EXPIRED
National Institutes of Health (NIH)
U24 Resource-Related Research Projects – Cooperative Agreements
See Section III. 3. Additional Information on Eligibility.
This limited competition Notice of Funding Opportunity (NOFO) issued by the NIH Helping to End Addiction Long-term (HEAL) Initiative and the Eunice Kennedy Shriver National Institute of Child Health and Human Development invite an application from the institution currently participating as the Data Coordinating Center in the Outcomes of Babies with Opioid Exposure (OBOE) consortium to complete the ongoing study and follow-up of study participants.
30 days prior to application receipt date
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
Not Applicable | December 19, 2023 | Not Applicable | March 2024 | May 2024 | July 2024 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
No late applications will be accepted for this Notice of Funding Opportunity (NOFO).
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the NOFO) 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.
The NIH Helping to End Addiction Long-term (HEAL) Initiative and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invite an application from the institution currently participating as the Data Coordinating Center grantee.
Among infants covered by Medicaid in 46 states, from 2004 to 2014 the incidence of neonatal opioid withdrawal syndrome (NOWS) increased from 2.8 to 14.0 cases per 1000 hospital births. The Healthcare Cost and Utilization Project (HCUP) 2020 data estimated that six newborns were diagnosed with NOWS for every 1,000 newborns – approximately one baby is diagnosed with NOWS every 24 minutes in the United States. Infants with NOWS may experience: tremors, irritability, sleep problems, hyperactive reflexes, seizures, stuffy nose/sneezing, poor feeding and sucking, vomiting, loose stools, dehydration, and increased sweating (https://www.cdc.gov/pregnancy/opioids/basics.html). NOWS also puts these children at increased risk of adverse neurodevelopmental outcomes.
This OBOE consortium is part of the NIHs HEAL initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to: (1) improve treatment and prevention of opioid misuse and opioid use disorder and (2) enhance pain management. More information about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative. Within the HEAL Initiative, OBOE is part of the Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) program.
The purpose of the OBOE program is to assess the effects of antenatal opioid exposure on the trajectory of brain development over the first 2 years of life to better understand the long-term impacts of antenatal opioid exposure and NOWs, as well as associated environmental, maternal, and neonatal factors, on neuroanatomical, medical, neurodevelopmental, behavioral, and home, social, and family outcomes. The program will compare neuroanatomical (as measured by serial neuroimaging studies), medical, neurodevelopmental, behavioral, and home, social, and family outcomes between children who have been exposed to opioids in utero and those who have not been exposed. Such research is needed to inform development of intervention trials, appropriate care practices, and treatments to improve outcomes for these vulnerable infants.
The objective is for awardees to work together as a Consortium to complete implementation of the ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study (https://www.clinicaltrials.gov/study/NCT04149509) with multi-modal assessments conducted of infants exposed to opioids in utero compared to unexposed infants from birth to two years of age to better understand the consequences of in utero opioid exposure. The study will determine associations with developmental and neurobehavioral outcomes and explore how specific factors (differing antenatal and postnatal exposures, severity of neonatal opioid withdrawal, maternal stress/depression/parenting) modify these effects. Participants will be assessed at 2-years of age with serial measures including neuroimaging, medical, neurodevelopmental, behavioral, and home, social, and family life assessments.
The OBOE Consortium currently consists of 4 Clinical Centers (CCs) and a Data Coordinating Center (DCC). For this limited recompetition, the Clinical Centers/Performance Sites will submit separate grant applications under RFA-HD-24-016. Under this RFA, RFA-HD-24-015, the DCC will include all the functions previously carried out by the Research Support and Administrative Cores, and will designate a lead Neuroimaging researcher.
It is each institutions responsibility to:
The OBOE Steering Committee (SC) consists of:
The SC has the primary responsibility for implementing the ACT NOW Longitudinal Study, including: completing enrollment, following participants over the course of 2 years, and conducting longitudinal assessments in multiple domains, analyzing and publishing study results, and sharing study data.
