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

Obstetric-Fetal Pharmacology Research

Centers (OPRC) (U54)        

Activity Code

U54 Specialized Center- Cooperative Agreements 

Announcement Type

Reissue of  RFA-HD-09-002

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HD-14-013   

Companion Funding Opportunity

None  

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

93.865     

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to announce the competition of the Obstetric-Fetal Pharmacology Research Centers (OPRC) - a specialized cooperative multicenter program in the obstetric pharmacology research. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) proposes to fund a limited number of research centers which will provide an arena for multidisciplinary interactions among basic and clinical scientists interested in establishing high quality translational research programs in the area of obstetric pharmacology.  The centers will also serve as national resources for clinical pharmacological research in women during normal and abnormal pregnancies.  Center investigators will be expected to work with NICHD staff in facilitating research collaborations and interactions within and among the centers.   Such a cooperative program will form a national network that facilitates the translation of knowledge from the basic sciences into the development of new treatments, and findings from clinical studies/trials into practice with ultimate goal of improving the safety and effectiveness of the medical treatment in pregnant women.       

Key Dates
Posted Date

July 15, 2014

Open Date (Earliest Submission Date)

August 15, 2014

Letter of Intent Due Date(s)

August 15, 2014  

Application Due Date(s)

September 15, 2014, 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 2014       

Advisory Council Review

January 2015   

Earliest Start Date

April 2015 

Expiration Date

September 16, 2014 

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

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


You will be sent to ASSIST to prepare and submit your application. Problems accessing or using ASSIST should be directed to the eRA Commons Help Desk.
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 FOA uses the U54 cooperative agreement mechanism with reconfiguration of the Obstetric-Fetal Pharmacology Research Units (OPRU) network and a new name - Obstetric-Fetal Pharmacology Research Centers (OPRC). Current OPRU network investigators are encouraged to apply.

The purpose of this FOA is to invite applications for the OPRC - a specialized cooperative multicenter program in obstetric pharmacology research. NICHD proposes to fund a limited number of research centers which will provide an arena for multidisciplinary interactions among basic and clinical scientists interested in establishing high quality translational research programs in the area of obstetric pharmacology.  The centers will also serve as national resources for clinical pharmacological research in women during normal and abnormal pregnancies.  Center investigators will be expected to work with NICHD staff in facilitating research collaborations and interactions within and among the Centers.   Such a cooperative program will form a national network that facilitates the translation of knowledge from the basic sciences into the development of new treatments, and findings from clinical studies/trials into practice, with ultimate goal of improving the safety and effectiveness of the medical treatment in pregnant women.

Background

Pharmacoepidemiological surveys indicate that nearly two-thirds of all pregnant women take up to four medications either by prescription or over-the-counter during pregnancy and labor. The majority of such medication use is either off-label or based on an empiric understanding of dosing, safety, and efficacy rather than based on well-designed and carefully monitored clinical studies during pregnancy. In addition, pregnancy induces extensive physiological and biochemical changes that involve the mother, placenta, and the fetus and typically lead to variations in the absorption, distribution, and elimination of drugs as well as response to treatment. Current therapeutic practice does not take into account these profound physiological and biochemical changes. Therefore, appropriate medication use during pregnancy is a major public health concern. 

To address this unmet medical need, NICHD established the Obstetric-fetal Pharmacology Research Unit (OPRU) network in 2004 to provide critical research infrastructure for pharmacokinetic (PK) and pharmacodynamic (PD) studies of medications used during pregnancy. During the funding period between 2004 and 2014, the OPRU network focused on several priority areas such as gestational diabetes, preterm birth, and preeclampsia as well as on opportunistic drugs being used as part of routine clinical care. Through multidisciplinary collaboration between the basic and clinical scientists, the OPRU conducted basic/translational studies to characterize and evaluate the impact of physiological, cellular, and molecular changes during pregnancy on drug disposition. The OPRU also performed clinical phase 1 and phase 2 trials to determine optimal dose and dosing range of the drugs for the above diseases/conditions during pregnancy.

