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)

Funding Opportunity Title

Safety and Effectiveness of Triple Antiretroviral Drug Strategies for Prevention of Mother to Child HIV Transmission (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HD-14-027

Companion Funding Opportunity

None 

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.865 

Funding Opportunity Purpose

This funding opportunity announcement (FOA) issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) invites applications to evaluate the safety and effectiveness of implementation of triple antiretroviral drug strategies for prevention of mother to child HIV transmission in resource-constrained settings - either an approach in which antiretroviral drugs stop after breastfeeding cessation in women who don't require therapy for their own health (termed by the World Health Organization "Option B') or a strategy in which life-long antiretroviral therapy is started in all pregnant women regardless of immune or clinical status (sometimes referred to as "Option B+"). 

Key Dates
Posted Date

February 11, 2013

Open Date (Earliest Submission Date)

July 30, 2013

Letter of Intent Due Date(s)

July 30 2013

Application Due Date(s)

August 30, 2013, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October/November 2013

Advisory Council Review

January 2014

Earliest Start Date

April 2014

Expiration Date

August 31, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). 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

This funding opportunity announcement (FOA) issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) invites applications to evaluate the safety and effectiveness of implementation of triple antiretroviral drug strategies for prevention of mother to child HIV transmission in resource-constrained settings - either an approach in which antiretroviral drugs stop after breastfeeding cessation in women who don't require therapy for their own health (termed by the World Health Organization "Option B') or a strategy in which life-long antiretroviral therapy is started in all pregnant women regardless of immune or clinical status (sometimes referred to as "Option B+"). 

Background

Guidelines for prevention of mother-to-child HIV transmission (PMTCT) in resource-constrained settings are rapidly changing due to:  increasing availability and decreasing cost of antiretroviral (ARV) drugs in such settings;  new evidence to support ARV treatment of infected individuals with high CD4 cell count to reduce sexual transmission to uninfected partners; increasing country experience with use of triple ARV regimens in pregnant women; and ambitious goals for elimination of pediatric HIV infection by 2015 (WHO/UNICEF Global Plan Towards the Elimination of new HIV Infections Among Children by 2015 and Keeping Their Mothers Alive).   The World Health Organization (WHO) currently recommends that all pregnant women with CD4+ lymphocyte counts <350 cells/µL or advanced HIV disease (WHO Stage 3 or 4 disease) should have immediate initiation of ARV therapy (ART); approximately 50-60% of HIV-infected pregnant women are in this category.  The 2010 WHO guidelines recommended that  women with higher CD4 counts receive either zidovudine after 14 weeks gestation with additional peripartum drugs and if breastfeeeding, infant nevirapine prophylaxis through cessation of breastfeeding (termed by WHO as “Option A”) or a triple ARV drug regimen after 14 weeks gestation through cessation of breastfeeding (termed by WHO as "Option B"). 

In an April 2012 program update,  WHO emphasized the potential programmatic and health benefits of the triple ARV drug regimen approach (“Option B”) for all pregnant women; this recommendation will significantly increase the number of pregnant women receiving combination ARV drugs during pregnancy and breastfeeding.  WHO also suggests that administration to pregnant women of a simplified, one daily, single pill, fixed-dose combination ARV regimen (tenofovir/lamivudine/efavirenz) that is the same as that recommended for treatment of non-pregnant individuals will result in greater efficiency and improve program implementation at the country level.  Additionally, many countries are considering switching to a strategy of starting all pregnant women on ART for life regardless of CD4 count (“Option B+”), which in addition to increasing the number of women receiving ARV drugs during pregnancy will also result in subsequent pregnancies being conceived while the women are receiving ARV drugs.  While the Option B/B+ strategies offer many benefits, there remain many important unanswered questions regarding wide-scale implementation of such programs and an urgent need for careful monitoring and evaluation, particularly of effectiveness and safety of these approaches.

With expansion of ARV drug use in pregnancy, more fetuses will be exposed to multiple  drugs, often from conception through delivery.   The new WHO program update recommends use of tenofovir/lamivudine/efavirenz in pregnancy because it is a simple, fixed dose combination one pill once daily regimen and is used in non-pregnant adults.  However, data on the safety of tenofovir and efavirenz in pregnancy for the fetus are limited.  Efavirenz has been associated with severe central nervous system birth defects in primates including neural tube defects, although the risk in humans is unclear.  Because the underlying incidence of neural tube defects in the general population is low (0.1-0.3%), a large number of exposures are needed to definitively rule out potential teratogenicity of first trimester efavirenz exposure.  Data on overall birth defects with tenofovir exposure are reassuring but renal and bone toxicity are seen with tenofovir used for therapy, some data suggest potential negative effects of in utero exposure to maternal TDF on infant growth, and primate data suggest a potential effect on fetal bone development.  The short-term and long-term effects of in utero exposure to ARVs in the fetus/infant/child have not been evaluated in resource-constrained settings; additionally, the underlying background incidence of birth defects in these settings has not been well defined.  The high incidence of malnutrition, including folate deficiency, and other comorbidities in pregnant women, could serve to increase the risk of birth defects with ARV use.   Widespread use of efavirenz in women of childbearing age, as now recommended by WHO, in resource-constrained settings may lead to increased rates of birth defects that will be difficult to detect without systematic study, particularly as the background rate of birth defects has not been defined in these settings. 

