2022 Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics |
Overview & Background
OMB # 0925-0766
Expiration Date: 4/2023
Public reporting burden for this collection of information is estimated to average 10-15 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0766). Do not return the completed form to this address.
Expiration Date: 4/2023
Public reporting burden for this collection of information is estimated to average 10-15 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0766). Do not return the completed form to this address.
This survey is closed. Please contact bpca@infinityconferences.com with questions.
OVERVIEW
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH), and the U.S. Department of Health and Human Services (HHS) invite all stakeholders, including physicians, clinicians, researchers, pediatric organizations and associations, patient representatives and other interested parties to submit nominations for pediatric research as it begins the Best Pharmaceuticals for Children Act (BPCA) annual prioritization process. NICHD is gathering nominations for a Therapeutic Area (e.g., pediatric condition, subpopulation or setting of care) that requires further study in children as well as the particular drug, biologic, or medical device that is being recommended for study in that area.
BACKGROUND
Nominations for the BPCA Priority List of Needs in Pediatric Therapeutics are solicited as a part of fulfilling NIH’s authority and responsibility to establish a program for pediatric drug testing and development as outlined in the BPCA legislation. The Priority List consists of key therapeutic needs in the medical treatment of children and adolescents; it is organized by Therapeutic Area, which can be a group of conditions, a subgroup of the population, or a setting of care. Each Priority List targets a few Therapeutic Areas for discussion and further prioritization.
For your reference, the 2020 BPCA Priority List of Needs in Pediatric Therapeutics is located on the BPCA website: https://www.nichd.nih.gov/research/supported/bpca/prioritizing-pediatric-therapies. NICHD has established a prioritization process through which all nominations will be considered and evaluated by leading pediatric experts and stakeholder representatives. The final Priority List is published in the Federal Register, and sets the agenda for NICHD’s focus on future BPCA-related activities.