Remarkable progress has been made in obstetric therapeutic research in the past few years. However, significant knowledge gaps remain in the understanding of mechanism of drug action for many of the drugs used during pregnancy.  By issuing this FOA, NICHD seeks to establish the next program using the U54 collaborative agreement mechanism to address research in obstetric-fetal pharmacology and therapeutics. The Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB) recognizes that the interactive needs of basic and clinical research necessary to address this challenge may be so complex that they cannot be solved by individual investigators working alone. Therefore, NICHD seeks to continue organized, multi-component obstetric-fetal pharmacology research programs that focus on topics of high priority and significance that are critically important to the mission of the OPPTB and NICHD, and that address important public health concerns for pregnant women.

Objectives

A major objective of the OPRC is to support specialized basic/translational and clinical obstetric-fetal pharmacology research programs of high quality, and to facilitate and accelerate bidirectional transfer of knowledge between the laboratory and clinic. This process of translating research between the laboratory and clinic is a continuum that encompasses all aspects of knowledge transfer from non-human animal models to humans. Application of information from rodent species to non-human primates, for example, is considered part of the translational continuum. However, the ultimate goal of supporting translational research through the OPRC is to improve the understanding and utilization of pharmacotherapeutics in pregnant women.  

This FOA is specifically designed to stimulate the obstetric-fetal pharmacology research community to organize and maintain research-based Centers of outstanding quality that, serving as national research resources, form a cooperative network with NICHD that fosters communication, innovation, and high quality obstetric-fetal pharmacology research. Such networking as afforded by the cooperative nature of this Centers Program will ensure that the obstetric pharmacology research community remains in the forefront of the development and utilization of new technologies that can be used to improve the safety and effectiveness of drug treatment in pregnant women.

Scope

The OPRC is composed of research-based Center grants designed to support interactive groups of research projects and supporting core service facilities. The research activities in these Center grants must comprise, by definition, a multidisciplinary approach to address research questions in obstetric-fetal pharmacology and therapeutics. These centers may have more than one theme, focus or emphasis, but all of the subprojects involved must be responsive to one or more of the specific research areas of obstetric pharmacology supported by the OPPTB. For example, one subproject could study the pathophysiological changes in pregnancy-related conditions/diseases that alter drug responses during pregnancy, while another subproject could study or discover biomarkers/molecular targets or small molecules or compounds for a novel treatment of pregnancy-related conditions/diseases. 

The objectives of this program require that one of the subprojects be entirely or predominantly clinical to study PK and/or PD of the drugs used in pregnancy and that the basic science subproject(s) be thematically linked to the clinical component(s) of the center.

Topics that are considered to be responsive to the research mission areas of the OPPTB include but are not limited to the bulleted items below.  These topics identify areas where research at the basic/clinical interface is deemed essential to the potential development of new leads or approaches to pharmacology research, as well as of diagnostic tools/devices for the detection, treatment and effective management of obstetric disorders.

  • Establish predictive non-clinical models including animal, cell, tissue and organ based systems, computational and system modeling to evaluate drug response and toxicity in pregnancy and developing fetus.
  • Study and identify biomarkers for safety, early prevention, and effective treatment of pregnancy- related diseases/conditions.
  • Develop and validate novel therapeutic agents for safe and effective treatment of pregnancy related diseases/conditions.
  • Perform non-clinical and clinical research to understand mechanisms of pregnancy-related changes in drug response and disposition.
  • Develop assays and analytic procedures that have the sensitivity, reproducibility, and value to inform obstetric medication development and use.
  • Develop outcome measures of drug exposure during pregnancy, assess the safety and toxicity of the drugs during pregnancy, postpartum, and in postnatal periods of development.
  • Establish interdisciplinary collaborative approaches to understand the PK and/or PD of medications use during pregnancy.

Applications proposing research activities focused exclusively on basic research, applied research in the support or performance of known and established pharmacologic assays, or analysis in support of ongoing clinical trials or applications or components thereof, or proposing epidemiological or large-scale trial research, will not be considered responsive to this FOA.

 
Components and Specific Requirements

OPRC will consist of the following main aspects:

1. Administrative Core

The administrative core provides oversight, support and management of clinical and basic/translational research activities, and provides coordination of communication and collaborations with the Logistic Coordinating Core and among other Centers of the OPRC. 

The administrative core will house appropriate administrative/business management staff and oversight mechanisms by the Center Director (PD/PI), and Associate Director (if applicable).  The Center Director (PD/PI) may also serve as the Project Lead on a Research Component of the OPRC.