Additionally, data from Europe and more recent data from Africa suggest that combination ART use in pregnancy, particularly use at conception and throughout pregnancy, may increase the risk of preterm birth, low birth weight, and stillbirth, leading to additional morbidity and mortality.  Systematic study of outcomes with appropriate control groups to establish the background rates of abnormalities such as birth defects, preterm birth, and developmental and growth abnormalities is required to delineate the benefits and risks of perinatal ARV exposures and to identify the most appropriate ARV regimens in pregnancy.

There are very limited data related to acceptability of initiation of ART, particularly life-long ART with Option B+, when administered for the purpose of prevention of transmission to partners and infants in women who would otherwise not be taking ARV drugs for treatment.  A number of studies from both resource-rich and constrained settings suggest particular problems with adherence to ART in women during the postpartum period and possibly also during pregnancy.  Recent studies from Africa also suggest that pregnant women starting ART may have a higher risk of loss-to-follow-up than non-pregnant individuals starting ART.   It is critical to obtain data to assess to what extent women are adherent to ART through the period of risk for MTCT and whether they continue to be adherent after the risk for MTCT has ceased (i.e., cessation of breastfeeding).

Integration of HIV care and treatment into maternal-child health programs, especially in rural areas, is difficult.  In addition, retention of women in care after delivery is challenging with high loss to follow up rates thus far.  Innovative mechanisms must be developed to facilitate starting women on ARV drugs during pregnancy and then maintaining them on treatment as they transition from pregnancy care to HIV care to minimize interruptions in therapy or suboptimal adherence which can lead to development of resistant virus and loss of treatment options.  These strategies may need to include task shifting, or training of nurses or mid-level providers in initiation and monitoring of ARV regimens with remote physician consultation.  Service delivery must be designed to maximize retention in care and adherence to drug regimens and to ensure a reliable supply chain of ARV and avoid stock-outs.

Studies to evaluate effectiveness of PMTCT interventions in resource-constrained settings on the ground have generally focused on short-term efficacy, evaluating infant infection status at age 6 weeks.  However, breastfeeding may continue for 12 months or longer, and data on the long-term efficacy of ARV interventions in terms of infant HIV-free survival after the period of breastfeeding has ceased is critical to understand the overall efficacy and safety of interventions.

It is hypothesized that Option B/B+ offers significant benefits of ARV for maternal health in women with high CD4 count and for prevention of sexual transmission.  Data to document these benefits will be critical to determine the true effectiveness and cost-efficacy of these interventions.  Cost-efficacy studies are needed to be able to provide governments with data to determine what PMTCT program is optimal for their setting.   Finally, the impact of the B/B+ ART interventions on the ability of country programs to serve all adults in need of ART needs to be evaluated, and whether the country is able to meet the needs of individuals who meet standard criteria for ART initiation with implementation of B/B+ ART for PMTCT programs.

Scope of Work

Applicants should propose novel methods for evaluating safety and effectiveness of implementing the strategy of use of triple ARV regimens for PMTCT (Option B/B+) in pregnant women in resource-constrained settings.  Areas of interest include, but are not limited to:

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.

Funds Available and Anticipated Number of Awards

NICHD intends to commit $5,000,000 total costs to fund 5-10 awards in fiscal year 2014.

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations.

Award Budget

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

Award Project Period

The scope of the award should determine the project period. The maximum period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

Required Registrations

Applicant Organizations

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

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

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

The letter of intent should be sent to:

George Siberry, MD, MPH
Maternal and Pediatric Infectious Disease Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institutes of Health
6100 Executive Boulevard, Room 4B11
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-496-7350
Email: siberryg@mail.nih.gov; wattsh@exchange.nih.gov  

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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

Resource Sharing Plan

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

Appendix

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

Foreign Institutions

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application before the deadline in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

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

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.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NICHD, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.     

Overall Impact

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? 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? How does the study address a priority research area related to safety and/or effectiveness of triple ARV regimens used for PMTCT? Can the proposed research, if successful, be generalized to PMTCT in different developing country settings?  Does the research have potential for promoting health of HIV-infected women and their children?  Will the answers to the research questions be relevant, useful and generalizable to the global efforts to scale up PMTCT and/or maternal/child HIV care services?

Investigator(s)    

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

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? Does the project incorporate new approaches to answer questions related to safety and efficacy of triple ARV programs? Will answering the research question add significantly to the knowledge base related to PMTCT, safety of in utero ARV exposure, and/or maternal/child HIV care?  

Approach

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

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

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? Do the investigators demonstrate they have access to the appropriate populations for studying safety/effectiveness of use of antiretroviral therapy to prevent perinatal HIV transmission in developing countries?      

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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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

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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

For some investigator-initiated clinical trials or epidemiology studies, NICHD may need to convert a grant to a cooperative agreement because substantial scientific involvement of NICHD staff is required; criteria include one or more of the following:  1) the investigator proposes an investigator-initiated clinical trial, a prevention, education, or control intervention, or an epidemiologic study for more than $500,000 in direct costs in any year; 2) regulatory support is required from NICHD; or 3) the study involves clinical studies or trials with more than minimal risk and considerable NICHD staff involvement is required to review and approve protocols and monitor.  Such conversion will be discussed with the PI, and terms of award agreed upon by both the investigator and NICHD scientific staff.

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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

Scientific/Research Contact(s)

For pediatric questions:

George Siberry, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-7350
Email: siberryg@mail.nih.gov

For obstetric questions:

Heather Watts, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6874
Email: wattsh@exchange.nih.gov 

Peer Review Contact(s)

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone:  301-496-1485
Email: duperes@mail.nih.gov

Financial/Grants Management Contact(s)

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone:  301-435-1485
Email: clarkb1@mail.nih.gov)

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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