EXPIRED
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Population Dynamics Research Infrastructure Program FY 2020 (P2C Clinical Trial Not Allowed
P2C Resource-Related Research Multi-Component Projects and Centers
Reissue of RFA-HD-19-014
RFA-HD-20-015
None
93.865
The goal of this funding opportunity announcement (FOA) is to advance the field of population dynamics research by increasing research impact, innovation, and productivity; developing junior scientists; and maximizing the efficiency of research support.
July 10, 2019
July 30, 2019
30 days prior to the application due date
August 30, 2019
All applicants 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.
Not Applicable
November 2019
January 2020
April 2020
August 31, 2019
Not Applicable
It is critical that applicants follow the Multi-Project (M) 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 goal of this funding opportunity announcement (FOA) is to advance the field of population dynamics research by increasing research impact, innovation, and productivity; developing junior scientists; and maximizing the efficiency of research support.
The objectives of this initiative are to:
This initiative will provide funding for population dynamics infrastructure cores at already productive population research centers. Applicant centers are expected to have a recent record of high impact, innovative scientific publications and competitiveness for peer-reviewed external funding for research within the scientific mission of the NICHD Population Dynamics Branch (PDB).
Cores
Applications must include a minimum of two research infrastructure cores, a mandatory Administrative Core plus a Development Core and/or one or more Scientific/Technical Cores. The Development Core is meant to develop junior scientists and advance new scientific research within the center. A Scientific/Technical Core is meant to provide scientific and/or technical services and/or resources to center researchers in order to enhance their research capabilities.
With the exception of the Development Core, which should focus on new projects, the cores should provide support for both existing projects and the development of new projects. The proposed cores should be effective in promoting scientific impact, innovation, productivity, and competitiveness, but need not be innovative themselves. This FOA encourages core activities promoting interdisciplinary collaborations and collaborations within and across institutions.
History, size, and institutional context of centers
This initiative invites applications from both recently- and long-established population dynamics research centers. This initiative is not limited to population dynamics research centers that have received previous funding from the NICHD Population Dynamics Research Infrastructure Program. Funds issued through this initiative are meant to foster scientific impact, innovation, productivity, and competitiveness for peer-reviewed external funding for research within the scientific mission of PDB in the next five-year project period, not to simply reward past performance. Competitiveness for external funding includes external funding for research within the PDB scientific mission from all sources, not solely funding from PDB. This initiative invites applications from population research centers of any size, from small to large. A center's productivity, impact, and innovation will be assessed relative to the number of center scientists; a highly productive small center may have greater impact than a moderately productive medium-sized center, even if the latter has numerically more grants and publications. Because this initiative is expected to enhance competitiveness for funding from NIH and other external sources, the applicant institution is expected to show a strong commitment to the center by providing support to the center.
Resources provided through this initiative are meant to augment existing administrative, scientific, and technical services and resources that are already available to the centers; these resources may not be used to offset or replace research infrastructure already provided by the applicant institution. Access to research infrastructure supported by this FOA may not be limited to a single research project or research team. Resources provided through this initiative are not meant to be a substitute for research projects, training, or conference grant funding; centers wishing to conduct those types of activities should submit separate applications for support through the appropriate mechanism.
Specific Areas of Research Interest
To be responsive to this initiative, the Primary Research Areas (PRAs) identified must be within the scientific mission of NICHD Population Dynamics Branch (PDB). The PDB scientific mission is to support research, research training, and data collection in three areas:
Research focusing primarily on elderly populations and individuals is not responsive to this initiative.
For the purposes of this initiative, "population dynamics research" and "population research" refer to research within the three areas described above. "Population" is defined as the aggregate collection of individuals in a defined geographic area, social, economic, and/or demographic group. Examples include the residents of New York City, married people in the United States, and African American children under age five. Aggregates defined by their participation in a study, program, or service or by having a diagnosis of a specific medical condition are not considered populations under this definition.
For the purposes of this announcement, the "NICHD Population Dynamics Research Infrastructure Program" refers to all grants and activities supported by RFA-HD-12-186, RFA-HD-13-007, RFA-HD-15-009, RFA-HD-16-017, RFA-HD-17-007, RFA-HD-18-013, RFA-HD-19-014, and predecessor announcements.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
New
Renewal of awards to RFA-HD-15-009, RFA-HD-14-016,
and RFA-HD-13-007
Resubmission
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.