  • The administrative core of each OPRC will support training:
  • As national resources for obstetric-fetal pharmacology research, the OPRC plays leadership roles in training of new researchers for the obstetric-fetal pharmacology research field.
  • To establish and maintain a training environment for predoctoral and/or postdoctoral fellows including clinical fellow investigators in the obstetric-fetal pharmacology research.
  • Each Center must coordinate and integrate the training programs across the OPRC with a goal of aiding the development of a new cadre of cross-disciplinary scientists in obstetric-fetal pharmacology. Utilization and adaptation of existing training programs are encouraged.

2. Research Project Components

(1) Clinical Research Project (Concept Proposal)

  • A minimum of one clinical study concept proposal should be proposed from each center for a potential collaborative project to be carried out by all Centers to provide peer reviewers and the NICHD an idea of capabilities of investigators. When the Center is awarded, the concept proposal from each Center selected will be discussed by the OPRC Steering Committee. Some concept proposals may be further developed into an OPRC collaborative project with the OPRC Steering Committee.
  • The Clinical Research Project should study the disposition, efficacy, and safety of medications whose pharmacologic profiles were found to differ during pregnancy. Within the Clinical Research Project, clinical pharmacological expertise is required to conduct PK and/or PD analysis to identify differences in drug disposition, effect, and/or toxicity during pregnancy compared to the non-pregnant state.  Phase 1 and/or phase 2 studies of existing or new molecular entities (NMEs) designed to treat pregnancy related conditions/diseases will be studied.

(2) Basic/Translational Research Project(s)

  • A basic/translational research component will elucidate basic mechanisms for differences in drug disposition and response during normal and abnormal pregnancies, and assess, characterize and validate biomarkers or molecular targets or compounds as potential novel therapeutic agents for safe and effective treatment of diseases/conditions in pregnant women.
  • At least one strong research project must thematically link to the clinical concept proposal proposed for a potential OPRC collaborative project.

(3) Pilot Projects (optional)

  • Pilot projects may be proposed for Years 01 and 02 to generate preliminary data for submission of an R01 or Center project, to develop new technologies that further enhance the research efforts of the Center, or to support clinical research studies that could form the basis for conduct of large scale clinical trials through the relevant NICHD funded Networks/Centers.

3. Logistic Coordinating Core (Optional)

Each application may include a Logistic Coordinating Core (LCC). One LCC will be selected to serve all the Centers and be responsible for ensuring that OPRC collaborative clinical studies/trials are carried out in compliance with applicable federal regulations and policies. The LCC will not perform data analyses nor provide statistical services to the OPRC clinical studies/trials; however, the LCC will facilitate and coordinate the OPRC clinical study activities, and ensure that all activities are implemented. 

The LCC will also perform a range of administrative functions including organizing Steering Committee and Data Safety Monitoring Committee meetings, arranging conference calls, and designing and maintaining a website that will contain information of the previous OPRU network and the current OPRC program. The LCC Director does not have to be a Project Leader. The LCC component can be within the applicant’s institution/Center or from a different institution as a subcontractor in the application.    

Steering Committee

The Steering Committee (SC) voting members consist of all PDs/PIs of the OPRCs, and the NICHD Program Scientist. The SC non-voting members include the LCC Director and the other NIH staff. The SC will be chaired by an investigator selected by the NICHD.

The SC will develop by consensus the protocols to be carried out by the OPRCs and oversee the conduct of the studies. The SC will also employ a consensus decision process to guide the OPRCs in evaluating the progress of member Center programs, their proposed new research initiatives within the scope of the approved program, the need to provide the entire OPRCs with access to new technologies, the need for collaborations either within or outside the OPRC, and the need to redirect certain efforts of member Centers due to either sufficient data acquisition to permit conclusion, the acquisition of data supporting an alternative study initiative or experience providing that the proposed research is no longer feasible, or, in the case of OPRC-side resources, lack of utilization.

Steering Committee Meetings:

The SC will meet in person twice a year throughout the project period. One meeting will be held in or near Bethesda, MD and one meeting will be held at an OPRC grantee site. Each OPRC should include funds for the PD(s)/PI(s) to travel to the SC meetings.   

Data Safety Monitoring Committee

The NICHD will appoint an independent Data Safety Monitoring Committee (DMC) in accordance with established policies to ensure data quality and participant safety of ongoing clinical studies/trials, and to provide independent advice to the NICHD regarding progress and the appropriateness of continuing each study. The DMC is composed of individuals with expertise in clinical trial design and conduct, obstetrics and clinical pharmacology and ethics.    

