June 12, 2023
None
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
The Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD, a component of the National Institutes of Health (NIH), intends to issue a sole source award using other transaction authority (OTA) for designing a public-private partnership to support pediatric medical device development and commercialization. NICHD in collaboration with the National Institute of Biomedical Imaging and Bioengineering (NIBIB), intend to fund the Foundation of the National Institutes of Health (FNIH) to carry out the initial scoping, design, establishment, and management of a public-private partnership (PPP) initiative in order to consolidate the national pediatric medical device ecosystem and develop strategies to de-risk development and commercialization of medical devices that address the needs of pediatric populations. The project will consist of two phases. The Design Phase will produce a white paper with a detailed plan to build and launch a PPP, focusing on the key primary processes of building the national pediatric medical device ecosystem, including networks of hospitals as well as decentralized systems; optimizing public and private financing and reimbursement for research and development of pediatric medical devices; and creating the self-sustaining entity that will administer and manage the partnership in the public trust. The Transition Phase will serve as a bridge between the Design and a future Implementation Phase.
OT authority provides the most expeditious vehicle by which NIH can secure those services while simultaneously providing close programmatic management. A grant, cooperative agreement, or contract could not be delivered with required flexibility to extend/expand the scope of work as needed.
At this time only one organization possesses the necessary authority, experience, expertise, and ability to work with NIH to rapidly build and manage this public-private partnership initiative and secure donor funds. Established by Congress in 1990 as a not-for-profit 501(c)(3) charitable and independent organization, the FNIH pursuant to its authority under section 499 of the Public Health Service Act, codified at 42 U.S.C. 290b, raises private funds to support the mission of the NIH and advances collaborations with biomedical researchers from universities, industry, and nonprofit organizations, including through public-private partnerships. The FNIH is the sole organization responsible for carrying out private donor solicitation in support of all 27 institutes and centers of the NIH. The FNIH facilitates the exchange of ideas between NIH and private partners in a pre-or non-competitive environment that is not possible otherwise.
Internal NIH experts in the management of extramural awards to spur biomedical R&D via public-private partnerships will provide an objective review of the application/plans provided by FNIH. An OT award will be made if the recipient can sufficiently demonstrate the organization’s ability to build and manage a complex, multi-entity public-private partnership that seeks to consolidate a national ecosystem that optimizes the translation of technological advancements into medical devices designed, evaluated, and approved for pediatric populations. An award will be made pending review of plans to deliver a PPP in a timely manner and pending review of the budget.
Antonello Pileggi, MD, PhD, MSCTI
Eunice Kennedy Shriver National Institute of Child Health and Human Development [NICHD]
Telephone: 301-402-5019
Email: [email protected]
Artisha Wright
Eunice Kennedy Shriver National Institute of Child Health and Human Development [NICHD]
Telephone: 301-827-1844
Email: [email protected]
and Human Services (HHS)
