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)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health (ORWH)

Funding Opportunity Title
Pelvic Floor Disorders Network (UG1 Clinical Trial Required)
Activity Code

UG1 Clinical Research Cooperative Agreements - Single Project

Announcement Type
Reissue of RFA-HD-16-012
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-HD-22-021
Companion Funding Opportunity
RFA-HD-22-022 , U24 Resource-Related Research Project (Cooperative Agreements)
Assistance Listing Number(s)
93.865, 93.313
Funding Opportunity Purpose

This funding opportunity announcement (FOA) invites applications from institutions/organizations interested in participating with the NICHD in an ongoing multicenter clinical program, the Pelvic Floor Disorders Network, which is designed to study clinical and health aspects of pelvic floor disorders in adult women.

Key Dates

Posted Date
October 13, 2021
Open Date (Earliest Submission Date)
November 06, 2021
Letter of Intent Due Date(s)

November 6, 2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
December 06, 2021 December 06, 2021 Not Applicable March 2022 May 2022 July 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

Expiration Date
December 07, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This funding opportunity announcement (FOA) invites applications from institutions/organizations interested in participating with the NICHD in an ongoing multicenter clinical program, the Pelvic Floor Disorders Network (PFDN) designed to study clinical and health aspects of pelvic floor disorders in women. Pelvic floor disorders for the purpose of this FOA include pelvic organ prolapse, urinary urgency/frequency, urinary incontinence, and fecal incontinence. Relevant areas of study in pelvic floor disorders include surgical and nonsurgical treatments, social and behavioral contributions, pharmacologic therapies, any outcomes from the broad array of treatments available, and prevention efforts, among others. Importance is also placed on the inclusion of innovative translational aims to contribute to the understanding of the etiology and pathophysiology of these disorders.

The Office of Research on Women’s Health (ORWH) is interested in supporting innovative, multidisciplinary, high-impact, translational research on pelvic floor disorders. The 2019-2023 Trans-NIH Strategic Plan for Women's Health Research includes goals and objectives that aim to increase and improve women's health research supported by NIH. Goal one of the strategic plan is to advance rigorous research relevant to women's health. Consistent with this goal, this initiative will gather evidence-based data to guide both surgical and non-surgical care and forge new directions for the diagnosis, treatment, and care for this large and growing clinical problem impacting the lives of women.

It is anticipated that 6-8 Clinical Sites will be involved in the program, along with one Data Coordinating Center.

Background

The PFDN was established by the NICHD in 2001 in response to an increasing awareness by the public and by health professionals of the need for more evidence-based data to guide both surgical and non-surgical care for this large and growing clinical problem. The overall objective of the Pelvic Floor Disorders Network (PFDN) is to facilitate interactions between a network of academic centers with the recruitment capabilities and research expertise needed to perform studies under rigorous common protocols that will provide efficient, high quality, evidence-based clinical answers to both providers and women. Studies include both careful analysis of standard treatment outcomes as well as testing new therapies and approaches to move the research agenda forward in novel directions for clinical benefit.Translational aims have also begun to be incorporated into the most recent PFDN studies and will continue to be encouraged.

Research Objectives and Scope

The scope of research for this FOA includes clinical problems in pelvic organ prolapse, urinary urgency/frequency, urinary incontinence, and fecal incontinence.The infrastructure is organized to allow for randomized double-blinded placebo-controlled trials followed by the analysis of both short-term and long-term outcome measures. Randomized trials are the preferred approach to clinical trials, though other experimental approaches such as observational studies are eligible, as appropriate, particularly when designed to inform the development of subsequent randomized trials. In all cases, good use of the multicenter capabilities and the collaborative process is paramount. Maximizing the use of the well-defined study populations in innovative translational aims which could contribute to etiology and pathophysiologic knowledge is also important.

Participation in the clinical protocols planned under this initiative are restricted to adult women because the prevalence of pelvic floor disorders is substantially greater in women than in men or children, and because treatment of pelvic floor disorders is markedly different in men and children compared to women.

Ongoing studies may be continuing or enrolling patients at the initiation of the next award period. The DCC and Clinical Sites selected to join the PFDN should be prepared to participate in ongoing protocols unless otherwise directed by the Steering Committee, External Scientific Oversight Board, and/or NICHD.

The NICHD intends for the PFDN to initiate at least one new protocol within the first year of the next award period in addition to completion of protocols not completed at the end of the current cycle. The topics of these new protocols will be decided cooperatively by the Steering Committee and must be approved by the External Scientific Oversight Board appointed independently by NICHD and by the NICHD leadership.

