproductive lives, including on the effects of HIV and antiretroviral treatment during pregnancies and post-partum and lactation periods, including but not limited to contraception, drug-drug interaction, and pregnancy outcomes.

Background

The number of women living with HIV continues to increase globally. With the availability of effective antiretroviral therapy, there is a critical need to understand the complex health needs of reproductive-age young women. CDC statistics have shown that in the United States 1 in 4 individuals living with HIV are women and that women accounted for approximately 19% of new infections in 2015. There is a disproportionate large number of Black/African Americans and Hispanic/Latina women affected by HIV, compared with women of other races/ethnicities. There is evidence that women experience more adverse effects of HIV treatment due to biological psychological, and social factors, that influence the way pregnant and non-pregnant women experience HIV infection. Pregnant women who have opioid misuse and opioid use disorder are at higher risk of acquiring and transmitting infections such as HIV and HCV to their children. Pregnant women with HIV who inject drugs have a worse clinical status, more adverse pregnancy outcomes and higher risk of mother to child transmission than non-injecting drug users.

As HIV becomes a chronic illness that needs lifelong management, reproductive health and the consequences of antiretroviral treatment, pregnancy, post-partum outcomes and HIV-associated complications and co-morbidities are areas that are important to study. Epidemiologic studies within a cohort of young women of reproductive age are crucial for understanding how long-term effects of HIV and its treatment influence health and disease.

Observational cohorts are valuable resources whose findings have generated scientific hypotheses, informed prevention strategies, and clinical trials. There is also a valuable investment in infrastructure for the analysis, collection and management of data and specimens, routine participant follow-up, and clinical events. These studies also help advance insights into behavioral, environmental, molecular, and genomic determinants related to health outcomes.

Scope

The purpose of this FOA is to support new and innovative epidemiology research on critical scientific questions on the clinical course of HIV infection and treatment in a large cohort of reproductive age women living with HIV. An understanding of the socio-dynamic factors that influence health care decisions, healthcare seeking behaviors and adherence especially the risk factors for pregnant and non-pregnant young women living with HIV who use or misuse drugs. To facilitate this novel epidemiology research, the NICHD will support new cohorts of at least 2000 reproductive age women to address research questions that are not easily studied in other cohorts supported by the NICHD.

 
Cohort Eligibility

Awards made under this FOA are intended to support hypothesis-driven cohort research that:

  • Enrolls at least 2,000 reproductive age pregnant and non-pregnant, behaviorally or perinatally infected women living with HIV from geographically distributed areas with high HIV rates within the US.
  • Supports research questions pertinent to young women with HIV of reproductive age range.
  • May leverage infrastructure used by other cohorts
  • Is innovative (creative study designs, novel surveillance methods, data linkage for mother and offspring outcomes, scientific hypotheses, use of new or emerging technologies)

Although multiple PD/PI applications are not required, multi-investigator, collaborative, interdisciplinary applications from newly established investigators are highly encouraged. The objective is to ensure that the most effective and comprehensive approaches to establishing or leveraging a large cohort of at least 2000 young reproductive age pregnant and non-pregnant women with behaviorally and perinatally acquired HIV and investigating the critical scientific issues are applied.

Selected Research Examples

Investigators should propose hypotheses about the impact of HIV and its treatment on young women's development, reproductive health, and disease outcomes throughout their reproductive life. The research questions below are used as examples and not meant to be prescriptive or limiting:

  • Effects of exposure to HIV and antiretroviral drugs on genetic and epigenetic outcomes in offspring
  • Effects of HIV and its treatment during conception, pregnancy, post-partum, and lactation period on the mother and offspring.
  • Changes in oral health and salivary function with HIV disease progression, persistence and ART treatment modifications
  • Impact of HIV disease or ARV therapy on co-morbid conditions chronic health conditions, on health outcomes.
  • Investigate co-infection such as CMV and syphilis and transmission to newborn
  • Postpartum depression, opioid use and misuse, and other mental health diagnoses’ impact on adherence and treatment outcomes
  • Impact of antiretroviral treatment on immunity and inflammatory biomarkers in offspring
Activities Supported Under this FOA

The NICHD intends to fund both scientific and infrastructural components of this new epidemiology cohort study. Supported activities include, but are not limited to, the following:

  • Manuscript preparation
  • Initial cross-sectional cohort data analyses
  • Follow-up of participants (e.g., medical record review, vital records searches, participant re-contact)
  • Data management, and administrative and communication tasks
  • Archiving and data sharing
  • Data cleaning and quality control
  • Collection, analysis, storage, and maintenance of biological samples
  • Detailed baseline assessment of cohort participants
  • Protocol development and approval
  • Identification and recruitment of cohort participants (population or clinic-/disease-based)
Data Harmonization

Applications that propose to preemptively address the challenges of analyzing data across multiple cohorts, such as by proposing to adopt or use data standards, common data elements, and/or standard ontologies that would facilitate harmonization and sharing/analysis of data across studies, are of high programmatic interest. For more information on common data elements, please refer to Section IV.7, Other Submission Requirements and Information, and the NIH's Common Data Element Resource Portal.   