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

Renewal

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

Funds Available and Anticipated Number of Awards

NICHD intends to commit approximately $4,800,000 in total costs in FY2015 to fund 4-6 awards.  Future year amounts will depend on annual appropriations.   

Award Budget

Applicants may request a budget for direct costs no more than $530,000/year (exclusive of facilities and administrative costs of subcontracts with collaborating organizations).

Award Project Period

The maximum period of support 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

  • 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) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

The Center Director should possess an M.D. or Ph.D. degree and should be an established investigator with record of external funding, but is not required to have a record of accomplishment in obstetric pharmacology research.

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.
Section IV. Application and Submission Information
1. Requesting an Application Package

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

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

  • 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:

Zhaoxia Ren, MD, PhD

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

6100 Executive Blvd Room 4A01D MSC 7510

Bethesda, MD 20892-7510
Telephone: 301-402-9340

Fax: 301-480-2897
Email: zren@mail.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12 pages

Admin Core

12 pages

Research Projects

6 pages

Logistic Coord Core

6 pages

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

  • Overall: required
  • Admin Core: required
  • Research Project:  Clinical Project - required
  • Research Project:  Basic/Translational Project(s) - up to two (one required; one optional)
  • Research Project:  Pilot Project(s) - optional, up to 2 pilot projects may be proposed
  • Logistic Coordinating Core: optional
Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims:  State the overall goals of the Center. The Specific Aims should not be the same as the specific aims of the other components, but should be overarching and at a high level.  

Research Strategy:  Describe the major themes of the overall Center, its goals and objectives, background information and the overall importance of the research to the theme of this program as outlined in the Section I. Funding Opportunity Description. Explain the strategy for achieving the goals defined for the Center and how the Administrative Core and each research project relate to that strategy.

Describe the roles of the Director and Associate Director and their qualifications as leaders of the Center. Describe the organizational structure of the Centers for Collaborative Research in obstetric-fetal pharmacology including the components of the Center and any existing resources of the institution(s) that will be leveraged by the Center. Explain how the different aspects of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goals of the Center, and how combined resources create a Center that is more than the sum of its parts.

Letters of Support:  Include any letters of support for the U54 Center Overall

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

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

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

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

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

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

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget (Administrative Core)

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

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

The PD/PI (Center Director) is required to be the Administrative Director and must commit to 2.4 person months (20%) full-time professional effort to administrative activities directly related to the Center. One or more Associate Directors may be named as well, but the combined efforts for the Center Director and the named Associate Directors should not exceed 6 person-months effort (equivalent to 50% full-time professional effort).

The budget for the Administrative Core must include $30,000 direct costs per year to support Training. The funds will provide translational research training experiences, both didactic and/or laboratory, for students, postdoctoral fellows or residents from other Centers, and post-residency scholars supported under NIH institutional training awards, and other training programs.

Steering Committee Meetings:   The SC will meet in person twice a year throughout the project period. One meeting will be held in or near Bethesda, MD and one meeting will be held at an OPRC grantee site.  The Administrative Core for each OPRC should include funds for PD(s)/PI(s) to travel to the SC meetings.   

PHS 398 Research Plan (Administrative Core)

Specific Aims:  Describe the specific aims of the Administrative Core.  

Research Strategy:  Describe the organization of the Administrative Core and the importance to the research theme of the Center. Explain the strategy for achieving the specific aims of the Administrative Core and the goals of the OPRC Program.

The Administrative Core will be responsible for the management and administration of the overall Center. This section of the application should describe the strategies and processes that will be used to manage the Center and achieve the goals.  The Administrative Core will also provide the coordination and communications with the LCC and the other Centers for the OPRC collaborative clinical studies. 

This Core, led by the Center Director, will provide oversight for the projects, promote coordination and collaboration within the Center and with investigators and organizations among other OPRCs. A narrative description should be provided that includes the planning and coordination of research activities; the integration of cross-disciplinary research; the oversight of fiscal and resource management; and the maintenance of ongoing communication. Indicate who will be responsible for each of these activities. Applicants should specify appropriate administrative/business management staff and oversight mechanisms by the Center Director, Associate Director, and/or a local Executive Committee.

When multiple performance sites are planned, the Administrative Core should include leadership and communication plans adequate to manage the multiple sites.