Note: A proposal for a clinical trial research protocol MUST be included as part of this application. Details of this requirement can be found in the Research Plan portion of this announcement.

Note: Investigators outside the funded PFDN Clinical Sites may be allowed to propose studies to be pursued using the PFDN infrastructure, Clinical Sites, and DCC with funding provided through a separate mechanism. Applicants MUST acknowledge their agreement to this potential approach for expanding the role of the network using satellite sites.

Examples of research topics which may be proposed include, but are not limited to:

  • Comparative effectiveness research on surgical treatments, pharmacologic therapies, devices, and other non-surgical treatments.
  • Primary prevention studies.
  • Management strategies to minimize recurrence of pelvic floor disorders and optimize outcomes.
  • Innovative research exploring new therapies utilizing findings from laboratory research in areas that could include, as examples, fecal transplants or pharmacogenetics.
  • Translational studies using human samples to investigate the etiology of pelvic organ prolapse, urinary incontinence or fecal incontinence, including the role of the microbiome and metabolome.

Projects that will be considered non-responsive for this FOA include, but are not limited to:

  • Studies which include men or children (defined as an individual <18 years old).
  • Investigation of Interstitial Cystitis (IC)/Bladder pain.
  • Research on recurrent urinary tract infections.
  • Investigations into Irritable Bowel Syndrome (IBS).
  • Generalized studies on pelvic pain.

Because this list of topics is not meant to be all-inclusive, applicants are STRONGLY ENCOURAGED to discuss program relevance with the Scientific/Research Contact indicated in Section VII. Agency Contacts before submission.

Organization and Governance of the Pelvic Floor Disorders Network Clinical Sites

The Pelvic Floor Disorders Network Clinical Sites will be a collaborative network of up to eight Clinical Sites, one Data Coordinating Center (DCC), and the NICHD. The DCC is supported by a separate award, described in detail in RFA-HD-22-022. Applicants are strongly encouraged to read this companion RFA. All Clinical Sites will be required to participate in a cooperative and interactive manner with one another, the NICHD and the DCC.

Throughout the term of this award, Clinical Sites will be responsible for proposing protocols that are appropriate and feasible for adoption by the Network, guiding protocol development, enrolling patients, analyzing results, and disseminating research findings.

A Steering Committee will be the main governing body of the Network and will be composed of the PDs/PIs of the Clinical Sites and the Data Coordinating Center and the NICHD Project Scientist. At the discretion of the NICHD, a Network Steering Committee Chairperson may be appointed and non-voting members from other NIH Institutes and Offices may be present. The structure and role of the Steering Committee and External Scientific Oversight Board are described below under Cooperative Agreement Terms and Conditions of Award.

Research topics of high priority are identified by the Steering Committee and lead to the design and implementation of protocols appropriate for the evaluation, diagnosis, prevention, and management of pelvic floor disorders. Protocols will be reviewed by an NICHD-selected External Scientific Oversight Board. Only those protocols approved by the External Scientific Oversight Board will be allowed to move forward.

A centralized DCC supports the activities of the Network. The functions of the DCC include developing protocol data management, devising novel comparative study designs, providing sample size calculations and statistical advice, developing data forms and protocol tools, performing data analyses, coordinating the activities of the Steering Committee, Protocol Review Committee, External Scientific Oversight Board and Data and Safety Monitoring Board, and overall study coordination and quality assurance.

If necessary to hasten accrual in Network studies, at the discretion of the vote of the Steering Committee (see below), the DCC, along with the NICHD and the Clinical Site PDs/PIs, will have the responsibility of identifying qualified and interested investigators at non-Network sites who wish to enroll patients in these studies. Arrangements for data collection and reimbursement of trial-related data collection costs at non-Network sites will be the responsibility of the DCC.

A Data and Safety Monitoring Board (DSMB) will monitor Network interventional studies. As a part of its monitoring responsibility, the DSMB will submit recommendations regarding the continuation of each study in its purview to the DCC. Funding for the functioning of the DSMB and the External Scientific Oversight Board will be provided through the base funds of the DCC.

Use of a single Institutional Review Board will be required pursuant to NIH policy. This Board will be identified by the Clinical Sites and DCC with NICHD consultation. The DCC will be responsible for the application and payment towards securing this single IRB.

Participation in Studies

As per the intent of the NICHD in supporting this network, multiple trials and descriptive studies will be conducted during the five-year project period. Clinical Sites selected to join the PFDN should be prepared to participate in any ongoing protocols.It is anticipated that initially one new study may be selected from the studies proposed by the successful applicants. However, a decision to fund a particular Clinical Site will not commit the Network to pursue the study protocol proposed by that Site.