Not Allowed: Only accepting applications that do not propose clinical trials
Need help determining whether you are doing a clinical trial?
NICHD intends to commit $1,600,000 in FY 2020 to fund four awards.
For renewal applications, requested annual direct costs may not exceed $500,000 or the amount of annual support (direct costs) the center receives from outside the applicant institution for population dynamics research and training, whichever is lower. In addition, the requested annual increase may not exceed $125,000 of the prior competitive award.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
o Hispanic-serving Institutions
o Historically Black Colleges and Universities (HBCUs)
o Tribally Controlled Colleges and Universities (TCCUs)
o Alaska Native and Native Hawaiian Serving Institutions
o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
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.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. 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.
There are three additional eligibility criteria for applications responding to this FOA:
Established Research Center. The applicant institution must have an established administrative unit (for example, a center or an institute) that administers or coordinates population dynamics research across the applicant institution, hereafter referred to as the "population research center." Funds from this FOA must be for this population research center and may not be used to establish a new population research center at the applicant institution. The PD/PI must be the director of the center when the application is submitted and/or the award is issued. As used in this FOA, an "established unit" has the following characteristics: the applicant institution has formally created the administrative unit; the unit has an administrative position and reporting structure within the applicant institution; the unit has dedicated space; the unit has a governance and organizational structure; the unit's director has defined responsibilities and authority; and the unit has rules or guidelines for selecting or recruiting members/affiliates.
Active Scientists. Applicants must have at least five active scientists working in population dynamics research, that is, research within the scientific mission of NICHD Population Dynamics Branch. Active population scientists must hold their primary affiliation with the applicant institution and this position (tenured or non-tenured) must be permanent; trainees, post-doctoral fellows, visiting professors, and scientists with primary appointments at other institutions are excluded. Active population dynamics scientists must meet both of the following criteria:
Funding by the NICHD Population Dynamics Branch. Applicants must have at least one active scientist, as defined above, who has received a research grant or other significant funding from the Population Dynamics Branch within the three most recently completed Federal fiscal years. The mechanisms that qualify are research project grants (e.g., R01, R03, R15, R21, R37, R00, U01, UH2/UH3); research program projects (P01); resource-related research project grants (R24, U24), excluding R24 grants funded through the Population Dynamics Centers program; individual career development awards for faculty (K01, K08, K23); institutional training grants (T32); education project grants (R25); and research contracts (N01, N02, N03, N44, Y01, Y02, Y03) that were funded or administered by the Population Dynamics Branch. Mechanisms that do not qualify are individual pre-doctoral and/or post-doctoral fellowships (e.g., F31, F32, K99), conference grants (e.g., R13, U13) and R24 or P2C grants funded through the Population Dynamics Centers program. Grants considered to be funded or administered by the Population Dynamics Branch have a grant number that includes the Institute/Center designation of "HD" and a program official who is a member of the Population Dynamics Branch staff.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Institutions may not hold more than one NICHD Population Dynamics Centers Research Infrastructure Program P2C or R24 award at a time. For example, institutions with awards from RFA-HD-16-017, RFA-HD-17-007, RFA-HD-18-013, or RFA-HD-19-014 are not eligible to apply. This prohibition precludes the submission of applications to this program from institutions with existing awards that will not complete their current competitive period within this fiscal year. Applications from such institutions will not be accepted for review.
The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is 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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Rosalind B. King, PhD
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
Telephone: 301-435-6986
Email: rozking@mail.nih.gov
Available Component Types |
Research Strategy/Program Plan Page Limits |
Overall |
12 |
Administrative Core |
6 |
Development Core |
12 |
Sci/Tech Core (use for Scientific/Technical Core) |
6 |
Additional page limits 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 a multi-component application.
The application should consist of the following components:
o Development Core: Optional, minimum 0; maximum 1
o Scientific/Technical Core: Optional, minimum 0; maximum 3
When preparing your application, use Component Type Overall .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete entire form.
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Follow standard instructions.