As national resources for obstetric-fetal pharmacology research, the OPRC plays leadership roles in training of new researchers for the obstetric-fetal pharmacology research field.   Each Center should include plans to establish and maintain a training environment for predoctoral and/or postdoctoral fellows, including clinical fellow investigators in the obstetric-fetal pharmacology research.  Each Center must coordinate and integrate the training programs across the OPRC with a goal of aiding the development of a new cadre of cross-disciplinary scientists in obstetric-fetal pharmacology. Utilization and adaptation of existing training programs are encouraged.

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

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

Letters of Support:  Include any letters of support specific to this component.

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.   

Planned Enrollment Report  (Administrative Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Research Project:  Clinical Project

When preparing your application in ASSIST, use Component Type ‘Research Projects.’

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

SF424 (R&R) Cover (Research Project:  Clinical Project)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project:  Clinical Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project:  Clinical Project)

Facilities and Other Resources:  Applicant clinical centers must have an academically-oriented OB/GYN department or division of maternal fetal medicine and a minimum of 2,700 births per year, provide evidence of research productivity in previous or ongoing clinical trials, especially those of cooperative or multicenter design, and have a potential to collaborate with the NICHD Maternal Fetal Medicine Units (MFMU) network site(s).

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

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

Project /Performance Site Location(s) (Research Project:  Clinical Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project:  Clinical Project)

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

  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 
  • The Project Lead of the Clinical Research Project should be board-certified in OB/GYN or maternal fetal medicine, and experienced in research design, participation in and implementation of collaborative clinical research/trials. It is expected that each U54 Center will collaborate with the other centers in the OPRC on the clinical studies and trials.
  • Senior/Key personnel of the Clinical Research Project should include a clinical pharmacologist who will assist the Project Lead in designing and conducting the PK and/or PD studies of drugs in pregnant women.
  • A statistician should be designated in the application to demonstrate the capability of the data analysis required to support their proposed science in the Center.
  • A research nurse coordinator with appropriate training, experience, qualifications and prior involvement in clinical research may be designated as needed in the application; additional research nursing and support staff should also be available.

Budget (Research Project:  Clinical Project)

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

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

PHS 398 Research Plan (Research Project:  Clinical Project)

Specific Aims:  Describe the specific aims of the Clinical Project.  

Research Strategy:   The Clinical Project should present a clinical study concept proposal for a potential collaborative project to be carried out by all Centers.  The concept proposal will provide peer reviewers and the NICHD an idea of capabilities of investigators. The Clinical Research Project should study the disposition, efficacy, and safety of medications whose pharmacologic profiles were found to differ during pregnancy.

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

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

Letters of Support:  Include any letters of support specific to this component.

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.   

Planned Enrollment Report  (Research Project:  Clinical Project)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Research Project:  Clinical Project)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.    

 
Research Project:  Basic/Translational Project

When preparing your application in ASSIST, use Component Type ‘Research Projects.’

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

SF424 (R&R) Cover (Research Project:  Basic/Translational Project)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project:  Basic/Translational Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project:  Basic/Translational Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

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

Project /Performance Site Location(s) (Research Project:  Basic/Translational Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project:  Basic/Translational Project)

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

  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.  
  • Project Leads should be investigators with a record of external funding as independent Principal Investigators/Program Directors, but are not required to have a record of accomplishment in obstetric pharmacology research.

Budget (Research Project:  Basic/Translational Project)

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

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

PHS 398 Research Plan (Research Project:  Basic/Translational Project)

Specific Aims:  Describe the specific aims of the Basic/Translational Project.  

Research Strategy:   Describe the research strategy of the project in the same detail and format as expected for an investigator-initiated R01 grant application. In addition, include a description of the relationship of the Research Project to the other Research Projects and how the Research Project addresses the overall goals of the Center. Describe how the Research Project contributes to the goals of the Administrative Core.

Letters of Support:  Include any letters of support specific to this component.

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

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

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

Planned Enrollment Report  (Research Project:  Basic/Translational Project)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Research Project:  Basic/Translational Project)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Research Project:  Pilot Project

When preparing your application in ASSIST, use Component Type ‘Research Projects.’

