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

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

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for multidisciplinary national conferences that will inform care and facilitate research for major issues in pediatric critical care medicine. Given that pediatric critical care is a relatively young and clinically demanding field of medicine, conducting research and establishing best practices is challenging. National conferences that convene experts from across the country hold the potential to establish the frameworks necessary to overcome these obstacles. It is anticipated that such conferences will foster collaboration among different clinical disciplines, geographically and culturally diverse institutions and medical centers, professional organizations and NIH Institutes. Specifically, it is hoped that these conferences will drive the development and acceptance of uniform definitions, facilitate the determination of common data elements, identify key knowledge gaps to advance research and/or foster discussions on how research findings can be used to best inform guidelines for patient care.

Pediatric critical care is a relatively nascent and clinically demanding field of medicine. Only recognized as an official subspecialty in the mid-1980s, it has undergone logarithmic growth in the past three decades. While the advent of this field appears to be associated with objective improvements in outcomes, challenges exist in conducting meaningful research to continually advance the field. To begin, the clinical demands, the pressing educational needs and the necessary administrative burdens required to meet the needs of this rapid growth have limited the number of practitioners available to pursue research in the field. Additionally, the discipline is confronted with the challenge of wide heterogeneity in the patient population, both in terms of pathophysiology as well as in developmental status. Such heterogeneity, in combination with a relatively small patient population both on a global level as well as at any individual center, creates challenges to identify both patterns of illness and best practices. Moreover, with pediatric intensive care unit mortality rates being consistently reported at less than 3% and seemingly ever-decreasing, identifying clinically relevant outcomes to determine best practices and optimal therapies is difficult. One seemingly cost-effective approach to combat these challenges and to advance care is through multidisciplinary national conferences.

This initiative is intended to solicit conference grant applications on a wide range of issues relevant to the diagnosis, care and management of critically ill and injured children. Specifically, conferences should address areas of high priority as identified by the Pediatric Trauma and Critical Illness Branch.

These areas include:

• Sepsis
• Acute lung injury / acute respiratory distress syndrome (ARDS)
• Multiple organ dysfunction syndrome (MODS)
• Brain insult and injury
• Serious and life-threatening trauma
• Palliative care
• Care of critical illness among children with complex, chronic healthcare conditions.

Additionally, conferences addressing common and essential pediatric intensive care interventions and processes including, but not limited to:

• Extracorporeal therapies (i.e., extracorporeal membrane oxygenation, renal replacement therapy)
• Cardiopulmonary resuscitation
• Ventilator management
• Hemodynamic support and monitoring
• Use of blood products will also be considered of high relevance

The proposed conferences must not only offer to describe the state of the field, but should also attempt to develop common data elements to inform future research, to identify key knowledge gaps to be addressed in subsequent research, and/or to facilitate discussions on how research findings can best inform guidelines for patient care. Further, all proposed conferences need to include a dissemination and implementation component. Specifically, the applications must include a plan delineating the manner in which conference findings will be shared with the greater pediatric critical care community, and then utilized to advance care and/or research in the field following the meeting.

Applications proposing conference topics other than those relevant to pediatric critical care medicine will not be considered responsive including those addressing minor trauma, non-critical pediatric conditions, and adult-focused critical care issues. Additionally, applications for meetings that will only be composed of experts from one or two centers, or regional areas, will receive low priority for funding. Further, the initiative should not be used to convene a planning meeting for a single R01 application.

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

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

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)
• 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

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 allowed.

Applicant Organizations

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

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

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

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

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.

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

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).

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.

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

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:

Robert Tamburro, MD, MSc
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-480-2619
Email: robert.tamburro@nih.gov

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

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.

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

Descriptive Title of Applicant's Project: Enter the title of the scientific conference.

Cover Letter: Advance permission to submit an application is required for all NIH conference grant applications, including new, resubmission, renewal, and revision applications. Advance permission to submit an application should be requested early in the process and no later than six weeks before the application due date. All applicants must include the permission-to-submit letter from the NIH Conference Grant Contact who has agreed to accept assignment of the application. Applications that do not include the permission-to-submit letter will not be accepted for review. Note that advance permission to submit an application does not guarantee funding.

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

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

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

All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions. The appropriate NIH IC conference award contact should be consulted for guidance regarding any IC-specific budget requirements. Enter the direct costs requested. Facilities and Administrative (F&A) costs are not allowed. Provide a narrative justification for each proposed personnel position, including the role of the individual in the conference and the proposed level of effort. Include information regarding efforts to obtain funding for this conference from other sources.

Allowable Costs: Salary (in proportion to the time or effort spent directly on the conference); rental of necessary equipment; travel and per diem or subsistence allowances; supplies needed for conduct of the conference (only if received for use during the budget period); conference services; publication costs; funds to help defray registration costs for some select attendees (for example, women, racial/ethnic minorities, persons with disabilities, other individuals who have been traditionally underrepresented in science, graduate students); speakers' fees.

Non-allowable costs: Meals/food and beverages; purchase of equipment; transportation costs exceeding U.S. carrier coach class fares; visas; passports; entertainment and personal expenses (such as tips; bar charges; personal telephone calls; laundry charges) dues; honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem or admiration; patient care; alterations or renovations; local participants' expenses; facilities and administrative costs/indirect costs.