Facilities & Other Resources: Explain the center's administrative position within the larger institution, including formal departments and other scientifically related centers. Explain how the scientific and institutional environments at the applicant institution contribute to the probability of success for achieving the specific aims described in this application. Describe the organizational resources available to the center. Identify the facilities to be used, including, but not limited to, dedicated space, computer facilities and resources, laboratories, and other facilities. If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project. Relative proximity of resources and size and shape of dedicated space may be presented in either graphic or narrative form. Describe only those resources that are directly related to achieving the specific aims described in this application or that complement the proposed research support cores. Provide any information describing the Other Resources available to the project (e.g., secure data room) and the extent to which they would be available to the project.
Describe institutional investment in the success of the center's Early Stage Investigators (ESI), e.g., resources for classes, travel, and training; collegial support such as career enrichment programs, assistance and guidance in the supervision of trainees involved with the ESI's projects, and availability of organized peer groups; logistical support such as administrative management and oversight and best practices training; and financial support such as protected time for research with salary support and coverage of supplies, equipment and technical personnel.
List types and amount of committed funding the center receives from the applicant institution. Examples include but are not limited to dedicated equipment, dedicated space, salary support for investigators or core staff, faculty appointments in subject areas relevant to the goals of the program, operating budgets, financial support for new space or equipment, and arrangements the center has to recover indirect costs. Include salaries only if the support is provided for a center-related function such as directing a center, managing a core, or similar activities. Institutional support for center and core personnel and research faculty should be reflected in the budget request. This information may be presented in tabular form.
Provide information about the center's external funding for population dynamics research, research training, and data collection that is within the mission of PDB and was received in either FY 2017 or FY 2018; select one fiscal year, do not present information for both. This information may be presented in tabular form. Comparable grants awarded in FY 2019 may be listed in a separate table. Report only direct costs; do not report total costs. Report only on funding for activities that are within the PDB mission; do not report all funding to all center affiliates.
List the following:
For all funding, provide the funder and grant/contract number (e.g., NICHD R01HD012345, NIA R03AG543210), the PD/PIs, the grant title, the direct costs for FY 2017 or FY 2018, and whether the grant is in a no-cost extension. If the center receives no funding in a category, state "None." For multiyear grants, estimate the amount that was spent or received in FY 2017 or FY 2018. For subcontracts, also provide the grantee institution and the PD/PI of the subcontract at the applicant institution.
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.
Specific Aims: The specific aims must address how the center plans to use the funding available through this FOA to achieve the primary objectives of this initiative. Applicants are required to identify their center's Primary Research Areas (PRAs) to be supported through this program, the areas in which the center expects to make its most significant contributions to population dynamics in the next five years. In terms of the first objective, on increasing the scientific impact, innovation, and productivity of population dynamics research, centers should focus primarily but not necessarily entirely on increasing scientific impact, innovation, and productivity within the center's PRAs. Applicant centers are required to provide evidence that the support they request through this initiative will contribute to the center achieving its specific aims.
Research Strategy: The Research Strategy section includes the Program overview and the Preliminary Studies/Progress Report.
1. Program Overview
The Program Overview should describe the applicant's specific aims, including the progress it plans to make in these PRAs, how the applicant plans to achieve these aims, and how the resources provided through this initiative enhance the applicant's ability to achieve these aims, over and above what the applicant would have been able to achieve without the funding from the initiative. Information provided elsewhere in the application for instance, in the cores, biographical sketches, and Research & Related Other Project Information section should not be repeated in this section.
New applications should not identify or contact potential advisory committee members; renewal applications should identify current advisory committee members. If the center plans to change the Center Director during the project period, explain how the next Center Director will be selected.
Describe how the center assesses the following: the scientific impact and innovation of the research produced by center affiliates; the productivity of center affiliates; the competitiveness for peer-reviewed external funding of affiliates; success in ensuring that junior scientists achieve research independence; and the cost-effectiveness of research infrastructure. Example assessment metrics include, but are not limited to: number of peer-reviewed publications overall, in major demography or social science journals, or in scientific journals with high impact scores; citation counts; number and/or size of grants and/or contracts; number of grant applications submitted; success rates of grant applications submitted; number of new investigator applications submitted and funded; and collection, compilation, and/or dissemination of widely used data sets or other resources. Publications and funding are important metrics of impact, innovation, productivity, and competitiveness, but, for the purposes of this initiative, evidence of the overall scientific impact on the field of population dynamics of a center's recent research is more important than mechanical counts of articles and grants.