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

SF424 (R&R) Cover (Research Project:  Pilot Project)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project:  Pilot Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project:  Pilot Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

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

Project /Performance Site Location(s) (Research Project:  Pilot Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project:  Pilot Project)

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

  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.  
  • Individuals receiving support from mentored career development awards (K awards) may serve as Project Leads on Pilot Projects.     

Budget (Research Project:  Pilot Project)

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

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

Funds for Pilot Project(s) should be requested as part of the Administrative Core budget.   Up to $50,000 direct costs per year may be requested to provide support for one or more pilot projects relevant to the center's goals in Year 01 and 02. Support for a pilot project is limited to a two-year period. However, the same level of funding may be requested for years 03-05. If a pilot project is favorably recommended for the initial two-year period, funds will be included each year for the full five years. Funds requested in Year 03-05 will be contingent upon review and approval of additional pilot projects by NICHD staff.

PHS 398 Research Plan (Research Project:  Pilot Project)

Specific Aims:  Describe the specific aims of the Pilot Project.  

Research Strategy:  Optional Pilot Projects may be proposed for Years 01 and 02 to generate preliminary data for submission of an R01 or Center project, to develop new technologies that further enhance the research efforts of the Center, or to support clinical research studies that could form the basis for conduct of large scale clinical trials through the relevant NICHD funded Networks/Centers.  The Research Strategy for Pilot Projects must be described in sufficient detail, comparable to the other Research Projects submitted in the application, to permit evaluation of the Pilot Project(s) using the review criteria listed under section V "Application Review Information", with the exception that little or no preliminary data are required for a Pilot Project.

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

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

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

Planned Enrollment Report  (Research Project:  Pilot Project)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Research Project:  Pilot Project)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Logistic Coordinating Core

When preparing your application in ASSIST, use Component Type ‘Logistic Coord Core’

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

SF424 (R&R) Cover (Logistic Coordinating Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Logistic Coordinating Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Logistic Coordinating Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

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

Project /Performance Site Location(s) (Logistic Coordinating Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Logistic Coordinating Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   
  • An individual who is knowledgeable and experienced in Investigational New Drug (IND) submissions should be designated to demonstrate expertise in FDA regulations for clinical trials in the LCC. 

Budget (Logistic Coordinating Core)

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

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

Each application may include a proposal for a Logistic Coordinating Core (LCC). The LCC budget cannot exceed $150,000 direct costs and will be awarded to one of the funded Centers.

The LCC budget must include travel costs for the LCC Director to attend the SC meetings and for at least four DMC members to attend annual DMC meeting that will be held in or near Bethesda, MD.

PHS 398 Research Plan (Logistic Coordinating Core)

Specific Aims:  Describe the specific aims of the Logistic Coordinating Core.  

Research Strategy: Each OPRC application may include a proposal for a LCC with a description of how the LCC would carry out its functions.  The LCC will serve all the Centers and coordinate the OPRC clinical study activities. The LCC will ensure all OPRC collaborative clinical studies/trials are carried out in compliance with applicable federal regulations and policies. The LCC will also perform a range of administrative functions including organizing SC and DMC meetings, arranging conference calls, and designing and maintaining a website that will contain information of the OPRU network and the current OPRC program.  

Letters of Support:  Include any letters of support specific to this component.

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

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

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

Planned Enrollment Report (Logistic Coordinating Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Logistic Coordinating Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

3. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

For this particular announcement for the OPRC applications (U54), peer review of scientific and technical merit focuses on three areas: (1) the Administrative Core (including ability to manage and oversee the Center as well as the Training program); (2) the collaborative Clinical Project, Basic/translational Research Project(s), and any optional Pilot Project(s); and (3) the U54 Center as integrated effort, creating a research enterprise that is greater than the sum of its parts. The overall U54 will be evaluated as an integrated research effort focused on a central scientific theme within the obstetric-fetal pharmacology research mission of the NICHD. The relationship and contributions of each proposed Research Project and Core to the overall Center goals will be evaluated and contribute to the overall impact/priority score.

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center 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?

Will the goals of the Center, if successful, lead to advances in obstetric-fetal pharmacology research and increase capability of the obstetric-fetal pharmacology research community?  

Investigator(s)

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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 Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Are the strategies for achieving the goals of the Center well-defined, feasible, and likely to lead to a multi-disciplinary effort within the Center, advance in obstetric pharmacology research, and increase the research capability of the larger obstetric-fetal pharmacology research community?  

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?