The SC meets 4 times per year and has monthly teleconferences. At least two meetings per year are expected to be face-to-face (weather and public health permitting), usually in the Washington, DC metro area. In general, SC meetings last for 1 day each, and are scheduled 12 months in advance. All SC members or their designees are expected to attend these meetings. The Steering Committee may create subcommittees to manage specific functions, such as a Publications Subcommittee.
Key activities of the OBOE Consortium will be to:
Scientific and Safety Monitoring Board (SSMB): A Scientific and Safety Monitoring Board (SSMB) has been established in accordance with the NICHD DSMB Policy for Clinical Trials to monitor the ACT NOW Longitudinal Study. The SSMB is responsible for safeguarding the interests of study participants and protecting study participants from unacceptable risk. The SSMB provides recommendations to the NICHD Director and consortium investigators on research design, data quality, and analysis issues, as well as conducting interim monitoring of trials for safety, efficacy, feasibility, and ethical conduct. Full members of the SSMB cannot be from any of the CCs, their satellite sites, or the DCC; the DCC PI is an ex officio member, providing statistical reports for SSMB review and logistical support for its meetings.
The clinical centers participating in the Consortium represent academic institutions with experience in multicenter clinical research. They must agree to abide by Consortium study objectives, policies, and procedures and have comparable staff, facilities, and equipment.
Each clinical site must designate a Principal Investigator (PI) responsible for all aspects of the center's participation in the Consortium. The Principal Investigator participates, with the NIH, the Steering Committee chair, the lead Neuroimaging investigator, and Data Coordinating Center PI, as a member of the Consortium Steering Committee.
The Principal Investigator has primary responsibility for:
As such, the PIs oversight responsibilities include:
Additional details about the CCs can be found in RFA-HD-24-014 UG1 – HEAL Initiative: Limited Competition: Clinical Centers for Completion of the Outcomes of Babies with Opioid Exposure (OBOE) Study (UG1 Clinical Trial Not Allowed).
The DCC is expected to participate collaboratively on the Steering Committee to achieve OBOEs objectives. As such, the DCCs specific objective is to develop, implement, and analyze results for study protocols, especially providing biostatistical expertise, computer programming, and project management to design protocols, develop statistical analysis plans, develop data management systems, manage study funds, monitor data integrity and study safety, and work with study investigators to analyze and publish study results, and comply with the NIH Data Management and Sharing Policy. The DCC is responsible for:
As with the CCs, the DCC will be required to set up appropriate master agreements (memoranda of understanding, subcontracts, data use agreements, etc.) with each CC to enable transfer of earned capitation funds and study data for all OBOE protocols between the DCC and each CC.
The DCC will have the following categories of personnel:
The DCC should have some degree of flexibility in staffing to be able to respond to changing work effort needs (i.e., changing number and complexity of protocols in various stages of development and implementation, submission deadlines for major conferences, etc.).
DCC Principal Investigator
The DCC PI participates, with the CC PIs, and the NICHD Project Scientist, as a member of the Steering Committee, with each Center getting one vote.
The DCC PIs responsibilities include: Obtaining and maintaining sIRB approval for consortium protocols.
Statisticians
DCC statisticians provide biostatistical expertise for protocol design, study monitoring, and results analyses. Under the supervision of the DCC PI, the statisticians are responsible for:
Research Coordinators and/or Project Assistants
DCC coordinators and research project assistants work closely with the DCC PI to implement consortium protocols and to provide support for overall consortium operations. Under the supervision of the DCC PI, Research Coordinators are responsible for:
Programming staff
DCC programming staff is primarily responsible for developing, maintaining, and updating the data management system(s). They work with the study PIs and DCC coordinators to program the data management system(s), manage data transmission, and provide support to the recruiting sites to resolve any data entry and transmission issues. DCC programming staff works with the DCC PI and coordinators to monitor data quality and to assist with data cleaning prior to statistical analysis. In addition, programming staff assist the DCC PI to generate required reports and manage the earned capitation distribution system.
Logistics and support staff
DCC support staff is responsible for providing logistical support for the consortium– scheduling meetings and teleconferences, securing meeting and lodging facilities and equipment, recording and distributing meeting minutes, etc.