It is anticipated that each protocol will be implemented in all of the Clinical Sites. Awardees must agree to actively enroll patients in at least one Clinical Network trial and/or descriptive study in the first year of the award. As specific protocols are developed, support will depend on the availability of funds, and per patient (capitation) funding made available. Clinical Sites that do not enroll patients in PFDN protocols or do not collaborate in the scientific development activities of the PFDN may not receive continuing support at the discretion of the Program Officer.

The exact number of protocols supported in the five-year program will depend on the nature and extent of the investigations proposed by the Steering Committee and on available funds. Both short-and-long term projects will be considered for prioritization and implementation.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New
Renewal

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

Clinical Trial?

Required: Only accepting applications that propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The NICHD and ORWH intend to commit approximately $1.8 million in fiscal year 2022 to fund 6-8 grants.

Award Budget

An applicant may request a budget of up to $170,000 per year in direct costs.

Award Project Period

An applicant may request a project period of five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

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

  • 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)

Local 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)

Federal Government

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

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

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Required Registrations

Applicant organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

The PD(s)/PI(s) for a Clinical Site should be able to demonstrate the ability to treat urinary urgency/frequency, urinary incontinence, fecal incontinence, and pelvic organ prolapse as well as other pelvic floor disorders both surgically and nonsurgically. Typically the PD(s)/PI(s) would be urogynecologists or urologists with board specialization in Female Pelvic Medicine and Reconstruction Surgery, but other types of physicians/surgeons are eligible if they can demonstrate this expertise.

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, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

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

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

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Esther Eisenberg, MD, MPH

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-6516
Email: esther.eisenberg@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Facilities and Other Resources: A detailed description of the clinical attributes of the Clinical Site must be provided. This should include imaging and diagnostic testing available for women with pelvic floor disorders. This may include, but is not limited to, multichannel and fluoroscopic urodynamic testing, ultrasound (specify endoanal, perineal, etc.), both dynamic and traditional MRI, and defecography. Any other unique technologies to the site should be described. Available space for performing Network-related activities should be described. The availability of a pharmacy capable of supporting clinical research must be documented and details on experience in preparation, administration, and storage of masked pharmaceuticals should be included. The Clinical Site should also describe the ability to collect and handle laboratory specimens.

Population Available for Clinical Research: The relevant characteristics of the patient population available for clinical research must be clearly defined, including the proportion of under-represented minorities. In order to provide peer reviewers with the relevant characteristics of the specific patient population available for study at the applicant Clinical Site, this information should include the number of inpatients and outpatients (presented separately) treated for pelvic floor disorders. Separate tallies should be presented for: 1) pelvic organ prolapse; 2) urinary incontinence and other relevant lower urinary tract disorders; 3) fecal incontinence; and 4) other pelvic floor disorder treatments specified by the Clinical Site. Applicants should also specify if ethnic/racial minorities are adequately represented. For applicants with more than one Clinical Site, please include each Consortium Site's information in a clearly identified separate section. If there are ongoing or pending studies/trials that will limit availability of patients for PFDN trials, these must be described for the review panel's consideration at the time of review.

SF424(R&R) Senior/Key Person Profile

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

The PD/PI should be a practicing physician able to care for all types of female pelvic floor disorders. One other investigator should be designated as the Alternate PD/PI who is able to serve in the absence of the PD/PI. The Alternate PD/PI may be one of the named PD(s)/PI(s) on a multiple PD/PI application. There must be at least three full time, academically oriented clinician investigator specialists in female pelvic floor disorders at each Clinical Site. At a minimum, this includes the PD/PI and at least two other investigators in specialties such as urogynecology, urology, gynecology, colorectal surgery, gastroenterology, geriatrics, radiology, and physical or occupational therapy.The biosketches of the PD(s)/PI(s) and other investigators should describe academic and clinical qualifications as well as current and planned clinical, research, administrative, and academic commitments. A complete description of the investigator’s training and qualifications in clinical care and research is required, including experience in research design and implementation of collaborative clinical research especially randomized clinical trials.

R&R Budget

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

A Base Budget estimate for the Clinical Site should be included for all years. The first year Base Budget will be limited to $170,000 in direct costs with allowances as follows:

  • Contact PD/PI: minimum 15 percent (1.8 person months) effort
  • Alternate PD/PI: minimum 10 percent (1.2 person months) effort
  • Research Nurse Coordinator: minimum 80 percent (9.6 person months) effort
  • Travel: a total of four quarterly, 2-day meetings per year; 2 meetings to the Washington D.C. area and 2 meetings at Clinical Site locations (generally one on the West Coast and one in the Central US). Funds should be budgeted to provide travel for the PD(s)/PI(s), Alternate PD/PI, and Research Nurse Coordinator. The PD(s)/PI(s) should make a commitment to attend all Steering Committee meetings.