Will the structure and functions of the Center promote obstetric-fetal pharmacology research beyond the traditional field of obstetrics, and provide significant research and educational opportunities?

Is there a suitable environment for Center interactions and cross-fertilization with scientists from other departments, fields of expertise and institutions?  

Additional Review Criteria - Overall

As applicable for the Center 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.

Center as an Integrated Effort

Will there be coordination, interrelationships, and synergy among the projects and cores as they relate to the central research theme?

What are the advantages of conducting the proposed research as a program over individual research projects?

Will the center structure enhance the value of the individual projects? Are mechanisms proposed for regular communication among the project leaders and outside collaborators?

Are the administrative structures in place for daily management of the Center, including internal evaluation of the research projects?

Are the qualifications and experience of the key personnel appropriate?

Will the quality of services provided by the Core(s) enable all center investigators to achieve their research goals?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable                          

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable                    

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Review Criteria for Administrative Core
Overall Impact - Administrative Core

Reviewers will assign an impact score based on the assessment of the Administrative Core in terms of the following review criteria. Separate criterion scores will not be assigned for the Administrative Core.

  • Qualifications, experience, and commitment of the Core Director(s) and other Core personnel;
  • The appropriateness of administrative structures and day-to-day management of the program;
  • A training plan to establish and maintain a training environment for predoctoral and/or postdoctoral fellows including clinical fellow investigators in the obstetric-fetal pharmacology research.
  • The decision-making process within the proposed center for the evaluation of research productivity, allocation of funds, and management of resources;
  • The quality of the services provided;
  • The process for prioritizing use of Core facilities by the various research projects;
  • The cost effectiveness and quality control of the Core;
  • The mechanisms proposed for regular communication and coordination among investigators in the program;
  • If a Core already exists, the effectiveness and relevance of provided services and development of new technologies or other significant advances;
  • The utility of the Core to the program.
  • The plan for program evaluation, including the use of an internal Executive Committee and External Advisory Committee.
Additional Review Criteria - Administrative Core

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable         

Renewals

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

Revisions

Not Applicable                         

Additional Review Considerations - Administrative Core

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) 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.

Review Criteria for Research Projects

For this particular announcement, note the following:  The Clinical Research Project, Basic/Translational Research Project(s), and any optional Pilot Projects will all be scored using the standard 5 criteria. 

The Clinical Research Project (Concept Proposal) will be evaluated for the quality, appropriateness and scientific relevance as well as the potential implementation in the Obstetric-fetal Pharmacology Research Centers in terms of the quality of proposed hypotheses, specific aim(s) and research strategies. The Concept Proposal is to provide peer reviewers and the NICHD an idea of the investigators' capabilities to participate in the development and design of multi-center cooperative common protocols in the OPRCs. When Centers are funded the Concept Proposals will be evaluated and prioritized by the OPRC Steering Committee and NICHD for the implementation.

Overall Impact - Research Projects

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

Scored Review Criteria - Research Projects

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

Significance

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

Will the goals of the Project, if successful, lead to advances in obstetric-fetal pharmacology research and increase capability of the obstetric-fetal pharmacology research community?  

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?   

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

Will the objectives of the Project contribute to multi-disciplinary efforts within the Center, advance obstetric pharmacology research, and increase the research capability of the larger obstetric-fetal pharmacology research community?  

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 - Research Projects

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable         

Renewals

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

Revisions

Not Applicable                         

 
Additional Review Considerations - Research Projects

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

Applications from Foreign Organizations

 Not Applicable      

Select Agent Research

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

Resource Sharing Plans

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

 
Review Criteria for Logistic Coordinating Core (LCC)
Overall Impact - Logistic Coordinating Core

Each Center may propose an LCC (optional) which will receive an overall impact   Separate criterion scores will not be assigned for the LCC.  The LCC will be scored according to the following review criteria:   

  • Does the LCC Director have experience in research administration and coordination?
  • Is there evidence of an ability to provide administrative support to all the participating Centers in terms of coordinating collaborative clinical studies/trials, and arranging and organizing Steering Committee, and Data Safety and Monitoring Committee meetings and conference calls?
  • Is there evidence of knowledge and experience in submitting Investigational New Drug (IND) applications to FDA for phase I clinical trials? 
  • Is there a logical plan for designing and maintaining a website for the OPRC program? 
Additional Review Criteria - Logistic Coordinating Core