NICHD provides funding to each CC and the DCC through Clinical Research Cooperative Agreements. NICHD uses this assistance mechanism when it anticipates its scientific and/or programmatic staff will need to have substantial involvement with the awardee(s) during performance of clinical research. The NICHD Program Staff will assist PIs in identifying research topics of high priority and designing and implementing protocols in the targeted research area.
The NICHDs Office of Clinical Research (OCR) staff, Program Official, and Grants Management will be responsible for overall grant stewardship. The Program Official, or his/her/their designee, will serve as the NICHD representative on the consortiums Scientific and Safety Monitoring Board (SSMB) in the manner delineated in the NICHD Data and Safety Monitoring Policy. A NICHD Project Scientist will be involved substantially with the awardees, serving as NICHDs voting representative on the Steering Committee, and working with investigators to design and implement protocols and analyze results. A Clinical Trials Specialist or Program Analyst will work with the Program Official and Project Scientist to help coordinate consortium management. The NICHDs OCR will work with the NICHD Program Staff to develop efficiencies, support grant stewardship, and provide policy guidance. OCR staff may attend SC and subcommittee/working group meetings as observers.
Independent of the governance above, the NICHD Director retains responsibility for all NICHD funded research. The NICHD Director receives the SSMBs recommendations on whether studies should be continued or terminated and can make an independent decision on how to proceed. The NICHD Director can override the decisions of the Steering Committee when it is in the strategic interest of the NIH/NICHD, and/or due to considerations of human subjects protection, and/or based on funding availability.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.
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 NOFO.
Not Allowed: Only accepting applications that do not propose clinical trials.
NICHD intends provide the following total cost funding for the Data Coordinating Center per fiscal year:
FY2024: $1,145,279
FY2025: $766,154
FY2026: $427,247
Application budgets need to reflect the actual needs of the proposed project. For the base/infrastructure budget, the Data Coordinating Center may request up to $346,000 for Year 1 direct costs in FY2024 with decreasing amounts for the following two years as enrollment and follow-up wind down. The annual maximum funding limit also needs to cover any capitation costs (and indirect costs to the CCs for this) to complete the study.
The maximum project period is 3 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
1. Eligible Applicants
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted 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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.
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.
Only the currently participating OBOE DCC Program Director(s)/Principal Investigator(s) are eligible to apply to this NOFO.
2. Cost Sharing
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity 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:
The letter of intent should be sent to:
Nahida Chakhtoura, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6872
Email: [email protected]
Page Limitations
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 NOFO.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed. The additional instructions apply:
Please provide a copy of the IRB-approved protocol as a pdf attachment using the filename Attachment 1. OBOE Protocol.
Please provide a summary of the DCCs clinical research experience as a pdf attachment using the filename Attachment 3. Research Experience.
Center Trials and Studies. Provide a table summarizing research productivity of completed studies at the CC and its satellite sites related to neonatal opioid withdrawal syndrome or neonatal abstinence syndrome. The table format must include:
The attachment may include interventional trials, observational studies, biospecimen collection, and/or translational studies that highlight your institutions clinical research experience in relation to the purpose and objectives of OBOE. Included studies do not need to have been completed (they can be ongoing) or have publications available. Applicants may include studies from fellows, but do not need to include every study. Select what is pertinent for highlighting institution/PI expertise that is relevant to the objective of the application.
Publications. Provide a bibliography of publications authored or coauthored by study team members related to neonatal opioid withdrawal syndrome or neonatal abstinence syndrome. The publication list should include any publications related to the studies listed in the Center Trials and Studies table and may also include other publications that show the applicants experience in clinical research, particularly related to the purpose and objectives of OBOE.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
DCC applicants must demonstrate leadership in the design and conduct of clinical trials, preferably in the pregnancy and/or neonatology fields, as well as a track record in successfully coordinating and implementing multi-center clinical trials. Applicants must demonstrate clinical research expertise in: biostatistics; computer programming of websites and clinical trial data management systems; and work with study investigators to design protocols, manuals and data collection forms, manage capitation funds, and monitor data integrity and study safety. Applicants are strongly encouraged to name an experienced research team that will support the project management and implementation of consortium studies.