2. Preliminary Studies/Progress Report
Applicants who have not received prior support from the NICHD Population Dynamics Research Infrastructure Program should include preliminary studies related to the center's PRAs and specific aims and describe existing research infrastructure activities related to the proposed cores. For renewal applications, include a progress report. If applicable, explain how the research emphasis of the center has changed since the prior competing application and why previously supported cores are being dropped or changed. Information provided elsewhere should not be repeated here.
Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off site (i.e., at an institution other than the applicant institution), a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.
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,
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. 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 requirements of the NIH Data Sharing Policy and 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).
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
PHS Human Subjects and Clinical Trials Information (Overall)
When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.
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.
When preparing your application, use Component Type Administrative Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package.
Annual direct costs for the Administrative Core may not exceed $160,000. Applicants should budget funds for the PD/PI to attend one annual NICHD Population Dynamics Research Infrastructure Program Principal Investigator meeting. This meeting is usually held in conjunction with the annual meeting of the Population Association of America.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Describe the Administrative Core's objectives and the administrative services to be supported through this initiative.
Research Strategy: The administrative core has two major functions. The first function is overseeing and coordinating the activities funded through the other cores supported through this FOA. The second function is maximizing the efficiency of funding for population dynamics research by minimizing the financial and time burdens of providing administrative support services associated with research projects. Activities may include aiding in compliance with the administrative and fiscal requirements of funding agencies, managing working paper series and other dissemination of the center's research findings, providing editing services, and managing coordination and communications with other population dynamics centers. The Administrative Core is mandatory.
Provide the following information for the Administrative Core:
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,
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. 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 requirements of the NIH Data Sharing Policy and 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).
Appendix:
Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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
When preparing your application, use Component Type Development Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Describe the Development Core's objectives and the current and planned support and services to be provided. The specific aims for the Development Core should explicitly address how the core will increase the scientific impact, innovation, productivity of population dynamics research conducted in the applicant center; increase the center scientists' competitiveness for peer-reviewed external funding in population dynamics research; and support experiences for junior scientists that will contribute to their research independence.
Research Strategy: The research strategy should address how the applicant plans to use support from this FOA to provide development activities and services above and beyond services and activities provided by the applicant institution and center.
All applicants requesting support for a Development Core must propose a seed grant (or pilot) program supporting small-scale and innovative research projects, especially those that will provide preliminary data leading to larger research efforts in population dynamics research. Seed grant programs may provide funding, but may also, in addition to or instead of, provide other types of support, such as research assistant(s) or dedicated consulting or mentorship. The Development Core may also support other types of development activities, including but not limited to, application preparation workshops/boot camp; seminar or brown bag series; working groups; and other internal workshops and conferences.
Provide the following information for the Development Core:
For seed grant programs, address all the items above and, in addition, include the following:
Renewal applications requesting an increase in funding over the prior competitive award must justify the need for additional funding. This justification should include evidence demonstrating the demand within the center for the new or expanded activity; an explanation of why, if the budget were held at the level of the most recent competitive segment, the new or expanded activities could not be supported through re-budgeting; a discussion of why existing NIH competitive funding mechanisms cannot be used to support the proposed or expanded activity; and a description of the metrics that will be used to assess whether the additional funding has resulted in enhancing the center's ability to achieve the objectives of this FOA.
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,:
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. 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 requirements of the NIH Data Sharing Policy and 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).
Appendix:
Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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.
When preparing your application, use Component Type Sci/Tech Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Describe the Scientific/Technical Core's objectives and the current and planned support and services to be provided. The specific aims should explicitly address how the core will increase the scientific impact, innovation, and productivity of population dynamics research conducted in the applicant center. Specific aims may also address how the core will increase the center scientists' competitiveness for peer-reviewed external funding in population dynamics research; and how it will support experiences for junior scientists that will contribute to their research independence.
Research Strategy: The research strategy should address how the applicant plans to use support from this FOA to provide scientific and technical services and resources above and beyond services and activities provided by the applicant institution and center. The services and resources to be provided should be designed to enhance the scientific innovation and technical sophistication of new projects by providing access to advanced scientific/technical expertise at the project development phase and should advance informal scientific education by exposing scientists to advanced methodologies. Examples of the areas for which scientific/technical services and resources may be offered include, but are not limited to, biodemography, support for accessing data and associated documentation, methodology, programming, spatial analysis, and statistical services including personnel and computer time. In order to exploit economies of scale, applicants are strongly urged to consolidate all scientific/technical services and resources under a single core. Applicants proposing more than one Scientific/Technical Core must justify the use of multiple cores by providing evidence that, compared with use of a single core, use of multiple cores will provide costs savings and/or demonstrably better provision of services and resources. Plans for the scientific and technical services and resources to be provided over the project period should reflect any planned innovations in the PRAs.