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

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

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

Research Strategy: Note that this section will be called "Conference Plan" in the system-generated Table of Contents.

Describe the objectives, specific program, and logistical arrangements for the conference. Describe the format and list the agenda and speakers, including the principal topics to be covered, problems to be addressed, and developments or contributions the conference might stimulate. Provide a detailed justification for the conference, including the scientific need, timeliness, and usefulness of the conference to the scientific community.

Applicants must provide documentation of appropriate representation of individuals from nationally underrepresented groups in the planning and implementation of, and participation in, the proposed conference.

Describe plans to seek appropriate representation during selection of organizing committee members, speakers, and other invited participants, such as session chairs and panel discussants. Describe plans to encourage participation and attendance by women, individuals from nationally underrepresented racial and ethnic groups, and persons with disabilities. Organizers of scientific conferences must document compliance with Federal civil rights laws, NOT-OD-15-152, Civil Rights Protections in NIH-Supported Research, Programs, Conferences and Other Activities, and the Guidelines for Inclusion of Women, Minorities, and Persons with Disabilities in NIH-Supported Conference Grants policy.

Attendance for some individuals will be dependent on the availability of resources for family care. The application should describe plans to identify resources for child care and other types of family care at or in close proximity to the conference site to allow individuals with family care responsibilities to attend. The information should allow attendees to make arrangements for family care as needed.

Describe the composition and role of the organizing committee, and provide the names and credentials of key participants (i.e. speakers, presenters, session moderators) in the conference, including the basis for their selection. Estimate anticipated geographic conference area where participants will come from (i.e., national, statewide), the expected size and composition of the audience, as well as the method of selection.

Describe plans for publicizing the conference to all interested participants and for publishing the proceedings (with the latter plan not being required). Identify related conferences held on the subject during the past 3 years and how the proposed conference is similar to and/or different from these, and why it is still necessary and useful. If this is one in a series of periodic conferences held by a permanent sponsoring organization, briefly describe and evaluate the last conference in the series.

Applications requesting multiple years of support must provide the following additional information for each future year requested, in as much detail as possible:

• conference topic(s)
• tentative dates, locations, and participants
• contingency plans for future conferences dependent upon, for example, the outcome of the first year's conference or developments in the field.

Letters of Support: Provide letters documenting the participation of the key conference participants, e.g. speakers, presenters, session moderators.

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

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

No appendix materials are allowed

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

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.

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

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

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.

This initiative is not subject to intergovernmental review.

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.

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.

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.

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.

After considering all of the review criteria, briefly summarize the significant strengths and weaknesses of the application and judge the likelihood that the proposed conference will have a substantial impact on the pursuit of the goals of NIH supported research, which is to advance our understanding of biological systems, to improve the control of disease, and to enhance health.

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.

Does this conference address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these endeavors on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Does the proposed conference offer to describe the state of the field, to develop common data elements to inform future research, to identify key knowledge gaps to be addressed in subsequent research and/or to facilitate expert discussions on how research findings can best inform guidelines for patient care?

Does the conference propose to effectively address an important issue(s) relevant to the diagnosis, care and management of critically ill and injured children?

Does the conference propose to effectively address common and essential pediatric intensive care interventions and processes including, but not limited to the following?

• Extracorporeal therapies (i.e., extracorporeal membrane oxygenation, renal replacement therapy)
• Cardiopulmonary resuscitation
• Ventilator management
• Hemodynamic support and monitoring
• Use of blood products

Is(are) the PD(s)/PI(s) well suited for organizing and fulfilling the goals of this conference? Are the qualifications and past performance of the PD(s)/PI(s) appropriate, and are they well suited for their described roles in the conference? Are the key personnel and selected speakers appropriate and well suited for their described roles in the conference?

Does the conference employ novel approaches or methods to fulfill its purpose? Does the conference draw together appropriate experts who may otherwise not have an opportunity to meet?

Are the format and agenda for the conference appropriate for achieving the specified goals? Is the conference timely for the subject matter? For applications designating multiple PDs/PIs, is the Leadership Plan approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the topics of the conference and the expertise of each of the PDs/PIs?

Does the application include an effective dissemination and implementation component? Does the application include an effective plan describing the manner in which conference findings will be used to advance care and/or research in the field following the meeting?

Is the conference site appropriate? Does the applicant organization have the ability to contribute to the probability of success? Do the proposed meetings, exhibits, interactions, etc., take advantage of unique features of the environment or employ useful collaborative arrangements? Is institutional support evident?

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.

Appropriate Representation

How well do the plans demonstrate appropriate representation of women, individuals from nationally underrepresented racial and ethnic groups, and persons with disabilities in the planning, organization, and execution of the proposed conference? For more information, see NOT-OD-15-152, Civil Rights Protections in NIH-Supported Research, Programs, Conferences and Other Activities, and the Guidelines for Inclusion of Women, Minorities, and Persons with Disabilities in NIH-Supported Conference Grants policy.

Generally, not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Not applicable

Not applicable

Not applicable

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.

Provision of Family Care Facilities

Are the plans to inform attendees about family care resources adequate?

Not applicable

Generally, not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Not Applicable

Not Applicable

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

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.
• Diversity representation among speakers and participants.
• Geographic distribution.

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.

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

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

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

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

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

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

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

Robert Tamburro, MD, MSc
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-480-2619
Email: robert.tamburro@nih.gov

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

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

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.

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