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
Resubmission

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

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials)

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The following NIH components intend to commit the following amounts in FY {2019}:

  • NICHD, $3.5 Million total costs, to support 1-2 awards
  • NIDCR, $500,000 total costs to support the same 1-2 awards.
Award Budget

Application budgets should not exceed $ 2.5 million in direct costs.  Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum 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, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are 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 Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

Denise Russo, PhD
Telephone: 301-435-6871
Fax: 301-496-8678
Email: drusso1@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Facilities and Other Resources:

As appropriate, describe available resources such as clinical and laboratory facilities, geographic distribution of space and personnel, and resources relevant to the effective implementation of a detailed baseline assessment of cohort participants and, if applicable, the efficient operation of a multi-site study.

Applicants must provide strong evidence of the availability of appropriate institutional resources and access to suitable participant populations.

For multi-site applications, information must be provided for each participating site.

Do not duplicate information collected in the PHS Human Subjects and Clinical Trial Information Form.

Other Attachments:

The attachments listed below must be completed and included in the application.

1. Baseline assessment

A brief description of the data that will be collected during the participant baseline assessment must be provided as an attachment using the filename "Baseline assessment.pdf" and may be up to 2 pages. Participant data may include, but are not limited to:

  • Offspring outcomes
  • Pregnancy outcomes
  • Repeated or longitudinal measurements to support scientific hypotheses, if applicable
  • Participant- or patient-reported outcomes
  • Clinical endpoints
  • Lifestyle factors
  • Co-morbidities and risk factors
  • Clinical characteristics and basic diagnostic information
  • Demographics (e.g., education, residential and occupational history)

2. Cohort management

A description of how the proposed cohort will be managed must be provided as an attachment using the filename "Cohort management.pdf" and may be up to 2 pages. Provide details for each bullet below:

  • Surveillance: Describe plans for active and/or passive participant follow-up or surveillance.
  • Innovative approaches: If applicable, describe the planned use of innovative approaches to data management/standards, data collection, and/or participant follow-up/surveillance.
  • Data harmonization: Describe plans for data harmonization, metadata generation, and adoption/use of data standards or common data elements. If these activities are not possible or feasible for the proposed study, applicants must explain why.
  • Data management: Describe how study data will be managed, including data cleaning, quality control, and database management approaches. Describe how clinical events will be adjudicated.
  • Training/monitoring: Describe how training and monitoring of study sites and staff will be managed.

3. Biospecimen Plan (if applicable)

If applicable, a Biospecimen Plan should be provided as an attachment using the filename "Biospecimen Plan.pdf". If included, it may be up to 2 pages. Provide details for each bullet below:

  • Plans for adherence to Good Laboratory Practices (GLP) and use of current best practices for biospecimen management and quality control
  • How study biospecimens will be collected, processed, analyzed, managed, tracked, and shared
  • Please specify where biospecimens will be stored  
  • Include a brief description of the biospecimens to be collected and, if applicable, plans for repeated or longitudinal biospecimen collection to support scientific hypotheses sampling
SF424(R&R) Senior/Key Person Profile

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

Biographical Sketch:

PD(s)/PI(s) must describe their experience with epidemiology cohort studies, specifically documenting their abilities to organize and manage a cohort study and its related activities.  If a PD/PI has no prior experience with epidemiology cohort studies, then describe experience with large research consortia or multi-site studies. If applicable, note whether the study team has ever worked together.

R&R or Modular Budget

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

Include budget support for travel to a yearly in-person meeting, as well as an initial kick-off meeting of investigators and NICHD program staff; these meetings will be held in the Washington, D.C. area.

Lead PD(s)/PI(s) are required to declare a minimum effort of 2.4-person months per year (equivalent to 20% effort); if the study is led by multiple PDs/PIs, then a minimum combined PD/PI effort of 2.4-person months per year is required.

Budget should include costs for biospecimen storage.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy:

Applicants proposing the involvement of Human Subjects should use the Research Strategy section to discuss the overall strategy, methodology, and analyses of the proposed research. Do not duplicate information collected in the PHS Human Subjects and Clinical Trial Information Form.