Provide the following information for the Scientific/Technical Core:
Renewal applications requesting an increase in funding over the prior competitive award must justify the need for additional funding. This justification should include evidence demonstrating the demand within the center for the new or expanded activity; an explanation of why, if the budget were held at the level of the most recent competitive segment, the new or expanded activities could not be supported through re-budgeting; a discussion of why existing NIH competitive funding mechanisms cannot be used to support the proposed or expanded activity; and a description of the metrics that will be used to assess whether the additional funding has resulted in enhancing the center's ability to achieve the objectives of this FOA.
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:
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. 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 requirements of the NIH Data Sharing Policy and 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).
Appendix:
Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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.
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) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. 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.
For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit 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) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness 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.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the infrastructure program 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 infrastructure program proposed).
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, an infrastructure program that by its nature is not innovative may be essential to advance a field.
Does the infrastructure program 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 infrastructure program 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?
Do the PRAs proposed in this application address important problems or critical barriers in population dynamics research?
If the overall plans for providing research infrastructure are successful, will scientific knowledge, approaches, and methods of research in population dynamics in this center improve? Will scientific knowledge, approaches, and methods of research in population dynamics beyond this center improve?
Will successful implementation of the overall plans for providing research infrastructure change the application of methods and perspectives of research in population dynamics to new topics with relevance to the scientific understanding of the health and well-being of populations? Will successful implementation of this infrastructure program serve to catalyze methods and perspectives in population dynamics over and above what the applicant could do without this infrastructure support?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the infrastructure program? 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?
In the PRAs and population dynamics overall, are the center affiliates productive, influential, and competitive for extramural funding?
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?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the infrastructure program? Have 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 infrastructure program 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?
Do governance and organizational structure, responsibilities of center leadership and advisors, and the membership policies and practices of this infrastructure program contribute to the likelihood of success?
Are the proposed types of research infrastructure support cores and the methods for providing core services appropriate for advancing the application's overall specific aims and PRAs?
Based on the plans presented in this application and, for renewals, past performance, overall, are the proposed types of research infrastructure support cores and the methods for providing core services likely to be cost effective and to increase the impact and innovation of the research done by center scientists and the productivity and competitiveness of center scientists in terms of extramural funding and publications?
For applications that propose supporting pilot projects or seed grants, are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects? Are the plans proposed for soliciting, reviewing, and selecting projects to fund appropriate?
For applications that promote interdisciplinary collaborations and collaborations within and across institutions, do the proposed core activities contribute to the likelihood of success?
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?
Is the level of institutional commitment adequate for the proposed infrastructure activities, taking into account the institutional context? Does the academic and physical environment contribute to the likelihood of success through research opportunities, space, equipment, and the potential for interaction with scientists from various departments, institutions or disciplines?
Do the eligibility and priorities for access to infrastructure activities, services, and resources contribute to the likelihood of success?
As applicable for the infrastructure program 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.
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.
When the proposed infrastructure program 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.
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.
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.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
or Renewals, the committee will consider the progress made in the last funding period. For applicants with past support from the NICHD Population Dynamics Research Infrastructure Program, has this support advanced the center's PRAs in population dynamics?
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.
Not Applicable
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).
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 .
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.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Reviewers will evaluate the following items in determining scientific and technical merit. Reviewers will provide a single impact score for the Administrative Core. Reviewers will not give separate scores for the individual items. Reviewers will not provide criteria scores.
Reviewers will evaluate the following items in determining scientific and technical merit. Reviewers will provide a single impact score for the Development Core. Reviewers will not give separate scores for the individual items. Reviewers will not provide criteria scores.
Reviewers will evaluate the following items in determining scientific and technical merit. Reviewers will provide a single impact score for the Scientific/Technical Core. Reviewers will not give separate scores for the individual items. Reviewers will not provide criteria scores.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) , convened by NICHD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
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 & Human Development (NACHHD) Council. The following will be considered in making funding decisions:
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.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.
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
Rosalind B. King, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6986
Email: rozking@mail.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.