Protections for Human Subjects

Not Applicable

Inclusion of Women, Minorities, and Children 

Not Applicable

Vertebrate Animals

Not Applicable

Biohazards

Not Applicable

Resubmissions

Not Applicable        

Renewals

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

Revisions

Not Applicable                         

 
Additional Review Considerations - Logistic Coordinating Core

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

Not applicable

Resource Sharing Plans

Not applicable

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:

  • 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

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

Section VI. Award Administration Information
1. Award Notices

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

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

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

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

Prior Approval of Pilot Projects

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

Pursuing research objectives consistent with the research scope of the FOA and research favorably recommended by peer review;

  • Conducting experiments and collecting the resulting data;
  • Analyzing, interpreting and presenting results and plans to the Steering Committee for approved activities;
  • Publishing results, conclusions, and interpretation of the studies.
  • The awardees will agree to: 1) accept the coordinating role of the Steering Committee which includes evaluating objectives and research goals of the Centers Program, and recommending modification, deletion or addition of protocols within the Centers Program; 2) follow any common protocols in which they participate for multicenter projects that are approved by the Steering Committee; and 3) accept the cooperative nature of the group process, including the establishment, where appropriate, of smaller collaborative groups comprised of interacting research projects and/or cores focused on a particular obstetric-fetal pharmacology research topic area.
  • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

Participating in the overall coordination of the OPRCs with the Steering Committee.  This includes efforts to improve and strengthen inter- and intra-center cooperation amongst the research projects of the Centers, particularly as they pertain to translational research activities within and between centers.  As a means of improving inter-center cooperation, the Project Scientist will directly participate in the activities of the smaller collaborative groups established by the Steering Committee comprising research projects focused on a particular obstetric-fetal pharmacology research topic area.  The Project Scientist will also assist the research efforts of the OPRCs by facilitating access to fiscal and intellectual resources provided by industry, private foundations and NIH intramural scientists.  The Project Scientist will, as required, help reprogram research efforts, including options to modify or terminate them, by mutual consent between the Centers Program and NICHD.  In the event of disagreements among Program participants, the Project Scientist will assist in forming an arbitration panel as discussed below.

  • Interacting with each individual center awardee evaluating objectives and research goals of that particular center, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted.  The Project Scientist will assist and facilitate this process and not direct it.  The Project Scientist will also provide assistance in reviewing and commenting on all major transitional changes of an individual center's activities prior to implementation to assure consistency with required goals of the OPRCs.
  • Retaining the option to recommend the withholding of support from a Center subproject materially failing to meet the technical performance requirements established by this Centers Program.  This includes identifying jointly with participants of the Steering Committee the need to add additional research subprojects or service cores to Centers or to phase out a Center subproject or core when performance standards have not been met.
  • Participating, where warranted, in data analyses, interpretations, and the dissemination of study findings to the research community and health care recipients including co-authorship of the publication or results of studies conducted by the Centers.
  • Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

A Steering Committee will be composed of the PD/PIs from each of the participating centers and one NICHD staff member from the OPPTB, NICHD, who will be the Project Scientist. A non-NIH Chairperson for the Steering Committee will be selected by the NICHD.  Meetings of the Steering Committee will be convened twice per year.  The purpose of these meetings is to share scientific information, assess scientific progress, identify new research opportunities and potential avenues of collaborations such as with industry, private foundations and/or NIH extramural and intramural scientists, establish priorities that will accelerate the translation of preclinical findings into clinical applications, reallocate resources and conduct the business of the cooperative research program.  In anticipation that some centers will have common research interests that address a specific basic and/or clinical research problem, it is envisioned that research focus groups will be formed to conduct coordinated research activities recommended by the Steering Committee.  The Steering Committee will approve multicenter protocols on specific research activities.  As needed, the Steering Committee will develop a publication policy regarding joint authorship of research reports derived from such collaborative efforts.

Each full member of the Steering Committee will have one vote except the LCC Director, who will serve as a non-voting member of the SC.  Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

Dispute Resolution:

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

3. Reporting

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

Finding Help Online: http://grants.nih.gov/support/index.html

TTY: 301-451-5939
Email: commons@od.nih.gov

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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

Scientific/Research Contact(s)

Zhaoxia Ren, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-9340
Email: zren@mail.nih.gov           

Peer Review Contact(s)

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
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: 301-435-6975
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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