Please include descriptions and biosketches for each of the individuals filling the roles below. Describe the qualifications and experience of each person, specifically documenting their respective abilities to organize, manage, and/or coordinate a DCC in the Network and to implement clinical trials.
The applicants are encouraged to assemble a diverse team that includes women and minorities.
Principal Investigator(s)
Applicants must identify a PI; multi-PI applications are allowed, but each awarded Center will only get one vote on the Steering Committee. PI(s) for the Data Coordinating Center should be biostatisticians with relevant educational experience (e.g., PhD in statistics). The PI must demonstrate a track record of successful multi-site clinical trial implementation, preferably in obstetrics and/or neonatology.
Research Coordinator(s)
Applicants must identify at least one full- or multiple nearly full-time Research Coordinator(s). The Research Coordinator(s) should have strong project management experience, including experience coordinating multi-site clinical trials, preferably in obstetrics and/or neonatology.
Additional Specialists
The application should propose a committed multidisciplinary team to conduct consortium studies, including:
Please include biosketches of biostatisticians and programmers who will work on the DCCs team to implement protocols.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
Each applicant should submit Base Budget estimates for all years. It is expected that the DCC PD/PI will make a substantial commitment of time and effort to the Consortium to administrative and research support-related activities. Each applicant should submit base budget estimates to cover support to complete OBOE study enrollment and all follow-up assessments. The budget should also include support for:
The proposed budget should include any costs for preparing and submitting the data to a data repository.
Total funding for the DCC includes both the base award (via this RFA) and funds for approved study-related expenses ("Capitation" funds). The DCC may be awarded Capitation funds to cover study expenses; after award of any grant from this application, the DCC may request a carryover of unspent capitation and/or base budget funds from the previous grant. This application's budget should include any capitation expenses needed to complete the study. The DCC will be responsible for issuing payments for approved and funded protocol expenses to the CCs, DCC, and for Neuroimaging capabilities . Capitation funds are generally distributed based on milestone achievements (e.g., recruiting a subject and/or transmitting specific study data to the DCC).
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
The overall objective of the OBOE consortium is to complete enrollment and multimodal longitudinal assessments from birth to age 2 years of a diverse cohort of newborns either exposed or unexposed to opioids in utero. Applicants should describe the specific aims and hypotheses for the Longitudinal Study, and activities and goals of the Consortium for the performance period of this project.
The application should indicate that the DCC will continue its current participation in OBOE study, including conducting participant follow-up. The application should NOT propose a new clinical trial or study.
Data Integrity and Safety Monitoring. Describe the applicants experience in data quality assurance (edits, audits, and data cleaning) and monitoring for clinical trials for safety, protocol adherence, and recruitment. Include experience with conducting, coordinating site monitoring visits and data audits. Describe the applicants experience conducting interim analyses for study safety and efficacy and reporting these, and unexpected, serious, and protocol-related adverse events to DSMBs.
Staffing and Management. Provide an overview of DCC staff, including their biostatistical expertise with obstetric, lactation, and neonatology clinical research, their computer programming expertise in developing and/or customizing online, secure, data management systems, and their project management experience in facilitating clinical trial protocol development and implementation. In addition, please provide details on available neuroimaging expertise.
Describe the applicants management plan for its statistician resources and working with multiple stakeholders (NIH staff, the Steering Committee, and study investigators) to prioritize competing statistical analysis needs (i.e., for protocol development, conference presentations and manuscripts statistical analyses, etc.). Provide a description of the organization and supervisory structure of the DCC team and experience in implementing multiple studies simultaneously with high-quality data collection and safety monitoring.
Special Strengths. Applicants are encouraged to describe special or unique strengths that may be relevant to OBOE research. This can include state-of-the art scientific capabilities such as imaging and assessment techniques as examples which may be shared or may be available to develop and expand the scientific productivity of the consortium.
Integration of research programs. If the applicant institution is also an NICHD Neonatal Research Network clinical center, the applicant must describe how the two research programs will be integrated. Applications from institutions that have a NIH Clinical and Translational Science Award (CTSA) should provide a letter of agreement from the CTSA PI that identifies the level and type of support that will be provided for this grant, should it be awarded.