When a Clinical site application has been favorably recommended and is being considered for funding, the applicant will be required to accept capitated protocol budgets for those studies underway in the Network, and participate in planning protocol budgets for studies under development. For additional information, please see Section VI. Award Administration Information.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Include Specific Aims for the Clinical Site application.

Research Strategy: The Research Strategy section should address all of the following issues:

  • Describe relevant experience of the proposed Clinical Site with previous or ongoing clinical trials, especially those of a cooperative or multicenter design, in the field of women's reproductive health or pelvic floor disorders. Contributions in key areas of research development and design, patient recruitment, retention and study completion, data collection and analysis, as well as a track record of publications should be described in the application.
  • Clinical sites that are current PFDN members should describe their participation and contribution to the Network in detail including patient enrollment in studies, involvement in trials, specific contributions to each trial (e.g., PD/PI at Clinical Site, protocol committee member), subcommittee activities and publications.
  • New applicants must describe their recent experience and participation in randomized clinical trials, preferably of a multicenter nature. Specific roles and activities (e.g., PD/PI, participating site, steering committee, writing committee, trial design and development) should be described for each study. Publications should be listed that resulted from participation in studies. For the proposed project period, describe plans for recruitment and retention of subjects.
  • Staffing and Management Plans: The application should describe strategies and plans for staffing and managing Clinical Site functions. The time commitment of each funded investigator will vary depending on the specific Network protocols ongoing at any particular time and the Clinical Site should have the ability to add or remove investigators as appropriate.
  • A research nurse coordinator or personnel with research training and experience in multiple clinical trials must be designated to coordinate day to day activities of the site. Additional research support staff should be available, as protocols may require patient recruitment at night or on weekends. Staff training and roles in clinical research and randomized clinical trials should be described in the application. The ability to have sufficient research staff to mask some staff for certain trials should be noted. Plans and procedures for quality information transfer to the Data Coordinating Center should be described.
  • Clinical Sites that propose to combine institutions or multiple sites must describe and justify the proposed organization and provide a detailed logistical plan for collaboration and cost-effective management. The history of the multi-site relationship should be described including eligibility and enrollment in previous clinical trials.
  • Special Strengths of the Institution: Applicants are encouraged to describe special or unique strengths of the site that may be relevant to female pelvic floor disorders research. This can include state-of-the art scientific capabilities such as modern imaging techniques, proteomics, genomics, microanalysis, genetics, clinical pharmacogenetics, and surgical techniques which may be shared or may be available to develop and expand the scientific productivity of the Pelvic Floor Disorders Network. Do not duplicate information described in Other Project Information, Facilities and Other Resources.
  • Concept proposal: A concept proposal for a project for the Pelvic Floor Disorders Network should be submitted. The concept proposal should be limited to no more than 3 pages, and have potential to be carried out in the Network taking advantage of the multicenter capabilities. An estimated budget for the concept proposal should be provided.This proposal should also demonstrate the Clinical Site’s ability to track and estimate potential subjects through any available computerized database. In addition, the concept proposal should address relevant ethical issues and the appropriate inclusion of minorities.The concept proposal will likely be invited for submission to the Steering Committee and the External Scientific Oversight Board and may or may not be considered for protocol development in the Network.

Letters of Support: Strong institutional commitment must be clearly documented with letters of support from appropriate individuals. There must be a clearly expressed intent to participate in a collaborative manner with the other Clinical Sites, the Data Coordinating Center, and the NICHD. Clinical Sites are expected to participate in all Network studies unless applicants describe implemented trials at their clinical site that conflict with ongoing Network studies described in this FOA as part of their application. Evidence of past support can also be cited. Letters should describe support in areas of grants management, personnel management, space allocation, procurement, equipment as well as general support of the research. Letters supporting the research capabilities and activities of the Clinical Site should be included. Multi-site applications should have appropriate letters of support for the collaboration.

Letters from the Service or Division Chairperson and the Chief Operating or Executive Officer of the facility where the applicant is based, must be included in the application. These letters must indicate support for the application and clearly state that appropriate clinical time commitments and schedule modifications will be made as needed to assure the applicant and Clinical Site's full participation in Network studies, as well as writing and administrative responsibilities as part of the Steering Committee. Assurance of cooperation with the policy for capitation of research costs for each individual protocol should also be provided from the departmental and institutional offices of sponsored research programs.