In the Research Strategy attachment, applicants must specifically address the following:

  • ·    Surveillance or follow-up of participants over time
  • ·    Investigation of endpoints of clinical significance and other health outcomes
  • ·    The study's multiple research hypotheses
  • ·    How the participant baseline assessment will support:

o  The short-, medium-, and long-term vision for the cohort

  • ·    How the proposed research will align with the MPIDB HIV scientific areas
  • ·    How the proposed cohort study will fill a gap or address critical scientific questions on the clinical course of HIV infection and treatment in reproductive age women living with HIV
  • ·    How the establishment of the proposed cohort study will permit research that will address multiple scientific hypotheses

 
Letters of Support:
A statement of commitment from each participating institution or organization must be provided. If parts of the study are to be provided by sources other than the NICHD, provide Letter(s) of Support signed by an authorized representative.

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Consistent with achieving the goals of the program, applications are expected to describe planned internal and external data and biospecimen sharing policies. It is expected that data derived from the cohort will be deposited in NICHD DASH and plans for storage and sharing of associated biospecimens should be outlined.

NICHD expectations for data sharing:

Data collected under this FOA are expected to be widely shared through the NICHD DASH (https://dash.nichd.nih.gov/) and/or other NIH-designated repositories. Metadata, protocols, manuals of procedures, algorithms for calculated data elements, and other documentation necessary to describe the study and resultant data to investigators not affiliated with the study are also expected to be widely available.

Genomic data sharing:

If proposing to generate large-scale human genomic data, applications are expected to also describe a genomic data sharing plan per the NIH Genomic Data Sharing (GDS) Policy (https://osp.od.nih.gov/wp-content/uploads/NIH_GDS_Policy.pdf). Even if applications do not propose to conduct genomic or other -omic analyses, these types of analyses may occur during future data collection cycles; as such, applicants may wish to anticipate the potential for these types of studies by incorporating relevant language regarding genomic data collection, analysis, and sharing into their informed consent process.

The NIH has developed several guidance documents to assist applicants with the NIH GDS Policy. Applicants are encouraged to review the following resources and to contact NHLBI staff to discuss any concerns about genomic data sharing:

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) 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 Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Section 2 - Study Population Characteristics

2.4 Inclusion of Women, Minorities, and Children

  • Justify the anticipated or projected sample size for the overall cohort and for any relevant subgroups (i.e., is the sample size sufficiently powered to address the study's aims?)

2.5 Recruitment and Retention Plan

  • Describe contingency plans to manage potential delays or barriers with participant recruitment in the overall cohort as well as in key subgroups
  • Provide estimates or other data (e.g., pilot data) to demonstrate the feasibility of meeting proposed recruitment goals, broken down by enrollment site if applicable
  • Demonstrate that each recruitment site has access to sufficient numbers of potential participants to attain its target enrollment

2.7 Study Timeline

Include the following milestones in the study timeline, as applicable:

  • Data cleaning and quality control
  • Anticipated start and end dates for participant recruitment and data collection(s), with anticipated timeline of 20%, 50%, 75% and 100% of recruitment sample
  • Finalized standard operating procedures (SOPs), data collection protocols, and informed consent/assent document(s)
  • Establishment of study infrastructure, such as committees, biospecimen storage, and study sites
  • IRB approval

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

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). 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.

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) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness 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.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies.  CDEs are data elements that have been identified and defined for use in multiple data sets across different studies.  Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.  NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository).  NIH has established a "Common Data Element (CDE) Resource Portal" ( http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection.  The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.  Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.     

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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?

Specific to this FOA:

Will the establishment of the cohort and the proposed cohort study be able to address multiple scientific hypotheses of high relevance to HIV research?   

Investigator(s)

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

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? 

Specific to this FOA:

Does the proposed cohort study address scientific questions on the clinical course of HIV infection and treatment in HIV-positive young women of reproductive age using novel approaches?

Are innovative approaches being used to the facilitate data collection and/or data management of the cohort? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the 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?  

Specific to this FOA:

Is there access to the appropriate population(s) and/or subgroups? Are there contingency plans to manage potential delays or barriers to participant recruitment?

Does the baseline assessment support the study's multiple research hypotheses, clinical endpoints, health outcomes and participant surveillance?

Are the plans for management, storage and sharing of study data and biospecimens rigorous?

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

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

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

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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 (GDS).

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

As part of the scientific peer review, all applications:

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

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

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

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)

Denise Anne Russo, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6871
Email: drusso1@mail.nih.gov

Gallya Gannot, DDS; PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-451-5096
Email: gallya.gannot@nih.gov

Peer Review Contact(s)

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-3415
Email: duperesxxx@mail.nih.gov

Financial/Grants Management Contact(s)

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

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798  
Email: rutbergd@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.

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