Experience in Conducting Clinical Trials. Without duplicating information requested in Other Project Information (Clinical Research Experience), describe the applicant's experience developing and conducting studies of neonatal opioid withdrawal syndrome. Include contributions in key areas of study development and design; patient recruitment, retention, and follow-up; study monitoring, data collection and statistical analysis; and study closeout, including data sharing and reporting final results to ClinicalTrials.gov.
Provide details on the approach to developing and maintaining a Network website, drafting and disseminating study materials and technical memos, providing technical support to CC staff, coordinating Steering Committee, subcommittee, and DSMB meetings.
Data Management System(s). Describe capabilities and experience in developing and/or customizing online, secure, data management systems that incorporate: real-time data entry, skip logic functionality, real-time edit checks (e.g., out-of-range values), and auditing capability; data import compatible with standard data formats; online data discrepancy and problem resolution; regular or real-time report generation; adverse event reporting and adjudication; randomization functionality; and email alert systems. Describe security and backup features to protect study participant data and Network resources.
Neonatal Follow-up. Describe the applicants plans for coordinating participant follow-up and tracking follow-up examiner training certifications. Describe procedures or plans to help CCs track infants to maintain contact with families, schedule appointments, actions taken for missed appointments, home visit appointment options, and other creative measures to increase follow-up compliance.
Because this program requires a team effort to be successful, departmental and institutional commitments to participate in Neonatal Research Network research should be clearly documented. Please provide letters of support from appropriate individuals at the DCC detailing:
Institutions with Clinical and Translational Science Awards (CTSA). Applications from institutions that have a NIH Clinical and Translational Science Award (CTSA) should provide a letter of agreement from the CTSA PI that identifies the level and type of support that will be provided for this grant, should it be awarded.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
Plans for Sharing Human and Non-Human Biospecimens
For sharing biospecimens, the DCC is responsible for maintaining an inventory of biospecimens managed across the consortium and, upon NICHD approval, coordinating submission of any remaining biospecimens to an NIH-approved repository on behalf of the consortium.
Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.Plans for Sharing Human and Non-Human Data
The award recipients and their collaborators must comply with all NIH HEAL Initiative Data Sharing Policy (https://heal.nih.gov/data/public-access-data), in line with broader efforts across NIH, as outlined in the NIH Strategic Plan for Data Science. Research teams funded by the NIH HEAL Initiative®, must make their HEAL data Findable, Accessible, Interoperable, and Reusable (FAIR).
NIH Data Management and Sharing Policy expects the timely release and sharing of data to be no later than the time of an associated publication, or the end of the award/support period, whichever comes first. Per the Policy, all applications, regardless of the amount of direct costs requested for any one year, are required to include a Data Management and Sharing Plan (the Plan) outlining how scientific data and any accompanying metadata will be managed and shared, regardless of whether the data are used to support scholarly publication. The Plan should describe data types, file formats, submission timelines, standards used in collecting or processing the data and other elements described in Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014). The Plan will be subject to assessment and approval by NIH Program Staff prior to funding. Awardees are required to comply with the approved Plan and any approved updates to the Plan. The Plan should be included with the final protocol for IRB approval as well.
For sharing human and non-human data, unless stipulated otherwise the approved Plan, the DCC is responsible for preparing and submitting protocol datasets. These HEAL-specific requirements should be integrated into the data management and sharing plan and implemented during data generation for HEAL-funded projects:
All data collected as part of the NIH HEAL Initiative should be collected under a Certificate of Confidentiality and entitled to the protections thereof. Institutions who receive Data and/or Materials from this award for performance of activities under this award are required to use the Data and/or Materials only as outlined by the NIH HEAL Initiative, in a manner that is consistent with applicable state and federal laws and regulations, including any informed consent requirements and the terms of the institutions NIH funding, including NOT-OD-17-109 and 42 U.S.C. 241(d). Failure to adhere to this criterion may result in enforcement actions.
