Notice Number: NOT-HL-08-121
Release Date: June 6, 2008
Closing Date for Responses: July 2, 2008
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)
This Notice is a time-sensitive Request for Information (RFI) on the needs for and impediments to the development of specific medical devices for diagnosing, treating, or curing pediatric diseases. This information will be used to assess the current needs for pediatric medical devices and will be shared at the HHS Interagency Pediatric Devices Stakeholders’ Public Meeting. This meeting will take place on July 23rd, 2008 in Bethesda, Maryland at the Natcher Auditorium on the campus of the National Institutes of Health (NIH). For more information on the meeting, please visit the following website: http://www.nichd.nih.gov/about/meetings/2008/devices.cfm.
This RFI is for planning purposes only and should not be construed as a solicitation for applications or proposals and/or as an obligation in any way on the part of the United States (U.S.) Federal government. The Federal government will not pay for the preparation of any information submitted and/or for the government's use of that information. Additionally, the government cannot guarantee the confidentiality of the information provided.
The Pediatric Medical Device Safety and Improvement Act of 2007, which is also known as Title III of the Food and Drug Administration Amendments Act of 2007, became law on September 27, 2007. The act specifies in Section 304c that a plan be developed for expanding pediatric medical device research and development. The plan is being developed through a joint effort of the National Institutes of Health, the Food and Drug Administration, and the Agency for Healthcare Research and Quality. http://www.fda.gov/oc/initiatives/hr3580.pdf.
The plan is specifically directed to include:
(1) any gaps in such research, which may include a survey of pediatric medical providers regarding unmet pediatric medical device needs, as needed; and
(2) a research agenda for improving pediatric medical device development and Food and Drug Administration clearance or approval of pediatric medical devices, and for evaluating the short- and long-term safety and effectiveness of pediatric medical devices.
Responses to this RFI will be used to help accomplish both of these parts of the plan.
This RFI invites the scientific community, health professionals, patient advocates, and the general public to provide comments and suggestions on the following issues:
1) Identify unmet medical needs for pediatric populations that could be addressed by medical devices for diagnosing, treating or curing pediatric diseases or conditions. Comments should include a statement whether a new device may be required or if existing medical devices could be adapted for the intended use in the relevant pediatric population. If possible, include information on the disease or condition such as the number of patients who could benefit, age ranges of those patients, natural history, current diagnostic and treatment options, and current health outcomes. In addition, please provide anticipated pediatric health outcomes and, if feasible, potential economic impacts that could result if the new or applicable device were to become available.
2) Identify obstacles to developing pediatric devices and provide recommendations for overcoming them. Recommendations may include specific funding mechanisms or programs that would enhance pediatric device development (e.g. public-private partnerships) or the application of scientific resources (e.g. the use of biomarkers, extrapolation of data from adult use, and standardized outcome measures).
3) Identify any ethical issues related to device development in children, particularly in non-emergency settings, that should be addressed when planning a device development program.
4) Identify essential criteria to assess the overall public health need, priority, and commercial potential of pediatric medical devices. If possible, provide specific details on the types of desired clinical and non-clinical studies, the type and extent of data to be collected, health outcomes, projections for use, costs of scale up and manufacture, financial projections, etc. that would be relevant for a systematic evaluation to decide if a project should continue development and seek commercialization.
5) Provide input on current pediatric device regulatory requirements.
To respond by July 3, 2008, please complete and submit the form on line at: http://www.surveymonkey.com/s.aspx?sm=DcR58_2fYykOJF98twHqgxvg_3d_3d.
Questions about this request for information may be directed to:
Steven Hirschfeld, M.D., Ph.D.
Captain, U.S Public Health Service
Associate Director for Clinical Research
Eunice Kennedy Shriver
National Institute of Child Health and Human Development
31 Center Drive, Room 2A03, MSC 2425
Bethesda, MD 20814
J. Timothy Baldwin, Ph.D.
Advanced Technologies & Surgery Branch
Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
Two Rockledge Centre, Room 8206
6701 Rockledge Drive
Bethesda, MD 20892-7940
Phone: (301) 435-0513
Fax: (301) 480-1454
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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