Key Dates

Related Announcements

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by

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

Office of Research on Women’s Health (ORWH)

Purpose

BACKGROUND

In order to enhance clinical trial stewardship and transparency, and thereby, further assure the success of its clinical trial enterprise, the NICHD proposed four principles that would guide its plan for continued commitment to infrastructure support for rigorous multisite clinical trials in Notice (NOT-HD-19-034) and at the Webinar (Strategic Plan 2020 Implementation: NICHD’s vision for multisite clinical trials infrastructure). The four guiding principles expressed in those forums included:

• Enhancing the rigor and reproducibility of clinical trial protocols
• Promoting greater availability of multisite clinical trial infrastructure to support trials from a wider range of investigators
• Facilitating data sharing and access to biospecimens to efficiently expand research capacity for all investigators
• Facilitating greater involvement of diverse populations in multisite clinical trials.

To operationalize these guiding principles, a funding opportunity announcement (PAR-23-037) was published to solicit applications for multisite clinical trials and observational studies to be conducted by and within the participating NICHD-supported Clinical Research Networks. Applications in response to PAR-23-037 will be submitted as investigator-initiated, multi-Principal Investigator (PI) grant applications by any qualified investigator in the extramural community (including NICHD Network investigators) in conjunction with the respective NICHD Network Data Coordinating Center (DCC). These applications will undergo the formal evaluation of NIH peer review. It is the intent that research projects conducted by these NICHD-supported Networks will be supported via this funding mechanism. However, it is recognized that there will be situations in which this process may not afford the nimbleness to respond to emerging health care crises and/or other time-sensitive opportunities and/or issues. Consequently, the purpose of this Notice is to affirm that NICHD will consider administrative supplement requests from Network awardees to address such situations and opportunities.

SCOPE AND WORK TO BE PERFORMED

These administrative supplement requests to existing NICHD-supported Network grants will be intended to leverage participating NICHD Networks (listed below) to address emerging health care crises and/or other time-sensitive opportunities and/or issues. All other proposals should be submitted via funding opportunity announcement PAR-23-037.

The scientific scope of this initiative is focused on specific areas of the NICHD mission and Strategic Plan, and the corresponding Networks that support those areas of study as depicted below. Thus, administrative supplement applications submitted in response to this Notice should address topics that align with, but are not necessarily limited to, one of the following Networks and their corresponding science:

• Maternal Fetal Medicine Units Network (MFMU)
• Neonatal Research Network (NRN)
• Global Network for Women's and Children's Health Research (GNWCHR)
• Collaborative Pediatric Critical Care Research Network (CPCCRN)
• Pelvic Floor Disorders Network (PFDN)

If an investigator from another NICHD Network or another area of science not directly aligned with the five Networks listed is interested in submitting an administrative supplement application for similar purposes, they are advised to contact the Scientific/Research Contact for this Notice.

A rigorous pre-application process similar to that utilized for PAR-23-037 will apply to this funding opportunity as well, but with an expedited timeline to the greatest extent possible. Only applications that receive approval to submit through the pre-application process will be considered for funding. Applications without that prior pre-application process approval will not be accepted in response to this Notice. It is anticipated that additional NICHD Networks will eventually be added to this initiative.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• For funding consideration, applicants must include NOT-HD-23-005 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Requests may be for one year of support only; however, the NICHD is willing to consider exceptions on a case-by-case basis.
• The proposed project period of the supplement cannot extend beyond that of the parent award.
• Any Network awardee wishing to apply for an administrative supplement to their Network infrastructure award must use this Notice to apply unless a separate and specific funding opportunity announcement exists.
• Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this Notice in order to facilitate efficient processing of the request.

Inquiries

Please direct all inquiries to:

Abisola Tepede, PharmD, RPh, PMP
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-480-4604
Email: NICHD-Network-ClinicalResearch@mail.nih.gov

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

Office of Research on Women’s Health (ORWH)
As a participating office on this NOSI: NOT-HD-23-005
In the Issued By section under NICHD

Elena Gorodetsky, M.D., Ph.D.
Office of Research on Women’s Health (ORWH)
Phone: 301-594-9004
Email: egorod@mail.nih.gov