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

The following modifications also apply:

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

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

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

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

Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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

 

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

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

Scored Review Criteria

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

Significance

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

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

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

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

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

Study Timeline


Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Resubmissions

Not applicable

Renewals

Renewals

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

Revisions

Revisions

Not applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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 will receive a written critique.

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.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, 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 recipients 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

  • Accepting the collaborative nature and the role of the group process as cooperative and participatory. This group includes investigators at the other PFDN Clinical Sites and in the Data Coordinating Center as well as with the NICHD Project Scientist, Program Official, and other NICHD and NIH staff.
  • Identification of priority research areas followed by design and execution of PFDN studies.
  • Projecting subject enrollment for specific protocols during a specified time frame (continuation and level of funding will be based on actual enrollment).
  • Supervision of personnel, interaction with Institutional Review Boards, interaction with Clinical Site grants management officials, and for collaboration and cooperation with the other Clinical Site PI(s), the Steering Committee, NICHD, and the DCC.
  • Collection and transmission of data to the DCC. The DCC will be tasked with data preparation and for making data available for public use, such as through the NICHD Data and Specimen Hub (DASH).
  • Analysis of data and publication of results of PFDN studies with the support of the DCC.
  • Recipients 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 HHS, PHS, and NIH policies.

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

NICHD Project Scientist--The NICHD Project Scientist will provide technical assistance and participate as one voting member of the Steering Committee. Specifically, the NICHD Project Scientist will provide:

  • Assistance with the identification of important areas of study.
  • Assistance in the development of study protocols.
  • Assistance in the development and review of capitation-based budgets, including the identification of study costs and special institutional needs.
  • Assistance in the review and evaluation of each stage of the program before subsequent stages are started, in conjunction with the Steering Committee, NICHD Program Official (see below), and the External Scientific Oversight Board, and make recommendations to enhance the scientific quality of the work.
  • Assistance in the reporting of results in the community of investigators and health care recipients.
  • Assistance with the conduct of the trials and other approved studies, including ongoing review of progress, possible redirection of activities to improve performance and cooperation, and frequent communication with other members of the Steering Committee.
  • Participation on the Steering Committee (voting member) and all active subcommittees.
  • Collaboration with NICHD Program Official in recommending administrative actions to enhance scientific productivity.

NICHD Program Official -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. This Program Official role is separate from the Project Scientist, and will include the following:

  • Carry out continuous review activities with the NICHD Project Scientist to ensure that objectives are being met and that all regulatory, fiscal and administrative matters are handled according to NIH guidelines.
  • Have the option to withhold support to a participating institution if technical performance requirements are not met, such as protocol compliance, enrollment targets, or randomization of subjects, in consultation with the Project Scientist.
  • Initiate a decision to modify or terminate a study based on the advice of the DCC, Steering Committee, DSMB or External Scientific Oversight Board, and Project Scientist.
  • Work with staff in NICHD Grants Management Branch, who will monitor and evaluate the fiscal concerns and administration, including Facilities and Administrative Fees.
  • Perform other duties required for normal program stewardship of awards.

Areas of Joint Responsibility include:

Steering Committee -The Steering Committee will be the main governing body of the PFDN and will have primary responsibility for developing research protocols by consensus, supervising the conduct of the studies, and reporting results. The Steering Committee will consist of the PD/PIs (one from each awarded Clinical Site), the PD/PI of the Data Coordinating Center, and NICHD Staff. The PFDN Project Scientist will be the only voting NICHD staff member of the Steering Committee. A member of the NICHD Grants Management Branch advises the Steering Committee on funding matters. Non-voting members may be appointed to the Steering Committee from other involved Institutes. Subcommittees will be established by the Steering Committee, as deemed appropriate. An outside chairperson, who is not participating as a PD/PI, will be selected by the NICHD. Data and Safety Monitoring Boards (DSMBs) will be created at the request of NICHD and supported by the Data Coordinating Center.

Each full member will have one vote. All major scientific decisions will be determined by super-majority vote of the Steering Committee. Recipient members of the PFDN 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 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 recipient. This special dispute resolution procedure does not alter the recipient'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, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

Scientific/Research Contact(s)

Esther Eisenberg, MD, MPH

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-6516
Email: esther.eisenberg@nih.gov

Elena K Gorodetsky
Office Of Research On Women's Health (ORWH)
Phone: (301) 402-1770
E-mail: egorod@mail.nih.gov

Peer Review Contact(s)

Sherry Dupere, PhD
Eunice Kennedy ShriverNational Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov

Financial/Grants Management Contact(s)

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
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, 45 CFR Part 75, and 2 CFR Part 200.


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