For protocols that generate large-scale human genetic data, recruiting sites will have to 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
For this NOFO, applicants must indicate in their institutions (and any satellite sites) Letter of Support their agreement to comply with the OBOE Data and Specimen Sharing Plans – including abiding by the negotiated Data Management and Sharing Plans for OBOE, the HEAL data sharing policy and DEC – and cooperate with consortium procedures needed to finalize and share study data per these Plans.
Each Clinical Center and/or satellite recruiting site is responsible for ensuring that each studys informed consent forms contain language allowing broad sharing and future use of study data and biospecimens in alignment with federal and local regulations and policies. Consent forms must notify participants that their data and, when relevant, imaging data and biospecimens (potentially for both maternal and child) may be shared with other consortium investigators, the study sponsor(s), applicable federal agencies, and, when relevant, industry partners. In addition, de-identified data, imaging data, and remaining biospecimens from each study may be shared with researchers outside of the consortium, including depositing them in NIH-approved public repositories. Clinical Centers and/or recruiting sites may also be required to obtain approval(s) from appropriate regulatory authorities (e.g., IRB) for sharing that data, particularly for studies conducted under a waiver of consent.
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
4. Submission Dates and Times
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIHs 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
6. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organizations profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy
Any instructions provided here are in addition to the instructions in the policy.
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
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 the proposed Center address the needs of the research consortium that it will serve ? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium ?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing clinical research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; is their leadership approach and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?
Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research consortium the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium , as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium ? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
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.
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 project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
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 Animals 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.
Not applicable
For Renewals, the committee will consider the progress made in the last funding period.
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.
Not applicable.
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
Not applicable.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NICHD, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications 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 NOFO. 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:
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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: Recipient 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 recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigators 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 NOFO.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicants integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
NICHDs Office of Clinical Research staff, a Program Official, and a Grants Manager will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the notice of award. . A NICHD Project Scientist will provide scientific input to the Network. A Clinical Trials Specialist or Program Analyst will work with the Program Official and Project Scientist to help coordinate Network management.
NICHD Office of Clinical Research
NICHDs Office of Clinical Research will work with NICHD Program Staff to develop efficiencies, support consortium stewardship, and provide policy guidance. Staff from the NICHD Office of Clinical Research (OCR) may attend SC and subcommittee/working group meetings as observers.
NICHD Program Official
In addition to general grant stewardship, a NICHD Program Official will:
NICHD Project Scientist
A NICHD Project Scientist will have substantial programmatic involvement that is above and beyond the typical stewardship role in other awards. As described below, the Project Scientist will:
Director of the NICHD
NICHD reserves the right to terminate or curtail a study (or an individual award) under a range of scenarios including but not limited to: (a) failure to implement the study protocol; (b) a substantial shortfall in subject recruitment, follow-up, data reporting and dissemination, quality control, or other major breach of the protocol; (c) substantive changes in the agreed-upon protocol with which NIH does not concur; (d) reaching a major study objective substantially ahead of schedule with persuasive statistical evidence; (e) human subject safety or ethical issues that may dictate a premature termination; or (f) a change in the state of science that changes equipoise or has other significant impact on the relevance of the question under study. Studies in which recruitment and/or participant follow-up milestones are not met, or for which regulatory approval has not been met within one year, and are unlikely to improve sufficiently to bring the study to completion within an acceptable budget or timeframe, may be closed for lack of progress. If NIH or the awardee concludes that the study is no longer feasible, the consortium shall submit a close-out plan to NIH within 2 months.
The NICHD Director receives the SSMBs recommendations on whether studies should be continued or terminated and can make an independent decision on how to proceed. The NICHD Director can override the decisions of the Steering Committee when it is in the strategic interest of the NIH/NICHD, human subject protection, and/or dependent on funding availability.
Areas of Joint Responsibility include:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.
3. Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
4. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 – Award Term and Condition 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: https://www.era.nih.gov/need-help (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Nahida Chakhtoura, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-7886
Email: [email protected]
Beda Jean-Francois, Ph.D.
National Center for Complementary & Integrative Health (NCCIH)
Phone: 202-313-2144
Email: [email protected]
Joanna Kubler-Kielb, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6916
Email: [email protected]
Saiyda Khan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-6260
Email: [email protected]
Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]
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 and 2 CFR Part 200.